Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares (UPSURGE)

Regeneron Pharmaceuticals

Status and phase: Terminated; Phase 3

Conditions: Gout

Treatments: Drug: Placebo; Drug: Allopurinol; Drug: Rilonacept

Study type: Interventional

Funder types: Industry

Identifiers

NCT01459796

IL1T-GA-1101

Details and patient eligibility

About

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

Enrollment: 220 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

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 criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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220 participants in 2 patient groups

Placebo

Experimental 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 51.

Treatment:

Drug: Placebo

Drug: Allopurinol

Rilonacept 80 mg

Experimental 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 51.

Treatment:

Drug: Allopurinol

Drug: Rilonacept