Conditions: Gout
Allocation: RANDOMIZED | Intervention model: PARALLEL
Enrollment: 220
Healthy volunteers: no

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

Detailed description:

Arms:
arm 1: 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. arm 2: 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.

Interventions: intervention 1: Rilonacept intervention 2: Placebo intervention 3: Allopurinol
Intervention descriptions: intervention 1: Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks. intervention 2: Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks. intervention 3: Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.

Protocol document: