Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (NCT01459796) | Clinical Trial Compass
TerminatedPhase 3
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
United States220 participantsStarted 2011-11
Plain-language summary
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
Who can participate
Age range18 Years – 80 Years
SexALL
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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.
What they're measuring
1
Percentage of Participants With Treatment Emergent Adverse Events (TEAEs)