Reported trial results for Psoriatic Arthritis

96 trials have reported results.

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

• NCT05071664 · results posted 23 July 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT05071664) enrolled 91 people with psoriatic arthritis — a condition involving joint inflammation and skin psoriasis. Participants were split into two groups: 59 people received a combination of two medicines (guselkumab plus golimumab), and 32 people received guselkumab plus a placebo (an inactive substitute). The trial's main goal was to measure how many people in each group reached what researchers called "Minimal Disease Activity" (MDA) at 24 weeks — a benchmark meaning a person's disease had reached a low enough level across several areas (joints, skin, pain, physical function, and tendon/ligament tenderness) to be considered well-controlled. The reported data shows that for the primary measure at 24 weeks, 28.8% of participants in the combination medicine group and 21.9% in the guselkumab-plus-placebo group reached the MDA benchmark. For the secondary measures, the reported data shows that at 24 weeks, 44.1% of the combination group and 21.9% of the placebo group met a separate joint-improvement benchmark known as ACR50 (meaning at least a 50% reduction in joint tenderness and swelling alongside other improvements). At the earlier 16-week mark, 32.2% of the combination group and 12.5% of the placebo group had reached the MDA benchmark. Among participants who had more significant skin involvement at the start, 54.5% of the combination group and 38.5% of the placebo group achieved at least a 90% reduction in a skin severity score (PASI 90) by week 24. Complete skin clearance (PASI 100) was reported in 31.8% of the combination group and 30.8% of the placebo group. A separate skin assessment showed a response in 54.5% of the combination group and 61.5% of the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03531073 · results posted 22 June 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT03531073) enrolled 446 people with psoriatic arthritis — a condition involving joint inflammation alongside psoriasis — all placed in a single "Standard Care Cohort," meaning they received their usual medical care. Of those who started, 300 completed the study and 146 did not finish. The trial was measuring two things: how active participants' psoriatic arthritis was, and how much the condition was affecting their day-to-day life. The reported data shows that for the primary measure — the Psoriatic Arthritis Disease Activity Score (PASDAS), which runs from 0 to 10 where higher numbers mean more active disease — the group's reported average score was 3.3. The study notes that a score below 3.2 is considered "low disease activity," so the reported figure sits just above that threshold. For the secondary measure — the Psoriatic Arthritis Impact of Disease questionnaire (PsAID), also scored 0 to 10 where 0 means no impact on daily life and 10 means the maximum possible impact — the reported average score was 3.0. The study notes that a score of 4 or below represents a level of symptoms patients generally find acceptable. It is worth noting that this was a single-group observational study, meaning there was no comparison group, and the results simply describe what was measured in people receiving standard care. No data on individual variation around these averages was included in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04882098 · results posted 4 February 2026

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,054 participants in total across three groups. The first group (388 people) received guselkumab injections every 8 weeks, the second group (280 people) received guselkumab every 4 weeks, and the third group (386 people) started on a placebo (an inactive treatment) before later switching to guselkumab. The trial was looking at how these treatments affected psoriatic arthritis — a condition involving joint pain and swelling linked to psoriasis. The main thing being measured was whether participants' joint swelling, tenderness, pain, and physical function improved by at least 20% after 24 weeks, using a standard scoring system called ACR 20. The reported data shows that at the 24-week mark, 68.3% of participants in the every-8-weeks guselkumab group and 66.6% in the every-4-weeks group met that 20% improvement threshold, compared with 47.0% in the placebo group. A secondary outcome looked at changes in joint damage visible on X-rays, measured using a scoring system where higher numbers indicate more structural damage (on a scale up to 528). The reported data shows average score changes of 0.54 and 0.55 for the two guselkumab groups, and 1.35 for the placebo group, after 24 weeks. Several other secondary outcomes relating to side effects and unwanted health events were listed in the trial registration, but no numbers for those outcomes were reported in the data submitted to ClinicalTrials.gov. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04108468 · results posted 2 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04108468) enrolled 84 adults with psoriatic arthritis — 41 in a group receiving methotrexate alone, and 43 in a group receiving both golimumab and methotrexate. The trial was measuring disease activity using two scoring tools across multiple time points over about a year. Of those who started, 38 in the methotrexate group and 39 in the combination group completed the study. The primary measurement used was the Psoriatic Arthritis Disease Activity Score (PASDAS) — a scale from 0 to 10 where a higher number means more disease activity. The reported data shows that at the main 24-week checkpoint, the methotrexate-only group had an average score of 3.09, while the golimumab-plus-methotrexate group had an average score of 2.70. The reported data also shows scores at other time points: at 12 weeks, scores were 3.70 and 3.01 respectively; at 36 weeks, 3.30 and 2.93; and at 52 weeks, 3.36 and 3.42. A second scoring tool (the Composite Psoriatic Disease Activity Index, a scale from 0 to 15) was also measured — at 12 weeks the scores were 4.10 and 3.49, and at 24 weeks they were 3.24 and 3.12, for the methotrexate-only and combination groups respectively. It is worth noting that the reported data shows the scores between the two groups appearing closer together by the 52-week mark than at earlier time points, though what this means clinically was not explained in the submitted results. No data on unwanted effects or other outcomes were included in what was reported to ClinicalTrials.gov for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04908202 · results posted 24 October 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04908202) looked at a medicine called deucravacitinib (taken as a 6 mg daily tablet) compared to a placebo (a dummy tablet with no active ingredient) in people with psoriatic arthritis. A total of 670 people entered the initial phase — 336 in the deucravacitinib group and 334 in the placebo group. The trial was structured in two stages: a placebo-controlled period (where neither participants nor researchers knew who was getting which tablet) and a later active-treatment period where everyone received the real medicine. The main thing being measured was how many participants showed at least a 20% improvement in joint tenderness, joint swelling, and several other disease-related scores by week 16 — a standard benchmark known as an "ACR 20 response." The reported data shows that by week 16, 54.2% of participants in the deucravacitinib group met the ACR 20 response threshold, compared with 34.1% in the placebo group. For a separate score that combines joint counts, a blood inflammation marker, and a participant self-assessment (called DAS28-CRP, rated roughly 1–9 with higher meaning more active disease), the deucravacitinib group showed an average decrease of about 1.41 points from their starting score, while the placebo group showed a decrease of about 0.89 points — in both cases, a lower score represents an improvement. On a daily-living difficulty questionnaire (HAQ-DI, scored 0–3 with lower being less difficulty), the deucravacitinib group showed an average decrease of 0.41 points versus 0.21 points in the placebo group. Among participants who also had significant skin psoriasis at the start of the trial, 51.9% in the deucravacitinib group achieved at least a 75% reduction in their skin score (PASI 75) by week 16, compared with 7.1% in the placebo group. On a general physical health quality-of-life questionnaire (SF-36 PCS, scored 0–100 with higher being better), the deucravacitinib group's average score increased by 6.41 points from baseline versus 3.85 points in the placebo group. For a measure of tenderness at specific attachment points around joints (enthesitis, scored 0–6), 48.3% of the deucravacitinib group and 46.1% of the placebo group who had this symptom at the start reached a score of zero by week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05855967 · results posted 22 August 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05855967) enrolled 250 participants in total — 150 people who had the skin condition psoriasis (PsO) without active joint involvement, and 100 people who had psoriasis alongside active psoriatic arthritis (PsA). All 250 received at least one dose of the study drug, ixekizumab, and the large majority completed the trial (141 and 94 participants respectively). The trial was measuring a range of things, including unwanted medical events that occurred during treatment, how much participants' skin improved, how doctors rated overall skin clearance, and how much joint-related disease activity improved. The reported data shows that, looking at serious unwanted medical events (SAEs) and other treatment-related events over 24 weeks, 1 participant in the main dosing group experienced a serious adverse event, while none did in the less-frequent dosing group; broader treatment-related events were reported in 60 participants in the main dosing group and 8 in the other. For the skin-only group, 86% of participants reached at least a 75% improvement in a standard skin-severity scoring tool (called PASI) by week 12, and 65.3% had their doctor rate their skin as "clear" or "minimal" on a separate five-point assessment scale. For the group with active joint disease, the reported data shows that 84% of participants met the standard threshold for meaningful joint-symptom improvement (called ACR20, meaning at least a 20% improvement across several joint and pain measures) by week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03885089 · results posted 19 June 2025

  According to the results reported on ClinicalTrials.gov, this trial involved 10 people who received an infliximab biosimilar (a medicine very similar to an already-approved treatment, made by Pfizer) given by intravenous drip. The trial was conducted in a single group — there was no comparison group. Eight of the 10 participants completed the study, and two did not finish. The trial was measuring two main things: any unwanted reactions that were linked to the medicine, and changes in the severity of participants' psoriasis (a skin condition) using standard scoring tools. The reported data shows that 2 out of 10 participants experienced an adverse drug reaction — meaning an unwanted medical event that was considered by their doctor to be related to the medicine. For the psoriasis severity scores, the trial used two standard tools. The PASI75 score measures the proportion of participants whose psoriasis improved by at least 75%, and the PASI90 measures those who improved by at least 90% — both of these were reported as 0%, meaning none of the participants met those improvement thresholds by the end of the study. For body surface area (the percentage of skin affected by psoriasis), the reported data shows a change of 30 percentage points from the start to the end of the study, though the direction of this change (whether it was an improvement or worsening) is not clearly distinguishable from the data as submitted. It is worth noting that this was a very small study with only 10 participants and no comparison group, so the reported figures reflect a very limited dataset. The reported data shows only what was measured and counted in this specific group — no broader conclusions can be drawn from these numbers alone. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04527380 · results posted 5 June 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04527380) involved 101 children and young people with Juvenile Idiopathic Arthritis (JIA) — a form of arthritis that affects children. Eighty-one participants received a medicine called ixekizumab, and 20 received a medicine called adalimumab, during what was called the "open-label treatment" (OLT) period, meaning everyone knew which medicine they were taking. The trial was measuring how many participants showed meaningful improvements in their arthritis, using a standard scoring system that looks at things like swollen joints, movement, and how the child and their parent rated their wellbeing. The reported data shows that, using the main measure (called JIA ACR30 — meaning at least a 30% improvement across several arthritis markers), 88.9% of participants in the ixekizumab group and 95.0% in the adalimumab group reached that threshold. Looking at higher levels of improvement, the reported figures for the ixekizumab and adalimumab groups respectively were: at least 50% improvement — 79% and 90%; at least 70% improvement — 64.2% and 65%; at least 90% improvement — 29.6% and 40%; and full (100%) improvement — 18.5% and 35%. For participants who also had psoriasis (a skin condition) covering at least 3% of their body, a skin severity score was also measured; the reported average change from the starting score was −3.80 points for the ixekizumab group and −0.70 points for the adalimumab group (lower scores indicate less severe skin involvement). Results for a later open-label extension period were not reported in the submitted data. It is worth noting that the two groups were quite different in size (81 versus 20 participants), so direct comparisons between them should be interpreted with care. The reported data also does not include information about side effects or safety outcomes in this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03769168 · results posted 23 May 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT03769168) involved 55 young people with Juvenile Idiopathic Arthritis (a form of arthritis that affects children and teenagers). Nineteen participants received a lower dose of a medicine called secukinumab (75 mg) and 36 received a higher dose (150 mg). Some participants later had their dose increased during the study. The trial was measuring how many participants showed improvement across six areas, including joint activity, physical function, and inflammation levels — using a scoring system called JIA ACR, which tracks whether those areas improved by set amounts (30%, 50%, 70%, 90%, or 100%) compared to the start of the study. The reported data shows that for the primary measure — whether at least three of the six areas improved by 30% or more (called a "JIA ACR 30 response") — 100% of participants in both dose groups met this threshold at most of the time points measured. For the secondary measures, the reported data shows that across the different time points, roughly 93–100% of participants across both groups met the "50% improvement" threshold, around 83–95% met the "70% improvement" threshold, around 73–84% met the "90% improvement" threshold, and approximately 54–67% met the "100% improvement" threshold. The reported data also shows that between approximately 63% and 72% of participants in the lower-dose group, and between approximately 64% and 72% in the higher-dose group, were recorded as having "inactive disease" — meaning no active joint swelling, normal inflammation markers, and minimal morning stiffness — at the various time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04908189 · results posted 13 April 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04908189) enrolled 729 people across three groups: 312 received a medicine called deucravacitinib, 312 received a placebo (a dummy treatment with no active ingredient), and 105 received another medicine called apremilast. The trial was primarily measuring how many participants in the deucravacitinib and placebo groups showed at least a 20% improvement in joint tenderness, joint swelling, and several other disease-related measures by week 16 — a standard benchmark in arthritis research known as "ACR 20." Several secondary measurements were also taken, including changes in overall disease activity, physical function, skin involvement, quality of life, and pain at the sites where tendons attach to bones (called enthesitis). The reported data shows that by week 16, 169 out of 312 participants in the deucravacitinib group and 123 out of 311 participants in the placebo group met the ACR 20 benchmark. For the secondary measures at week 16: a disease activity score (rated on a scale of 1.0 to 9.4, where lower is better) changed by minus 1.31 points in the deucravacitinib group compared with minus 0.91 points in the placebo group. A physical function questionnaire score (where lower means less difficulty) changed by minus 0.31 in the deucravacitinib group and minus 0.22 in the placebo group. For skin symptoms, 63 participants in the deucravacitinib group and 23 in the placebo group achieved at least a 75% improvement in a skin severity score. A general quality-of-life physical score (where higher means better) improved by 6.19 points in the deucravacitinib group and 4.26 points in the placebo group. Among participants who had tendon attachment pain at the start of the trial, 74 in the deucravacitinib group and 66 in the placebo group had that pain fully resolve by week 16. Results for the apremilast group were not reported for these outcome measures in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01550003 · results posted 23 October 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 193 children and young people in total, split into three groups based on body weight: 18 participants weighing 10 to under 20 kg, 63 weighing 20 to under 40 kg, and 112 weighing 40 kg or more. The trial was measuring how much of the study drug, certolizumab pegol (CZP), was present in participants' blood at certain time points, whether the body produced antibodies (proteins that can react against the drug) in response to it, and how many participants experienced serious unwanted medical events or had to stop taking the drug because of such events. It is worth noting that none of the participants were recorded as having completed the study, and all were recorded under "not completed." The reported data shows that the amount of drug measured in the blood at week 16 varied depending on both the weight group and whether participants received the original or a reduced dose. In the reduced-dose groups, blood levels were reported as approximately 1.6, 9.2, and 13.9 micrograms per millilitre (a standard unit of drug concentration) for the lightest to heaviest weight groups respectively. In the original-dose groups, the figures were approximately 22.9, 25.8, and 33.6 micrograms per millilitre. At week 48, similar patterns were seen, though the figure for the original-dose group in the lightest weight category was not reported. Regarding antibodies against the drug, at week 16 a total of 69 participants in the reduced-dose group and 77 in the original-dose group were reported to have detectable antibody levels; at week 48 those numbers were 58 and 47 respectively. The reported data also shows that across all weight groups, 46 participants in total experienced serious unwanted medical events during the study (5 in the lightest group, 20 in the middle group, and 21 in the heaviest group). Additionally, 25 participants permanently stopped taking the study drug due to unwanted medical events (0 in the lightest group, 9 in the middle group, and 16 in the heaviest group). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03895203 · results posted 23 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03895203) enrolled 852 adults with psoriatic arthritis across three groups during the first 16-week phase: 281 received a placebo (inactive treatment), 431 received bimekizumab (BKZ) at 160 mg every four weeks, and 140 received adalimumab (ADA) at 40 mg every two weeks. The trial was measuring how well these treatments reduced joint and skin symptoms of psoriatic arthritis over time, using a range of standardised scoring tools to track things like joint tenderness and swelling, skin coverage, physical function, and overall disease activity. The reported data shows that for the main outcome — the proportion of participants whose arthritis symptoms improved by at least 50% (known as an ACR50 response) by week 16 — roughly 10% of placebo participants met this threshold, compared with around 44% in the BKZ group and around 46% in the ADA group. For secondary outcomes, the reported data shows that among participants who also had significant skin psoriasis at the start, about 61% in the BKZ group and 41% in the ADA group had at least a 90% improvement in their skin score by week 16, compared with about 3% in the placebo group. On a physical function questionnaire (HAQ-DI, scored 0–3 where lower is better), scores in the BKZ group fell by about 0.26 points from the start, compared with about 0.09 points in the placebo group. On a broader quality-of-life physical score (SF-36 PCS, where higher is better), the BKZ group reported an average improvement of about 6.2 points versus about 2.3 points for placebo. Regarding a measure of low overall disease activity (Minimal Disease Activity), about 45% of both the BKZ and ADA groups met that threshold at week 16, compared with about 13% of the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03896581 · results posted 16 October 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03896581) enrolled 400 people — 133 received a placebo (an inactive dummy treatment) and 267 received a medicine called bimekizumab 160mg. The vast majority completed the trial: 125 in the placebo group and 263 in the bimekizumab group. The trial was primarily measuring what proportion of participants achieved an "ACR50 response" — meaning their joint tenderness, joint swelling, and several other arthritis-related measures all improved by at least 50% from where they started. It also looked at a range of secondary measures, including physical function in daily activities, skin psoriasis coverage, quality of life, and whether participants reached a state of very low disease activity. The reported data shows that for the main outcome at week 16, 43.4% of participants in the bimekizumab group met the ACR50 response criteria, compared with 6.8% in the placebo group. For the secondary outcomes, the reported data shows: on the daily physical function scale (HAQ-DI, scored 0–3 where lower means less difficulty), the bimekizumab group had an average change of −0.375 points from their starting score, versus −0.070 in the placebo group (a negative number indicates improvement). For participants who also had skin psoriasis covering at least 3% of their body, 68.8% in the bimekizumab group achieved a 90% or greater improvement in their psoriasis score by week 16, compared with 6.8% in the placebo group (at week 4, those figures were 26.7% versus 0%). On the general quality-of-life physical score (SF-36 physical component, 0–100 where higher is better), the bimekizumab group showed an average improvement of 7.3 points from baseline versus 1.4 points in the placebo group. Finally, 44.2% of the bimekizumab group reached a state of minimal disease activity (meaning very low scores across multiple arthritis and psoriasis measures) compared with 6.0% in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05758402 · results posted 10 October 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 368 people with moderate to severe psoriasis (a skin condition) across two groups: 181 participants in the "EARP Group," where a short questionnaire called the EARP was used to screen for psoriatic arthritis (a type of joint inflammation that can occur alongside psoriasis), and 187 participants in the "Routine Practice Group," where doctors used their own clinical judgement to decide who might have the condition. All participants completed the study with no drop-outs reported. The trial's main goal was to compare how many people in each group were correctly identified as having psoriatic arthritis, using a recognised scoring system called CASPAR as the reference standard. The reported data shows that in the EARP Group, 8 out of 181 participants were detected as having psoriatic arthritis through the questionnaire and then confirmed by the CASPAR criteria. In the Routine Practice Group, 6 out of 187 participants were detected through the doctor's judgement and confirmed by CASPAR. For the secondary measurements — which looked at how accurately each approach identified people with and without the condition — the reported data shows 8 true positives and 129 true negatives in the EARP Group, and 6 true positives and 157 true negatives in the Routine Practice Group. Across both groups combined, participants who were confirmed as having psoriatic arthritis had an average age of around 48 years, compared to roughly 44 years for those without it. Average body weight (measured as BMI, a ratio of weight to height) was reported as 25.02 for those with psoriatic arthritis and 25.76 for those without. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT05171270 · results posted 25 September 2024

  According to the results reported on ClinicalTrials.gov, this trial enrolled 503 adults with psoriatic arthritis, and all 503 completed the study. The trial was looking at how treatment decisions were made during medical consultations — specifically, how often doctors changed a patient's treatment (either stepping it up or scaling it back), and how patients felt about their condition and their interactions with their doctor. It also looked at whether a patient-reported questionnaire called the PsAID-12 — which asks people to rate how much their psoriatic arthritis affects their daily life on a scale of 0 to 10 — had any influence on the doctor's treatment decisions. The reported data shows that out of 503 participants, 160 had their treatment escalated — meaning their dose was increased, their medication was changed, or a new medication was added. By comparison, 22 participants had their treatment reduced in some way. The average PsAID-12 score (where 0 is best and 10 is worst) across the group was reported as 3.6. For patient satisfaction with their consultation, the median CollaboRATE score (0–9, where 9 is best) was 9. The median score on the PEPPI questionnaire — which measures how confident patients felt during their healthcare consultation, on a scale of 5 to 25 where higher is better — was reported as 23 out of 25. Finally, the median score for how much doctors said the PsAID-12 influenced their treatment decision was 3 out of 5, where 3 means "no impact on treatment decision" on that particular scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04209205 · results posted 26 April 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT04209205) enrolled 381 adults with psoriatic arthritis — a condition involving joint inflammation alongside the skin condition psoriasis. Around 191 people received the active drug, AIN457 (also known as secukinumab), given by intravenous drip at a starting dose of 6 mg/kg followed by 3 mg/kg, while 190 people received a placebo (an inactive dummy infusion). The trial's main goal was to measure how many participants showed a meaningful reduction in joint tenderness and swelling — plus improvements in pain, physical function, and inflammation markers — after 16 weeks. By the end of the study period, 173 people in the treatment group and 167 in the placebo group had completed the trial. The reported data shows that for the primary measure — the proportion of participants who achieved at least a 50% improvement across a set of joint and symptom scores (called an ACR50 response) — 31.35% of those in the treatment group reached this level, compared with 6.33% in the placebo group. For a lower threshold of improvement (ACR20, meaning at least 20% improvement across the same measures), the reported figures were 59.60% in the treatment group versus 29.01% in the placebo group. The reported data also shows that 22.45% of those receiving the active drug met a "minimal disease activity" standard (meaning most of their disease markers were at low levels), compared with 5.28% in the placebo group. Among participants who had more significant skin involvement at the start of the trial, 47.85% in the treatment group showed a 90% reduction in their skin score (PASI90), versus 6.46% in the placebo group. For the remaining secondary measures, the reported data shows that a composite disease activity score (PASDAS, rated 0–10 with lower being better) fell by an average of 2.24 points in the treatment group and 1.11 points in the placebo group from the start of the study. A questionnaire measuring how much difficulty participants had with daily physical tasks (HAQ-DI, scored 0–3 with lower being better) showed an average decrease of 0.39 points in the treatment group; the placebo group's average score increased slightly by 0.15 points — meaning, on average, slightly more difficulty was reported in that group by week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03747939 · results posted 5 January 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT03747939) enrolled 308 participants in its first phase — 105 received a placebo (a dummy treatment with no active ingredient) and 203 received apremilast 30 mg. The trial was measuring how many people with psoriatic arthritis reached what researchers called "minimal disease activity" — a specific threshold where joint swelling, joint tenderness, skin involvement, pain, physical function, and tendon-area tenderness all fell within very low ranges at the same time. This was the main question the trial set out to answer at the 16-week mark. The reported data shows that at 16 weeks, 33.9% of participants in the apremilast group met the minimal disease activity measure, compared with 16.0% in the placebo group. For several other measures also recorded at 16 weeks: roughly 70.2% of the apremilast group and 51.8% of the placebo group reached a low-activity or remission threshold on a combined joint-and-pain score (cDAPSA); 74.0% versus 69.0% had very few or no swollen sentinel joints; 66.2% versus 44.4% had very few or no tender sentinel joints; 30.4% versus 19.1% rated their overall disease activity as very low on a self-reported scale; and 29.4% versus 13.1% rated their joint pain as very low on a self-reported pain scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04109976 · results posted 30 November 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 214 participants in total — 107 people in each of two groups. One group used a standard safety syringe (called BKZ-SS) to inject themselves with a medicine called bimekizumab, and the other group used an auto-injector device (called BKZ-AI) to do the same. The trial was measuring whether participants could successfully give themselves the full dose using these devices, without experiencing any device-related problems serious enough to stop them continuing. Nearly all participants finished the trial — 106 out of 107 completed it in the syringe group, and all 107 completed it in the auto-injector group. The reported data shows that, at the very first injection session (baseline) and again at Week 4, 100% of participants in both groups were recorded as having successfully self-administered the complete dose without any device-related problems that would have stopped them from continuing. In other words, every single participant across both groups met the trial's definition of a "safe and effective" self-injection at both time points measured. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03926195 · results posted 1 August 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled 109 male participants — 54 taking filgotinib (a medication being studied) and 55 taking a placebo (an inactive dummy treatment). The trial was designed to measure whether filgotinib affected sperm, specifically looking at sperm concentration (how many sperm are in a sample), sperm movement, and total sperm count. The main question the trial asked was whether participants experienced a drop of 50% or more in sperm concentration after 13 weeks of treatment. The trial also included a longer extension phase running up to about three years, though fewer participants completed that stage. The reported data shows that for the main outcome at Week 13 — the proportion of participants whose sperm concentration fell by 50% or more — 13.0% of those in the filgotinib group and 7.5% in the placebo group met that threshold. For secondary outcomes at Week 13, the filgotinib group showed an average change in sperm movement (total motility) of −2.3 percentage points, compared with −1.7 percentage points in the placebo group. The average change in total sperm count was −2.1 million sperm per ejaculate in the filgotinib group, versus −9.6 million in the placebo group. At Week 26, participants were divided into further subgroups based on how their underlying condition was responding to treatment, and the reported numbers for those subgroups varied across measures; full details of those figures are included in the ClinicalTrials.gov record. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02925338 · results posted 25 January 2023

  According to the results reported on ClinicalTrials.gov, this observational study followed 1,426 people across five condition groups over two years. The groups were: Crohn's Disease (547 people), Ulcerative Colitis (230), Rheumatoid Arthritis (142), Ankylosing Spondylitis (411), and Psoriatic Arthritis (96). Most participants were adults, with a small number of children included in the Crohn's Disease and Ulcerative Colitis groups only. The study was tracking how people went while receiving Inflectra (a medicine given by infusion), looking at things like how long they stayed on the treatment without stopping it due to a lack of response or intolerance, and background information such as how long they had lived with their condition before joining the study. The reported data shows that, when measuring the percentage of participants who did not experience what the researchers called a "treatment failure" — meaning they did not permanently stop Inflectra due to poor response, intolerance, or a related death — the figures over the two-year period were: 59.2% for Crohn's Disease, 53.5% for Ulcerative Colitis, 53.5% for Rheumatoid Arthritis, 61.1% for Ankylosing Spondylitis, and 64.6% for Psoriatic Arthritis. The reported data also shows that participants had typically been living with their condition for many years before joining the study — for example, an average of around 10 years for Crohn's Disease and around 15 years for Rheumatoid Arthritis. Pre-treatment check-lists (to confirm eligibility before starting Inflectra) were completed for the large majority of participants across all groups. The reported data also shows that a notable proportion of participants did not complete the full two-year study period — for instance, 226 out of 547 in the Crohn's Disease group and 160 out of 411 in the Ankylosing Spondylitis group did not finish. Reasons for some participants stopping a previous biological medicine (before joining this study) were also recorded, though the breakdown across all categories was not fully reported in the available data for every group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01421069 · results posted 14 November 2022

  According to the results reported on ClinicalTrials.gov, this trial involved 127 participants in the initial (parent) study phase, all of whom received the medication etanercept. Of those, 119 completed that phase. The study then continued into an extension phase, where 109 participants went on to take part, with 84 ultimately completing the extension. The trial was designed to track and record certain medical events — specifically cancers, serious medical events, and infections — that occurred in participants over the course of both the parent and extension study periods. The reported data shows that across both the parent and extension studies combined, 1 participant was reported to have had a malignancy (cancer). When it came to serious adverse events — meaning significant medical occurrences such as hospitalisation, life-threatening situations, or lasting disability — 45 participants were reported to have experienced one. The reported data shows that 14 participants experienced serious infections (defined as life-threatening, disabling, or requiring hospitalisation with intravenous antibiotics), and 12 participants had what were termed "medically important infections" (requiring intravenous or intramuscular anti-infective treatment and/or hospitalisation). In total, 111 participants were reported to have had any infection of any kind across both study periods. For the extension study period specifically, the reported data shows 67 participants experienced treatment-related infections and 6 experienced injection site reactions. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03773978 · results posted 7 October 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03773978) looked at baricitinib, a tablet medicine, in children and young people with juvenile idiopathic arthritis (JIA) — a form of arthritis that affects children. The trial had two main stages. In the first stage, 220 participants all received baricitinib, to check how their bodies handled the medicine and to allow their disease to settle. In the second, "double-blind withdrawal" stage, 82 participants continued on baricitinib and 81 were switched to a placebo (a dummy tablet with no active medicine), without anyone knowing which they were receiving. The main thing being measured was how long it took for a participant's arthritis to "flare" — meaning their symptoms meaningfully worsened — once they were in that second stage. The reported data shows that for the primary outcome (time to disease flare), a result was only reported for the placebo group: the median time to flare was approximately 27 weeks (about 6 months). A corresponding number for the baricitinib group was listed as "not available" in the submitted data, meaning a comparable figure for that group was not reported in the structured results. For the secondary outcomes, researchers tracked the percentage of participants whose symptoms improved by at least 30%, 50%, 70%, 90%, or 100% across six standard measures of disease activity (such as number of swollen joints, doctor's assessment, and parent's assessment of the child's wellbeing). The reported data shows that across multiple time points during the open-label first stage, between roughly 73% and 93% of baricitinib-treated participants met the 30%-improvement threshold, between about 68% and 82% met the 50%-improvement threshold, between about 55% and 68% met the 70%-improvement threshold, between about 29% and 44% met the 90%-improvement threshold, and between about 15% and 29% met the 100%-improvement threshold. In the double-blind second stage, the placebo group generally showed lower percentages across all these thresholds compared to the baricitinib group at the same time points, though specific time-point breakdowns for that stage were not separately labelled in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03031782 · results posted 15 August 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03031782) studied a medicine called AIN457 (also known as secukinumab) in children and young people with two forms of juvenile idiopathic arthritis — a type of long-term joint condition in children. The trial ran in up to three treatment periods. In the first period, 86 participants started and 83 finished. In the second period, 75 participants were split between the active medicine and a dummy treatment (placebo), and in the third period, 11 participants received the active medicine. The trial measured things like disease flare-ups, joint activity scores, and how much participants' symptoms changed over time. The reported data shows that for the main outcome — how many participants had a disease flare-up during the second treatment period — 10 out of 37 participants receiving AIN457 experienced a flare, compared with 21 out of 38 participants who received the placebo (dummy treatment). For the secondary outcomes measured during the first treatment period, the reported data shows that 90.4% of all participants on AIN457 met the threshold for at least a 30% improvement on a standard arthritis response scale, 86.7% met the 50% improvement threshold, 69.9% met the 70% threshold, 39.8% met the 90% threshold, and 25.3% met the 100% threshold. Scores measuring joint activity and physical function also showed reported reductions from the starting point, ranging from approximately 53% to 79% improvement across different measures, with a smaller reported median reduction of around 14% in a blood marker of inflammation (C-reactive protein). The reported data also shows reductions in two composite disease activity scores (tools that combine several measurements into a single number) during the first treatment period: one score reduced by approximately 10.5 points and another by approximately 13.4 points from their starting values. Results for some subgroups and time points were reported separately for the two arthritis types included in the trial. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04115748 · results posted 16 May 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04115748) enrolled 67 people across four groups during the main 16-week study: 19 received filgotinib 200 mg, 19 received filgotinib 100 mg, 9 received adalimumab 40 mg, and 20 received a placebo (a dummy treatment with no active ingredient). A smaller long-term extension then followed participants who completed the main study through to week 50, though none completed that extension phase. The trial was measuring various aspects of psoriatic arthritis disease activity, including joint tenderness and swelling, skin involvement, and participants' own assessments of pain and function. The reported data shows that for the main outcome — the proportion of participants whose joint and disease activity scores improved by at least 20% by week 12 — the figures were: 76.8% in the filgotinib 200 mg group, 63.2% in the filgotinib 100 mg group, 67.2% in the adalimumab group, and 44.8% in the placebo group. For the secondary measures, the reported data shows reductions over 16 weeks in several composite disease activity scores across all groups. For example, on one composite score (PASDAS, rated 0–10 where lower is better), average reductions of around 2.5 points were reported for filgotinib 200 mg and adalimumab, around 2.0 for filgotinib 100 mg, and around 1.0 for placebo. The proportion of participants reaching a "minimal disease activity" threshold by week 16 was reported as approximately 44% for filgotinib 200 mg, 47% for filgotinib 100 mg, 38% for adalimumab, and 16% for placebo. It is worth noting that this trial had a relatively small number of participants and a large proportion did not complete the main study phase, which the data does not fully explain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03410992 · results posted 4 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03410992) enrolled 435 people with moderate to severe plaque psoriasis — 86 received a placebo (a dummy treatment with no active ingredient) and 349 received bimekizumab 320 mg given every four weeks. The trial was primarily measuring how many participants showed a large improvement in their psoriasis by week 16, using two standard skin-scoring tools: one called PASI (which rates the redness, thickness, and scaling of psoriasis patches across the body) and another called IGA (where a doctor rates overall severity on a scale from "clear" to "severe"). A PASI90 response meant at least a 90% reduction in the skin score from the start of the trial. According to the results reported on ClinicalTrials.gov, at week 16, 90.8% of participants in the bimekizumab group met the PASI90 threshold, compared with 1.2% in the placebo group. For the doctor's overall rating (IGA), 92.6% of the bimekizumab group were rated "clear" or "almost clear" with at least a two-category improvement, compared with 1.2% in the placebo group. The reported data also shows secondary results at week 16: complete skin clearance by the PASI score (PASI100) was reported in 68.2% of the bimekizumab group versus 1.2% placebo; a "completely clear" IGA rating was reported in 69.6% versus 1.2%; and at the earlier four-week mark, a 75% improvement in the PASI score was reported in 75.9% of the bimekizumab group versus 1.2% placebo. The reported data shows the trial also tracked a patient-reported pain score using a daily diary rated from 0 (no pain) to 10 (very severe pain), though the full numerical results for some secondary measures were truncated in the available data and could not be fully reported here. The trial included additional phases where some participants who had not improved by week 16 were offered what is called "escape treatment" (open-label bimekizumab), and others were re-randomised to different dosing schedules out to week 56; however, the full results for those later phases are not detailed in the data provided. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03671148 · results posted 2 March 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03671148) enrolled 444 people in total — 220 in the placebo group and 224 in the risankizumab group — all of whom had psoriatic arthritis (a condition involving joint inflammation alongside the skin condition psoriasis). The trial's main goal was to measure how many participants showed a meaningful improvement in their joint symptoms after 24 weeks, using a standard checklist called the ACR20, which looks at tender joints, swollen joints, pain, physical function, and inflammation markers. The reported data shows that at the 24-week mark, 51.3% of participants in the risankizumab group met the ACR20 improvement threshold, compared with 26.5% in the placebo group. For the secondary measurements: at week 16, the ACR20 response was reported as 48.3% (risankizumab) versus 25.3% (placebo). For skin involvement — measured by a psoriasis scoring tool called PASI 90, which looks at a 90% or greater reduction in skin lesion severity — 55.0% of the risankizumab group and 10.2% of the placebo group reached that level at week 24. A broader measure of disease control called Minimal Disease Activity was reached by 25.6% of the risankizumab group and 11.4% of the placebo group. The reported data also shows changes in two self-reported questionnaire scores at week 24. On the HAQ-DI (a scale from 0 to 3 measuring everyday physical difficulty, where lower is better), scores changed by −0.22 in the risankizumab group and −0.05 in the placebo group from the start of the trial. On the SF-36 Physical Component Summary (a quality-of-life scale from 0 to 100, where higher is better), scores increased by 5.87 in the risankizumab group and 2.01 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03675308 · results posted 24 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03675308) enrolled 964 people — 481 in the placebo group and 483 in the risankizumab group. The vast majority completed the study (467 and 473 respectively). The trial was measuring outcomes in people with psoriatic arthritis, a condition involving joint inflammation and skin psoriasis. The main thing researchers were tracking at 24 weeks was whether participants reached a standardised level of joint improvement, known as an "ACR20 response" — meaning at least a 20% improvement in tender joints, swollen joints, and several other measures of disease activity assessed by both doctors and patients. The reported data shows that at the 24-week mark, 57.3% of participants in the risankizumab group met the ACR20 joint improvement threshold, compared with 33.5% in the placebo group. A similar pattern was reported at 16 weeks (56.3% versus 33.4%). For the skin-related measure (PASI 90 — at least a 90% reduction in the area and severity of psoriasis), the reported figures were 52.3% for risankizumab and 9.9% for placebo. Regarding "minimal disease activity" — a state where most signs of the disease are at very low levels — 25.0% of the risankizumab group and 10.2% of the placebo group met that threshold at week 24. The reported data also shows changes in disability and nail psoriasis scores. On the disability questionnaire (scored 0–3, where lower is better), the risankizumab group showed an average change of −0.31 from their starting score, compared with −0.11 in the placebo group — with a negative number indicating improvement. For nail psoriasis severity (scored 0–130, lower being better), the average change was −9.76 in the risankizumab group versus −5.57 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03370133 · results posted 3 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03370133) involved people with psoriasis and compared three options: a placebo (inactive treatment), bimekizumab (320 mg every four weeks), and ustekinumab. A total of 567 people entered the first phase of the trial — 83 received placebo, 321 received bimekizumab, and 163 received ustekinumab. The trial was primarily measuring two things at the 16-week mark: how many participants achieved at least a 90% reduction in their skin disease score (using a detailed scoring system called PASI, which rates the redness, thickness, scaliness, and area of affected skin), and how many were rated as "clear" or "almost clear" by a clinician using a separate five-point scale (called the IGA). The reported data shows that at 16 weeks, around 85% of participants in the bimekizumab group met the 90%-or-more skin score improvement threshold (PASI90), compared with approximately 50% in the ustekinumab group and about 5% in the placebo group. For the clinician-rated "clear or almost clear" measure, the reported figures were roughly 84% for bimekizumab, 53% for ustekinumab, and 5% for placebo. For the secondary outcomes, the reported data shows that complete skin clearance (100% improvement in the skin score, PASI100) at 16 weeks was recorded for about 59% of the bimekizumab group, 21% of the ustekinumab group, and 0% of the placebo group. A patient-reported pain score (measured daily on a 0–10 scale) showed a meaningful improvement in approximately 77% of bimekizumab participants, 68% of ustekinumab participants, and 17% of placebo participants at week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03104374 · results posted 25 January 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03104374) enrolled 642 adults across four groups to study the drug upadacitinib in people with psoriatic arthritis. Two groups received upadacitinib from the start — either a 15 mg or 30 mg daily dose — while two groups started on a placebo (an inactive dummy treatment) before later switching to upadacitinib. The trial ran in two periods, and the main thing it was measuring was how many participants showed at least a 20% improvement in joint tenderness, joint swelling, and several other disease markers by week 12 — a standard benchmark in arthritis research known as an "ACR20 response." The reported data shows that at week 12, around 24% of participants in the placebo group met that improvement benchmark, compared with approximately 57% in the 15 mg upadacitinib group and 64% in the 30 mg group. For the secondary measures, the reported data shows that scores on a standard disability questionnaire (where a lower score means less difficulty with daily tasks) improved by an average of 0.10 points in the placebo group, 0.30 points in the 15 mg group, and 0.41 points in the 30 mg group at week 12. For skin psoriasis specifically, the reported data shows that by week 16, roughly 9% of placebo participants, 37% of 15 mg participants, and 40% of 30 mg participants had their skin largely clear or almost clear according to a doctor's assessment. Fatigue and general physical wellbeing scores also showed reported numerical differences between groups, with the upadacitinib groups recording larger average improvements than the placebo group on both measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03104400 · results posted 25 January 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03104400) looked at people with psoriatic arthritis — a condition involving joint inflammation and skin symptoms. In the first phase of the trial (up to about one year), 1,705 participants were enrolled across five groups: one receiving a placebo (dummy treatment), one receiving adalimumab (an existing medicine), and three receiving different doses or schedules of upadacitinib (the medicine being studied). A second, longer phase ran from about one year to five years, with 1,464 participants continuing. The trial measured several things, including how much joint tenderness and swelling improved, how well participants could perform daily tasks, the severity of skin psoriasis, and any changes in joint damage visible on X-rays. The reported data shows that for the main outcome — the proportion of participants whose joint tenderness, swelling, and overall disease activity improved by at least 20% by week 12 — 36.2% of the placebo group reached this threshold, compared with 65.0% in the adalimumab group, 70.6% in the upadacitinib 15 mg group, and 78.5% in the upadacitinib 30 mg group. For everyday physical function (measured on a 0–3 scale where lower scores mean less difficulty), the reported average improvement from the starting point at week 12 was −0.14 for the placebo group, −0.34 for adalimumab, −0.42 for upadacitinib 15 mg, and −0.47 for upadacitinib 30 mg. Regarding skin psoriasis at week 16, the proportion of participants whose skin was rated "clear" or "almost clear" with a meaningful improvement was 10.9% (placebo), 38.5% (adalimumab), 41.9% (upadacitinib 15 mg), and 54.0% (upadacitinib 30 mg). The reported data also shows that at week 16, the proportion achieving at least a 75% reduction in psoriasis severity score was 21.3% (placebo), 53.1% (adalimumab), 62.6% (upadacitinib 15 mg), and 62.4% (upadacitinib 30 mg). By week 24, the change in a score measuring structural joint damage on X-rays (where a negative number suggests less damage) was +0.25 for placebo, +0.01 for adalimumab, −0.04 for upadacitinib 15 mg, and +0.03 for upadacitinib 30 mg — all changes were very small. Also at week 24, the proportion of participants meeting a broad "minimal disease activity" standard (covering joints, skin, pain, and function) was 12.3% (placebo), 33.3% (adalimumab), 36.6% (upadacitinib 15 mg), and 45.4% (upadacitinib 30 mg). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02662985 · results posted 7 December 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02662985) enrolled 166 people across two groups — 83 received secukinumab (a medication given at 150 mg or 300 mg doses) and 83 received a placebo (an inactive treatment) to start with. The trial was measuring joint inflammation using specialised ultrasound scanning, as well as broader markers of disease activity. It ran across three periods, including a longer extension phase, and the large majority of participants completed all stages. The reported data shows the following for the main measure — a joint inflammation score (called GLOESS, rated on a scale of 0 to 144, where higher numbers mean more inflammation detected on ultrasound). At 12 weeks, the secukinumab group's score changed by an adjusted average of −9.05 points, while the placebo group's score changed by an adjusted average of −5.86 points — meaning both groups showed a reduction, with the secukinumab group showing a larger reduction on average. For the secondary measures, 56 out of 83 participants in the secukinumab group met the threshold for at least 20% improvement across joint counts and other disease markers (called ACR-20), compared with 26 out of 83 in the placebo group. For a more stringent 50% improvement benchmark (ACR-50), 38 secukinumab participants and 7 placebo participants met that threshold. A separate inflammation scoring system (SPARCC, scored 0–16) also showed average reductions in both groups: −2.23 in the secukinumab group and −1.57 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT04428502 · results posted 14 September 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT04428502) enrolled 127 people with psoriatic arthritis — a condition involving joint inflammation linked to psoriasis — who were all treated with a medicine called etanercept. Of those 127 participants, 113 completed the study, while 14 did not finish. The trial was looking at disease activity over time, and in particular whether results differed between two groups: those who tested positive for a certain antibody called anti-cyclic citrullinated peptide (ACCP-positive) and those who tested negative (ACCP-negative). The main things the trial set out to measure — changes in a joint disease activity score called DAPSA at one month and twelve months — were not reported in the data submitted to ClinicalTrials.gov, so those figures are not available. However, the reported data shows a secondary measure called the DAS28 ESR score, which is another way of rating how active joint disease is on a numbered scale (scores above 3.2 suggest moderate to high disease activity). At month one, the ACCP-positive group had an average score of 4.2 and the ACCP-negative group had 4.1. At month six, those figures were 4.06 and 3.35 respectively. By month twelve, the reported data shows the scores had moved to 3.34 for the ACCP-positive group and 2.66 for the ACCP-negative group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03963401 · results posted 4 August 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03963401) enrolled 219 adults with rheumatoid arthritis across six groups. Participants were assigned to receive either a placebo or one of three daily doses of an investigational medicine called PF-06700841 (10 mg, 30 mg, or 60 mg) for the first 16 weeks. After that initial period, those on placebo or the lowest dose were switched to a higher dose, and the trial continued for a further 36 weeks — 52 weeks in total. The trial was primarily measuring how many participants reached a standard rheumatoid arthritis improvement benchmark (called ACR20), which requires at least a 20% improvement across several measures of joint pain, swelling, and overall disease activity. The reported data shows that at Week 16, around 43% of participants in the placebo group met the ACR20 benchmark, compared with approximately 65% in the 10 mg group, 67% in the 30 mg group, and 75% in the 60 mg group. A similar pattern was reported in a subgroup of participants who had not previously tried a particular class of medicines (TNF inhibitors). For a stricter benchmark — at least 50% improvement (ACR50) — the reported figures at two early time points ranged roughly from 1% to 17% across the different groups. For an even stricter 70% improvement benchmark (ACR70), reported figures at those same early time points ranged from approximately 1% to 5%. The reported data also shows reductions in the number of tender or painful joints across all groups over the course of the trial, with the numbers varying by dose and time point; a negative change indicates fewer painful joints than at the start. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01169844 · results posted 27 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01169844) enrolled 28 participants in total — 19 in the group that received the study drug AIN457 (also known as secukinumab) throughout the whole trial, and 9 in a group that started on a placebo before later switching to AIN457. The trial was measuring how often participants experienced adverse events (unwanted health changes or symptoms during the study) and serious adverse events (severe health events such as those requiring hospitalisation or that were life-threatening), as well as tracking levels of the drug in participants' blood over time. The reported data shows that, of those who received AIN457 from the start, 5 out of 19 participants experienced adverse events, while 2 out of 9 participants in the placebo-then-AIN457 group experienced adverse events. No serious adverse events were reported in either group. Regarding drug levels in the blood, the reported data shows various concentration figures measured at steady state (the point where the drug level in the body has stabilised). For example, one set of measurements recorded average drug concentrations of 80.0 micrograms per millilitre (µg/mL) in the AIN457-from-the-start group and 68.8 µg/mL in the placebo-then-AIN457 group, with other timepoint readings also provided. A planned measurement of a protein called IL-17 in the blood was not reported due to limitations with the testing method used. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02980692 · results posted 19 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02980692) enrolled a total of 391 participants across five groups — four groups receiving different doses of a study treatment called SUNPG1623, and one group receiving a placebo (an inactive treatment). The trial was looking at people with what appears to be psoriatic arthritis, a condition affecting the joints. The main thing being measured was how many participants showed at least a 20% improvement in joint tenderness and swelling, along with improvements in several other assessments — a standard measure known as the "ACR20 response." The trial had two phases: a controlled period where some participants received the study drug and others received placebo, followed by a follow-up period. The reported data shows that during the first (placebo-controlled) phase, the proportion of participants reaching the ACR20 response was approximately 79% in Dose Group I, 77% in Dose Group II, 71% in Dose Group III, and 73% in Dose Group IV. In the placebo group, the reported proportion was approximately 51%. During the follow-up period, the reported proportions reaching this same measure were higher across all groups — ranging from around 81% to 93% across the four treatment dose groups, and approximately 81% among participants who had previously been in the placebo group and were moved to one of the treatment doses. The reported data also shows changes in the number of tender joints over time, with all groups showing a reduction in tender joint counts from their starting point, though the data provided for some of the secondary measures appeared incomplete and not all timepoint figures were fully reported. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03881059 · results posted 17 May 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03881059) enrolled 203 adults across three groups: 66 received a placebo (dummy treatment), 70 received a lower dose of BMS-986165 (6 mg), and 67 received a higher dose (12 mg). The trial was studying psoriatic arthritis — a condition involving joint pain and skin involvement — and measured how participants responded over 16 weeks across a range of joint, skin, pain, and daily-functioning measures. The trial had two parts; in Part B, most placebo participants were switched to another medicine called ustekinumab, while some participants in the BMS-986165 groups continued on the same treatment. The reported data shows that for the main outcome — the proportion of people whose joint symptoms improved by at least 20% (a standard benchmark called ACR20) — 31.8% of the placebo group, 52.9% of the 6 mg group, and 62.7% of the 12 mg group reached that threshold at Week 16. For a higher bar of 50% joint improvement (ACR50), the reported figures were 10.6%, 24.3%, and 32.8% respectively, and for 70% improvement (ACR70), they were 1.5%, 14.3%, and 19.4%. For skin involvement, the proportion of people whose skin scores improved by at least 75% (PASI75) was reported as 20.4% for placebo, 42.4% for the 6 mg group, and 59.6% for the 12 mg group. The reported data also shows changes in everyday physical functioning and quality of life. On the HAQ-DI scale (0–3, where lower means less difficulty with daily tasks), the average change from the start of the trial was −0.11 for placebo, −0.37 for the 6 mg group, and −0.39 for the 12 mg group. On the SF-36 physical health summary (0–100, where higher means better health), the average change was 2.3 for placebo, 5.6 for the 6 mg group, and 5.8 for the 12 mg group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02798211 · results posted 28 January 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02798211) looked at a medicine called secukinumab in people with psoriatic arthritis — a condition that causes joint pain and swelling alongside a skin condition. The trial compared two doses of secukinumab (300 mg and 150 mg) against a placebo (a dummy treatment with no active ingredient). In the first part of the trial, 103 people were in the 300 mg group, 103 in the 150 mg group, and 52 in the placebo group. The main thing being measured was how many people reached a standard improvement benchmark — called ACR20 — meaning their joint tenderness, swelling, and several other measures improved by at least 20% by week 16. The reported data shows that by week 16, around 51% of people in the 300 mg group, 37% in the 150 mg group, and 23% in the placebo group met the ACR20 improvement benchmark. For a stricter version of this benchmark (at least 50% improvement, called ACR50), the reported figures were approximately 28% in the 300 mg group, 24% in the 150 mg group, and 6% in the placebo group. The trial also looked at two specific features of psoriatic arthritis: dactylitis (painful swelling of the fingers or toes) and enthesitis (inflammation where tendons or ligaments attach to bone). The reported data shows that at week 16, among those who had dactylitis at the start, around 53% of the 300 mg group, 44% of the 150 mg group, and 65% of the placebo group still had dactylitis. For enthesitis, using one measurement scale, around 64% of the 300 mg group, 58% of the 150 mg group, and 77% of the placebo group still had the condition at week 16. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02745080 · results posted 27 January 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT02745080) enrolled 853 adults with psoriatic arthritis — 426 assigned to receive secukinumab (300 mg injected under the skin) and 427 assigned to receive adalimumab (40 mg injected under the skin). The trial ran as a head-to-head comparison of the two treatments, with neither group taking additional disease-modifying medicines. The main thing being measured was how many participants in each group showed at least a 20% improvement in joint-related signs and symptoms (called an ACR20 response) at 52 weeks, while staying on their assigned treatment the whole time without needing extra medicines. By the end of the study, 371 participants in the secukinumab group and 338 in the adalimumab group had completed it. The reported data shows that, for the main outcome at week 52, 67.4% of participants in the secukinumab group and 61.5% in the adalimumab group met the ACR20 response criteria. For the secondary outcomes: a skin-severity score called PASI-90 (meaning at least a 90% improvement in skin symptoms) was reached by 65.4% in the secukinumab group compared with 43.2% in the adalimumab group. A stricter joint measure — ACR50, meaning at least 50% improvement — was recorded in 49.0% of the secukinumab group and 44.8% of the adalimumab group. A questionnaire measuring everyday physical functioning (HAQ-DI, scored 0–3, where lower is better) showed an average improvement of −0.58 in the secukinumab group and −0.56 in the adalimumab group from the start of the trial. Finally, among participants who had tendon or ligament inflammation at the start, 60.5% in the secukinumab group and 54.2% in the adalimumab group had no recorded signs of it at week 52. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02969525 · results posted 25 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02969525) enrolled 206 participants across five groups in its first phase: 42 received a placebo (a dummy treatment with no active ingredient), and the remaining 164 received one of four different doses of the investigational medicine bimekizumab (BKZ) — 16 mg, 160 mg, 160 mg with a loading dose, or 320 mg. The trial was measuring how participants with psoriatic arthritis responded to different doses of BKZ over 12 weeks, using a set of standardised joint and symptom scoring tools. After the initial 12-week phase, participants continued into a second phase where doses were adjusted, with roughly 199 people starting that stage. The reported data shows that the main result being tracked was the proportion of participants whose joint symptoms improved by at least 50% by week 12 — a benchmark known as ACR50. In the placebo group, 7.1% of participants reached that level of improvement, compared with 26.8% in the 16 mg group, 41.5% in the 160 mg group, 46.3% in the 160 mg loading-dose group, and 24.4% in the 320 mg group. The reported data also shows results for a less strict measure (20% improvement, or ACR20): placebo 19.0%, 16 mg 53.7%, 160 mg 73.2%, 160 mg loading dose 61.0%, and 320 mg 51.2%. For participants who also had skin psoriasis covering at least 3% of their body, separate skin-scoring results were reported; for example, the proportion achieving a 75% improvement in their skin score at week 12 ranged from 10.0% in the placebo group to as high as 72.7% in the 320 mg group. The proportion of participants who experienced at least one adverse event (any unwanted medical occurrence during the study) was also recorded: 57.1% in the placebo group (up to week 12) and between 33.3% and 74.6% across the BKZ dose groups over their respective follow-up periods. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02814175 · results posted 23 November 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02814175) looked at psoriatic arthritis — a condition affecting the joints and skin. It ran in two parts. In Part 1, 122 people were assigned to receive an escalating dose of methotrexate (a medicine commonly used for arthritis) and 123 people received a combination of methotrexate plus adalimumab (a biological medicine given by injection). Part 2 involved a further 227 participants spread across four different groups, which examined various combinations and adjustments of these treatments. The trial was measuring things like joint activity, skin impact, pain, and overall quality of life. The reported data shows that for the main (primary) outcome in Part 1 — the proportion of people reaching a state called "minimal disease activity" (meaning at least 5 out of 7 markers of disease were at a low level) — 13.1% of those in the methotrexate-only group and 41.5% of those in the combination group reached that point. For the secondary outcomes, the reported data shows that skin-related quality of life scores (rated 0–30, where lower is better) fell by 3.1 points in the methotrexate group and 5.9 points in the combination group from where they started. A standard joint disease activity score (rated 0–10, lower is better) dropped by 0.9 and 2.0 points respectively, and a patient-reported impact score (also 0–10, lower is better) dropped by 1.7 and 3.3 points. A count of painful swollen fingers and toes (in those who had this at the start) fell by 0.9 and 2.8 respectively. Using another standard measure of joint improvement (ACR scores), the reported data shows that 32.8% versus 67.5% of participants achieved a 20% improvement level, 16.4% versus 45.5% achieved a 50% improvement level, and 8.2% versus 30.9% achieved a 70% improvement level. Outcome data for Part 2 groups was not reported in the submitted results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02319759 · results posted 14 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02319759) looked at a medicine called guselkumab in people with psoriatic arthritis — a condition involving joint inflammation and skin psoriasis. The trial started with 49 people in a placebo group (an inactive dummy treatment) and 100 people in the guselkumab group. Participants were tracked across several stages up to 56 weeks, with some later switching between treatments. The main thing being measured at week 24 was whether participants reached a standard joint-improvement benchmark known as an "ACR 20 response" — meaning their swollen and tender joint counts, plus several other measures like pain scores and physical function, had each improved by at least 20% from the start of the trial. The reported data shows that at week 24, around 58% of participants in the guselkumab group met the ACR 20 benchmark, compared with around 18% of those in the placebo group. For the secondary measures, the reported data shows that 78.6% of guselkumab participants with skin psoriasis reached the PASI-75 skin improvement benchmark (at least a 75% reduction in a standard psoriasis severity score), compared with 12.5% of the placebo group. The reported data also shows that physical function scores (measured on a scale where lower numbers mean less difficulty) changed by an average of −0.42 in the guselkumab group and −0.06 in the placebo group — a negative number meaning less difficulty reported. For participants who had tendon or ligament pain at specific sites (called enthesitis), the reported data shows a 100% average reduction in that pain score in the guselkumab group, versus a 33.33% average reduction in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03162796 · results posted 14 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT03162796) enrolled 381 adults with psoriatic arthritis across three groups: 126 received a placebo (a dummy treatment with no active ingredient), 127 received guselkumab every 8 weeks, and 128 received guselkumab every 4 weeks. The trial ran in stages over about 60 weeks, with the main comparison between the groups happening over the first 24 weeks. The primary thing the trial was measuring was how many participants in each group achieved a meaningful improvement in joint swelling, joint tenderness, pain, physical function, and other arthritis markers — a standard benchmark called an ACR 20 response, meaning at least a 20% improvement across those areas. The reported data shows that at week 24, 22.2% of participants in the placebo group met that ACR 20 benchmark, compared with 52.0% in the every-8-weeks guselkumab group and 59.4% in the every-4-weeks group. For a higher level of improvement (ACR 50, meaning at least 50% improvement across the same measures), the reported figures were 8.7% for placebo, 29.9% for the every-8-weeks group, and 35.9% for the every-4-weeks group. Among participants who also had significant psoriasis skin involvement at the start, 15.4% in the placebo group showed a meaningful skin improvement by week 24, compared with 57.3% and 75.3% in the two guselkumab groups respectively. The reported data also shows changes in physical function scores and a standard disease activity score (DAS28-CRP, a combined measure of joint counts and a blood marker of inflammation scored from 0 to 10); all three groups showed some average reduction from their starting scores, with the guselkumab groups showing larger average reductions than the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01516957 · results posted 27 August 2020

  According to the results reported on ClinicalTrials.gov, this trial tested a medicine called AMG 827 (given by injection under the skin) in people with psoriatic arthritis — a condition that causes joint pain and swelling linked to the skin condition psoriasis. During the main, placebo-controlled part of the trial, 55 people received a dummy (placebo) injection, 57 received AMG 827 at a lower dose (140 mg), and 56 received it at a higher dose (280 mg). A second, open-label phase (where everyone knew what was being given) then started with 156 participants, though none were recorded as having completed that phase. The trial's main goal was to measure how many people showed at least a 20% improvement in joint symptoms — including tender and swollen joint counts, doctor's and patient's overall ratings of disease activity — after 12 weeks. The reported data shows that, for the primary measure at 12 weeks, 19.2% of participants in the placebo group met the 20% improvement threshold, compared with 39.6% in the 140 mg group and 44.0% in the 280 mg group. For a tougher 50% improvement target, the figures were 3.8% (placebo), 15.1% (140 mg), and 15.7% (280 mg). For an even higher 70% improvement target, 0% of the placebo group reached it, compared with 5.7% (140 mg) and 5.9% (280 mg). The reported data also shows changes in two composite disease-activity scores after 12 weeks: on the CDAI scale (where a reduction of 6.5 is considered a moderate improvement), the placebo group's score fell by an average of 3.96 points, while the 140 mg and 280 mg groups fell by 11.32 and 11.25 points respectively. On the DAS28 scale (where scores above 5.1 suggest active disease), average reductions were 0.42 points for placebo, 1.17 points for 140 mg, and 1.06 points for 280 mg. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01818804 · results posted 9 June 2020

  According to the results reported on ClinicalTrials.gov, this trial involved 145 people in total — 73 assigned to take omega-3 fatty acid supplements (n-3PUFA) and 72 assigned to take olive oil as a comparison. Most participants finished the trial: 68 in the omega-3 group and 65 in the olive oil group. The trial was measuring changes in two heart-related readings — heart rate variability (a measure of how the nervous system controls the heart's rhythm, which is linked to cardiovascular health) and pulse wave velocity (a measure of artery stiffness) — as well as changes in rheumatoid arthritis disease activity using a scoring system called DAS28. The reported data shows the following changes over the course of the trial. For heart rate variability, the omega-3 group showed a change of +13.38 milliseconds, while the olive oil group showed a change of −13.48 milliseconds. For pulse wave velocity (artery stiffness), the omega-3 group showed a change of +0.01 metres per second and the olive oil group showed a change of +0.08 metres per second. For the DAS28 disease activity score — where lower numbers suggest less active disease — the omega-3 group showed a change of −0.22 units and the olive oil group showed a change of −0.05 units. These are the changes from the start to the end of the study as recorded for each group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01976364 · results posted 21 May 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT01976364) looked at tofacitinib, a medicine used for psoriatic arthritis. It had two parts: a main study over 36 months, in which 686 people took part (465 completed it), and a smaller sub-study over 12 months, in which 179 people took part — 89 taking tofacitinib together with methotrexate (another arthritis medicine), and 90 taking tofacitinib together with a placebo (a dummy medicine with no active ingredient). The trial was primarily measuring undesirable medical events that occurred during treatment, as well as changes in participants' ability to carry out daily activities and overall disease activity scores. The reported data shows that, across all participants in the main study, 83.7% experienced at least one adverse event (an unwanted medical occurrence during the study period), and 16.8% experienced a serious adverse event — meaning one that led to hospitalisation, was life-threatening, caused lasting disability, or was otherwise considered significant. In terms of how severe those events were, the trial recorded 1,632 mild events (ones that did not interfere much with daily life), 1,045 moderate events, and 136 severe events. The reported data also shows that 646 participants had abnormal results on blood or urine tests, while 9 participants had a change in their lab results that was considered clinically significant (that is, meaningful enough to be worth noting) by the study doctors. For the sub-study, the reported data shows small changes in two scores used to measure how participants were faring day-to-day. On the HAQ-DI scale — which measures how difficult everyday tasks like dressing, walking, and eating feel, scored from 0 (no difficulty) to 3 (extreme difficulty) — the average change from the start of the study to month 6 was 0.017 in the tofacitinib-plus-methotrexate group and 0.043 in the tofacitinib-plus-placebo group. On the PASDAS scale — a combined disease activity score ranging from 0 to 10, where higher means more severe — the average change was 0.138 in the tofacitinib-plus-methotrexate group and 0.229 in the tofacitinib-plus-placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01752634 · results posted 13 May 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT01752634) enrolled 397 adults in total across six groups, testing three different doses of an injectable medicine called secukinumab (75 mg, 150 mg, and 300 mg) against a placebo (an inactive injection) in people with rheumatoid arthritis who also had psoriasis. The trial ran in two stages — up to 24 weeks for the main analysis, then continuing out to 260 weeks (around five years). The main thing the trial was measuring was how many participants reached a standard benchmark of joint improvement called ACR20, which means at least a 20% improvement in joint tenderness, joint swelling, and several other disease-activity measures. The reported data shows that at the 24-week mark, out of 99 people who received the 75 mg dose, 29 reached the ACR20 benchmark; out of 100 in the 150 mg group, 51 did; and out of 100 in the 300 mg group, 54 did. In the combined placebo group (98 participants), 15 reached that benchmark. For the secondary measurements — which looked at skin involvement, overall disease activity scores, physical quality-of-life scores, and a daily-tasks disability score — the reported data shows varying numbers across the dose groups. For example, on a skin improvement measure (PASI75, meaning at least 75% improvement in psoriasis-affected skin), the numbers of participants reaching that point were 14, 28, and 26 in the 75 mg, 150 mg, and 300 mg groups respectively, compared with 7 in the placebo group. Changes in disease activity scores, physical wellbeing scores, and disability scores were also reported as numerical changes from the starting point, with the placebo group generally showing smaller reported changes than the secukinumab groups across those measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02605642 · results posted 13 January 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02605642) enrolled 334 people in total across two groups: 227 participants who had never previously received a biologic medicine (a type of medicine made from living cells) for their inflammatory arthritis, and 107 participants who had been taking a medicine called Remicade and switched to a related medicine called CT-P13 (also known as Inflectra or Remsima). The trial was observational, meaning researchers watched and recorded what happened in real-world clinical practice rather than assigning people to different treatments in a controlled way. It looked at people with one of three conditions — rheumatoid arthritis, ankylosing spondylitis, or psoriatic arthritis — and tracked things like how long they stayed on CT-P13, how long they had been living with their condition before joining the study, and what doses they received. The reported data shows that, on average, participants who had never had a biologic medicine before stayed on CT-P13 for approximately 404 days, while those who switched from Remicade stayed on it for approximately 542 days. In terms of how long people had been living with their condition before joining the study, the biologic-naïve group had been diagnosed for roughly 33 to 53 months on average (depending on the condition), while the group who switched from Remicade had been diagnosed for roughly 134 to 189 months on average — suggesting the switchers had been living with their disease considerably longer. The reported starting dose of CT-P13 was 3 milligrams per kilogram of body weight for the biologic-naïve group and 4 milligrams per kilogram for the switcher group. The reported data also shows that 40 participants in the biologic-naïve group and 8 in the switcher group had a change in their dose at some point during the observation period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03066609 · results posted 30 December 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT03066609) enrolled 543 adults with psoriasis (a skin condition causing red, scaly patches). Participants were assigned to one of three groups during the first phase: 136 received a lower dose of secukinumab (150mg), 272 received a higher dose (300mg), and 135 received a placebo (a dummy treatment with no active ingredient). The trial measured two main things: how many participants achieved a 75% reduction in their psoriasis severity score (called PASI 75 — a standardised scoring system that rates how much skin is affected and how inflamed it looks), and how many achieved a near-clear or clear skin rating from a doctor (called IGA 0/1, where 0 means completely clear and 1 means almost clear). The reported data shows that, at the primary measurement point, 112 out of 136 participants in the 150mg group, 254 out of 272 in the 300mg group, and 6 out of 135 in the placebo group met the PASI 75 threshold. For the doctor's skin clearance rating (IGA 0/1), the reported figures were 92 out of 136 in the 150mg group, 214 out of 272 in the 300mg group, and 4 out of 135 in the placebo group. Among those who had already responded well at 12 weeks and continued into the longer maintenance phase (up to 52 weeks), the reported data shows 94 participants in the 150mg group and 235 in the 300mg group still met the PASI 75 threshold at week 52, while 65 and 162 respectively still met the IGA 0/1 threshold at that same point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02750800 · results posted 6 November 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 412 participants across six different conditions: ankylosing spondylitis, Crohn's disease, psoriasis, psoriatic arthritis, rheumatoid arthritis, and ulcerative colitis. All participants received adalimumab alongside a patient support programme called AbbVie Care 2.0. The trial was measuring changes in participants' self-reported quality of life over 12 months, using several standard questionnaires that ask people to rate things like physical ability, pain, mental wellbeing, and daily activities. Of the 412 who started, 314 completed the study and 98 did not. The reported data shows that on the main quality-of-life measure — a physical wellbeing score out of 100 (where higher is better) — the average score across the different disease groups rose by between approximately 4 and 12 points from the starting point after 12 months. The reported data also shows similar upward shifts on a mental wellbeing score, ranging from about 6 to nearly 12 points across the disease groups. On a separate overall health rating scale (0–100, where higher is better), the reported average increases ranged from around 11 points for the psoriasis group to about 30 points for the psoriatic arthritis group. For the bowel disease groups, a bowel-disease-specific quality-of-life questionnaire (scored 10–70) showed reported average increases of around 12 points for Crohn's disease and 16 points for ulcerative colitis. For the skin condition groups, a skin-specific questionnaire (scored 0–30, where lower is better) showed reported average decreases of about 9 points for psoriasis and 6 points for psoriatic arthritis — both indicating movement toward a better score on that scale. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03357471 · results posted 25 October 2019

  According to the results reported on ClinicalTrials.gov, this trial looked at whether people could use an electronic injection device (called an "e-Device") to give themselves their own doses of a medicine called certolizumab pegol. A total of 67 people took part — 35 in a group that injected every two weeks, and 32 in a group that injected every four weeks. Nearly all participants finished the trial (33 and 32 respectively, with only 2 people in the two-weekly group not completing it). The reported data shows that at the second clinic visit, 100% of participants in the every-two-weeks group and 96.88% (just under 97 in 100) in the every-four-weeks group were recorded by a healthcare provider as having successfully given themselves the full dose without any device-related problems that would stop them continuing to use it. At the first clinic visit, both groups recorded 100%. The reported data also shows that none of the medicine cassettes (the containers holding the drug) showed any signs of damage or structural problems after use in either group. Additionally, the trial tracked blood pressure and pulse rate over time. Small average changes were recorded — for example, systolic blood pressure (the top number in a blood pressure reading) changed by an average of −0.12 mmHg in the two-weekly group and −2.31 mmHg in the four-weekly group — but the trial was not primarily designed to measure these, and the figures reported were very small shifts from starting values. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01623752 · results posted 16 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,821 people in total — 1,378 with rheumatoid arthritis, 440 with psoriatic arthritis, and 3 whose diagnosis was unclear. The trial ran in two phases, each lasting 78 weeks (roughly 18 months), making a potential total of around three years. The main thing the trial was measuring was any change in joint damage visible on X-rays of the hands and feet, using a scoring system called the Modified Sharp Score (mTSS). On this scale, a score of zero means no visible damage, and higher numbers mean more damage; the maximum possible score was 448 for rheumatoid arthritis and 528 for psoriatic arthritis. The reported data shows that at the start of Phase 1, participants with rheumatoid arthritis had an average baseline score of 25.1, and those with psoriatic arthritis had an average of 14.7. By the end of Phase 1 (week 78), the reported change from that baseline was +0.6 for the rheumatoid arthritis group (a small increase in the damage score) and −0.4 for the psoriatic arthritis group (a very small decrease). By the end of Phase 2 (week 156), the reported change from baseline was +1.4 for rheumatoid arthritis participants and +0.7 for psoriatic arthritis participants. The trial also looked at how the rate of X-ray change compared to the period before treatment began. The reported data shows that in Phase 1, the rate of score change per year shifted from approximately +0.96 units per year (pre-treatment) to −0.27 units per year during the trial for rheumatoid arthritis participants, and from approximately +1.06 units per year to −1.00 units per year for psoriatic arthritis participants. It is worth noting that a large number of participants did not complete the study — for example, around 631 of the 1,378 rheumatoid arthritis participants did not finish Phase 1 — and the reasons for this were not detailed in the data provided here. No safety or side-effect data was included in the structured results submitted to ClinicalTrials.gov for this summary. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01078558 · results posted 5 July 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 5,920 participants across three groups: 2,836 people with rheumatoid arthritis (RA), 1,127 people with psoriatic arthritis (PsA), and 1,957 people with ankylosing spondylitis (AS). The trial was observational in nature, tracking several measures of disease activity over time — including a doctor's overall rating of disease activity, the number of tender and swollen joints (out of 28 assessed), two blood markers of inflammation (CRP and ESR), and a physical function score called the HAQ%. It is worth noting that a large proportion of participants did not complete the study across all three groups. The reported data shows changes from the starting point (baseline) across all three groups at multiple time points during the study. For the doctor's disease activity rating (scored 0–100, where higher means worse), reported changes ranged from around −34 to −47 points across the groups and time points. For tender joints, the reported reductions ranged from about −1.6 to −10.4 joints, and for swollen joints from about −1.3 to −9.0 joints. The reported data shows that the blood inflammation markers (CRP and ESR) also recorded reductions from baseline across all groups throughout the study. For physical function (HAQ%), the reported reductions ranged from approximately −19 to −33 percentage points across the groups and time points, where a lower score indicates less difficulty with daily tasks. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01892436 · results posted 12 June 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01892436) involved 457 people with psoriatic arthritis — a condition causing joint pain and swelling alongside psoriasis. Participants were divided into four groups: those receiving secukinumab at either 75 mg or 150 mg, or a matching placebo (dummy treatment) for each dose group. The trial measured how participants' joint symptoms changed over time using several scoring systems, including the ACR scores (which track improvements in tender and swollen joint counts alongside other measures of disease activity), a disability questionnaire called the HAQ-DI, and a combined disease activity score called the DAS28. Of the 457 who started, 380 completed the overall study period. The reported data shows that across the primary outcome — the ACR20, which measures whether a participant had at least a 20% improvement across multiple joint-related measures — the percentages of participants reaching this threshold were broadly similar across all four groups at the time points measured. For example, at one measured time point, approximately 69–79% of participants across all groups (including placebo groups) were reported to have reached the ACR20 threshold. For the ACR50 (at least 50% improvement), reported figures ranged from roughly 42–57% across groups, and for ACR70 (at least 70% improvement), figures ranged from approximately 24–35%. The reported data also shows changes in the HAQ-DI disability score (on a 0–3 scale), with all groups showing reductions (improvements) in the range of about 0.35 to 0.56 points from their starting scores. Similarly, the DAS28 disease activity score decreased across all groups by roughly 1.8 to 2.4 points from baseline across the time points reported. It is worth noting that the similar numbers seen across both the active treatment and placebo groups are part of what the trial was designed to examine, and interpreting what those patterns mean requires clinical expertise. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02986373 · results posted 28 May 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 145 people who received the study drug risankizumab. Of those, 106 completed the trial and 39 did not finish. The trial was an extension study looking at people who had previously taken part in a related trial. It was primarily measuring how many participants experienced adverse events (that is, any unwanted medical occurrences during the study period). It also tracked joint health over time using X-rays and measured how participants' joint symptoms responded, using a standard rheumatology assessment called the ACR20 (which looks for at least a 20% improvement in joint tenderness, swelling, and several other markers). The reported data shows that out of 145 participants, 87 experienced at least one adverse event during the study. Of these, 22 experienced a serious adverse event (a more severe medical event such as one requiring hospitalisation), and 1 death was reported. Other specific adverse event categories were reported with counts of 7, 5, 5, 2, 2, 2, 1, and 1 participants respectively, though the individual labels for each of these categories were not included in the data provided here. For joint health, X-ray scores (on a scale of 0 to 528, where higher numbers mean worse joint damage) changed by an average of 0.12 units at one earlier time point, 0.38 units at Week 24 of this extension study, and 0.34 units at Week 48. The reported data also shows that at the start of this extension study (Week 0), 43.4% of participants met the ACR20 response threshold — meaning they showed at least a 20% improvement across the required joint and symptom measures compared to their original starting point. By Week 4, that figure was reported as 55.6%. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01989468 · results posted 16 April 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01989468) enrolled 414 people across five groups to test two doses of a medicine called secukinumab (150 mg and 300 mg) against a placebo (an inactive treatment) in people with psoriatic arthritis. The main thing the trial set out to measure was how many participants in each group met a standard called "ACR20" at week 24 — a benchmark used in arthritis research that requires at least a 20% improvement in swollen and tender joint counts, plus improvements across several other measures such as pain scores and physical function assessments. The reported data shows that, at week 24, 58 out of 138 participants in the 150 mg group and 67 out of 139 in the 300 mg group met the ACR20 benchmark, compared with 22 out of the combined placebo group. For a stricter benchmark requiring at least 50% improvement (ACR50), the reported numbers were 26 participants (150 mg), 48 participants (300 mg), and 12 in the placebo group. The trial also measured changes in an overall disease activity score (rated on a scale where higher numbers mean more active disease); the reported average change from the starting score was −1.24 points for the 150 mg group, −1.56 points for the 300 mg group, and −0.64 points for the placebo group. For the skin-related measure (PASI75, meaning at least a 75% improvement in psoriasis skin involvement), 34 participants in the 150 mg group, 29 in the 300 mg group, and 6 in the placebo group met that threshold. A tighter skin benchmark (PASI90) was met by 25, 21, and 4 participants respectively. A quality-of-life physical function score (where higher is better, on a 0–100 scale) showed average changes from baseline of +1.68 (150 mg), +4.41 (300 mg), and −0.10 (placebo) at one reported time point. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT03151551 · results posted 2 April 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 283 participants in the ixekizumab group and 283 in the adalimumab group — 566 people in total. Both groups had psoriatic arthritis (a condition involving joint inflammation and skin psoriasis). The trial was measuring how many participants, after 24 weeks of treatment, showed a meaningful improvement in *both* their joint symptoms (at least 50% better on a standard joint score called ACR50) *and* complete clearance of their skin psoriasis (a score called PASI100, meaning 100% improvement in skin involvement). The reported data shows that for the main combined measure — improving joints and clearing skin at the same time — 36% of participants in the ixekizumab group and 27.9% in the adalimumab group met that combined target. Looking at the two measures separately: for joint improvement alone (ACR50), the reported figures were 50.5% for ixekizumab and 46.6% for adalimumab. For complete skin clearance alone (PASI100), the reported figures were 60.1% for ixekizumab and 46.6% for adalimumab. The reported data also shows changes in some additional measures. The average number of tender joints fell by about 15.9 points in the ixekizumab group and 14.9 points in the adalimumab group. Swollen joint counts fell by roughly 9.6 and 9.5 points respectively. Participants' self-reported joint pain (on a 0–100 scale) dropped by an average of about 37.2 points for ixekizumab and 36.5 points for adalimumab. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02376790 · results posted 22 February 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02376790) enrolled 851 adults with psoriatic arthritis — a condition involving joint inflammation alongside a skin condition called psoriasis. Participants were split into three groups of roughly equal size: 284 received methotrexate alone, 284 received etanercept alone, and 283 received both medicines together. The trial's main goal was to measure how many people in each group showed a meaningful improvement in their joint symptoms after 24 weeks, using a standard scoring system called ACR20 — which counts someone as a "responder" if they showed at least 20% improvement in tender joints, swollen joints, and several other measures of pain and disease activity. The reported data shows that at the 24-week mark, 50.7% of participants in the methotrexate-alone group met the ACR20 response threshold, compared with 60.9% in the etanercept-alone group and 65.0% in the combination group. For a separate measure called Minimal Disease Activity (MDA) — a standard used specifically for psoriatic arthritis that looks at joints, skin, pain, and physical function — the reported figures at week 24 were 22.9% for methotrexate alone, 35.9% for etanercept alone, and 35.7% for the combination group. The reported data also tracked how these response rates changed across earlier time points, and measured changes in the number of tender joints over time; by week 24 the average reduction in tender joint count was reported as approximately 10 joints for the methotrexate group, 11 joints for the etanercept group, and 12 joints for the combination group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01768858 · results posted 28 January 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 96 people, all of whom received the medication adalimumab. Of those, 74 completed the study and 22 did not finish. The trial was looking at two main things: whether participants' beliefs about their medicine changed over 12 months (measured using a questionnaire called the Beliefs About Medicines Questionnaire, or BMQ), and whether those beliefs were linked to how consistently participants took their medication (measured using the Morisky Medication Adherence Scale, or MMAS). The reported data shows that, on average, participants' BMQ scores — which reflect beliefs about their prescribed medicine, including how necessary it feels and any concerns about it — decreased by 1.4 points over 12 months (on a scale of 10 to 50, where higher numbers mean stronger beliefs). The reported correlation (a measure of how closely two things move together, ranging from -1 to +1) between BMQ scores and medication-taking behaviour at 12 months was -0.173, meaning there was only a very weak relationship between the two measures. On the secondary measures, the reported data shows that adherence scores (how consistently people took their medicine) increased slightly by 0.2 points between months 3 and 12, and treatment satisfaction scores rose modestly across several categories over the same period. Scores on disease activity questionnaires for both rheumatoid arthritis and ankylosing spondylitis — conditions the medication is used for — appeared to decrease over the course of the study, though the data as submitted does not clearly label which individual time-point figures correspond to which measurement. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02986139 · results posted 31 October 2018

  According to the results reported on ClinicalTrials.gov, this trial enrolled 111 people in total — 56 in one group and 55 in the other. It was a crossover study, meaning participants tried both versions of the medicine (etanercept) at different times: an existing commercial formulation and a newer formulation. The main thing being measured was how much pain people felt at the injection site immediately after receiving each version, rated on a scale from 0 mm (no pain at all) to 100 mm (worst pain imaginable). The reported data shows that, for the primary outcome of injection site pain, the commercial formulation scored an average of 23.6 mm on the pain scale, while the new formulation scored an average of 19.8 mm. When results were broken down by disease type (a secondary outcome), the commercial formulation scored 23.7 mm for those with rheumatoid arthritis (RA) and 23.3 mm for those with psoriatic arthritis (PsA), while the new formulation scored 20.5 mm for RA and 17.2 mm for PsA. For another secondary outcome — the number of people who experienced side effects — the reported data shows 10 participants had side effects with the commercial formulation and 8 with the new formulation, though the data as submitted includes several sub-categories whose full labels were not provided in the available results. It is worth noting that 5 participants did not complete the study across both groups, though the reasons were not detailed in the data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02414633 · results posted 16 October 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02414633) enrolled 148 participants, all of whom were treated with Humira (adalimumab) for psoriatic arthritis. All 148 participants completed the study. The trial used a questionnaire called the WPAI:PsA — a tool where people rate how much their condition affects their ability to work and carry out daily activities, with scores expressed as percentages (0% meaning no impact, 100% meaning complete impact). The main thing the trial was measuring was the change in overall work impairment over 24 weeks. The reported data shows that, at the start of the study, participants reported an average overall work impairment score of about 40%. By week 24, that score had changed by approximately −25 percentage points (a negative number in this questionnaire means the score went down, which the researchers described as an improvement). At earlier check-in points — weeks 4, 12, and 16 — the reported changes were approximately −16, −19, and −26 percentage points respectively. For the breakdown of work impairment: the amount of work time missed (absenteeism) started at around 8% and the reported changes ranged from about −5 percentage points across all time points. The score for impairment while actually at work (presenteeism) started at around 38% and changed by roughly −15 to −24 percentage points across the check-ins. The reported data also shows that scores related to everyday activity impairment (starting at about 42%) changed by approximately −17 to −27 percentage points across the measurement points. A separate arthritis symptom questionnaire (scored on a scale of 15 to 75) started at around 47 points and the reported change was approximately −18 points by week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02181673 · results posted 21 December 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 480 adults with psoriatic arthritis — 239 in the placebo group and 241 in the golimumab (active treatment) group — across two periods running from Week 0 to Week 60. At Week 24, participants who had been on placebo were switched to golimumab for the second half of the trial. The trial was primarily measuring whether golimumab led to a meaningful improvement in joint swelling, joint tenderness, pain, and physical function by Week 14, using a standard scoring system called ACR 20 (which counts someone as a "responder" if they show at least 20% improvement across several joint and symptom measures). The reported data shows that at Week 14, 75.1% of participants in the golimumab group met the ACR 20 response threshold, compared with 21.8% in the placebo group. For a higher bar of improvement (ACR 50, meaning at least 50% improvement), the reported figures were 43.6% for golimumab versus 6.3% for placebo. Among participants who also had a skin condition (psoriasis), 59.2% on golimumab showed at least a 75% improvement in skin score (PASI 75), compared with 13.6% on placebo. The reported data also shows results for several secondary measures. On a physical function questionnaire (scored 0–3, where lower means less difficulty), the golimumab group's average score changed by −0.60 from the start, compared with −0.12 in the placebo group. For joint damage visible on X-ray (scored 0–528, where lower is better), the golimumab group's average score changed by −0.36, while the placebo group's score increased by 1.95. For participants who had tendon and ligament pain at the start of the trial, a tenderness index (scored 0–6) changed by −1.8 in the golimumab group and −0.8 in the placebo group. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02349295 · results posted 14 December 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02349295) enrolled 363 adults across three groups during the main double-blind phase: 123 people received ixekizumab every two weeks, 122 received it every four weeks, and 118 received a placebo (a dummy injection with no active medicine). The trial was measuring whether the drug ixekizumab — given at two different dosing schedules — produced changes in joint and skin symptoms in people with psoriatic arthritis, compared to placebo. Participants were followed across several phases, including an initial 24-week blinded period, a longer extension period of up to around three years, and a follow-up period afterwards. The reported data shows that the primary outcome — a standardised joint improvement measure known as ACR20 (meaning at least a 20% improvement across several joint-related assessments) — was recorded in approximately 19.5% of placebo participants, 53.3% of those receiving ixekizumab every four weeks, and 48.0% of those receiving it every two weeks at week 12. The reported data also shows that for a higher level of joint improvement (ACR50, meaning at least 50% improvement), the figures were approximately 5.1% for placebo, 35.2% for every-four-weeks dosing, and 33.3% for every-two-weeks dosing. For an even higher threshold (ACR70), the reported figures were 0% for placebo, 22.1% for every-four-weeks, and 12.2% for every-two-weeks. For a skin-related measure (PASI 75, meaning at least a 75% improvement in a psoriasis skin scoring system), the reported figures were 10.4% for placebo, 57.4% for every-four-weeks, and 61.8% for every-two-weeks. A physical function questionnaire score (HAQ-DI, where lower numbers indicate less difficulty with daily tasks) showed average changes from starting scores of −0.2 for placebo, −0.6 for every-four-weeks dosing, and −0.4 for every-two-weeks dosing. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01860976 · results posted 2 August 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01860976) enrolled 213 people in the abatacept group and 211 in the placebo group for the initial blinded treatment phase. The trial was looking at people with psoriatic arthritis — a condition involving joint inflammation linked to the skin condition psoriasis. The main thing the trial measured was how many participants showed a meaningful improvement in joint symptoms (called an "ACR 20 response") by around day 169, roughly six months into treatment. An ACR 20 response means a person's tender and swollen joint counts improved by at least 20%, along with improvement in several other measures such as pain, physical function, and a doctor's overall assessment. The reported data shows that at day 169, approximately 39.4% of people in the abatacept group met the ACR 20 response threshold, compared with 22.3% in the placebo group. For physical function (measured by a questionnaire called the HAQ, which assesses how much difficulty people have with everyday activities), 31.0% of the abatacept group showed a meaningful improvement versus 23.7% in the placebo group. Among participants who had not previously used a type of medicine called a TNF inhibitor, the reported ACR 20 response rates were 44.0% (abatacept) versus 22.2% (placebo); among those who had previously used a TNF inhibitor, the figures were 36.4% versus 22.3%. For X-ray measures of joint damage not progressing, 42.7% of the abatacept group and 32.7% of the placebo group were classified as non-progressors. For skin involvement (in those with at least 3% of their body surface affected by psoriasis), 26.7% of the abatacept group and 19.6% of the placebo group showed at least a 50% improvement in their skin score. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01877668 · results posted 6 July 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01877668) enrolled 422 adults with psoriatic arthritis across five treatment groups: tofacitinib 5 mg twice daily (107 people), tofacitinib 10 mg twice daily (104 people), adalimumab 40 mg every two weeks (106 people), and two placebo groups who later switched to one of the tofacitinib doses (52 and 53 people respectively). The trial measured things like joint tenderness and swelling, participants' ability to perform everyday tasks, and X-ray changes in joints over time. The reported data shows that at the three-month mark, roughly 50% of people in the tofacitinib 5 mg group, 61% in the tofacitinib 10 mg group, and 52% in the adalimumab group showed at least a 20% improvement across a set of joint and symptom measures, compared with about 33% in the placebo group. On a scale measuring difficulty with everyday activities like dressing, walking, and eating (where a lower score means less difficulty), the reported average score fell by about 0.35 points in the tofacitinib 5 mg group, 0.40 in the tofacitinib 10 mg group, and 0.38 in the adalimumab group, compared with a drop of about 0.18 in the placebo group. For the secondary measures looking at X-ray joint damage scores at 12 months, the reported changes from starting scores were very small across all groups (ranging from −0.07 to +0.09 on a scale of 0–528). The reported percentage of people whose X-ray joint damage score worsened by more than a small threshold at 12 months ranged from about 2% to 9% across the groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02029495 · results posted 19 May 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 478 people across three groups: 159 received brodalumab at a dose of 210 mg, 158 received brodalumab at 140 mg, and 161 received a placebo (a dummy treatment with no active ingredient). Nearly all participants completed the study. The trial was measuring two things in people with psoriatic arthritis: joint-related improvement using a standard scoring tool called ACR20 (which looks at tender and swollen joint counts alongside other symptoms like pain and physical function), and skin-related improvement using a tool called PASI75 (which measures how much the psoriasis patches on the skin reduced in size and severity). The reported data shows the following for the primary measure — the proportion of participants who achieved the ACR20 joint improvement threshold: 0% in the 210 mg brodalumab group, 21.8% in the 140 mg brodalumab group, and 36.5% in the placebo group. For the secondary skin measure (PASI75 — meaning at least a 75% reduction in skin psoriasis severity), the reported data shows 70.3% of the 210 mg brodalumab group, 55.6% of the 140 mg brodalumab group, and 0% of the placebo group reached this threshold. It is worth noting that the 0% figure for the 210 mg group on the joint measure and the 0% figure for the placebo group on the skin measure appear as reported in the submitted data; no further explanation for these figures was included in the structured results. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02028169 · results posted 27 April 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 120 adults with psoriatic arthritis (a condition causing joint inflammation alongside psoriasis) who were starting a type of medication called an anti-TNF treatment. Of the 120 who began the study, 92 completed it and 28 did not. The trial measured how the condition affected people's ability to work and carry out daily activities over nine months, using a standard questionnaire called the Work Productivity and Activity Impairment (WPAI) tool, where a score of 0% means no impact and 100% means complete impact on productivity or activity. The reported data shows that, at the start of the study, participants reported an average of 20.5% of work time missed due to their condition (absenteeism), and this figure was reported as 4.9% by month nine. For "presenteeism" — meaning how much the condition reduced productivity while people were actually at work — the average started at 53.7% and was reported as 19.5% at month nine. Overall work productivity impairment started at 42.8% and was reported as 15.3% at month nine, while impairment in everyday activities started at 60.2% and was reported as 23.0% at month nine. Note that these figures represent measurements taken at different time points across the study, and the data as submitted does not specify which exact time point each individual figure corresponds to beyond the overall nine-month period. The reported data also shows results from secondary measures. A disability questionnaire (scored 0 to 3, where higher means more difficulty) started at an average of 1.73 and was reported as 1.08 at the final time point. For joint-related response measures at month nine — which assess percentage improvement in tender and swollen joints alongside other indicators — the data shows that 86.8% of participants met the threshold for a 20% improvement, 63.7% met the threshold for a 50% improvement, and 41.8% met the threshold for a 70% improvement; the remaining percentages in each category did not meet those thresholds. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01680159 · results posted 13 March 2017

  According to the results reported on ClinicalTrials.gov, this trial tested a treatment called TA-650 in people with different types of psoriasis — including plaque psoriasis, psoriatic arthritis, pustular psoriasis, and psoriatic erythroderma. A total of 51 participants entered the main treatment phase, of whom 43 completed it. The trial was measuring changes in skin disease severity and, depending on the type of psoriasis, other relevant signs such as joint pain. The reported data shows that one of the main things measured was the proportion of participants whose skin disease score (called the PASI score, rated 0–72 where higher means more severe) improved by 75% or more. According to the results reported on ClinicalTrials.gov, at the start of the trial none of the participants across any group had reached that level of improvement (0%). At a later point in the trial, 13.7% of all participants overall had reached that 75% improvement mark, with 16.1% in the plaque psoriasis group and 40.0% in the psoriatic erythroderma group. The reported data also shows that average PASI scores across the overall group appeared to move from 14.70 at the start down to 7.60 and then 7.25 at later time points, though some subgroup figures were not reported for all time points. For plaque psoriasis specifically, the proportion of participants rated as having "cleared" or "minimal" skin lesions by their doctor was reported as 0% at the start, rising to various figures at later check-ins, reaching as high as 69.2% at one recorded time point. For the psoriatic arthritis subgroup, a self-reported joint pain score (on a 0–100 scale where 100 is worst) started at a median of 59.5 and was recorded as low as 8.0 at one later time point, though the data was not reported in a way that allows a straightforward before-and-after comparison across all time points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT02154425 · results posted 6 February 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02154425) enrolled 18 breastfeeding mothers who were already taking a medication called certolizumab pegol (CZP) — a drug used to treat certain inflammatory conditions. Eighteen mothers entered an initial screening period, and 17 went on to complete the main sampling period. The trial was measuring how much of this medication, if any, could be detected in the mothers' breast milk at various points over roughly ten days. Mothers were grouped depending on whether they received their CZP dose every two weeks (Q2W) or every four weeks (Q4W). The reported data shows that breast milk samples were collected on Days 0, 2, 4, 6, 8, and 10. For the group receiving CZP every four weeks (Q4W), the concentration of the medication in breast milk was not reported (shown as "NA" — meaning no figure was provided) at any of the six time points. For the group receiving CZP every two weeks (Q2W), concentrations were also not reported on Days 0, 2, and 10, but small numerical figures were recorded on Days 4, 6, and 8 — at approximately 0.036, 0.037, and 0.039 micrograms per millilitre respectively. To put that in context, these are very small numbers on a measurement scale, though it is not for this summary to draw any conclusions about what those numbers mean. The reported data does not include outcome figures for a number of the time points, so a complete picture across both groups and all days is not available from what was submitted. No information about infant outcomes or any other effects was included in the structured results data provided here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01313858 · results posted 1 November 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,613 people across three groups: 524 with rheumatoid arthritis, 546 with psoriatic arthritis, and 543 with ankylosing spondylitis. The trial was observational, meaning it watched and recorded how participants fared over time rather than randomly assigning them to different treatments. It measured several things, including participants' own ratings of their overall health, their ability to carry out everyday activities, levels of fatigue, and general quality of life. It also recorded any unwanted health events (called adverse events) that occurred during the study. The reported data shows that, for overall health status (rated on a 0–10 scale where lower means feeling better), all three groups started at around 5.5–5.7 and their scores were reported at multiple points during the study, eventually reaching around 2.4–3.1 by the final measurement — meaning scores moved closer to the "free of complaints" end of the scale over time. For everyday functioning (measured as a percentage, where higher is better), all three groups showed increases from their starting scores across the study period. For fatigue (scored 0–52, where higher means less fatigue), all three groups also showed increases from their starting scores. For quality of life (scored 1–15, where lower means fewer problems), all three groups showed decreases from their starting scores. The reported data shows that 320 rheumatoid arthritis participants, 309 psoriatic arthritis participants, and 281 ankylosing spondylitis participants experienced at least one adverse event. Of those, 75, 70, and 59 participants respectively experienced at least one serious adverse event. It is important to note that this study did not include a comparison group receiving a different or no treatment, so the numbers above describe what was measured and recorded, not a comparison between treatments. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01695239 · results posted 27 October 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01695239) enrolled 417 people with active psoriatic arthritis across four groups in the main treatment phase: 106 received a placebo (dummy treatment), 101 received adalimumab every two weeks, 107 received ixekizumab every four weeks, and 103 received ixekizumab every two weeks. The trial was measuring how well participants responded to treatment using a set of standard rheumatology scoring tools that look at things like joint tenderness, swelling, pain, and physical function. The study ran in several stages, including an initial 24-week blinded period, a longer extension phase, and a follow-up period. The primary thing being measured was the percentage of people who achieved an "ACR20 response" at week 24 — meaning at least a 20% improvement in both tender and swollen joint counts, plus improvement in at least three other measures such as pain, general wellbeing, and a blood marker of inflammation. The reported data shows that 30.2% of people in the placebo group reached this threshold, compared with 57.4% in the adalimumab group, 57.9% in the ixekizumab every-four-weeks group, and 62.1% in the ixekizumab every-two-weeks group. For a stricter measure requiring at least 50% improvement (ACR50), the reported figures were 15.1% (placebo), 38.6% (adalimumab), 40.2% (ixekizumab Q4W), and 46.6% (ixekizumab Q2W). For the strictest measure — at least 70% improvement (ACR70) — the reported figures were 5.7%, 25.7%, 23.4%, and 34.0% respectively. A secondary measure of physical function (the HAQ-DI questionnaire, scored 0–3 with lower meaning less difficulty) was also tracked, though the full change-from-baseline figures in the data provided were truncated and cannot be fully reported here. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01925768 · results posted 13 June 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01925768) enrolled 219 people with psoriatic arthritis — 109 were assigned to receive a placebo and 110 were assigned to receive a medicine called apremilast (30 mg). The trial was measuring whether apremilast reduced joint tenderness and swelling compared to a placebo, using a standard rheumatology scoring system called ACR20. To meet this score, a participant needed to show at least a 20% improvement in tender and swollen joint counts, plus improvement across several other measures such as pain, overall disease activity, physical function, and a blood marker of inflammation called C-reactive protein. The reported data shows that at the 16-week mark — the trial's main measurement point — approximately 38% of participants in the apremilast group met the ACR20 response threshold, compared to approximately 20% in the placebo group. At 24 weeks, the reported figures were approximately 44% for the apremilast group and 25% for the placebo group. The reported data also shows results for several additional measures at 24 weeks. On a disability questionnaire (scored 0–3, where lower is better), the placebo group's average score changed by −0.17 and the apremilast group's by −0.27 from where they started. On a broader disease activity score (DAS28, scored 0–9.4), the reported average changes were −0.76 for placebo and −1.26 for apremilast. On two quality-of-life measures related to physical functioning (part of a survey called the SF-36, where higher scores indicate better function), the placebo group showed average improvements of 1.26 and 1.60 points respectively, while the apremilast group showed average improvements of 3.94 and 5.00 points respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01392326 · results posted 4 February 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01392326) enrolled 606 people in total — 202 in each of three groups. One group received a 75 mg dose of the study drug (secukinumab, also referred to as AIN457), one received a 150 mg dose, and one received a placebo (a dummy treatment with no active ingredient). The trial was primarily measuring how many participants showed a meaningful improvement in joint symptoms — specifically, at least a 20% improvement across several standard measures of joint pain, swelling, and overall disease activity (a standard benchmark known as "ACR20"). A number of secondary measurements were also taken, including skin symptom improvement (relevant to participants who also had psoriasis), changes in overall disease activity scores, physical functioning, and quality of life. The reported data shows that, for the primary measure (ACR20 joint improvement), around 50.5% of participants in the 75 mg group and 50.0% in the 150 mg group met that threshold, compared with 17.3% in the placebo group. For participants who had significant skin involvement from psoriasis, the reported data shows that 64.8% (75 mg group) and 61.1% (150 mg group) achieved a 75% reduction in their skin score (PASI75), compared with 8.3% in the placebo group; and 49.1% and 45.4% respectively achieved an even larger 90% skin score reduction (PASI90), compared with 3.7% in the placebo group. For the secondary measures, the reported data shows changes in overall disease activity scores, physical functioning scores, and daily activity scores were all numerically larger in both secukinumab groups than in the placebo group, though the scale and meaning of each of those measures differ. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00809614 · results posted 13 November 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT00809614) enrolled 42 people in total — 28 received two doses of the study drug AIN457 (also known as secukinumab, given intravenously at 10 mg per kilogram of body weight), and 14 received a placebo (an inactive treatment). The trial was measuring how participants with psoriatic arthritis responded to treatment over several weeks, using two main scoring systems: the ACR criteria (which looks at joint tenderness, swelling, pain, and other disease measures) and the PsARC criteria (which also looks at joint counts and overall disease assessments). A higher percentage of "responders" means more people in that group met the threshold for improvement on those scales. The reported data shows that at Week 6, for the primary ACR20 measure (at least 20% improvement across several joint and disease measures), 39% of people in the AIN457 group were recorded as responders, compared with 23% in the placebo group. For the stricter ACR50 threshold (50% improvement), the reported figures were 17% versus 8%, and for ACR70 (70% improvement), 9% versus 0%. For the PsARC primary measure at Week 6, 43% of the AIN457 group were recorded as responders compared with 38% in the placebo group. Secondary outcome data also tracked skin disease severity (PASI scores, on a scale of 0–72 where lower means less disease) and joint tenderness at specific body sites (MASES scores, 0–13 scale) at multiple time points; the reported data shows scores in both groups shifting across the study weeks, though specific time-point details for all secondary measures were included in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01519089 · results posted 13 August 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01519089) enrolled 95 people in total — 47 in a lower-dose group and 48 in a higher-dose group — who were taking a medicine called CP-690,550 (also known as tofacitinib) twice daily at either 5 mg or 10 mg. The trial was measuring several things at 16 weeks: how much participants' psoriasis (a skin condition) improved using two scoring tools, how much joint-related symptoms changed for those with psoriatic arthritis, and how many participants experienced certain serious events such as cardiovascular (heart and blood vessel) problems or cancer. By the end of the study, 40 people in the lower-dose group and 33 in the higher-dose group had completed it. The reported data shows that, at Week 16, approximately 62.8% of participants in the lower-dose group and 72.7% in the higher-dose group had at least a 75% reduction in their psoriasis severity score (a measure called PASI75 — essentially meaning their skin scoring had dropped by at least three-quarters compared to the start). Separately, around 67.4% of the lower-dose group and 68.2% of the higher-dose group were rated by their doctor as having skin that was "clear" or "almost clear" at Week 16. For the joint-symptom measure (ACR20 — a standard way of scoring at least 20% improvement across several joint-related assessments), 100% of participants in both groups were reported as meeting that threshold at Week 16, though the data does not provide further detail on the size of the subgroup this applied to. The reported data also shows that zero participants in either group were recorded as having an adjudicated cardiovascular event or a malignancy (cancer) event across the study period. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01690299 · results posted 4 August 2015

  According to the results reported on ClinicalTrials.gov, this trial enrolled 250 adults with psoriasis across three groups during the first phase (weeks 0 to 16): 84 people received a placebo (a dummy treatment), 83 received apremilast (a tablet), and 83 received etanercept (an injection). The trial was primarily measuring how many participants had their psoriasis severity score — called a PASI score, which rates redness, thickness, scaling and the area of skin affected on a scale from 0 to 72 — reduce by at least 75% after 16 weeks. After this first phase, participants moved into a longer extension phase running to about two years, where all groups received apremilast, with roughly 73–80 people starting in each of the three carry-over groups. The reported data shows that, at the 16-week mark, 39.8% of people in the apremilast group and 48.2% of people in the etanercept group reached that 75% improvement threshold in their PASI score, compared with 11.9% in the placebo group. For a less strict measure — a 50% improvement in PASI score — the reported figures were 62.7% for apremilast and 83.1% for etanercept, versus 33.3% for placebo. When doctors rated overall skin clearance on a 0–4 scale (where 0 is clear and 4 is severe), 21.7% of apremilast participants and 28.9% of etanercept participants were rated as clear or almost clear, compared with 3.6% on placebo. The reported data also shows that the affected body surface area changed by an average of −47.7% in the apremilast group and −56.1% in the etanercept group, versus −16.3% in the placebo group. On a quality-of-life questionnaire scored from 0 (best) to 30 (worst), average scores changed by −8.4 points for apremilast, −7.8 for etanercept, and −3.9 for placebo. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01365455 · results posted 29 May 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01365455) looked at a medicine called AIN457 (also known as secukinumab) for people with plaque psoriasis — a skin condition causing red, scaly patches. A total of 738 people took part in the initial phase, split into three groups: 245 received a 150 mg dose, 245 received a 300 mg dose, and 248 received a placebo (a dummy treatment with no active ingredient). The trial tracked participants across three stages — an induction period (the first 12 weeks), a maintenance period (out to 52 weeks), and a follow-up period. The main things being measured were how much participants' psoriasis improved on two standard scoring systems used in skin disease research. The reported data shows that at 12 weeks, 71.6% of participants in the 150 mg group and 81.6% in the 300 mg group had at least a 75% reduction in their psoriasis score (a widely used benchmark in psoriasis research), compared with 4.5% in the placebo group. On a separate rating scale where a doctor scored the skin as "clear" or "almost clear," 51.2% of the 150 mg group and 65.3% of the 300 mg group reached that level, compared with 2.4% in the placebo group. A stricter measure — a 90% reduction in psoriasis score at 12 weeks — was reported for 39.1% (150 mg), 59.2% (300 mg), and 1.2% (placebo). For participants who had already responded well at 12 weeks, the reported data shows that at 52 weeks, 126 of 174 in the 150 mg group and 161 of 200 in the 300 mg group still met that response level; the placebo group number at 52 weeks was not reported. Self-reported symptom scores for itching, pain, and scaling also showed reductions from the starting point in both active treatment groups, while the placebo group showed little to no change; one figure in the 300 mg itching data appears inconsistent in the submitted data and may reflect a reporting error, so that specific number should be interpreted with caution. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01901185 · results posted 21 November 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 77 people, though 2 did not go on to use the device, leaving 75 participants who completed the study. The trial was looking at a self-injection device called Autoinjector A, used to deliver a medicine called etanercept. The main thing the trial was measuring was how often people could successfully give themselves an injection at home — outside of a medical setting — over a five-week period. The reported data shows that, out of all the injections that were actually attempted (not missed), 97.8% were recorded as successful — meaning the device signalled that the injection was complete and no liquid was left pooling on the skin. For the secondary measures, device engineers examined the equipment after the study and found that 2.4% of injection attempts were recorded as a device system failure. Looking at specific steps in the injection process where errors were recorded: 4.3% of injections involved an error icon lighting up on the device, 1.9% involved difficulty loading the cassette, 1.6% involved difficulty pressing the start button, and 1.1% involved difficulty removing the purple cassette cap. The reported data also notes that, across the 75 participants who used the device, 21 experienced some kind of adverse event (an unexpected medical occurrence during the study), 1 experienced a serious adverse event (defined as a medically significant event such as hospitalisation or a life-threatening occurrence), and 10 experienced an adverse device effect (an event considered related to use of the device). No further breakdown of these events was provided in the submitted results data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01307423 · results posted 15 August 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01307423) enrolled 528 adults across three starting groups: 176 received a placebo (a dummy treatment with no active ingredient), 175 received apremilast at a lower dose (20 mg), and 177 received apremilast at a higher dose (30 mg). The trial was measuring whether apremilast reduced the signs and symptoms of psoriatic arthritis — a condition that causes joint pain and swelling in people who also have psoriasis. Participants were followed for up to five years in total, moving through different phases of the study. The reported data shows that the main thing being measured at week 16 was the proportion of participants who met a standard set of improvement targets for joint tenderness, swelling, pain, and physical function (known as an ACR20 response — meaning at least 20% improvement across several measures). According to the results reported on ClinicalTrials.gov, 15.9% of the placebo group met this threshold, compared with 28.0% in the lower-dose apremilast group and 30.7% in the higher-dose apremilast group. For a separate measure of day-to-day physical function (scored 0–3, where lower is better), the placebo group showed virtually no change from their starting score (+0.012), while the lower-dose group showed a change of −0.156 and the higher-dose group −0.205 — with a negative number indicating a move toward less difficulty. Similar patterns in these numbers were also reported at week 24. The reported data shows additional measurements were taken across the full five-year period, including quality-of-life scores and other joint assessments, though the full details of all secondary outcomes are not completely captured in the available data extract. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01172938 · results posted 20 May 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 504 participants in total across three groups during the first phase: 168 people received a placebo (a dummy treatment with no active ingredient), 168 received a lower dose of apremilast (20 mg), and 168 received a higher dose of apremilast (30 mg). The trial ran in several stages over a number of years, with some participants continuing into longer-term follow-up phases. The main thing the trial was measuring was whether participants met a standard set of joint-related criteria — known as an ACR20 response — at 16 weeks. This means their tender joint count, swollen joint count, and at least three other measures such as pain, overall disease activity, and physical function all improved by at least 20% from where they started. The reported data shows that at week 16, 19.0% of participants in the placebo group met the ACR20 response criteria, compared with 30.4% in the 20 mg apremilast group and 38.1% in the 30 mg apremilast group. At week 24, the reported figures were 13.1% for placebo, 25.6% for the 20 mg group, and 35.1% for the 30 mg group. The trial also measured physical function using a questionnaire called the HAQ-DI, scored from 0 (no difficulty) to 3 (very severe difficulty). The reported data shows that at week 16, average scores changed by −0.086 in the placebo group, −0.198 in the 20 mg group, and −0.244 in the 30 mg group, where a negative number indicates a reduction in reported difficulty. Similar patterns were reported at week 24. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01212770 · results posted 20 May 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01212770) enrolled 505 people with psoriatic arthritis across three starting groups: 169 received a dummy tablet (placebo), 169 received apremilast at a lower dose (20 mg), and 167 received apremilast at a higher dose (30 mg). The first phase ran for 24 weeks, after which participants on placebo were switched to one of the apremilast doses, and the trial then continued for several more years to monitor participants over the longer term. The trial was primarily measuring how many people in each group achieved a recognised standard of joint improvement — called an ACR20 response — at 16 weeks. This means their tender and swollen joint counts, plus several other measures such as pain and physical function scores, each improved by at least 20%. The reported data shows that at the 16-week mark, 18.3% of those in the placebo group met the ACR20 response threshold, compared with 28.4% in the lower-dose apremilast group and 40.7% in the higher-dose apremilast group. At 24 weeks, the reported figures were 15.4% for placebo, 26.6% for the lower dose, and 31.1% for the higher dose. The trial also measured physical function using a questionnaire scored from 0 (no difficulty) to 3 (very severe difficulty), where a lower score represents less disability. At 16 weeks, the reported average change from the starting score was −0.065 for placebo, −0.131 for the lower dose, and −0.192 for the higher dose; similar patterns were reported at 24 weeks. A quality-of-life measure focused on physical functioning also showed reported average changes of 1.14 (placebo), 2.29 (lower dose), and 3.47 (higher dose) at 16 weeks, on a scale where higher numbers represent better physical function. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01212757 · results posted 19 May 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01212757) enrolled 488 adults with psoriatic arthritis across three initial groups: 162 received a placebo (a dummy treatment with no active ingredient), 163 received a lower dose of apremilast (20 mg), and 163 received a higher dose of apremilast (30 mg). The trial ran in several phases over up to five years. The first 24 weeks compared the active drug against placebo; after that, all participants moved to active treatment, with some continuing into longer-term follow-up phases. The main thing the trial was measuring at week 16 was how many participants achieved a standard benchmark of improvement in their joint symptoms — known as an "ACR20 response" — which required at least a 20% improvement in tender and swollen joint counts, plus improvement in several other measures such as pain, overall disease activity, and physical function. The reported data shows that at week 16, around 18.9% of participants in the placebo group met the ACR20 response benchmark, compared with 37.4% in the 20 mg apremilast group and 32.1% in the 30 mg apremilast group. Similar patterns were reported at week 24, with 15.7% of the placebo group, 31.3% of the 20 mg group, and 24.7% of the 30 mg group meeting that benchmark. The trial also tracked participants' self-reported ability to carry out everyday physical tasks (using a standard questionnaire scored from 0 to 3, where lower scores mean fewer difficulties). The reported average change from the starting score at week 16 was -0.053 for placebo, -0.157 for the 20 mg group, and -0.193 for the 30 mg group — with a negative number meaning scores moved in the direction of fewer reported difficulties. By week 24, those figures were -0.085, -0.165, and -0.206 respectively. Scores on a broader quality-of-life physical functioning questionnaire also showed reported differences between groups, though the clinical meaning of these numbers was not described further in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01009086 · results posted 13 March 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 615 people with psoriatic arthritis across three groups: 206 received a placebo (a dummy treatment with no active ingredient), 205 received a 45 mg dose of ustekinumab, and 204 received a 90 mg dose of ustekinumab. The trial ran for 24 weeks and measured things like joint swelling and tenderness, physical function, and skin involvement. By the end of the study, 162 placebo participants, 158 in the 45 mg group, and 170 in the 90 mg group had completed the trial. The reported data shows that the main thing being measured — called an "ACR 20 response," which means at least a 20% improvement in joint counts and several other assessments — was recorded in 22.8% of placebo participants, 42.4% of those on the 45 mg dose, and 49.5% of those on the 90 mg dose at week 24. For physical function (measured on a scale where lower scores mean less difficulty with daily tasks), the reported average change from the start of the trial was -0.10 for the placebo group, -0.31 for the 45 mg group, and -0.40 for the 90 mg group. Among participants who had significant skin involvement at the start, 11.0% of the placebo group, 57.2% of the 45 mg group, and 62.4% of the 90 mg group showed at least a 75% improvement in a skin severity score. A separate measure of joint damage visible on X-rays — which combined data from two similar trials — showed average score changes of +0.97 (placebo), +0.40 (45 mg), and +0.39 (90 mg), where a higher number indicates more damage progression. Additional measures of joint improvement at stricter thresholds (50% and 70% improvement) also showed different numbers across the three groups, with the placebo group consistently recording the lowest figures. For example, a 50% joint improvement response was reported in 8.7% of the placebo group, 24.9% of the 45 mg group, and 27.9% of the 90 mg group; a 70% improvement response was reported in 2.4%, 12.2%, and 14.2% respectively. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01077362 · results posted 27 February 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 312 adults across three groups: 104 received a placebo (a dummy treatment with no active ingredient), 103 received a 45 mg dose of ustekinumab, and 105 received a 90 mg dose of ustekinumab. The trial was primarily measuring how many participants showed a meaningful improvement in their joint symptoms — specifically swollen and tender joint counts alongside other disease measures — at 24 weeks. Secondary measurements included changes in participants' ability to carry out daily tasks, improvements in skin psoriasis coverage, and whether joint damage visible on X-rays had changed. The reported data shows that for the main outcome — the proportion of participants showing at least a 20% improvement in joint disease measures (called an "ACR 20 response") at week 24 — approximately 20% of the placebo group reached this threshold, compared with around 44% in both the 45 mg and 90 mg ustekinumab groups. For the skin psoriasis measure (at least a 75% improvement in a skin severity score), the reported figures were 5% for placebo, 51% for the 45 mg group, and 56% for the 90 mg group. For daily functioning (scored on a scale where lower means less difficulty), the placebo group's average score changed by −0.03, while both ustekinumab groups changed by around −0.21 to −0.22. On the X-ray joint damage score (where a higher number means more damage), the placebo group showed an average change of 0.97, compared with approximately 0.40 in both ustekinumab groups — though this particular measurement was drawn from pooled data across two separate studies rather than this trial alone. The reported data also shows that for higher thresholds of joint improvement (50% and 70% improvement), the proportions of participants reaching those levels were lower across all groups, with the placebo group consistently reporting the smallest percentages. All figures described here are as submitted by the trial sponsor and reflect what was observed in this specific group of study participants only. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01273519 · results posted 24 February 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 155 people across three groups: 78 with Rheumatoid Arthritis (RA), 30 with Psoriatic Arthritis (PsA), and 47 with Ankylosing Spondylitis (AS) — all conditions that cause joint pain and inflammation. The trial ran for 12 months and was primarily measuring how participants rated their pain over time, using two types of scales: a sliding scale from 0 (no pain) to 100 (worst pain imaginable), and a four-point scale ranging from no pain to severe pain. Not everyone finished the study — 59 RA participants, 25 PsA participants, and 39 AS participants completed it. The reported data shows that across all three groups combined, the average pain score that participants gave themselves on the 0–100 sliding scale started at 58.3 at the beginning of the study, and the figures recorded at each check-in were 34.3 at 3 months, 27.1 at 6 months, 21.7 at 9 months, and 14.6 at 12 months. Doctors rating the same participants' pain on the same scale reported figures of 56.6 at the start, dropping to 31.2, then 25.3, then 19.1, and finally 12.2 at 12 months. For pain over the previous three months on the same sliding scale, participants reported starting at 64.3, with figures of 38.2, 30.9, 24.7, and 17.4 at each subsequent check-in. The reported data also shows shifts in how participants categorised their pain severity on the four-point scale: at the start, 63 people rated their current pain as severe and 61 as moderate, while at month 12, only 2 rated it as severe and 14 as moderate, with 40 rating it as mild and 49 as no pain. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01155570 · results posted 8 October 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 734 participants in Japan, all of whom received the medication Humira (adalimumab) for psoriasis — a skin condition causing red, scaly patches. There was no comparison group; everyone received the same treatment. This study was required by the Japanese government as a condition of approving Humira in Japan. Of the 734 who started, 708 were included in the main analysis and 592 completed the study, with 142 not completing it. The reported data shows that doctors assessed skin severity using two tools at several points during the study. The first was a Physician's Global Assessment (PGA) — a 6-point scale where 0 means the skin is clear and 5 means very severe disease. The average PGA score reported was 2.2 (described as "mild") at week 4, 1.8 at week 8, 1.5 at week 16, and 1.2 (close to "minimal") at week 24. The second tool was the PASI score — a scale from 0 (no psoriasis) to 72 (very severe) — which was reported as 5.0 at week 16. Regarding unwanted events during the study, the reported data shows that 237 participants experienced some kind of adverse event (an unwanted or unexpected health occurrence), 35 had a serious adverse event, 191 had a reaction considered possibly related to the medication, 24 had a serious reaction possibly related to the medication, 4 participants died, and 48 discontinued due to adverse events or other reasons. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01083121 · results posted 20 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,779 people who were already being treated with adalimumab (a medicine used for conditions such as rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and Crohn's disease). There was only one group — everyone received adalimumab — and the trial was observational, meaning it watched and recorded what happened rather than comparing it to another treatment. Of those who started, 1,698 completed the study and 81 did not. The reported data shows that the main thing measured was how many participants experienced adverse events (unexpected or unwanted medical occurrences). According to the results reported on ClinicalTrials.gov, 171 participants experienced at least one adverse event of any kind. Of these, 116 experienced events considered related to the medicine, 47 experienced serious adverse events (meaning events that led to hospitalisation, were life-threatening, or had other significant consequences), and 58 experienced serious events considered related to the medicine. Seven participants experienced unexpected adverse drug reactions, and 30 experienced events that were rated as severe in intensity. Additionally, 120 participants had an adverse event that interrupted or caused discomfort in their usual activities (rated moderate), and 21 experienced an adverse event considered mild. For the secondary outcome — where the treating doctor gave an overall assessment of how each patient was doing — the reported data shows that across the four disease groups, the majority of participants were assessed as "improved": 478 out of the rheumatoid arthritis group, 37 out of the psoriatic arthritis group, 790 out of the ankylosing spondylitis group, and 50 out of the Crohn's disease group. Smaller numbers were assessed as showing "no change" (52, 2, 41, and 6 respectively) or "aggravated" (11, 1, 3, and 0 respectively). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00760669 · results posted 12 August 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,061 people who all received the medicine infliximab. The study was looking at a condition called ankylosing spondylitis — a form of inflammatory arthritis that mainly affects the spine — and tracked participants over 30 weeks. There was no comparison (placebo) group; everyone in the trial received the same treatment. Of the 1,061 who started, 1,031 completed the study and 30 did not finish. The reported data shows the following changes from the start of the study to week 30. On the BASDAI — a self-reported score from 0 (no disease activity) to 10 (very severe) that measures things like pain, fatigue and morning stiffness — the average starting score was 7.52, and it changed by −5.23 points by week 30. Two blood tests used to indicate inflammation were also measured: the ESR (a test of how quickly red blood cells settle in a tube) started at an average of 60.75 mm per hour and changed by −21.80 mm per hour; the CRP (a protein released during inflammation) started at an average of 7.94 mg/dL and changed by −4.81 mg/dL. For joint assessments, the average number of swollen joints (out of 28 examined) started at 9.75 and changed by −5.46, while the average number of tender joints started at 13.31 and changed by −7.35. A skin-scoring measure called the PASI was also listed as a primary outcome, but no numerical results were reported in the submitted data for that measure. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT01078402 · results posted 7 February 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled a total of 789 adults across three groups: 431 people with Rheumatoid Arthritis (RA), 124 with Psoriatic Arthritis (PsA), and 234 with Ankylosing Spondylitis (AS). All participants received the medication adalimumab (brand name Humira) by self-injection and were followed for up to 13 months. The trial was measuring changes in disease activity scores, physical function, how well participants were able to self-inject, and how consistently participants stuck to their injection schedule. The reported data shows that for the primary outcomes — looking at disease activity scores after 3 months — 251 out of 385 RA participants with available data recorded a meaningful drop in their RA disease activity score (a decrease of 1.2 or more on the DAS28 scale), while 56 did not show this level of change, and 78 were not assessable. For PsA and AS participants, the trial measured whether their disease activity score (BASDAI) dropped by 50% or more; the reported data shows 24 out of 62 PsA participants and 138 out of 270 AS participants recorded this level of decrease. For physical function (measured on a scale of 0 to 3, where lower means less difficulty), the reported average score across all participants started at 1.6 at the beginning of the study and was reported as 1.0 at month 13. Regarding self-injection, the reported data shows that around 89.5% of all participants were recorded as able to carry out their own injections appropriately by the end of the study. On treatment scheduling, 722 out of 756 participants were recorded as having missed no injections, while 23 missed some. Among those who stopped treatment early for any reason, the average time on treatment before stopping was reported as approximately 29 weeks across all groups. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00747344 · results posted 5 October 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 121 participants across two groups during its initial controlled period — 60 people received a placebo (an inactive treatment) and 61 received ustekinumab 45 mg. The trial was mainly measuring how many people's psoriasis improved significantly after 12 weeks, using a standard scoring system called the PASI (Psoriasis Area and Severity Index), which runs from 0 (no psoriasis) to 72 (very severe psoriasis). After the controlled period ended, participants moved into a second phase where those originally on placebo switched to ustekinumab, and those already on ustekinumab continued. The reported data shows that at the 12-week mark, 3 out of 60 people in the placebo group achieved at least a 75% improvement in their PASI score, compared with 41 out of 61 people in the ustekinumab group. For a second measure — a doctor's overall rating of the skin, scored from 0 (clear) to 5 (very severe) — the reported data shows that 5 out of 60 placebo participants received a rating of "cleared" or "minimal," compared with 43 out of 61 in the ustekinumab group. A third measure looked at quality of life using a questionnaire scored from 0 to 30, where a lower score means a better quality of life. The reported data shows the placebo group's score changed by an average of −0.5 points from the start, while the ustekinumab group's score changed by an average of −11.2 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00267956 · results posted 5 September 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 146 adults in its first phase (called the "controlled period") — 70 people received a placebo (a dummy treatment with no active ingredient) and 76 received the drug ustekinumab given four times. After that first phase ended, participants moved into a second period where they could all receive ustekinumab, bringing the total who entered that second phase to 129. The trial was measuring how people with psoriatic arthritis (a condition combining joint inflammation and the skin condition psoriasis) responded to ustekinumab compared to placebo over 12 weeks, using a set of standard assessments of joint tenderness, swelling, pain, and everyday functioning. The reported data shows that for the main goal — the number of people who achieved at least a 20% improvement across several joint and symptom measures by week 12 (known as an "ACR 20 response") — 10 out of 70 people in the placebo group reached this level, compared to 32 out of 76 in the ustekinumab group. For the secondary measures, the reported data shows that 5 placebo participants and 19 ustekinumab participants reached a 50% improvement level (ACR 50), while 0 placebo and 8 ustekinumab participants reached a 70% improvement level (ACR 70). For skin symptoms specifically, 3 people in the placebo group and 33 in the ustekinumab group showed at least a 75% improvement in a psoriasis severity score. On a questionnaire measuring how the disease affected quality of daily life (scored 0 to 30, where lower is better), the placebo group showed no average change from the start, while the ustekinumab group showed an average decrease of 6 points. On a separate questionnaire measuring difficulty with everyday tasks (scored 0 to 3), the placebo group showed no average change, while the ustekinumab group showed an average decrease of 0.25 points. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00303186 · results posted 30 July 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 107 people who had a form of arthritis linked to psoriasis called Psoriatic Arthritis (PsA) that had not responded well to previous treatments — sometimes called "refractory" PsA. Of the 107 who started, 55 completed the study and 52 did not finish. The trial was primarily focused on measuring the financial costs associated with the disease and its treatment over five years, looking at things like medication costs, hospital visits, specialist appointments, transport, and lost work productivity. It also tracked several measures of how participants' joints and skin were doing over time. The reported data shows that the average monthly cost per person at the 12-month mark was approximately €1,026, and at the 60-month (five-year) mark it was approximately €986. The trial also calculated something called an Incremental Cost-Effectiveness Ratio (ICER) — a way of expressing how much it costs to gain one additional "quality-adjusted life year" (a unit that combines length and self-reported quality of life). The reported ICER figure was approximately €39,679. For the joint and skin measures: out of 75 participants assessed for a joint improvement score (ASAS20), 37 met the response threshold; out of 86 assessed using a separate joint response measure (PsARC), 38 met that threshold. For skin involvement, the average psoriasis severity score (on a scale of 0 to 72, where higher means more severe) was reported as 5.04 at one time point, 1.29 at another, and 2.08 at a third — though the specific time points for each of these three figures were not clearly labelled in the data as submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00962741 · results posted 19 July 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 127 children and young people who were receiving the medication etanercept for juvenile idiopathic arthritis (a form of arthritis that affects children). There was no comparison group — all participants received etanercept. The trial ran for up to about two years and tracked how participants responded over time using a standard scoring system called the "ACR Pedi 30." This score measures whether a child's arthritis showed at least 30% improvement across several areas, such as the number of swollen joints, a doctor's assessment of disease activity, a parent or patient's assessment of pain, physical function, joint movement, and a blood marker called C-reactive protein. The reported data shows that at the 12-week mark — the trial's main measurement point — 88.6% of participants met the ACR Pedi 30 response threshold. The reported data also shows that, across a series of follow-up time points tracked over the longer study period, the proportion of participants meeting this threshold ranged from around 71% at an early time point up to approximately 99% at a later one. The trial also tracked a stricter measure called the "ACR Pedi 50," which required at least 50% improvement across the same areas; the reported figures for this measure ranged from around 51% at an early time point to approximately 98% at a later one. Results were also reported separately for three subgroups of participants — those with extended oligoarticular JIA, enthesitis-related arthritis, and psoriatic arthritis — and the reported numbers across time points followed broadly similar patterns within each subgroup. Of the 127 participants who started the trial, 119 completed it and 8 did not, though the reasons for non-completion were not detailed in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00954915 · results posted 19 April 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled just one participant who received the study drug, teplizumab. The trial was designed to look at a number of things, including safety signals (such as changes in vital signs, heart tracings, physical examination findings, and blood test results), as well as how psoriasis changed over the course of the study using several standard skin assessment tools. The reported data shows that one participant started the trial and one participant completed it, with no one recorded as having dropped out. For the primary focus area — tracking adverse events (unexpected or unwanted health changes) — the data reports that one participant was assessed. For all of the secondary measures, which included three different scoring systems used to rate the severity and extent of psoriasis on the skin, as well as measurements of teplizumab levels in the blood, no numerical results were reported in the data submitted to ClinicalTrials.gov. Because only a single person took part and because most of the outcome measurements were not reported, the data available from this trial is very limited. No conclusions about how teplizumab affected psoriasis can be drawn from what has been submitted. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00239720 · results posted 21 March 2012

  According to the results reported on ClinicalTrials.gov, this trial (NCT00239720) compared a drug called hOKT3gamma1 (Ala-Ala) against a placebo (an inactive treatment) in people with a joint condition. The trial was very small, with only 4 participants in total — 3 in the active drug group and 1 in the placebo group. The main thing the trial set out to measure was the proportion of participants who completed at least two rounds of treatment and showed a meaningful improvement in their joint symptoms at 6 months. "Meaningful improvement" was defined as at least a 1-point improvement on a doctor's or patient's overall rating scale, plus at least a 30% reduction in scores measuring joint tenderness or swelling across up to 68 joints. The reported data shows that 2 out of 3 participants in the drug group completed the study, while the 1 participant in the placebo group did not complete it. However, the results for the primary outcome measure — the proportion of participants who met the improvement targets at 6 months — were not reported in the data submitted to ClinicalTrials.gov. Because the trial was so small and the outcome numbers are missing, it is not possible to draw any meaningful conclusions from the figures available. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00534313 · results posted 22 November 2010

  According to the results reported on ClinicalTrials.gov, this trial involved 170 people across four groups who had psoriatic arthritis (a condition combining joint inflammation and the skin condition psoriasis). Participants were assigned to receive one of three different dosing regimens of a medicine called abatacept, or a placebo (a dummy treatment with no active ingredient). The trial ran in two stages: a shorter initial period and a longer follow-up period. The trial was measuring, among other things, how often unwanted medical events occurred, how participants' joint symptoms responded, how their skin lesions looked, and how their quality of life and physical function changed over time. The reported data shows that across all treated participants during the longer follow-up period, 20 people experienced what are classified as serious adverse events (significant unwanted medical events, such as those requiring hospitalisation), of whom 4 had events considered possibly related to the study drug. No deaths were reported. A total of 123 participants experienced any kind of adverse event (any unwanted symptom or change in health), with 58 of those considered possibly related to the study drug, and 4 people stopped taking the study drug because of an adverse event. Regarding joint symptoms, the reported data shows that between roughly 47% and 62% of participants in each group showed at least a 20% improvement in joint-related measures at around one year, with figures varying by group. Scores measuring skin lesion appearance, physical disability, and quality of life also showed changes from the starting point across all groups, including the placebo group, though the figures varied between groups and time points. The data was not reported in a way that allows a straightforward comparison between active treatment and placebo for all measures. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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• NCT00683384 · results posted 16 November 2010

  According to the results reported on ClinicalTrials.gov, this trial involved 93 participants, all of whom received a treatment called etanercept (a medication given by injection). Ninety-one of the 93 participants completed the study, while 2 did not finish. The trial was set up to track unwanted or unexpected health events — known as adverse events — that participants reported on their own (without being specifically prompted), looking at any such events that occurred up to 30 days after each injection. The reported data shows that, for the primary outcome measure, 7 out of 93 participants reported a spontaneous adverse event within 30 days of receiving an injection. No further breakdown of what those events were is included in the data provided. It is also worth noting that no secondary outcome measure results were included in the submitted data, so no additional figures are available to describe. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

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Not medical advice. These are results as reported by the trial sponsor to a public registry, summarised in plain English. They describe what a trial recorded, not whether a treatment is suitable for any person. Verify anything important against the original registry record and discuss what it means for you with your doctor.