Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)

Regeneron Pharmaceuticals

Status and phase: Completed; Phase 3

Conditions: Gout

Treatments: Other: Placebo; Biological: Rilonacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT00856206

IL1T-GA-0815

Details and patient eligibility

About

The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy. Subjects will participate in this study for approximately 20 weeks. Rilonacept is being studied for use in preventing gout flares in subjects on urate-lowering therapy.

Enrollment: 1,315 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 American Rheumatism Associatio (ARA) for the classification of acute gout arthritis of primary gout;
• Subjects with history of gout, initiating or currently on urate lowering; therapy who are at risk of gout flare.

Exclusion criteria

• Acute gout flare within 2 weeks prior to the screening visit and during the screening visit;
• 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: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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1,315 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 15.

Treatment:

Other: Placebo

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 15.

Treatment:

Biological: Rilonacept