Reported trial results for Gout

52 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

• NCT04762498 · results posted 19 May 2026

  According to the results reported on ClinicalTrials.gov, this trial (NCT04762498) looked at two different doses of a medicine called pegloticase, given together with another medicine called methotrexate, in people with gout. A total of 54 people entered an initial run-in phase where they took methotrexate alone; 51 of them moved on to receive pegloticase. From there, 25 people were assigned to the lower dose (16 mg of pegloticase plus methotrexate) and 26 to the higher dose (30 mg plus methotrexate). The trial measured how the drug moved through the body (pharmacokinetics) and tracked levels of uric acid in the blood — uric acid being the substance that builds up and causes gout symptoms. The reported data shows that after the first dose, the peak blood concentration of pegloticase was 6.09 µg/mL in the 16 mg group and 11 µg/mL in the 30 mg group. By week 24, the pre-dose (trough) blood concentration was 1.33 µg/mL in the 16 mg group and 2.76 µg/mL in the 30 mg group. Regarding uric acid levels, the trial tracked how often participants had a pre-infusion uric acid reading below 6 mg/dL (a commonly used threshold in gout management). The reported data shows that at several scheduled visits across the 24-week treatment period, roughly 78–91% of participants in the 16 mg group and 83–88% of participants in the 30 mg group had uric acid levels below that threshold. Over the full 24-week period, participants in both groups spent approximately 87% of the time with uric acid levels below 6 mg/dL, according to the reported figures. 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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• NCT05289544 · results posted 6 March 2026

  According to the results reported on ClinicalTrials.gov, this trial involved 267 adults who were split into two groups. One group (132 people) took part in a phone-based walking program called "Walk With Ease" straight away, while the other group (135 people) was placed on a delay before joining the same program. The trial was measuring two main things: changes in pain levels, and changes in physical function (specifically, how many times participants could stand up from a chair in 30 seconds). By the end of the study, 109 people in the first group and 115 in the second group had completed the trial. The reported data shows that pain was measured using a scale from 0 mm (no or low pain) to 100 mm (high pain). Across three separate measurement points, the immediate program group's pain scores changed by −4.0, −1.04, and −5.02 on that scale, while the delayed group's scores changed by −4.49, +0.35, and −4.89. A negative number here means the score went down (i.e., lower on the pain scale) and a positive number means it went up slightly. For the chair stand test — where participants stood up and sat down as many times as they could in 30 seconds — the reported data shows the immediate program group's count changed by +0.98, +1.0, and +0.79 repetitions across three measurement points, while the delayed group's count changed by +0.48, +0.69, and +0.45 repetitions. A positive number here means participants completed more repetitions on average. It is worth noting that the data as submitted does not clearly label which measurement point (for example, which week or month) each set of numbers belongs to, so the timing of these results cannot be confirmed from the information 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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• NCT04746989 · results posted 27 February 2026

  According to the results reported on ClinicalTrials.gov, this trial compared two existing medicines — probenecid and allopurinol — and looked at how often people developed dementia over time. The study drew on a very large pool of records, starting with over 8,100 people in the probenecid group and more than 286,000 in the allopurinol group, though the final matched comparison used 8,115 people in each group. The main thing being measured was the rate at which participants received a dementia diagnosis (including Alzheimer's disease, vascular dementia, and several related conditions), expressed as the number of new cases per 1,000 years of combined follow-up time across all participants. The reported data shows several sets of incidence rates (new cases per 1,000 person-years — meaning how many diagnoses occurred across every 1,000 years of combined follow-up time in that group). Across the different measurements recorded, the probenecid group returned figures of 14.44, 22.07, 15.87, and 4.96 per 1,000 person-years. The allopurinol group returned corresponding figures of 18.23, 19.40, 17.54, and 6.29 per 1,000 person-years. The trial report does not provide labels explaining what each individual pair of numbers refers to (for example, different time points or subgroups), so those details are not available 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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• NCT04596540 · results posted 3 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04596540) enrolled 153 adults across three groups: 51 received a lower dose of SEL-212 (called SEL-212A), 49 received a higher dose (SEL-212B), and 53 received a placebo (a dummy treatment with no active ingredient). All participants received at least one dose of their assigned treatment. The trial was primarily measuring whether the treatment could bring a substance in the blood called uric acid — which builds up in people with gout — below a target level of 6 mg/dL (milligrams per decilitre) and keep it there for at least 80% of the time during the sixth month of the study. The reported data shows that in the sixth month, 40% of participants in the low-dose group and 46% in the high-dose group met this uric acid target, compared with 11% in the placebo group. For secondary measures, the reported average reduction in uric acid from the start of the study was 4.0 mg/dL in the low-dose group, 5.1 mg/dL in the high-dose group, and 0.6 mg/dL in the placebo group. The reported data also shows changes in a quality-of-life physical score (where higher numbers mean better self-reported physical health): the low-dose group showed a change of +10.4 points, the high-dose group +8.4 points, and the placebo group +3.8 points. Among participants who had visible uric acid deposits (called tophi) at the start of the study, 83% in the low-dose group and 93% in the high-dose group showed at least a 50% reduction in the size of at least one deposit by the end of the study, compared with 54% 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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• NCT03934099 · results posted 3 December 2025

  According to the results reported on ClinicalTrials.gov, this trial tested an investigational medicine called LC350189 at three different doses — 50 mg, 100 mg, and 200 mg — compared to a placebo (a dummy treatment with no active ingredient). The trial was measuring levels of uric acid in the blood, specifically a substance called serum uric acid (sUA). High uric acid in the blood is associated with gout. A total of 143 people took part across the four groups, and 128 of them completed the study. The reported data shows that the main thing being measured was the proportion of participants whose blood uric acid level dropped below 5.0 mg/dL (a unit used to measure concentration in the blood) by Day 84 of the trial. According to the results reported on ClinicalTrials.gov, in the 50 mg group, 47.1% of participants reached that level; in the 100 mg group, 44.7% did; and in the 200 mg group, 62.2% did. In the placebo group, 2.9% reached that level. A second threshold — below 6.0 mg/dL — was also measured, with 58.8%, 63.2%, and 78.4% of participants in the 50 mg, 100 mg, and 200 mg groups respectively reaching it, compared to 2.9% in the placebo group. The reported data also shows the maximum percentage reduction in uric acid levels during the study: the 50 mg group saw an average reduction of 46.67%, the 100 mg group 50.64%, and the 200 mg group 66.79%, while the placebo group saw a reduction of 11.20%. 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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• NCT04075903 · results posted 3 December 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT04075903) enrolled a total of 200 participants who were split into two groups: 135 people in the intervention group and 65 people in a control group. All 200 participants completed the study with no drop-outs recorded. The trial was measuring things related to gout — a type of painful joint condition — and tracked whether participants visited a GP or specialist for gout-related care during the study period. The reported data shows one primary outcome measure: the number of participants in each group who attended an outpatient visit to a primary care doctor or specialist for gout treatment. According to the results reported on ClinicalTrials.gov, 64 out of 135 participants in the intervention group attended such a visit, compared with 35 out of 65 participants in the control group. No additional outcome measures — such as secondary outcomes or any details about side effects — appear to have been submitted in the structured results data available, so those figures 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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• NCT05007392 · results posted 30 July 2025

  According to the results reported on ClinicalTrials.gov, this trial (NCT05007392) enrolled 226 people in the febuxostat group and 225 in the dotinurad group — 451 participants in total. The trial was comparing two medicines used to lower uric acid levels in the blood (high uric acid is associated with gout). The main thing the trial was measuring was how many participants reached a blood uric acid level at or below 6.0 mg/dL (milligrams per deciliter, a standard target level) after 24 weeks of treatment. Around 197–220 participants per group were included in the various analyses, with some dropping out before the study ended. The reported data shows that at the 24-week mark — the trial's primary measurement point — 38.1% of participants in the febuxostat group and 73.6% in the dotinurad group had uric acid levels at or below the 6.0 mg/dL target. At the earlier 12-week check, the reported figures were closer: 50.5% for febuxostat and 55.5% for dotinurad. Looking at how uric acid levels changed over time, both groups started with a similar average uric acid level of around 9.65–9.67 mg/dL. The reported data shows that by week 16, the average level had fallen to around 6.24 mg/dL in the febuxostat group and 4.65 mg/dL in the dotinurad group, with similar patterns continuing through weeks 20 and 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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• NCT03636373 · results posted 27 October 2023

  According to the results reported on ClinicalTrials.gov, this trial enrolled a very small number of people — 3 participants received etanercept (a medicine that targets inflammation) and 2 received triamcinolone acetonide (a corticosteroid injection), giving a total of 5 participants. One person in the etanercept group did not finish the trial. The trial was measuring joint pain levels and how patients and doctors rated the response to treatment in people with an acutely painful joint condition. The reported data shows that the main thing being measured was joint pain intensity at 72 hours after treatment, rated on a 0–10 scale (where 0 means no pain and 10 means intense pain). Participants in the triamcinolone acetonide group reported an average pain score of 1.5 at that point, while those in the etanercept group reported an average score of 5. For secondary measures, the reported data shows that pain scores in both groups were higher at the start and generally lower at later time points. In terms of how patients rated their overall response to treatment, 2 of the triamcinolone acetonide participants rated it as "good," while in the etanercept group, 1 rated it as "none" and 1 as "good." Regarding the use of extra pain relief ("rescue medication"), 1 of 2 triamcinolone acetonide participants and 2 of 3 etanercept participants used it at some point during the study. Adverse events (unwanted side effects) were reported in 1 participant from each group, with serious adverse events reported in 1 triamcinolone acetonide participant and 2 etanercept participants, though no further detail on the nature of these events was provided in the submitted data. It is important to note that with only 5 participants in total, this trial was extremely small, and the numbers above reflect very few individuals. 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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• NCT03905512 · results posted 17 October 2023

  According to the results reported on ClinicalTrials.gov, this trial compared two treatments for gout — an investigational treatment called SEL-212 and an existing treatment called KRYSTEXXA. A total of 83 people were assigned to the SEL-212 group and 87 to the KRYSTEXXA group, making 170 participants in all. The trial was primarily measuring how many people in each group had their blood uric acid level (a key marker in gout) kept below a target level of 6 mg/dL for at least 80% of the time across months 3 and 6 of the study. The reported data shows that for the main (primary) outcome — keeping uric acid below the target for at least 80% of the time across those two months — 44 out of 83 participants in the SEL-212 group and 40 out of 87 in the KRYSTEXXA group met that measure. For one of the secondary outcomes, looking only at month 6, 45 SEL-212 participants and 41 KRYSTEXXA participants kept their uric acid below the target for at least 80% of the time; when looking at 100% of the time during month 6, the numbers were 38 and 36 respectively. The trial also measured quality of life using several questionnaires. The reported data shows small changes from the start of the study in both groups across measures of physical disability, overall disease severity, and general health — with both groups showing some degree of change in most of these scores, though the specific meaning of each number depends on the scale used for that questionnaire. 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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• NCT04087720 · results posted 26 July 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT04087720) enrolled 20 people who received a treatment called pegloticase, which is given by infusion. The trial was looking at whether the treatment could lower a substance in the blood called uric acid (high levels of which are linked to gout) to below certain target levels, and also whether participants reported changes in pain and day-to-day functioning over 24 weeks. Fifteen of the 20 participants completed the study, and five did not. The reported data shows that for the main outcome — the proportion of participants who kept their blood uric acid level below 6 mg/dL for at least 80% of the time during the sixth month of the study — 88.9% of participants met this target. For a stricter secondary target of below 5 mg/dL over the same period, the reported figure was also 88.9%. The trial also tracked self-reported pain scores (on a 0–100 scale, where 0 means no pain and 100 means severe pain) and a measure of physical disability in daily life (on a 0–3 scale, where higher numbers mean greater difficulty). The reported data shows that pain scores appeared to decrease from the starting point at several points during the study, with changes ranging from around −16 to −35 points across the time periods measured. Similarly, the disability score appeared to decrease from the starting point, with reported changes ranging from approximately −0.25 to −0.52 across the measured time points. The data does not specify the exact time points associated with each of these individual figures. 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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• NCT04067492 · results posted 25 July 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 47 people across six groups to test different doses of an investigational treatment called RPH (at 4 mg, 20 mg, 40 mg, 80 mg, and 160 mg doses) compared with a known anti-inflammatory gel, Voltaren® (diclofenac). The trial was measuring changes in joint pain, swelling, tenderness, and redness over time, with the main focus being how much joint pain changed after 72 hours of treatment. Pain was measured using a 100 mm scale where 0 meant no pain at all and 100 meant the worst pain imaginable. Most participants completed the study — only three people across all groups did not finish. The reported data shows that at the 72-hour mark, pain scores had changed from where they started (baseline) by the following amounts on that 100 mm scale: the RPH 4 mg group dropped by about 7.9 mm; RPH 20 mg dropped by about 38.6 mm; RPH 40 mg dropped by about 19.8 mm; RPH 80 mg dropped by about 33.4 mm; RPH 160 mg dropped by about 30.6 mm; and the Voltaren® group dropped by about 36.5 mm. For the secondary outcomes, the reported data shows only small numbers of participants in each group rated their response to treatment as "excellent" or "good" at the early time points reported. Similarly, very few participants showed recorded changes in joint swelling or tenderness across the groups, and data on joint redness (erythema) was also collected across all time points, though detailed breakdowns across every individual time point were not fully reported 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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• NCT03994731 · results posted 16 May 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT03994731) enrolled 152 adults with gout who had not responded well to standard treatments. Participants were split into two groups: 100 people received the drug pegloticase together with methotrexate (a medicine sometimes used to suppress the immune system), and 52 people received pegloticase together with a placebo (a dummy pill with no active ingredient). The trial's main goal was to measure how many people in each group were able to keep their blood uric acid level — the substance that builds up and causes gout — below a target of 6 mg/dL for most of the sixth month of treatment. The reported data shows that at the Month 6 mark (the primary measurement point), 71% of participants in the pegloticase-plus-methotrexate group met the uric acid target, compared with 38.5% in the pegloticase-plus-placebo group. At Month 12, those figures were 60% versus 30.8%. Among participants who had gout "tophi" (lumps under the skin caused by uric acid crystal build-up) at the start of the trial, 53.8% of the methotrexate group and 31.0% of the placebo group had at least one of those lumps fully resolve by Week 52. The reported data also shows changes in three self-reported questionnaire scores at Week 52. For a disability score (where lower means less disability), both groups improved slightly — the methotrexate group's average score dropped by 0.35 points and the placebo group's by 0.31 points, on a scale of 0 to 3. For a self-reported pain score (0 = no pain, 100 = severe pain), the methotrexate group's average score fell by about 31 points and the placebo group's by about 23 points. For an overall health score (0 = very well, 100 = very poor), the methotrexate group's average score fell by about 29 points and the placebo group's by about 19 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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• NCT02959918 · results posted 14 February 2022

  According to the results reported on ClinicalTrials.gov, this trial (NCT02959918) enrolled a total of 152 participants across 14 different treatment groups. The trial was testing two investigational treatments for gout — SEL-037 (also called pegadricase, given on its own) and SEL-212 (a combination of SEL-037 and another drug called SEL-110, given at various doses and schedules). Participants received up to five monthly intravenous (drip) infusions. The trial was primarily looking at how many people in each group experienced serious unwanted health events during treatment. It also measured how many participants had their blood uric acid level (a marker associated with gout) fall below a target level of 6 mg/dL. The reported data shows that, for the primary focus area — tracking serious or notable unwanted health events — the number of participants counted across the 12 groups for which data was provided ranged from 3 people (in the two smallest groups receiving SEL-037 alone) up to 23 people (in the largest SEL-212 combination group). These figures represent the number of participants in each group who were included in the safety review; the data as submitted does not provide a separate breakdown of how many within each group experienced a specific serious event. For the secondary measure — blood uric acid falling below the 6 mg/dL target — the reported data shows that 0 out of the participants receiving SEL-037 alone reached that level by the third treatment point, while 51 out of those receiving the SEL-212 combination for three doses (then SEL-037 for two) did so, and 23 out of those receiving SEL-212 for all five doses reached that level. By the fifth treatment point, the reported figures were: not applicable for the SEL-037-alone group, 27 participants in the three-dose SEL-212 group, and 21 in the five-dose SEL-212 group. The reported data also breaks these uric acid results down by individual dosing sub-groups. Across the various SEL-212 combination arms, the number of participants reaching the uric acid target by the third treatment point ranged from 1 to 12 people per group, while 0 participants in either SEL-037-alone group reached that target. Data for two of the sub-groups at the fifth treatment point 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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• NCT02579096 · results posted 11 January 2022

  According to the results reported on ClinicalTrials.gov, this trial enrolled 940 people in total — 468 in one group and 472 in the other. It was a two-treatment crossover study, meaning participants in one group took allopurinol (a gout medicine) for the first part of the trial, then switched to a dummy version of febuxostat (another gout medicine), while the other group did the reverse. The trial was looking at gout — a painful condition caused by uric acid build-up in the joints — and the main thing it was measuring was how many people experienced at least one gout flare (a sudden, painful attack) during the final phase of the study, which ran from weeks 49 to 72. The reported data shows that by the time the final phase began, 389 people remained in one group and 391 in the other. A gout flare was counted if a participant reported at least three out of four symptoms — warm joints, swollen joints, pain greater than 3 out of 10 at rest, or self-identifying it as a gout flare — or if they took medication to treat a flare. According to the results reported on ClinicalTrials.gov, during this final phase, 135 out of 389 participants in the allopurinol-first group experienced at least one gout flare, compared with 165 out of 391 participants in the febuxostat-first group. No other outcome measures were included in the submitted results data, so further detail beyond this primary result was not 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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• NCT03303989 · results posted 10 November 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03303989) enrolled 35 adults in total — 24 in a group receiving pegloticase (a gout medication given by infusion) combined with mycophenolate mofetil (MMF, an immune-suppressing tablet), and 11 in a group receiving pegloticase combined with a placebo (an inactive tablet). The trial was measuring how many participants could bring their blood uric acid level down to 6 milligrams per deciliter (mg/dL) or lower — a commonly used target in gout management — and keep it there over 12 weeks. Most participants finished the study: 22 out of 24 in the pegloticase-plus-MMF group, and 10 out of 11 in the pegloticase-plus-placebo group. The reported data shows that, for the main outcome — reaching and staying at or below the uric acid target of 6 mg/dL over 12 weeks — 19 out of 24 participants in the pegloticase-plus-MMF group met this target, compared with 4 out of 11 participants in the pegloticase-plus-placebo group. The remaining participants in each group (3 in the MMF group and 6 in the placebo group) did not meet this target over the 12-week period. No secondary outcome data was included in the structured results submitted to ClinicalTrials.gov, so those figures cannot be 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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• NCT03226899 · results posted 4 November 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT03226899) enrolled 242 people with gout — 118 in a group that received a placebo (a dummy tablet) alongside a standard gout medicine called a xanthine oxidase inhibitor (XOI), and 124 in a group that received lesinurad (an additional gout medicine) also alongside a XOI. The trial's main goal was to measure how many participants reached a blood uric acid level below 6.0 mg/dL — a commonly used target level in gout management — after six months of treatment. The reported data shows that none of the participants were recorded as having "completed" the study in the milestone data submitted, though results were still reported for the outcome measures. The reported data shows that for the main measurement at six months, about 33.8% of participants in the placebo plus XOI group reached the uric acid target of below 6.0 mg/dL, compared with about 58.8% in the lesinurad plus XOI group. When uric acid levels were tracked at multiple time points across the study, the reported percentages reaching that target varied — ranging roughly from 10% to 43% in the placebo group and from around 11% to 59% in the lesinurad group at different points in time. In terms of how much uric acid levels changed from the starting point, the reported data shows reductions across both groups at all time points measured, with the lesinurad group generally showing larger reductions in absolute terms across most time points. Two secondary measures — relating to kidney function (estimated creatinine clearance, a way of estimating how well the kidneys filter waste) at 24 months — had no numbers reported in the submitted data, so those figures are not 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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• NCT01431638 · results posted 19 July 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01431638) enrolled 397 people in total — 133 in the Canakinumab pre-filled syringe group, 132 in the Canakinumab lyophilizate (a powder form) group, and 132 in the Triamcinolone Acetonide (a steroid injection) group. The trial was measuring how often unwanted medical events (called adverse events) occurred across the three groups, and also tracked things like how often gout flares happened again, and how participants rated their pain over time. The reported data shows that the primary thing being counted — the number of people who experienced any adverse event — was 78 out of 133 in the pre-filled syringe group, 65 out of 132 in the powder form group, and 64 out of 132 in the steroid group. For new gout flares, the trial used a statistical estimate (a way of calculating the probability of a flare occurring over the study period) — the reported figures were approximately 65.5% for the pre-filled syringe group, 75.4% for the powder form group, and 73.0% for the steroid group. When participants were asked to score their pain on a scale from no pain to unbearable pain (0–100), the reported data shows all three groups started at similar pain levels (around 74–75 out of 100) and all three groups reported reductions in pain scores over the course of the study, with changes ranging from roughly minus 35 to minus 36 points by the later 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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• NCT01470989 · results posted 9 July 2021

  According to the results reported on ClinicalTrials.gov, this trial (NCT01470989) enrolled 456 people in total — 227 received a single injection of canakinumab (150 mg) and 229 received a single injection of triamcinolone acetonide (40 mg), a steroid commonly used for gout flares. The trial followed participants across a core study period and up to three extension periods over a longer timeframe. The main thing the trial was measuring was the rate of unwanted medical events (called adverse events), serious adverse events, and deaths, expressed as how often these occurred per 100 years of combined patient participation time. The reported data shows that in the canakinumab group, adverse events occurred at a rate of 873 per 100 patient-years, compared with 451 per 100 patient-years in the triamcinolone acetonide group. Serious adverse events were reported at a rate of 59 per 100 patient-years for canakinumab and 25 per 100 patient-years for triamcinolone acetonide. Deaths were reported at a rate of 2 per 100 patient-years in both groups. As a secondary measure, the reported data shows the average number of new gout flares per person over the observation period was approximately 1.1 in the canakinumab group and 2.5 in the triamcinolone acetonide group. The trial also asked participants to rate their gout pain on a simple scale; the reported data shows that 102 canakinumab retreatment participants and 72 participants from the other group rated their pain as none or mild at one timepoint, and 104 versus 69 at another timepoint, though further detail on timing was not reported 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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• NCT02287818 · results posted 28 October 2020

  According to the results reported on ClinicalTrials.gov, this trial (NCT02287818) involved two groups of participants: 60 people received a placebo (a dummy treatment with no active ingredient) and 67 people received a medicine called AC-201. The trial was measuring how many people in each group reached a blood uric acid level below 6.0 mg/dL — uric acid is a substance naturally found in the blood, and this particular level is a commonly used target in gout-related research. Not everyone completed the study: 53 out of 60 in the placebo group and 54 out of 67 in the AC-201 group finished. The reported data shows that, when looking at the primary outcome — the number of participants whose blood uric acid dropped below 6.0 mg/dL — 33 out of 60 people in the placebo group and 43 out of 67 people in the AC-201 group reached that level. No secondary outcome measure data appears to have been submitted to ClinicalTrials.gov, so those results are not available to report 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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• NCT01472692 · results posted 16 December 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT01472692) compared a medicine called febuxostat against a placebo (a dummy treatment with no active ingredient) in two groups of participants. The trial was measuring two things: changes in 24-hour blood pressure readings and changes in pulse wave velocity (a measure of how stiff the arteries are, where a higher reading can suggest stiffer blood vessels). However, the reported data shows that the number of participants who started, completed, or did not complete the study was recorded as zero for both groups, which suggests that participant enrolment figures were not properly submitted to ClinicalTrials.gov. The reported data shows no numerical results for either of the two primary outcome measures — that is, no figures were provided for changes in blood pressure or changes in artery stiffness for either the febuxostat group or the placebo group. Because these measurements are absent from the submitted data, it is not possible to describe what the trial found for these outcomes. The data was simply not reported in the structured results available on 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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• NCT02790463 · results posted 12 November 2019

  According to the results reported on ClinicalTrials.gov, this trial (NCT02790463) involved two groups of people being monitored for gout management. One group received "usual care" (782 participants) and the other received an "intervention" (681 participants). The trial was measuring two things: how many people reached a target level of uric acid in their blood (uric acid is a substance that, at high levels, is linked to gout), and how many people stuck to their prescribed medicines. The reported data shows that when it came to reaching the target blood uric acid level at one year, 117 out of 782 people in the usual care group and 204 out of 681 people in the intervention group reached that target. Regarding sticking to prescribed medication, 250 out of 782 people in the usual care group and 341 out of 681 people in the intervention group were recorded as adherent. It is worth noting that 309 participants in the intervention group did not complete the study, and the data does not explain why. The reported data does not include any further breakdown of results beyond these participant counts, so no additional figures can 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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• NCT02855437 · results posted 28 October 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 44 people in total (23 in one group and 21 in the other). It was a "crossover" study, meaning everyone tried both methods of reporting gout flares — one group started with an Interactive Voice Response (IVR) phone system and then switched to a smartphone app called RheumPRO, while the other group did it the other way around. The trial was measuring two things: which method people preferred, and how practical (feasible) each method was, judged by how often participants actually completed the weekly check-in questions. The reported data shows a strong difference in preference. Out of the total study population, only 3 participants said they preferred the IVR phone system, while 28 participants said they preferred the RheumPRO smartphone app. Regarding how often participants completed the weekly questions, the reported data shows the IVR system had an 81% weekly response rate and the RheumPRO app had an 80% weekly response rate — meaning both methods had a broadly similar completion rate across the study. No other outcome measures were included 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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• NCT01112982 · results posted 7 August 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 74 people with a confirmed diagnosis of gout. Two participants did not complete the study, leaving 72 who finished. The main thing the trial was measuring was how many of those participants showed signs of a type of ongoing joint inflammation — called synovial pannus (a thickening of the joint lining that can cause damage) — in their most affected joint, which was scanned using an MRI (a detailed medical imaging technique). A smaller group of participants then took a uric-acid-lowering medicine called febuxostat for nine months and had a follow-up MRI to see whether that inflammation had changed. The reported data shows that, at the start of the trial, 63 out of 74 participants had evidence of this ongoing joint inflammation on their MRI scan. For the secondary (additional) measurements, the reported data shows that 25 out of the sub-study participants showed a significant reduction in the severity of that inflammation after nine months on febuxostat. The trial also looked at other gout-related changes visible on MRI, including joint erosions (31 participants), bone deposits called tophi inside the bone (25) or in soft tissue (11), fluid in the joint (14), bone marrow swelling (40), and soft tissue swelling (28). The average uric acid level in the blood over the two years before the study was reported as 7.93 mg/dL. Inflammation severity, rated on a scale of 1 to 6, was reported as an average of 2.99 for the main group and 3.42 for the febuxostat sub-study group at the time of their scans. 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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• NCT03316131 · results posted 18 July 2019

  According to the results reported on ClinicalTrials.gov, this trial enrolled 36 adults in total, split into two groups of 18. It used a "crossover" design, meaning each group received both treatment combinations but in a different order — one group received Treatment A followed by Treatment B, and the other received Treatment B followed by Treatment A. All 36 participants completed the first treatment period, and 35 completed the second (one person in the first group did not finish). The trial was measuring how three medicines — verinurad, febuxostat, and dapagliflozin — affected the level of uric acid (a natural waste product in the body) in urine and blood, and how the medicines moved through the body over seven days. The reported data shows that for the main (primary) outcome looking at peak uric acid excreted in urine, both groups showed a decrease from their starting level by Day 7 — a reduction of about 12.87 mg in one group and 13.15 mg in the other. The trial also measured how much of the medicines (verinurad and two of its breakdown products, called M1 and M8) were present in the bloodstream on Day 7. The reported peak blood-level figures (known as Cmax, meaning the highest concentration reached) ranged from roughly 15 to 26 nanograms per millilitre across the two groups and three substances. A related measure of overall medicine exposure over time (AUClast) ranged from approximately 141 to 221 hours·nanograms per millilitre. For the secondary outcomes, blood uric acid levels also showed a reported decrease from baseline — around 327 units in one group and 265 units in the other (measured in micromoles per litre). The time it took for the medicines to reach their peak level in the blood was reported as 4 hours across all substances and both groups, and the medicines remained measurable for up to 24 hours. 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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• NCT01808144 · results posted 30 January 2018

  According to the results reported on ClinicalTrials.gov, this trial involved two groups of participants who were each taking a combination of two medicines — febuxostat (80 mg) plus either a lower dose (200 mg) or a higher dose (400 mg) of lesinurad. A total of 97 people started in the lower-dose group and 99 in the higher-dose group. The trial was measuring uric acid levels in the blood (uric acid is a substance that builds up in people with gout) and whether lumps under the skin caused by uric acid build-up, called tophi, fully disappeared over the course of the study period. The reported data shows that, among participants still being tracked at the 12-month extension point, 77.8% of those in the lower-dose combination group and 82.5% of those in the higher-dose combination group had blood uric acid levels below 5.0 mg/dL — the target level the trial was measuring against. For the second measure, looking only at participants who had at least one tophus (uric acid lump) at the start of the study, the reported data shows that 54.3% in the lower-dose group and 61.0% in the higher-dose group had at least one of those lumps completely resolve by the 12-month extension point. It is worth noting that a notable number of participants did not complete the study — 40 in the lower-dose group and 48 in the higher-dose group — and the figures above reflect only those who remained in the study at that time. 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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• NCT02279641 · results posted 20 December 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 12 participants in total, split into two groups of 6 (referred to as Sequence A and Sequence B). All 12 participants completed the study. The trial was a pharmacokinetic study — meaning it was designed to track how two drugs, RDEA3170 (also known as verinurate) and allopurinol, move through the body when taken alone compared to when taken together. Researchers measured things like how high drug levels rose in the blood, how quickly they peaked, how long they stayed in the body, and how much was passed out in urine. The reported data shows the following when comparing the drugs taken alone versus in combination. For allopurinol itself, the peak blood level (highest concentration reached) was 1.13 µg/mL when taken alone, and 1.51 µg/mL when taken with RDEA3170. For oxypurinol — a substance the body naturally produces from allopurinol — the peak blood level was 12.8 µg/mL alone, dropping to 8.68 µg/mL in combination. In terms of how long drugs took to reach their peak, allopurinol peaked at around 1.5 hours alone and 1.25 hours in combination; oxypurinol peaked at 4 hours alone and 3.5 hours in combination; RDEA3170 peaked at 3 hours whether taken alone or with allopurinol. For the amount passed out in urine over 24 hours, allopurinol figures were similar (25.4 mg alone vs 22.7 mg combined), while oxypurinol urinary amounts were higher in combination (231 mg alone vs 275 mg combined). Several other detailed measurements covering drug exposure over time and how long drugs remained detectable in the body were also reported, with the data not reported for RDEA3170 alone in some of the exposure calculations. 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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• NCT01459796 · results posted 18 July 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT01459796) enrolled 220 people in total — 94 in the placebo group (a dummy treatment with no active ingredient) and 126 in the rilonacept 80 mg group. The trial was looking at rilonacept, a medicine being tested for gout, and measured two main things: how often unwanted medical events (called "treatment-emergent adverse events") occurred during or shortly after treatment, and how often participants experienced gout flares (sudden, painful gout attacks) over the course of the study. The reported data shows that, for the main outcome — the proportion of participants who experienced any unwanted medical event during the study — the numbers were very similar between the two groups: approximately 68.1% of the placebo group and 68.3% of the rilonacept group reported at least one such event. Within those, around 12.8% of the placebo group and 19.0% of the rilonacept group had serious events (meaning events involving hospitalisation, a life-threatening situation, or other significant outcomes). The reported data also shows that 22.3% of participants in the placebo group required "rescue medication" (additional treatment needed because of ongoing gout flares), compared with 8.7% in the rilonacept group. It is worth noting that the data for several secondary outcomes — including the percentage of participants who experienced at least one or two gout flares at 24 weeks or 52 weeks — was not reported in the results submitted to ClinicalTrials.gov, so no numbers are available for those measures. Additionally, the records show zero participants listed as having "completed" the study in either group, though the reason for this is not explained 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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• NCT00855920 · results posted 28 April 2017

  According to the results reported on ClinicalTrials.gov, this trial (NCT00855920) involved 225 people in total, spread across three groups: one group received a placebo (dummy treatment) plus indomethacin (a standard anti-inflammatory medicine); a second group received rilonacept (the medicine being studied) plus indomethacin; and a third group received rilonacept plus a placebo instead of indomethacin. The trial was measuring how much joint pain changed over the first three days of treatment, using a simple 0–4 pain scale where 0 meant no pain and 4 meant extreme pain. Most participants completed the study, though a small number in each group did not finish. The reported data shows that the main result — the average change in pain scores across 24, 48, and 72 hours — was a reduction of 1.40 points in the placebo-plus-indomethacin group, 1.55 points in the rilonacept-plus-indomethacin group, and 0.69 points in the rilonacept-plus-placebo group (all from their starting scores). The reported data also shows pain score changes at each individual time point. At 24 hours, the reductions were 1.16, 1.44, and 0.55 points respectively. At 48 hours they were 1.36, 1.54, and 1.08 points. By 72 hours the reported figures were 1.41, 1.57, and 1.29 points across the three groups. These are the numbers as recorded in participants' daily diaries and do not on their own tell us what the differences between groups mean in a broader sense. 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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• NCT00829829 · results posted 28 April 2017

  According to the results reported on ClinicalTrials.gov, this trial looked at a medicine called rilonacept in people with gout. A total of 241 people were enrolled across three groups — 80 received a placebo (dummy treatment), 80 received a lower dose of rilonacept (80 mg), and 81 received a higher dose (160 mg). The trial ran for 16 weeks (about four months) and was measuring how often participants experienced gout flares — painful episodes typical of a gout attack — during that time. The reported data shows that, on average, participants in the placebo group had 1.06 gout flares each over the 16-week period, while those in the 80 mg rilonacept group had an average of 0.29 flares, and those in the 160 mg group had an average of 0.21 flares. Looking at secondary measures, the reported data shows that 46.8% of placebo participants had at least one gout flare, compared with 18.8% in the 80 mg group and 16.3% in the 160 mg group. For two or more flares, the figures were 31.6% (placebo), 5.0% (80 mg), and 3.8% (160 mg). The average number of days participants experienced gout flare symptoms was reported as 5.52 days for the placebo group, 2.36 days for the 80 mg group, and 0.98 days for the 160 mg group. Days where participants rated their pain at 5 or more out of 10 were reported as 2.13, 0.85, and 0.35 days respectively across the three 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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• NCT01654276 · results posted 13 January 2017

  According to the results reported on ClinicalTrials.gov, this trial enrolled 24 adults who had both gout and high uric acid levels in the blood (a condition called hyperuricemia). The trial tracked several body measurements over roughly six months. Of the 24 people who started, 18 completed the full study period, while 6 did not finish. The reported data shows the following figures recorded at the end of the study for the group as a whole: average body mass index (BMI, a measure of body weight relative to height) was 33.4 kg/m², and average blood uric acid level was 4.4 mg/dl. Blood creatinine — a marker used to check how well the kidneys are filtering — was reported at 0.98 mg/dl. Blood pressure, measured using a monitor worn over the day (called ambulatory blood pressure monitoring), was reported as 126 mmHg for the top (systolic) reading and 75 mmHg for the bottom (diastolic) reading. Blood glucose (sugar) was reported at 107 mg/dl. It is worth noting that the data submitted does not include starting (baseline) measurements alongside these figures, so the reported numbers represent values at the study's endpoint only, and no comparison figures were 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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• NCT02187029 · results posted 11 November 2016

  According to the results reported on ClinicalTrials.gov, this trial looked at an investigational drug called PF-06743649, which was being studied in people with high levels of uric acid in their blood (a condition linked to gout). A total of 30 people took part across two groups (called cohorts): some received different doses of the drug (2.5 mg to 10 mg, 40 mg, or 5 mg depending on their cohort), and others received a placebo (a dummy treatment with no active ingredient). The trial measured changes in uric acid levels in the blood, as well as a range of safety-related checks including side effects, blood test results, vital signs like blood pressure, and heart readings (ECGs). The reported data shows that at the start of the trial, uric acid levels were broadly similar across all groups, ranging from about 8.8 to 9.3 milligrams per decilitre (mg/dL). After 14 days of treatment, the reported percentage change in uric acid levels at 24 hours after the last dose was approximately −52.9% for those on the lower doses (2.5–10 mg), and approximately −67.5% for those on the 40 mg dose. By comparison, the placebo group showed a change of approximately −1.4%. No data for this measure was reported for the Cohort 2 (5 mg) group. Regarding safety-related measures, the reported data shows that adverse events (unexpected medical occurrences during the trial) were recorded in 2 out of 7 participants in the low-dose group, 3 out of 3 in the 40 mg group, 3 out of 11 in the Cohort 2 group, and 4 out of 9 in the placebo group. One serious adverse event was reported in the Cohort 2 group. No participants across any group were reported to have concerning changes in vital signs or heart readings based on the predefined criteria. 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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• NCT01493531 · results posted 26 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 610 people with gout across three groups: 204 took lesinurad 200 mg combined with allopurinol, 200 took lesinurad 400 mg combined with allopurinol, and 206 took a placebo (inactive treatment) combined with allopurinol. The trial was mainly measuring how many people in each group had their blood uric acid level drop below a certain target (6.0 mg/dL — a level considered important in gout management) by the six-month mark. It also looked at gout flare-ups and the shrinking of tophi (lumps that can form under the skin in some people with gout) over 12 months. The reported data shows that by month six, 55.4% of people in the lesinurad 200 mg plus allopurinol group, and 66.5% of people in the lesinurad 400 mg plus allopurinol group, had uric acid levels below the target, compared with 23.3% in the placebo plus allopurinol group. For gout flares requiring treatment during months six to twelve, the reported average number of flares per person was 0.7 in the 200 mg group, 0.8 in the 400 mg group, and 0.9 in the placebo group. Regarding tophi, among participants who had at least one measurable tophus at the start of the trial, 31.4% in the 200 mg group, 27.6% in the 400 mg group, and 33.3% in the placebo group had at least one tophus fully resolve by month 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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• NCT01650246 · results posted 26 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 143 participants, all of whom received lesinurad 400 mg. The trial was measuring two things: how many participants had their blood uric acid level drop below a certain threshold (6.0 mg/dL, a level often used as a treatment target in gout management), and how many unwanted medical events occurred during the study period. It is worth noting that the data shows zero participants were recorded as having "completed" the study, with all 143 listed as "not completed" — the reasons for this were not reported in the submitted data. The reported data shows that out of the 143 participants, 68 had a blood uric acid level below 6.0 mg/dL during the study. Separately, 105 treatment-emergent adverse events (that is, unwanted medical occurrences that happened after starting the study medication) were recorded across the group. No further breakdown of those adverse events — such as what types occurred or how serious they were — was included 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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• NCT01510769 · results posted 26 May 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 324 people with gout who had visible uric acid crystal deposits under the skin (called tophi). Participants were split into three groups: one group took a lower dose of lesinurad (200 mg) combined with febuxostat, another took a higher dose of lesinurad (400 mg) combined with febuxostat, and a third group took a dummy pill (placebo) combined with febuxostat. All three groups therefore received febuxostat. The trial was measuring uric acid levels in the blood, changes to the tophi, and quality of life over 6 to 12 months. Not everyone finished the study — 79, 84, and 87 participants completed it in each of the three groups respectively. The reported data shows that by the six-month mark, the proportion of participants whose blood uric acid level fell below the target of 5.0 mg/dL (a standard measurement unit for uric acid) was 56.6% in the lower-dose lesinurad group, 76.1% in the higher-dose lesinurad group, and 46.8% in the placebo group. For the secondary outcomes measured at 12 months, the proportion of participants who had at least one tophus completely disappear was 25.5%, 30.3%, and 21.1% across the three groups respectively. When looking at either complete disappearance or a reduction of at least 50% in the size of at least one tophus, the reported proportions were 56.6%, 58.7%, and 50.5%. For quality of life, measured using a disability questionnaire (where a higher score means more disability), the proportion of participants who showed a meaningful improvement was 44.2%, 33.3%, and 52.5% across the three 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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• NCT02374164 · results posted 27 April 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 36 participants in total, divided into three groups of 12. It was a crossover study, meaning each participant took different versions of a drug called febuxostat XR (an extended-release tablet) across three separate treatment periods. The trial was measuring how the drug moves through the body — specifically, how much of the drug gets into the bloodstream and how quickly it peaks — depending on the dose (40 mg or 80 mg) and whether it was taken with food or without food. The reported data shows the following numbers for the two main measurements taken from blood samples. The first measurement, called the **peak concentration** (the highest level of drug detected in the blood), was reported as approximately 1,020 ng/mL for the 80 mg dose taken with food, compared with about 1,532–1,562 ng/mL for the 80 mg dose taken fasting (without food). For the 40 mg fasting dose, the reported peak was around 755 ng/mL. The second measurement, called **total exposure** (a way of capturing how much drug was present in the blood over the entire time it was measured), was broadly similar for the 80 mg fed and 80 mg fasting groups — around 7,605–7,816 ng·hr/mL versus 7,687–8,076 ng·hr/mL respectively. For the 40 mg fasting dose, the reported total exposure figures were roughly half those of the 80 mg fasting dose, at around 3,646–3,745 ng·hr/mL. 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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• NCT01508702 · results posted 12 February 2016

  According to the results reported on ClinicalTrials.gov, this trial enrolled 214 people in total — 107 received lesinurad (400 mg) and 107 received a placebo (a dummy treatment with no active ingredient). The trial was measuring how many participants reached a specific level of uric acid in their blood — uric acid being a substance that builds up in some people and can cause problems in the joints. The target level the trial was tracking was a blood uric acid reading below 6.0 mg/dL (milligrams per decilitre, a standard unit of measurement). Not everyone finished the study: 84 people in the lesinurad group and 94 in the placebo group completed it. The reported data shows that, out of the participants measured for the main outcome, 32 people in the lesinurad 400 mg group reached a blood uric acid level below 6.0 mg/dL, compared with 2 people in the placebo group. No other outcome measures were included in the structured data provided, so further details beyond this primary result were not reported in the data available 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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• NCT01988402 · results posted 5 January 2015

  According to the results reported on ClinicalTrials.gov, this trial (NCT01988402) enrolled 35 people experiencing an acute gout attack — 16 in the allopurinol group and 19 in the sugar pill (placebo) group. Most participants finished the trial: 14 in the allopurinol group and 17 in the placebo group. The trial was measuring whether taking allopurinol during an acute gout attack made any difference compared to a placebo, looking mainly at how long the attack lasted, and also at pain levels, a doctor's assessment of gout activity, and uric acid levels in the blood. The reported data shows that the primary outcome — the number of days until the gout attack resolved — was 15.4 days on average for the allopurinol group and 13.4 days for the placebo group. For pain at day 28, participants rated their pain on a 0–10 scale (where 0 means no pain and 10 means the worst pain), with the allopurinol group averaging 1.79 and the placebo group averaging 2.0. The reported data shows that doctors rated gout activity at day 28 as 0 out of 10 for both groups. Blood uric acid levels — a marker that is often elevated in people with gout — were reported as 6.4 mg/dL in the allopurinol group and 8.2 mg/dL 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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• NCT01712204 · results posted 1 December 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01712204) enrolled 82 people in total — 41 who received a placebo (a dummy treatment with no active ingredient) and 41 who received a medicine called AC-201. The trial was measuring how many gout flares (sudden, painful episodes of gout) each person experienced over the course of the study. Of those who started, 33 people in the placebo group and 36 people in the AC-201 group completed the trial. The reported data shows that the one primary outcome measured was the average number of gout flares per person. The placebo group reported an average of 3.02 flares per person, while the AC-201 group reported an average of 2.45 flares per person. No secondary outcome measures were included in the structured data submitted to ClinicalTrials.gov, so those results — if collected — were not reported there 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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• NCT01399008 · results posted 28 July 2014

  According to the results reported on ClinicalTrials.gov, this trial (NCT01399008) enrolled 100 people across three groups: 35 received arhalofenate 400 mg, 32 received arhalofenate 600 mg, and 33 received a placebo (a dummy treatment with no active ingredient). The trial was measuring changes in the level of uric acid in the blood — a substance that plays a role in gout — after participants took their assigned treatment. Most participants completed the study: 32, 27, and 31 people finished in each group respectively. The reported data shows that the primary thing being tracked was the percentage change in blood uric acid levels from the start of the trial to the end, looking at participants who followed the study protocol closely. According to the results reported on ClinicalTrials.gov, the group taking arhalofenate 400 mg had an average reduction of 16.0% in their blood uric acid levels. The group taking arhalofenate 600 mg had an average reduction of 9.9%, and the placebo group had an average reduction of 9.5%. No other outcome measures were included in the submitted results data — if additional measurements were taken, they were not reported in the data available 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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• NCT01391325 · results posted 17 June 2014

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,732 people, all of whom received allopurinol, a medication commonly used to lower uric acid levels in people with gout. Of those who started, 1,238 completed the study and 494 did not finish. The trial was primarily set up to look at how often participants experienced unwanted side effects (called "treatment emergent adverse events") while taking the medication. It also tracked uric acid levels in the blood, how often gout flares occurred, and changes in participants' quality of life over six months. The reported data shows that 55.1% of participants experienced at least one unwanted side effect during the study period. For the secondary measurements, 43.4% of participants had their blood uric acid level fall below 6.0 mg/dL (a commonly used target level) at the six-month mark. The reported data also shows that 33.4% of participants experienced at least one gout flare that needed treatment during the study. Regarding quality of life, participants completed a standard survey (called the SF-36) that measures physical and mental wellbeing on a scale where higher scores mean less difficulty. The reported data shows an average improvement of 3.88 points in the physical score and 0.71 points in the mental score from the start of the study to six months. 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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• NCT01082640 · results posted 25 September 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 96 people in total — 32 in each of three groups: a placebo (dummy treatment) group, a group taking febuxostat 30 mg twice daily, and a group taking febuxostat 40/80 mg once daily. The trial was looking at whether febuxostat, a medicine used to lower uric acid levels in the blood, had any effect on kidney function in people with chronic kidney disease. By the end of the 12-month study, 15 people in the placebo group, 17 in the twice-daily febuxostat group, and 24 in the once-daily febuxostat group had completed the trial. The reported data shows that the main thing being measured was the change in a blood marker called serum creatinine (a substance that builds up in the blood when kidneys are not filtering as well) from the start to the end of the study. Starting levels were similar across groups (around 2.1–2.5 mg/dL). Over 12 months, the placebo group's creatinine rose by 0.19 mg/dL on average, the twice-daily febuxostat group's rose by 0.09 mg/dL, and the once-daily group's rose by 0.23 mg/dL. A second measure of kidney function — eGFR (an estimate of how well the kidneys are filtering, where a higher number is better) — also changed over the year: the placebo group's eGFR fell by about 2.05 units on average, the twice-daily febuxostat group's rose slightly by 0.33 units, and the once-daily group's fell by 0.86 units. These are the numbers as submitted; the data does not include information about whether these differences were considered statistically meaningful. For the additional measures reported, the data shows that none of the placebo participants reached a serum urate (uric acid) level below 6 mg/dL at 12 months, compared with 68.8% of the twice-daily febuxostat group and 45.2% of the once-daily group. The trial also collected information on how the body processed febuxostat at various doses, with reported figures for drug clearance and drug exposure across the different dosing groups, as described 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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• NCT00111657 · results posted 18 January 2013

  According to the results reported on ClinicalTrials.gov, this trial enrolled 37 people, all of whom received the study treatment, pegloticase (also called PEG-uricase), a medication given by infusion. There was only one group in the study — no placebo or comparison group. Of the 37 who started, 21 completed the trial and 16 did not finish. The trial was primarily measuring whether the treatment could lower a substance in the blood called uric acid (a waste product that can build up and cause gout) to below a certain level (6 mg/dL). Several secondary things were also tracked, including joint swelling and tenderness, whether participants developed antibodies (proteins the immune system can produce in response to a foreign substance), and how much of the drug was present in the blood after the first dose. The reported data shows that 17 out of 37 participants had their blood uric acid reduced to below the 6 mg/dL target — the main goal of the study. For joint symptoms, the reported figures show counts of swollen and tender joints at different time points: 13, 2, 9, and 6 joints respectively, though the data as reported does not specify clearly which time points these figures correspond to. The reported data shows that 15 out of 37 participants developed antibodies to the treatment. After the first infusion, the highest recorded drug concentration in the blood (known as Cmax, meaning the peak level measured) was reported as 25.6 mU/mL. For two other secondary measures — changes in the body's total uric acid pool and the ratio of uric acid to creatinine in urine — no numerical results 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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• NCT01356498 · results posted 2 December 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 149 people in total across six groups. Participants had gout and were being studied in two phases: a randomised controlled part (RCT) and an open-label extension (OLE), where everyone received active treatment. The groups differed by how often they received the study drug (every two weeks, labelled "q2", or every four weeks, labelled "q4"), and whether they had previously responded to the drug or not, or had been on placebo before switching to active treatment. The main thing the trial was measuring was the level of uric acid in the blood (measured in mg/dL — a standard unit for this substance). Not all participants completed the study: completion numbers ranged from 2 to 24 people depending on the group. The reported data shows that uric acid levels varied considerably between groups. Those classed as "responders" on the every-two-weeks schedule recorded average uric acid levels of around 1.33–1.40 mg/dL across measurement points, and every-four-weeks responders recorded around 1.91–1.95 mg/dL. By contrast, the non-responder groups and those who had been on placebo before switching recorded much higher average levels, ranging from roughly 4.69 to 9.94 mg/dL across measurement points. For the secondary measures, the reported data shows that when it came to gout flares (painful attacks), the average number of flares per person over each three-month period was generally lower in the responder groups (around 0.4–0.8) compared to non-responder or placebo-switch groups (up to 2.3). Regarding the lumps under the skin caused by gout (called tophi), more participants in the responder groups showed a complete disappearance of at least one such lump compared to non-responder groups. A self-reported physical health score (out of 100, where higher is better) was also recorded, with most groups scoring in the low-to-mid 30s at the start and somewhat higher at a later point, though scores remained below the scale's midpoint 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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• NCT01029652 · results posted 18 November 2011

  According to the results reported on ClinicalTrials.gov, this trial compared two treatments for gout flares: canakinumab (150 mg) and triamcinolone acetonide (a steroid injection, 40 mg). A total of 115 people were enrolled in each group — 230 participants altogether — for the initial 12-week period, with smaller numbers continuing into two follow-up periods extending out to 72 weeks. The trial was measuring how quickly pain eased after treatment, how many participants went on to have new gout flares, and how long it took before any new flare occurred. The reported data shows that, when looking at how long it took for participants to experience at least a 50% reduction in their worst joint pain, the canakinumab group reached that point at a median (midpoint of the group) of 48 hours, compared with 72 hours in the steroid group. For complete disappearance of pain over time, the median time was not able to be calculated for either group — meaning not enough participants in either group fully reached zero pain during the measurement window. By the end of 12 weeks, about 34.5% of canakinumab participants and 31.3% of steroid participants had reported complete resolution of pain at some point. Regarding new gout flares during those 12 weeks, the reported data shows approximately 18.6% of the canakinumab group experienced at least one new flare, compared with 34.8% in the steroid group. The average number of new flares per person over 12 weeks was reported as 0.21 in the canakinumab group and 0.53 in the steroid group. The time-to-first-new-flare figures were also not able to be calculated from the data 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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• NCT00675103 · results posted 28 June 2011

  According to the results reported on ClinicalTrials.gov, this trial involved 7 people who received the study drug, pegloticase, given as an 8 mg infusion (a drip into a vein) every two weeks. Four of the seven participants completed the trial, while three did not finish. The trial was measuring two things: the number of participants who experienced adverse events (unwanted or unexpected health events that occurred during the study), and how levels of uric acid in the blood changed over time. Uric acid is a substance that builds up in the body and is associated with gout. The reported data shows that all 7 participants had at least one adverse event recorded during the study, and 2 participants had a specific category of adverse event (the trial record does not provide further detail on what type). Regarding uric acid levels in the blood, the reported data shows an average level of 8.5 mg/dL at the starting point (baseline), which dropped to 4.0 mg/dL after the first dose, and was recorded at 7.7 mg/dL around the time of the third dose. These numbers represent the average across participants at those timepoints; no further breakdown of these figures was reported in the submitted data. It is worth noting that with only 7 participants, this was a very small study, and the submitted data does not include comparison figures from a group who did not receive the drug. 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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• NCT00819585 · results posted 6 May 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 432 participants across two phases. In the main ("core") part of the study, participants were divided into seven groups — six receiving different doses or dosing schedules of a medicine called canakinumab, and one receiving a low dose of colchicine (a commonly used gout medicine). The trial was primarily measuring how many gout flares — episodes of sudden, painful joint swelling — each person experienced over the study period. A smaller follow-on ("extension") phase involved a further 341 participants across four groups. The reported data shows that in the core study, the average number of gout flares per person ranged from about 0.2 to 0.5 across the five single-dose canakinumab groups (25 mg through 300 mg), while the group receiving canakinumab on a regular four-weekly schedule averaged 0.7 flares per person — the same average as the colchicine group. When looking at the percentage of participants who had at least one gout flare within 16 weeks, the reported figures ranged from about 14.8% to 27.3% across the single-dose canakinumab groups, compared to 16.7% for the regular canakinumab schedule and 44.4% for the colchicine group. Participants who did experience flares also rated their pain on two scales (a 0–100 sliding scale and a 1–5 scale); the reported pain scores during flares varied across groups, but no single pattern was consistent across all measures. Some data points for these pain scales were not fully reported for all groups 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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• NCT00549549 · results posted 24 February 2011

  According to the results reported on ClinicalTrials.gov, this trial enrolled 402 people across four treatment groups: 101 received a low dose of celecoxib (50 mg), 99 received a medium dose of celecoxib (400/200 mg), 99 received a high dose of celecoxib (800/400 mg), and 103 received indomethacin (50 mg), which was used as a comparison medicine. The trial was measuring how much joint pain, tenderness, swelling, redness, and warmth changed over time — using rating scales filled in by either the patient or their doctor. The reported data shows that for the main measure — how much a patient's pain score changed between the start of the trial and Day 2 — all four groups started with similar pain scores (roughly 2.7 to 3.0 out of 4). By Day 2, the reported average decreases in pain score were: −1.14 for the low-dose celecoxib group, −1.23 for the medium-dose celecoxib group, −1.51 for the high-dose celecoxib group, and −1.62 for the indomethacin group. For the secondary measures, the reported data shows that joint tenderness and swelling scores — also rated on a scale — decreased across all four groups between the start and Days 5, 9, and 14. Similarly, the number of participants whose doctor recorded redness or warmth in the affected joint fell noticeably across all groups by Days 9 and 14 compared to the start of 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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• NCT01018420 · results posted 23 November 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 18 healthy participants in total — 15 received colchicine (a medicine commonly used for gout and inflammation) and 3 received moxifloxacin (an antibiotic used here as a comparison). All 18 participants completed the study with no drop-outs. The trial was primarily measuring how colchicine moves through the bloodstream — specifically, how high its concentration peaks in the blood and how long it stays there over time. The reported data shows three key blood-concentration figures for colchicine. The peak concentration reached in the blood (called Cmax) was reported as 6.84 ng/mL (nanograms per millilitre — a very small unit of measurement). The total "exposure" to colchicine over time — that is, the area under a curve plotting blood concentration against time, up to the last measurable point — was reported as 104.95 ng-hr/mL, and when that curve was extended mathematically out to infinity, the figure was 118.20 ng-hr/mL. These numbers describe the shape and duration of how colchicine appeared in the blood, not whether it produced any particular benefit. The reported data also shows heart-rhythm measurements (called QTcF intervals, measured in milliseconds — a way of checking whether a medicine might affect the heart's electrical activity) taken at multiple time points for both groups. For the colchicine group, these readings ranged from approximately 388 to 402 milliseconds across the different time points. For the moxifloxacin group, readings ranged from approximately 397 to 416 milliseconds, with the highest figure recorded at hour 23. The data does not include any further interpretation of what these numbers mean clinically. 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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• NCT01017042 · results posted 20 November 2009

  According to the results reported on ClinicalTrials.gov, this trial involved 13 participants who all completed the study — none dropped out. The trial was looking at how a two-dose course of oral colchicine (a 1.2 mg dose followed by a 0.6 mg dose) is absorbed into the bloodstream. Specifically, it measured how high the drug's concentration in the blood peaked, how much of the drug was present in the blood over time, and whether the drug had any effect on heart rhythm (measured using an ECG, a test that records the heart's electrical activity). The reported data shows that the peak level of colchicine measured in the blood plasma was 6,192.77 picograms per millilitre (a picogram is an extremely small unit of measurement). For the "area under the curve" figures — a way of capturing the total amount of drug present in the blood over a period of time — the reported value up to 96 hours was 43,787.55 pg-hr/ml, and when that estimate was extended to account for the drug still leaving the body beyond 96 hours, the figure was 52,070.06 pg-hr/ml. Regarding heart rhythm, the trial tracked a specific ECG measurement called the corrected QT interval (a measure of how long it takes the heart to reset between beats) at several time points. The reported data shows the values were 402.28 milliseconds at baseline (before dosing), 397.38 at 30 minutes, 399.26 at 1 hour, 401.51 at 2 hours, and 402.38 at 4 hours after 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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• NCT00175019 · results posted 7 September 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 1,086 people with gout across three groups: 606 took febuxostat 80 mg once daily, 388 took febuxostat 120 mg once daily, and 92 took allopurinol once daily (a medicine already commonly used for gout). The trial ran for up to three years and was mainly measuring how many participants had their blood uric acid level (a substance linked to gout) drop below a target level of 6.0 mg/dL — the level doctors generally aim for in gout management. By the end of the study, 412, 217, and 35 participants respectively had completed the full course in each group. The reported data shows that at the one-month mark, 80.8% of the febuxostat 80 mg group, 87.0% of the febuxostat 120 mg group, and 46.0% of the allopurinol group had blood uric acid levels below the 6.0 mg/dL target. By month 36, those figures were 90.8%, 91.5%, and 90.0% respectively. The reported data also shows that average blood uric acid levels fell from the starting point by about 47% in the febuxostat 80 mg group, about 53% in the febuxostat 120 mg group, and about 32% in the allopurinol group. For participants who had visible gout deposits (called tophi) at the start of the study, the reported size of the main deposit at 12 months had reduced by around 82% in the febuxostat 80 mg group, 79% in the febuxostat 120 mg group, and 56% in the allopurinol group — though these are percentage changes and do not tell us the actual size of the deposits. 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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• NCT00175006 · results posted 16 July 2009

  According to the results reported on ClinicalTrials.gov, this trial enrolled 13 participants, all of whom had tophi — firm lumps that can form under the skin in people with gout, caused by a build-up of uric acid crystals. All 13 participants completed the study. The trial was not testing a treatment; instead, it was measuring how consistently tophi could be measured — specifically, whether two separate measurement sessions and two separate raters (people doing the measuring) would produce similar size readings for the same lump. The reported data shows that the size of each tophus was estimated by measuring its length and width in millimetres and calculating an area. To check consistency, the trial looked at two things: how much the measurements varied when the same rater measured the same tophus on two different visits (taken no more than 10 days apart), and how much the measurements varied when two different raters measured the same tophus. The reported data shows an average difference of 29% between the two visits for the same rater, and an average difference of 32% between the two different raters. In plain terms, these numbers represent the typical gap — as a percentage — between one measurement and another, whether taken at a different time or by a different person. The reported data does not include any treatment outcomes, as this study was focused purely on understanding how reliable this method of measuring tophi actually is in practice. No safety or efficacy data was reported as part of these 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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• NCT00174967 · results posted 16 July 2009

  According to the results reported on ClinicalTrials.gov, this trial looked at three different daily doses of a medicine called febuxostat (40 mg, 80 mg, and 120 mg) compared to a dummy pill (placebo) with no active ingredient. A total of 153 people took part across the four groups, and most completed the study. The trial was measuring whether the medicine could lower the level of uric acid in the blood — specifically, whether it could bring that level below a particular threshold (6.0 mg/dL, a standard measurement unit for uric acid). Uric acid is a substance that, when too high, is associated with gout. The main result was recorded at day 28 of the trial. The reported data shows that by day 28, none of the participants (0%) in the placebo group reached the target uric acid level, while 56% of those on the 40 mg dose, 76% on the 80 mg dose, and 94% on the 120 mg dose were reported to have reached it. Similar patterns were reported at earlier check-ins (days 7, 14, and 21), with the higher doses generally associated with a greater proportion of participants reaching the target level. The reported data also shows that uric acid levels fell from the starting point across all three febuxostat groups throughout the study — for example, by day 14 the reported average reductions were around 37% for the 40 mg group, 42% for the 80 mg group, and 57% for the 120 mg group. In the placebo group, uric acid levels showed little change, with a reported change of around +1–2% at those same 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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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.