Phase 3
Completed N=241
PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
Intercritical Gout
Source: ClinicalTrials.gov NCT00829829 ↗
Enrolled (actual)
241
Serious AEs
3.8%
Results posted
Apr 2017
Primary outcomePrimary: Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) — 1.06; 0.29; 0.21 Number of Gout flares per participant
◆ Published Evidence
Highly cited
117citations · ~8 / year
Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study.
Summary
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
Linked Publications
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Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) |
1.06; 0.29; 0.21 | — |
| SECONDARY Number of Modified Gout Flares Per Participant From Day 1 to Day 112 (Week 16) |
1.19; 0.40; 0.28 | — |
| SECONDARY Percentage of Participants With at Least One Gout Flare From Day 1 to Day 112 (Week 16) |
46.8; 18.8; 16.3 | — |
| SECONDARY Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 112 (Week 16) |
31.6; 5.0; 3.8 | — |
| SECONDARY Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) |
5.52; 2.36; 0.98 | — |
| SECONDARY Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Participant From Day 1 to Day 112 (Week 16) |
2.13; 0.85; 0.35 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification; of the acute arthritis of primary gout;
- At least 2 gout flares in the year prior to the screening visit;
- Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
Exclusion Criteria
- Acute gout flare within 2 weeks of the screening visit or during screening;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the screening visit;
- Previous exposure to Rilonacept;
- Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.
Data sourced from ClinicalTrials.gov (NCT00829829) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.