Phase 2
N=83
Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
Gout
Bottom Line
View on ClinicalTrials.gov: NCT00610363 ↗Enrolled (actual)
83
Serious AEs
3.6%
Results posted
May 2017
Primary outcome: Primary: Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12) — 0.79; 0.15 Number of gout flares per participant
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Rilonacept (Biological); Placebo (for Rilonacept) (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Regeneron Pharmaceuticals
- Primary completion
- Oct 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Gout Flares Per Participant Assessed From Day 1 to Day 84 (Week 12) |
0.79; 0.15 | — |
| SECONDARY Percentage of Participants With at Least One Gout Flare From Day 1 to Day 84 (Week 12) |
45.2; 14.6 | — |
| SECONDARY Mean Number of Gout Flares Per Month Per Participant From Day 1 to Day 84 (Week 12) |
0.30; 0.06 | — |
| SECONDARY Mean Number of Gout Flare Days Per Participant From Day 1 to Day 84 (Week 12) |
5.17; 1.41 | — |
| SECONDARY Mean Number of Gout Flare Days Per Month Per Participant From Day 1 to Day 84 (Week 12) |
2.09; 0.52 | — |
| 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 84 (Week 12) |
2.02; 0.22 | — |
| SECONDARY Number of Gout Flare Days With Participant's Pain Score of 5 or More (From Daily Diary) Per Month Per Participant From Day 1 to Day 84 (Week 12) |
0.87; 0.07 | — |
Summary
This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.
Eligibility Criteria
Inclusion Criteria
- Male or female greater than 18 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.
Exclusion Criteria
- Acute gout flare within 2 weeks of the screening visit and 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.
Data sourced from ClinicalTrials.gov (NCT00610363). 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.