A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
Overview
- Phase
- Phase 3
- Intervention
- Placebo
- Conditions
- Gout
- Sponsor
- Regeneron Pharmaceuticals
- Enrollment
- 248
- Primary Endpoint
- Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)
- Status
- Completed
- Last Updated
- 9 years ago
Overview
Brief 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.
Investigators
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.
Arms & Interventions
Placebo
Two subcutaneous injections of Placebo (for Rilonacept ) as a loading dose on Day 1 followed by a single injection once a week (qw) from Week 1 to Week 15.
Intervention: Placebo
Rilonacept 80 mg
Two subcutaneous injections of Rilonacept 80 mg (for a total of 160 mg) as a loading dose on Day 1, followed by a single 80 mg injection of Rilonacept qw from Week 1 to Week 15.
Intervention: Rilonacept
Rilonacept 160 mg
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) as a loading dose on Day 1, followed by a single 160 mg injection of Rilonacept qw from Week 1 to Week 15.
Intervention: Rilonacept
Outcomes
Primary Outcomes
Number of Gout Flares Per Participant Assessed From Day 1 to Day 113 (Week 16)
Time Frame: Day 1 to Day 113 (Week 16)
Gout flare was defined as acute articular pain typical of a gout attack that required treatment with an anti-inflammatory therapeutic: had at least 3 of the following 4 signs or symptoms: joint swelling, tenderness, redness, and pain and with at least 1 of the following: rapid onset of pain, decreased range of motion, joint warmth or other symptoms similar to a prior gout flare. Number of gout flares per participant was reported for this outcome measure.
Secondary Outcomes
- Number of Gout Flare Days Per Participant From Day 1 to Day 113 (Week 16)(Day 1 to Day 113 (Week 16))
- Number of Modified Gout Flares Per Participant From Day 1 to Day 113 (Week 16)(Day 1 to Day 113 (Week 16))
- Percentage of Participants With at Least One Flare From Day 1 to Day 113 (Week 16)(Day 1 to Day 113 (Week 16))
- 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)(Day 1 to Day 113 (Week 16))
- Percentage of Participants With at Least Two Flares From Day 1 to Day 113 (Week 16)(Day 1 to Day 113 (Week 16))