A Clinical Trial to Study the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy

Phase 3

• Conditions: Gout

• Registration Number: CTRI/2009/091/000832
• Lead Sponsor: Regeneron Pharmaceuticals, Inc.777 Old Saw Mill River RoadTarrytown, NY 10591Telephone: +914 345 7400Fax : +914 347 2847

Brief Summary

This is a randomized, double blind, placebo-controlled, multi-center, parallel group Phase III study.In this study two rilonacept doses will be evaluated; a 320 mg loading dose followed by a weekly 160 mg maintenance dose, and a 160 mg loading dose followed by a 80 mg weekly maintenance dose. This study will be conducted in 240 patients across 85 sites in 5 countries including India. This study would be conducted at 12 Indian sites and will enroll 80 subjects in India. It is hypothesized that in subjects with hyperuricemia and gout who are initiating therapy with allopurinol, the mean number of gout flares from Day 1 to Week 16 in subjects randomized to rilonacept 80 mg or 160 mg weekly will be less than the mean number of Gout flares from Day 1 to Week 16 in subjects randomized to placebo.The primary end points will be the number of gout flares per subject assessed from Day 1 to Week 16. Number of patients to be enrolled in India: 80Total Number of sites: 12Anticipated date of enrollment: November 15, 2009

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 80

Inclusion Criteria

Male or female 18 to 80 years of age Previously met the preliminary criteria of the 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.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The number of gout flares per subject assessed from Day 1 to Week 16.	number of gout flares

Secondary Outcome Measures

Name	Time	Method
The number of gout flares per subject from Day 1 to Week 16. The proportion of subjects with at least one flare from Day 1 to Week 16 The proportion of subjects with at least two flares from Day 1 to Week 16 The mean number of gout flare days per subject assessed from Day 1 to Week 16 The mean number of days with the subjects pain score of 5 or more (daily diary) per subject from Day 1 to Week 16	number of days with the subjects pain score of 5 or more

Trial Locations

Locations (12)

Apollo Gleneagles Hospitals Ltd.; 🇮🇳 Circular, India

Apollo Hospital educational and Research Foundation; 🇮🇳 Hyderabad, ANDHRA PRADESH, India

Apollo Hospital International Limited; 🇮🇳 Estate,, India

Chanre Rheumatology Immunology Center and Research; 🇮🇳 Bangalore, KARNATAKA, India

Kasturba Medical College & Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Krishna Institute of Medical Sciences; 🇮🇳 -500, India

M. S. Ramaiah Medical College and Teaching Hospital; 🇮🇳 Bangalore, KARNATAKA, India

Naman Hospital; 🇮🇳 Sigra,, India

Pristine Hospital and Research Centre Pvt Ltd; 🇮🇳 Bangalore, KARNATAKA, India

Ruby Hall Clinic; 🇮🇳 Pune, MAHARASHTRA, India

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Apollo Gleneagles Hospitals Ltd.

🇮🇳Circular, India

Dr Syamasis Bandyopadhyay

Principal investigator

sambando@yahoo.co.uk