Reported trial results for Ankylosing Spondylitis

30 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

• NCT04732117 · results posted 30 January 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04732117) enrolled 137 people in total — 68 received secukinumab and 69 received a placebo (an inactive dummy treatment) — during the first 16-week blinded phase, where neither participants nor their doctors knew who was receiving which treatment. Almost all participants then continued into an open-label phase (where everyone knew what they were receiving) for additional follow-up. The trial was measuring responses in people with ankylosing spondylitis (a type of inflammatory spinal condition) across several standardised scoring tools that assess things like pain, function, morning stiffness, and overall disease activity. The reported data shows that, for the main outcome — a score called ASAS40, which measures whether a person improved meaningfully across at least three out of four areas (overall disease activity, back pain, physical function, and inflammation) — approximately 58.7% of participants in the secukinumab group and 26.0% of participants in the placebo group reached that threshold at 16 weeks (among those who had not previously used a related class of medication). For all participants combined, the reported figures were approximately 60.1% (secukinumab) versus 24.8% (placebo). The reported data also shows that on a disease activity scoring tool called BASDAI (scored 0–10, with higher meaning more active disease), the average score fell by about 3.70 points in the secukinumab group and 2.15 points in the placebo group from where they started. Around 64% of the secukinumab group and 26% of the placebo group achieved at least a 50% reduction in that BASDAI score. A blood marker of inflammation (hsCRP) was also measured; the reported ratio of the week-16 value compared to the starting value was 0.38 for the secukinumab group and 0.74 for the placebo group, meaning both groups showed lower levels than at the start, with a larger reported reduction in the secukinumab 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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• NCT02557308 · results posted 9 December 2024

  According to the results reported on ClinicalTrials.gov, this trial (NCT02557308) enrolled a total of 329 participants across eight treatment groups. The groups included people who stayed on, or switched to or from, one of three types of infliximab-based medicines: Remsima (a biosimilar medicine), Remicade (the original brand), or another anti-TNF medicine (a class of medicines that target a protein involved in inflammation). The trial was primarily tracking specific medical events of concern — such as serious infections, certain types of cancer, liver problems, and serious infusion reactions — in people with ankylosing spondylitis, a type of inflammatory joint disease. It also measured patients' own ratings of their pain, physical function, and overall disease status, as well as doctors' assessments. The reported data shows that for the primary outcome — tracking serious medical events of special interest — only 1 participant in the Remsima group was recorded as experiencing such an event (specifically, an infusion-related reaction or hypersensitivity reaction); all other groups recorded zero events for the categories with data provided. It is worth noting that the completion data shows very few participants recorded as having formally completed the study across most groups, which may affect how the numbers should be interpreted. For the secondary outcomes, the reported data shows scores across different time points for things like physical function (BASFI), spinal pain, and doctor and patient global assessments — all measured on numerical scales. For example, baseline spinal pain scores in the Remsima group were reported as around 52.9 out of 100, compared to around 18.7 at a later time point; however, the data was not reported in a way that allows straightforward before-and-after comparison 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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• NCT03259074 · results posted 9 March 2023

  According to the results reported on ClinicalTrials.gov, this trial (NCT03259074) enrolled 859 people with ankylosing spondylitis (a type of inflammatory spinal condition). Participants were divided into three groups: one received a lower dose of the study drug AIN457 (150 mg) for part of the study then switched to placebo, one received a higher dose of AIN457 (300 mg) throughout, and one received a comparator medicine called GP2017 (40 mg). The trial ran for approximately two years (104 weeks) and its main focus was measuring whether participants' spines showed changes on X-ray over that time. The reported data shows that, for the primary outcome — the proportion of participants whose X-ray spine scores did not worsen beyond a small threshold over two years — results were similar across all three groups: approximately 66% in the lower-dose AIN457 group, 67% in the higher-dose AIN457 group, and 66% in the GP2017 group. For the secondary outcomes, the reported average change in the X-ray spine score from the start to two years was small and similar across groups (around 0.54–0.72 points on a scale of 0–72). Among participants who already had certain bony growths on the spine at the start, roughly 54–57% across all groups had no new such growths at two years. MRI scans (a type of detailed imaging) measuring inflammation in the spine and pelvis showed small reductions in inflammation scores across all groups. Finally, in the two AIN457 groups only, around 83% of participants in each group met a standard measure of symptom improvement (at least a 20% improvement across key areas such as pain and 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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• NCT04169373 · results posted 21 September 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04169373) investigated a medicine called upadacitinib (15 mg daily) in people with axial spondyloarthritis — a type of inflammatory condition that mainly affects the spine and joints. The trial was made up of two separate studies running alongside each other. In Study 1, 209 people received a placebo (a dummy pill) and 211 received upadacitinib. In Study 2, 158 received placebo and 156 received upadacitinib. After the first blinded phase, participants moved into an open-label phase (where everyone received the active medicine) and, for some, a later withdrawal phase to see what happened when the medicine was stopped. In total, several hundred participants were involved across all phases of the trial. The reported data shows that the main thing being measured at 14 weeks was the proportion of participants who achieved a substantial improvement on a standardised scoring system called ASAS40 — broadly, this means noticeably better scores across several areas including back pain, physical function, morning stiffness, and the person's own rating of their disease. In Study 1, 44.5% of those taking upadacitinib reached this threshold, compared with 18.2% of those taking placebo. In Study 2, the reported figures were 44.9% for upadacitinib and 22.5% for placebo. Secondary measures also reported in the data — including changes in a disease activity score called ASDAS, MRI spine inflammation scores, and another symptom scale called BASDAI 50 — all showed larger numerical changes in the upadacitinib groups compared with placebo groups at 14 weeks. For example, in Study 1 the ASDAS score (where a bigger drop means less disease activity) changed by −1.52 in the upadacitinib group versus −0.49 in the placebo group, and 43.1% of the upadacitinib group reached the BASDAI 50 improvement threshold compared with 16.7% 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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• NCT04285229 · results posted 28 June 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04285229) enrolled 147 participants who had been diagnosed with radiographic axial spondyloarthritis (a type of inflammatory spinal condition, sometimes called ankylosing spondylitis). Participants were randomly assigned to receive either a placebo (an inactive injection) or a medicine called ixekizumab (80 mg every four weeks). The trial ran in several stages: an initial blinded period where neither participants nor researchers knew who received which treatment, followed by an extended treatment period and a follow-up period. The main thing being measured was whether participants achieved a meaningful improvement — called an ASAS40 response — across four areas: overall disease activity, spinal pain, physical function, and morning stiffness. This applied specifically to participants who had not previously used a class of medicines called biological DMARDs. The reported data shows that in the main measurement (ASAS40 response among those who had not previously used biological DMARDs), 40.9% of participants in the ixekizumab group met this improvement threshold, compared with 7.8% in the placebo group. When looking at the broader group of all participants (including those with prior biological treatment experience), the reported figures were 37.8% for ixekizumab and 8.2% for placebo. A related but slightly less strict measure — called ASAS20 (at least a 20% improvement across the same areas) — was reported at 59.5% for ixekizumab versus 35.6% for placebo. The reported data also shows changes in several scoring scales used to track disease activity and physical function. On the ASDAS disease activity score, the ixekizumab group showed an average change of −1.33 points from their starting score, compared with −0.19 in the placebo group. On the BASDAI symptom questionnaire (scored 0–10), average changes were −2.39 versus −0.90, and on the BASFI physical function index (also 0–10), average changes were −1.36 versus −0.49. In all cases, a more negative number means a lower score compared with the starting 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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• NCT03178487 · results posted 1 June 2021

  According to the results reported on ClinicalTrials.gov, this trial enrolled 187 people in total — 94 in a group that started on placebo before switching to upadacitinib 15 mg, and 93 in a group that received upadacitinib 15 mg throughout. The trial was studying upadacitinib, a medicine being investigated for ankylosing spondylitis (a type of inflammatory arthritis affecting the spine). The trial ran in two periods, and the main thing being measured at 14 weeks was whether participants reached a defined level of improvement across four areas: their own rating of disease activity, back pain, physical function, and morning stiffness. The reported data shows that at 14 weeks, about 51.6% of participants taking upadacitinib 15 mg met the main improvement target (called an ASAS 40 response), compared with 25.5% of those on placebo. For the secondary measures, the upadacitinib group showed an average change in a combined disease activity score (ASDAS) of −1.45 points from the start, compared with −0.54 in the placebo group — where a negative number means the score went down (lower is considered better on this scale). On an MRI-based measure of spinal inflammation (SPARCC spine score, out of a maximum of 108), the reported average change was −6.93 in the upadacitinib group versus −0.22 in the placebo group. Roughly 45.2% of the upadacitinib group met a separate improvement benchmark called BASDAI 50, compared with 23.4% on placebo. On a quality-of-life questionnaire (scored 0–18, where lower is better), the average change was −4.20 for upadacitinib versus −2.67 for placebo. Finally, 19.4% of the upadacitinib group reached a threshold called "partial remission" (very low scores across all four disease areas), compared with 1.1% on 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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• NCT03502616 · results posted 11 January 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03502616) looked at a medicine called tofacitinib in people with ankylosing spondylitis, a type of inflammatory back condition. A total of 270 people took part — 134 were assigned to receive tofacitinib and 136 were assigned to receive a placebo (a dummy treatment) first, before later switching to tofacitinib. The main thing the trial measured was whether participants reached a meaningful improvement in their disease activity by week 16, using a standard scoring system called ASAS20, which tracks back pain, physical function, morning stiffness, and overall disease activity. The reported data shows that at week 16, about 56% of participants in the tofacitinib group met the ASAS20 improvement threshold, compared with about 29% in the placebo group. For a stricter improvement target (called ASAS40, meaning a larger improvement across the same areas), the reported figures were about 41% in the tofacitinib group and about 13% in the placebo group. Regarding adverse events (unexpected medical occurrences recorded during the study), the reported data shows that 73 participants in the tofacitinib group and 70 in the placebo group experienced at least one such event up to week 16; across the full 48-week period, those numbers rose to 103 and 93 respectively. No participants in either group were reported to have met the criteria for abnormal vital signs such as pulse rate or blood pressure in most categories, though small numbers had some variations noted. 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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• NCT02552212 · results posted 17 August 2020

  According to the results reported on ClinicalTrials.gov, this trial looked at certolizumab pegol (CZP), a medication given by injection, in people with ankylosing spondylitis — a type of inflammatory arthritis affecting the spine. In the first part of the trial (weeks 0 to 52), 158 people received a placebo (a dummy treatment with no active ingredient) and 159 received CZP. After week 52, 243 participants moved into an open-label extension phase (meaning everyone knew they were receiving CZP) that ran through to week 156. The trial measured things like disease activity scores, pain, stiffness, and physical function using established rating scales, as well as the levels of CZP in participants' blood at various time points. The reported data shows that at week 52, around 47% of people in the CZP group met what is called a "major improvement" threshold on a disease activity score (meaning their score dropped by at least 2 points out of a possible 10-point range), compared with about 7% in the placebo group. Separately, at week 12, around 48% of people in the CZP group met a different response measure — which required improvements of at least 40% across several areas including pain, function, and global disease assessment — compared with about 11% in the placebo group. Regarding blood levels of CZP, the reported data shows concentrations of roughly 51 µg/mL at week 1, 36 µg/mL at week 2, and around 55 µg/mL (CZP group) and 49 µg/mL (placebo-to-CZP group) at week 4; baseline concentration data 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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• NCT02696031 · results posted 7 August 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02696031) enrolled 555 adults across three groups in its main phase: 185 received secukinumab with a loading dose schedule, 184 received secukinumab without a loading dose, and 186 received a placebo (an inactive treatment). A further 372 participants continued into a longer extension phase lasting up to around four years. The trial was measuring responses in people with ankylosing spondylitis (a type of inflammatory spinal condition) using a standard scoring system called ASAS — a set of measures that tracks things like back pain, physical function, morning stiffness, and spinal movement. The main question the trial asked was how many participants showed a meaningful improvement (called an "ASAS40 response," meaning at least a 40% improvement across most of those areas) at weeks 16 and 52, focusing on participants who had not previously tried a class of medicines called TNF inhibitors. The reported data shows that at week 16, 68 out of 185 participants (roughly 37%) in the secukinumab loading-dose group and 70 out of 184 (roughly 38%) in the no-loading-dose group met the ASAS40 threshold, compared with 50 out of 186 (roughly 27%) in the placebo group. At week 52, those numbers were 58 (about 31%) and 66 (about 36%) in the two secukinumab groups, versus 34 (about 18%) in the placebo group. For the secondary measures — which looked at all participants, not just those who hadn't previously used TNF inhibitors — the reported data shows similar patterns across the different response thresholds tested (ASAS20, ASAS40, ASAS 5/6, and partial remission), with the secukinumab groups consistently reporting higher numbers of participants meeting each threshold compared with the placebo group. For example, 40–39 participants in the secukinumab groups versus 13 in the placebo group were reported to meet the "partial remission" criterion 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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• NCT02509026 · results posted 16 June 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02509026) enrolled 210 people with ankylosing spondylitis (a type of inflammatory spine condition) and followed them through up to three stages. All participants received etanercept, a medicine given by injection, for 24 weeks (the "induction" period). Those whose disease activity reached a low level then had the medicine withdrawn for up to 40 weeks (the "withdrawal" period), and those whose condition worsened during that time were offered 12 weeks of retreatment. The trial was primarily measuring how many people experienced a "flare" — a return of significant disease activity — after the medicine was stopped. The reported data shows that, of the 119 participants who entered the withdrawal period after stopping etanercept, 74.8% experienced a flare within 40 weeks. The reported median time to flare — that is, the point by which half of those who flared had done so — was around 16.1 weeks after stopping the medicine. The trial also tracked a disease activity score (called ASDAS-CRP, a combined measure of symptoms and a blood marker) at multiple time points. The reported data shows that, during the treatment period, the proportion of participants recorded as having low disease activity on this score rose from less than 1% at the start to around 62.6% by week 24. During the withdrawal period those proportions varied across visits, and during the retreatment period roughly 53–62% of participants were recorded in the low disease activity range at the 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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• NCT02696798 · results posted 30 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 316 adults with ankylosing spondylitis (a type of inflammatory spinal arthritis). Participants were divided into three groups: 104 received a placebo (an inactive treatment), 114 received a medicine called ixekizumab every four weeks, and 98 received ixekizumab every two weeks. The trial measured how participants responded using several scoring tools that asked people to rate their pain, stiffness, fatigue, and ability to carry out daily activities — all on scales from 0 to 10, where higher numbers generally meant worse symptoms. The reported data shows that for the main outcome — the proportion of people who met a specific threshold of improvement across four symptom areas (known as an ASAS40 response) — 12.5% of the placebo group, 25.4% of the every-four-weeks group, and 30.6% of the every-two-weeks group reached that threshold. For a less demanding improvement measure (ASAS20), the reported figures were 29.8% for placebo, 48.2% for every-four-weeks, and 46.9% for every-two-weeks. The reported data also shows changes in disease activity scores: the placebo group's average disease activity score (ASDAS) changed by −0.11, compared with −1.16 and −1.13 for the two ixekizumab groups. Similarly, other symptom scores — covering daily functioning (BASFI) and overall disease activity (BASDAI) — showed larger average reductions in the ixekizumab groups than in the placebo group, though all figures are as reported and reflect group averages rather than individual 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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• NCT01863732 · results posted 30 July 2019

  According to the results reported on ClinicalTrials.gov, this trial involved 274 people in total across four groups. All participants had ankylosing spondylitis (a type of inflammatory spinal arthritis) and were receiving the medicine secukinumab (also called AIN457). Two groups had been on secukinumab (at either a 75 mg or 150 mg dose) from the start of the original trial, while two other groups had started on a placebo (a dummy treatment with no active ingredient) before switching to secukinumab. The trial was measuring whether improvements in symptoms held up over a long follow-up period — from about two years (week 104) through to five years (week 260). The main thing being tracked was a score called ASAS 20, which measures whether a person's symptoms improved by at least 20% across several areas relevant to their condition. The reported data shows that across the three time points measured between years two and five, roughly 70–85% of participants in each group were recorded as meeting this threshold. A related measure, ASAS 40 (at least 40% improvement across those same areas), showed that roughly 49–69% of participants across the groups were recorded as meeting that higher bar at the various time points. No formal statistical comparisons between the groups were carried out by the researchers, so the numbers are descriptive only. It is worth noting that the number of participants who completed the full study was lower than those who started — for example, 87 of the original 100 in the 75 mg group and 75 of the original 87 in the 150 mg group finished the study, meaning some participants' results were not included in the later 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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• NCT02897115 · results posted 5 July 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02897115) enrolled 22 people with ankylosing spondylitis (a type of inflammatory spinal arthritis) — 14 in a "treat-to-target" group, where treatment was actively adjusted to reach a specific disease activity goal, and 8 in a "standard of care" group, who received usual treatment without that structured target. The trial ran for 32 weeks and measured disease activity, quality of life, and the impact on work and daily activities. It is worth noting that only 3 participants in the treat-to-target group and none in the standard of care group were recorded as having completed the study, meaning a large proportion did not finish. The reported data shows that the main thing being measured was the percentage of participants whose disease activity score (a combined measure called ASDAS, which uses things like back pain ratings and a blood inflammation marker) fell into the "inactive disease" range at week 32. According to the results reported on ClinicalTrials.gov, 80% of participants in the treat-to-target group reached that inactive disease threshold, compared with 0% in the standard of care group. For quality of life (measured on a scale from 0 to 1, where 1 represents full health), the treat-to-target group's score changed by +0.446 from the start of the trial, while the standard of care group's score changed by −0.287 — though it should be noted the data as submitted appears to contain some duplicate or unclear entries for several of these secondary measures. The reported data also shows changes in work and daily activity scores, where a negative number means less impairment reported. In the treat-to-target group, scores for work impairment while present at work changed by −23.3 percentage points, time missed from work by −100 percentage points, total work productivity impairment by −90 percentage points, and overall daily activity impairment by −36 percentage points. In the standard of care group, all of these scores moved in the opposite direction, increasing by between 20 and 30 percentage points, indicating more reported impairment over time. Because so few participants completed the trial, these numbers are based on a very small sample and should be interpreted with great 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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• NCT02159053 · results posted 10 April 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02159053) enrolled 350 people in total across three groups: 116 received secukinumab 150 mg with a "loading dose" (extra doses at the start), 117 received secukinumab 150 mg without a loading dose, and 117 received a placebo (an inactive treatment). The trial was measuring how people with ankylosing spondylitis — a type of inflammatory spinal condition — responded to the medication compared to placebo, using a range of standardised questionnaires and blood tests over 16 weeks. The reported data shows that for the main outcome — the proportion of participants who met a standard set of improvement criteria across four areas (overall disease activity, back pain, physical function, and morning stiffness) — 60.5% in the loading-dose group, 65.5% in the no-loading-dose group, and 49.1% in the placebo group reached that threshold at 16 weeks. For a stricter version of those same criteria (requiring greater improvement), the reported figures were 39.5%, 38.2%, and 29.5% respectively. A blood marker linked to inflammation (high-sensitivity C-reactive protein) showed reported average changes of −4.23 and −6.57 (in ratio units) for the two secukinumab groups, compared to +0.62 for the placebo group. On a disease activity score (rated 0–10, where higher means worse), the reported average reductions from starting scores were approximately 2.4 and 2.5 points for the secukinumab groups, and 1.9 points for the placebo group. A physical quality-of-life score (where higher numbers mean less disability) showed reported average increases of about 6.8 and 7.2 points in the secukinumab groups, and 4.7 points 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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• NCT02407223 · results posted 13 March 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02407223) enrolled 356 people with ankylosing spondylitis (a type of inflammatory spinal arthritis) across three groups: 116 received a placebo (an inactive treatment), 118 received ustekinumab at a 45 mg dose, and 122 received ustekinumab at a 90 mg dose. The trial was measuring how participants responded to treatment at 24 weeks using several standardised scoring tools that assess things like back pain, physical function, morning stiffness, and overall disease activity. It is worth noting that the data shows no participants were recorded as having formally "completed" the study under that milestone category, which may reflect how the trial's design tracked participants through different phases such as early escape and crossover points. The reported data shows that for the main outcome — the proportion of participants achieving a meaningful improvement on a standard disease activity score (called ASAS 20, which measures at least a 20% improvement across several symptom areas) — the figures at week 24 were 47.6% in the placebo group, 55.4% in the ustekinumab 45 mg group, and 49.4% in the ustekinumab 90 mg group. For a higher level of improvement (ASAS 40, meaning at least 40% improvement), the reported figures were 25.6%, 33.7%, and 28.2% respectively. The proportion of participants reaching a disease activity score considered "inactive" was reported as 7.3% (placebo), 14.5% (45 mg), and 12.9% (90 mg). The reported data also shows that on a measure of physical function (the BASFI scale, where lower numbers indicate fewer limitations), all three groups showed a reduction from their starting scores at week 24: −2.11 for placebo, −2.28 for the 45 mg group, and −1.90 for the 90 mg group. A blood marker of inflammation (high-sensitivity C-reactive protein) also showed reductions across all groups over the 24 weeks, with the largest reductions reported in the ustekinumab 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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• NCT02333383 · results posted 15 January 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 201 people with a condition called ankylosing spondylitis — a type of inflammatory arthritis that mainly affects the spine. Of those who started, 160 completed the study and 41 did not finish. The trial was measuring how often participants experienced certain joint-related complications alongside their spinal condition, specifically: swelling in joints outside the spine (peripheral arthritis), tenderness where tendons or ligaments attach to bone (enthesitis), and swelling of fingers or toes (dactylitis). Participants were treated with a medicine called adalimumab and were assessed at multiple points during the study. The reported data shows that at the start of the study (before any treatment), approximately 46% of participants had peripheral arthritis, about 33% had enthesitis, and roughly 3% had dactylitis. For those who had enthesitis at the beginning, scores on a standardised tenderness scale (ranging from 0 to 13, where higher means worse) were reported to have decreased by between 1.85 and 2.50 points across different time points — with negative numbers indicating a reduction in tenderness sites. Among participants who had dactylitis at the start, scores on a digit inflammation scale (0 to 20) were reported to have decreased by between 3.83 and 5.00 points across time points. For those with swollen joints at the start, the count of tender joints was reported to have decreased by between 1.82 and 2.60 across time points. A separate measure called the BASDAI — a questionnaire where patients rate their symptoms — showed that between 128 and 142 participants (out of those assessed at each time point) achieved at least a 50% improvement in their score from their starting point, though the number assessed varied across visits. 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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• NCT02438787 · results posted 1 October 2018

  According to the results reported on ClinicalTrials.gov, this trial (NCT02438787) enrolled 315 people with ankylosing spondylitis (a type of inflammatory spinal arthritis) across three groups: 104 received a placebo (an inactive treatment), 106 received ustekinumab at a 45 mg dose, and 105 received ustekinumab at a 90 mg dose. The main thing the trial was measuring was whether participants reached a defined level of improvement in their symptoms — including back pain, physical function, and inflammation — by week 24. A number of secondary measures looked at different ways of scoring disease activity and physical ability. The reported data shows that for the primary measure (a scoring system called ASAS 40, which captures meaningful improvement across several symptom areas), 12.3% of people in the placebo group, 19.2% in the 45 mg group, and 26.9% in the 90 mg group reached that threshold at week 24. For a related but slightly less stringent measure (ASAS 20), the reported figures were 27.4%, 31.5%, and 37.3% respectively. On a separate disease activity scoring tool (BASDAI 50, measuring at least a 50% improvement in disease severity), 11.0% of the placebo group, 15.1% of the 45 mg group, and 28.4% of the 90 mg group met the threshold. Scores measuring physical function (BASFI) showed average reductions from baseline of −1.29 (placebo), −1.74 (45 mg), and −2.17 (90 mg) on a 0–10 scale, where lower numbers indicate less limitation. Very few participants in any group reached the threshold for "inactive disease" on another scoring tool (0%, 2.7%, and 3.0% respectively). The reported data also shows changes in a blood marker of inflammation (hsCRP), though multiple time-point figures were provided in the data and their individual timepoints were not clearly labelled in the submission, so a full breakdown cannot be described here without risk of misrepresentation. It is also worth noting that a large proportion of participants across all three groups did not complete the study as originally assigned — for example, 43 people in the placebo group crossed over to active treatment at week 24, which is a common design feature in these types of trials. 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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• NCT02186873 · results posted 13 November 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT02186873) enrolled 208 people in total — 103 in a group that started on a placebo (a dummy treatment) before switching to golimumab, and 105 in a group that received golimumab from the start. The trial was measuring responses in people with a form of spinal arthritis, looking at whether their symptoms — including back pain, stiffness, fatigue, and ability to carry out daily activities — changed over 16 weeks. By the end of the study, 94 participants in the placebo-then-golimumab group and 97 in the golimumab group had completed the trial. The reported data shows that for the primary outcome — the proportion of participants who had at least a 20% improvement on a standard arthritis symptom scale (called ASAS 20) by week 16 — 26.2% of the placebo group and 73.3% of the golimumab group met that threshold. For a stricter measure requiring at least 40% improvement (ASAS 40), the reported figures were 8.7% in the placebo group and 47.6% in the golimumab group. On another standard measure of disease activity (BASDAI 50, meaning a 50% improvement in a self-rated symptom score), 14.6% of the placebo group and 41.0% of the golimumab group reached that level. The reported data also shows changes in physical function and quality-of-life scores. On a physical function scale of 0–10 (where lower is better), the placebo group's average score decreased by 0.471 points and the golimumab group's by 2.386 points from where they started. On a general health quality-of-life survey scored out of 100 (where higher is better), the physical health component improved by an average of 2.86 points in the placebo group and 8.52 points in the golimumab group, while the mental health component improved by 0.78 points and 6.47 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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• NCT01061723 · results posted 8 August 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01061723) enrolled 301 people with ankylosing spondylitis (a type of inflammatory spinal arthritis) across six groups. Fifty or so participants were assigned to each group: one group received a placebo (a dummy injection with no active medicine), and the other five received different doses and dosing schedules of a medicine called sarilumab. The trial ran for 12 weeks and was mainly measuring how many participants experienced a meaningful improvement in their symptoms — specifically a 20% reduction in scores across several areas including pain, physical function, and overall wellbeing. The reported data shows that for the primary measure — the proportion of people who met the 20% improvement threshold at week 12 — the placebo group came in at 24%, while the sarilumab groups ranged from about 19% (100 mg weekly) up to 38% (150 mg weekly). For a stricter 40% improvement threshold, the placebo group was at 8%, and the sarilumab groups ranged from roughly 6% to 20%. The reported data also shows that a small number of participants in each group reached what was defined as "partial remission" (very low scores across all four symptom areas), ranging from about 2% in several groups up to around 8% in two of the sarilumab groups and the 100 mg every-two-weeks group. On two additional scales measuring disease activity and physical function (the ASDAS and BASDAI scores, where lower numbers mean less disease activity), all groups — including placebo — showed some decrease from their starting scores over the 12 weeks, with the reported reductions in the sarilumab groups generally somewhat larger than in the placebo group. Changes in a measure of spinal movement (BASMI) were small and similar 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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• NCT01118728 · results posted 21 June 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 223 people with ankylosing spondylitis (a type of inflammatory back condition) who received a medicine called sarilumab. The trial was measuring two main things: first, how many participants experienced unwanted medical events (called adverse events) during treatment; and second, how many participants showed a meaningful improvement in their symptoms according to a standard scoring system used in ankylosing spondylitis research. It is noted in the data that none of the 223 participants were recorded as having "completed" the study under that category, with all 223 listed as "not completed" — though this likely reflects how the study's administrative milestones were recorded rather than meaning everyone dropped out. The reported data shows that, for the primary outcome looking at unwanted medical events, 67.3% of participants experienced at least one treatment-emergent adverse event (that is, an unwanted medical occurrence that happened or got worse after starting the medicine). Serious adverse events — meaning events that were life-threatening, required hospitalisation, or caused significant disability — were reported in 5.4% of participants. Additionally, 8.1% of participants stopped taking the treatment due to these events. For the secondary outcome, the reported data shows the percentages of participants who met the ASAS20 response — a measure meaning their symptoms improved by at least 20% across several areas including back pain, physical function, morning stiffness, and overall disease activity. The figures reported across different time points were 30.3%, 40.1%, 46.0%, 41.9%, 59.5%, and 57.1%, though the specific time points each figure corresponds to were not included 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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• NCT01668004 · results posted 3 August 2016

  According to the results reported on ClinicalTrials.gov, this trial (NCT01668004) enrolled 101 adults with ankylosing spondylitis (a type of inflammatory spinal condition) who were given a medication called golimumab (GLM) at a dose of 50 mg. Of the 101 people who started and received treatment, 76 completed the study and 25 did not finish. The trial was mainly looking at whether the rate of a painful eye inflammation called uveitis — a known complication of ankylosing spondylitis — changed after people started golimumab, comparing the year before treatment to the year after. It also looked at disease activity scores and rates of other related conditions affecting the gut and skin. The reported data shows that in the year before starting golimumab (or another similar medication), there were 9.8 new uveitis (eye inflammation) attacks per 100 people per year. In the year after starting golimumab, that figure was reported as 2.2 new attacks per 100 people per year. A separate measure — looking at the overall proportion of people who experienced a uveitis attack at any point during each one-year period — was reported as 0.08 (or 8 in 100) for both the period before and after treatment. For the secondary outcomes, the reported data shows that 33% of participants reached a 50% improvement threshold on a standard disease activity questionnaire (called BASDAI) at three months. On another disease activity measure (called ASDAS), 40.5% of participants reached a "clinically important improvement" level and 19% reached a "major improvement" level at three months. The data for rates of gut inflammation (IBD) and skin condition (psoriasis) was not reported in the results 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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• NCT01091675 · results posted 10 June 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01091675) involved 57 people who were given a medicine called etoricoxib. The trial was looking at a condition called Ankylosing Spondylitis — a type of inflammatory arthritis that mainly affects the spine. Of the 57 people who started the trial, 23 completed it and 34 did not finish. The main thing the trial set out to measure was how many participants met a specific set of response criteria known as ASAS criteria. To assess this, researchers used a scoring tool called the BASDAI (Bath Ankylosing Spondylitis Disease Activity Index), which asks six questions about symptoms and uses a scale of 1 to 10. A participant was considered to have met the response criteria if their BASDAI score improved by at least 2 points. The reported data shows that 19% of participants met this response threshold. No secondary outcome measure data was included in the submitted results. It is also worth noting that a large number of participants — 34 out of 57 — did not complete the trial, which the reported data does not explain further. 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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• NCT01583374 · results posted 17 March 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01583374) looked at a medicine called apremilast in people with ankylosing spondylitis, a type of inflammatory arthritis affecting the spine. A total of 490 people took part in the first phase of the trial, split across three groups: 164 received a placebo (a dummy pill with no active ingredient), 163 received apremilast at a lower dose (20 mg), and 163 received apremilast at a higher dose (30 mg). The main thing the trial was measuring was how many people in each group showed a meaningful improvement — at least 20% better — across four areas: overall disease activity, back pain, physical function, and morning stiffness. This was assessed at Week 16. The reported data shows that at Week 16, approximately 36.6% of people in the placebo group, 35.0% in the apremilast 20 mg group, and 32.5% in the apremilast 30 mg group met that improvement threshold. For the secondary measures reported at Week 24, the numbers were similarly close across all three groups. For example, the percentage of people meeting the same improvement threshold at Week 24 was reported as 31.7% (placebo), 36.2% (apremilast 20 mg), and 33.7% (apremilast 30 mg). Changes in physical function scores, disease activity scores, and quality-of-life scores were also small and broadly similar across all three groups 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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• NCT01209702 · results posted 11 February 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT01209702) involved people with ankylosing spondylitis — a type of inflammatory arthritis mainly affecting the spine. A total of 306 participants took part across two parts of the study. In Part 1, 51 people received a placebo (an inactive treatment) and 51 received tocilizumab. In Part 2, 51 received a placebo and 153 received tocilizumab. The trial was measuring whether tocilizumab led to meaningful improvements in participants' symptoms, including pain, physical function, morning stiffness, and their overall sense of how their condition was affecting them. The reported data shows that the main goal of the trial — known as the primary outcome — was to look at the percentage of participants who achieved at least a 20% improvement across several symptom areas by week 12 (this is called an ASAS20 response). In Part 1, 37.3% of those who received tocilizumab and 27.5% of those who received the placebo reached this level of improvement. For a stricter measure of improvement (40% across symptom areas, or ASAS40) at week 12, the reported figures were 11.8% for the tocilizumab group and 19.6% for the placebo group. The reported data also shows that in Part 2 at week 24, 0% of participants in both the placebo and tocilizumab groups met the ASAS20 response threshold, though it is worth noting that very few participants remained in Part 2 at that stage. For a measure of disease activity called the BASDAI score (rated 0–10, where lower is better), both groups started with scores around 6.4–6.9, and both showed modest reductions by the end of their respective treatment periods; the changes reported ranged from approximately –0.53 to –1.17 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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• NCT01209689 · results posted 17 January 2013

  According to the results reported on ClinicalTrials.gov, this trial (NCT01209689) enrolled 113 people in total — 91 received the medicine tocilizumab (at a dose of either 4 or 8 mg/kg) and 22 received a placebo (a dummy treatment with no active ingredient). The trial was investigating a condition called ankylosing spondylitis, a form of inflammatory arthritis affecting the spine. The main thing the trial set out to measure was how many participants in each group met a specific improvement threshold — known as ASAS20 — by week 12. This threshold counted someone as a "responder" if they reported at least a 20% improvement across areas including overall wellbeing, pain, physical function, and morning stiffness. It is worth noting that the reported data shows that none of the participants were recorded as having "completed" the study in the formal milestone tracking, which may reflect how the trial's data was entered rather than what actually happened. The reported data shows that at week 12, approximately 12.7% of participants in the tocilizumab group met the ASAS20 responder threshold, compared with 14.3% of participants in the placebo group. In plain terms, that means roughly 1 in 8 people receiving tocilizumab and roughly 1 in 7 people receiving the placebo reached that level of improvement by that point. No other outcome measure results were included in the data submitted to ClinicalTrials.gov, so further detail on secondary outcomes was not reported and cannot be described 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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• NCT00247962 · results posted 8 November 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 566 people with ankylosing spondylitis (a type of inflammatory arthritis that mainly affects the spine). Participants were split into two groups: 379 received etanercept and 187 received sulphasalazine, both existing medicines used for this condition. The trial's main goal was to measure how many people in each group achieved a recognised level of symptom improvement, known as "ASAS 20" — meaning at least a 20% improvement across key areas such as pain, physical function, and overall disease activity, rated on a 0–100 scale. The reported data shows that, for the primary measure, 287 out of 379 participants in the etanercept group and 99 out of 187 participants in the sulphasalazine group reached the ASAS 20 level of improvement. The trial also measured quality of life using a questionnaire called ASQoL, where scores range from 0 (better quality of life) to 18 (worse quality of life). The reported data shows that the etanercept group started with an average score of around 11.03 and this changed to 6.21 by the end of the study period, while the sulphasalazine group started at around 11.32 and reached 9.06. It should be noted that the exact timing of these follow-up scores was not fully 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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• NCT00939003 · results posted 6 March 2012

  According to the results reported on ClinicalTrials.gov, this trial enrolled 192 people in total — 97 received a placebo (an inactive dummy treatment) and 95 received adalimumab, a medication being studied for a type of inflammatory back condition. The trial had two stages: a blinded phase where neither participants nor researchers knew who was receiving which treatment, followed by an open-label phase where everyone received the active medication. The main thing the trial measured was how many participants reached a level of improvement called "ASAS40" — meaning they showed at least a 40% improvement across several areas including pain, overall disease activity, physical function, and morning stiffness. The reported data shows that in the blinded treatment phase, 33 out of 95 people in the adalimumab group reached the ASAS40 improvement threshold, compared with 14 out of 97 people in the placebo group. For a less demanding measure of improvement (ASAS20, requiring at least 20% improvement), the reported figures were 47 in the adalimumab group versus 29 in the placebo group. On another measure called BASDAI50 — a 50% reduction in a disease activity score — 32 people in the adalimumab group and 14 in the placebo group met that threshold. A smaller number in each group reached what researchers defined as "partial remission" (very low scores across all four areas): 15 in the adalimumab group and 5 in the placebo group. The trial also measured quality-of-life scores using a standard questionnaire (SF-36 physical component); the reported average change from the starting score was 5.5 points in the adalimumab group and 2.0 points in the placebo group, where a higher number indicates greater improvement. Regarding side effects, the reported data shows that 55 out of 95 people in the adalimumab group and 57 out of 97 people in the placebo group experienced at least one adverse event (an unwanted health event) during the blinded phase; no further breakdown of those events is included 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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• NCT01114880 · results posted 4 November 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 344 people in total — 229 received adalimumab and 115 received a placebo (an inactive treatment used for comparison). The trial was looking at a condition involving inflammatory back pain, and it ran in two back-to-back periods: the first 12 weeks, then a further 12 weeks through to week 24. The main thing the trial was measuring was how many participants met a set of pre-defined response criteria — known as ASAS20 — which required a person to show at least a 20% improvement across several areas including their own rating of disease activity, back pain, physical function, and morning stiffness. The reported data shows that at the end of the first 12-week period (the primary measurement point), 154 out of 229 participants in the adalimumab group met the ASAS20 response criteria, compared with 35 out of 115 in the placebo group. By the end of week 24, the reported data shows 180 participants in the adalimumab group and 85 in the group that had switched from placebo to adalimumab met the ASAS20 criteria. For a stricter version of the response measure (ASAS40, requiring at least 40% improvement), the reported figures were 102 versus 11 participants at week 12, and 134 versus 63 at week 24. A further measure looking at improvement across five of six health areas (ASAS5/6) showed 128 versus 14 participants at week 12, and 150 versus 69 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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• NCT00762463 · results posted 23 August 2011

  According to the results reported on ClinicalTrials.gov, this trial involved people with Ankylosing Spondylitis — a type of inflammatory arthritis mainly affecting the spine. A total of 240 participants were enrolled at the start, split evenly between two groups: 120 took celecoxib 200 mg and 120 took diclofenac SR 75 mg daily. This first part of the trial ran for 6 weeks. After that, participants who were still in the study could enter a 6-week extension phase, where some were switched to a higher dose of celecoxib 400 mg. The trial's main focus was measuring how participants themselves rated their overall pain, using a sliding scale from 0 (no pain) to 100 (worst possible pain). The reported data shows that at the start of the trial, both groups rated their pain at similar levels — around 62.9 mm for the celecoxib group and 63.6 mm for the diclofenac group. By week 6, the celecoxib group's average pain score had dropped by 23.8 mm from their starting point, while the diclofenac group's dropped by 27.1 mm. At weeks 2 and 4, both groups also reported lower pain scores compared to their starting levels, with changes ranging from roughly 18 to 23 mm. By week 12, the reported changes from baseline ranged from about 21 to 31 mm across all four groups, depending on whether participants stayed on their original medication or switched to the higher celecoxib dose. The reported data also shows that participants rated their overall sense of how their Ankylosing Spondylitis was affecting them on a 1-to-5 scale (where 1 is very good and 5 is very poor). Changes from baseline in this rating were small across both groups and all time points measured, ranging from approximately −0.3 to −0.6 across weeks 2, 4, 6, and 12. 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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• NCT00085644 · results posted 11 March 2010

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called adalimumab in people with ankylosing spondylitis, a type of inflammatory back condition. The trial had two stages: a blinded phase (where neither doctors nor participants knew who received the real medicine or a dummy treatment) and a later open-label phase (where everyone received adalimumab). In the blinded phase, 208 people received adalimumab and 107 received the placebo (dummy treatment). In the open-label phase that followed, 311 participants received adalimumab, and 202 of those completed it. The trial measured changes in symptoms using standardised scoring tools, as well as any changes visible on spinal X-rays over two years. The reported data shows that during the blinded phase, 121 out of 208 people in the adalimumab group met the threshold for a meaningful reduction in symptoms on a standard scoring tool (called ASAS 20, which looks at things like back pain, physical function, and overall disease activity), compared with 22 out of 107 in the placebo group. For the X-ray measure of spinal changes over two years, the reported average change in score for those who received adalimumab was 0.9 points on a scale of 0 to 72, which was also compared against a separate historical patient group. During the longer open-label phase, the number of participants meeting the ASAS 20 threshold at various time points across five years ranged from around 153 to 204. On a scale measuring how patients rated their own disease activity (0 = no activity, 100 = severe), the reported average change from starting point ranged from about −25 to −41 points across the follow-up period. The reported data also shows that when higher thresholds for symptom reduction were applied (ASAS 50 and ASAS 70, meaning larger improvements were required), fewer participants met those thresholds at each time point — for example, ASAS 50 responses ranged from about 105 to 144 participants, and ASAS 70 responses from about 62 to 102 participants across the five-year follow-up 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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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.