Phase 3
N=1,315
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
Gout
Bottom Line
View on ClinicalTrials.gov: NCT00856206 ↗Enrolled (actual)
1,315
Serious AEs
3.4%
Results posted
Apr 2017
Primary outcome: Primary: Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) — 59.1; 66.6; 13.0; 27.5 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Rilonacept (Biological); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Jan 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) |
59.1; 66.6; 13.0; 27.5; 3.9; 3.1 | — |
| SECONDARY Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16) |
1.73; 0.51 | — |
| SECONDARY Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16) |
51.1; 25.7 | — |
| SECONDARY Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16) |
34.7; 11.7 | — |
| SECONDARY Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16) |
7.66; 2.66 | — |
Summary
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.
Eligibility Criteria
Inclusion Criteria
- Male or female 18 to 80 years of age;
- Previously met the preliminary criteria of American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
- Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.
Exclusion Criteria
- Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
- Persistent chronic or active infections;
- History of an allergic reaction to allopurinol;
- History or presence of cancer within 5 years of the Screening Visit;;;
Data sourced from ClinicalTrials.gov (NCT00856206). 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.