A Multi-Center, Randomized, Double-Blind, Placebo Controlled Trial of the Safety of Rilonacept for the Prophylaxis of Gout Flares in Patients on Urate- Lowering Therapy
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 1,315
- Locations
- 124
- Primary Endpoint
- Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;;;
Outcomes
Primary Outcomes
Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Baseline up to Week 20
Any untoward medical occurrence in a participant who received investigational medicinal product (IMP) was considered an AE without regard to possibility of causal relationship with this treatment. Treatment-emergent adverse events (TEAEs) were defined as AEs that developed or worsened or became serious during on-treatment period (time from the administration of first dose of study drug up to 35 days after the last dose of study drug). A serious adverse event (SAE) was defined as any untoward medical occurrence that resulted in any of the following outcomes: death, life-threatening, required initial or prolonged in-patient hospitalization, persistent or significant disability/incapacity, congenital anomaly/birth defect, or considered as medically important event. Any TEAE included participants with both serious and non-serious AEs.
Secondary Outcomes
- Number of Gout Flare Days Per Participant From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))
- Number of Gout Flares Per Participant Assessed From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))
- Percentage of Participants With at Least One Flare From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))
- Percentage of Participants With at Least Two Flares From Day 1 to Day 112 (Week 16)(Day 1 to Day 112 (Week 16))