PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1 (PRE-SURGE1)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Intercritical Gout

Treatments: Drug: Rilonacept 80 mg; Other: Placebo; Drug: Rilonacept 160 mg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00829829

IL1T-GA-0810

Details and patient eligibility

About

The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.

Enrollment: 241 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female 18 to 80 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;
• Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;

Exclusion criteria

• Acute gout flare within 2 weeks of the screening visit or 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;
• Previous exposure to Rilonacept;
• Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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241 participants in 3 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 15.

Treatment:

Other: Placebo

Rilonacept 80 mg

Active Comparator group

Description:

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 15.

Treatment:

Drug: Rilonacept 80 mg

Rilonacept 160 mg

Active Comparator 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 15.

Treatment:

Drug: Rilonacept 160 mg