Phase 3
N=248
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
Gout
Bottom Line
View on ClinicalTrials.gov: NCT00958438 ↗Enrolled (actual)
248
Serious AEs
4.8%
Results posted
Apr 2017
Primary outcome: Primary: Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16) — 1.23; 0.35; 0.34 Gout flares
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Placebo (Drug); Rilonacept (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Dec 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16) |
1.23; 0.35; 0.34 | — |
| SECONDARY Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16) |
1.51; 0.62; 0.48 | — |
| SECONDARY Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16) |
56.1; 25.6; 20.5 | — |
| SECONDARY Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16) |
32.9; 8.5; 6.0 | — |
| SECONDARY Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16) |
11.7; 4.30; 1.86 | — |
| 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 113 (Week 16) |
4.28; 1.67; 0.88 | — |
Summary
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout. Participants will participate in this study for approximately 22 weeks. Rilonacept was being studied for use in preventing allopurinol-induced gout flares.
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 (NCT00958438). 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.