Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Study Overview
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Brief Summary
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The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.

Official Title
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A Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares

Conditions
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Gout

Intervention / Treatment
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* Drug: Rilonacept
* Drug: Placebo
* Drug: Allopurinol


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Key Inclusion criteria: Male or female participants aged 18 to 80 years; Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout; Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit; A self-reported history of at least 2 gout flares in the year prior to screening. Exclusion Criteria: Key Exclusion criteria: Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug; Participants requiring dialysis; Participants who had had an organ transplant; Persistent chronic or active infections; Previous exposure to rilonacept; Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days prior to the screening visit.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Placebo<br>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 51. | Drug: Placebo<br>* Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.<br>Drug: Allopurinol<br>* Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.<br>|
| Experimental: Rilonacept 80 mg<br>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 51. | Drug: Rilonacept<br>* Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.<br>Drug: Allopurinol<br>* Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment Emergent Adverse Events (TEAEs) | 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. 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 and including 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. | Day 1 to Day 392 (Week 56) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With at Least One Gout Flare From Day 1 to Day 168 (Week 24) | 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. Percentage of participants with at least one gout flare at Week 24 was to be reported for this outcome measure. | Day 1 to Day 168 (Week 24) | 
| Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 168 (Week 24) | 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. Percentage of participants with at least two gout flares at Week 24 was to be reported for this outcome measure. | Day 1 to Day 168 (Week 24) | 
| Percentage of Participants With at Least One Gout Flare From Day 1 to Day 364 (Week 52) | 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. Percentage of participants with at least one gout flare at Week 52 was to be reported for this outcome measure. | Day 1 to Day 364 (Week 52) | 
| Percentage of Participants With at Least Two Gout Flares From Day 1 to Day 364 (Week 52) | 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. Percentage of participants with at least two gout flares at Week 52 was to be reported for this outcome measure. | Day 1 to Day 364 (Week 52) | 
| Percentage of Participants With Rescue Medication From Day 1 to Day 364 (Week 52) | Participants who required rescue medication after having 2 or more gout flares during the treatment period were evaluated. | Day 1 to Day 364 (Week 52) |