Status:
TERMINATED
Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Gout
Eligibility:
All Genders
18-80 years
Phase:
PHASE3
Brief Summary
The purpose of this study was to determine the safety and tolerability of rilonacept for participants with gout who were initiating allopurinol.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2013
Estimated Enrollment :
220 Patients enrolled
Trial Details
Trial ID
NCT01459796
Start Date
November 1 2011
End Date
June 1 2013
Last Update
July 18 2017
Active Locations (74)
Enter a location and click search to find clinical trials sorted by distance.
1
Birmingham, Alabama, United States
2
Mesa, Arizona, United States
3
Phoenix, Arizona, United States
4
Scottsdale, Arizona, United States