Intercritical Gout

Regeneron IL1T-GA-0810

INDICATION:
Intercritical gout

TITLE:
A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

IRB NAME:
Copernicus Group IRB

STATUS:
Closed

PHASE:
3

PURPOSE:
To determine the efficacy of 160 mg and 80 mg of subcutaneous (SC) rilonacept therapy compared with placebo in the prophylaxis of flares in subjects with intercritical gout initiating therapy with allopurinol

ELIGIBILITY: 
Candidates must:

• Be male or female aged 18  to 80 years
• Have previously met American Rheumatism Association (ARA) preliminary criteria for classification of acute arthritis of primary gout (if any 6 or more of the 13 criteria are present, serially or simultaneously, during any interval of observation) or monosodium urate monohydrate microcrystals have been identified in joint fluid
• Serum uric acid ≥7.5 mg/dL and, according to the treating physician or investigator, the subject is a candidate for and does not have a contraindication to allopurinol treatment
• A self-reported history of ≥2 gout flares in the year before the screening visit

DURATION:
Nine visits over 20 weeks

CONTACT/ADDITIONAL INFO:
Isabella Rodrigues, PhD
Clinical Research Coordinator
908-277-8630