Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 2

Conditions: Gout

Treatments: Other: Placebo (for Rilonacept); Biological: Rilonacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00610363

IL1T-GA-0619

Details and patient eligibility

About

This was a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who were beginning another additional treatment. Participants participated in this study for approximately 24 weeks. Rilonacept was being studied for use in preventing gout attacks in participants who had gout.

Enrollment: 83 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female greater than 18 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.

Exclusion criteria

• Acute gout flare within 2 weeks of the screening visit and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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83 participants in 2 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

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 16.

Treatment:

Other: Placebo (for Rilonacept)

Rilonacept 160 mg

Experimental group

Description:

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 16.

Treatment:

Biological: Rilonacept