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

• Register: CTRI
• Last refreshed on: 4 May 2013
• Main ID: CTRI/2009/091/000832
• Date of registration: 26-10-2009
• Primary sponsor: Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591 Telephone: [phone] Fax : [phone]
• Public title: A Clinical Trial to Study the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy
• Scientific title: A Multi-Center, 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
• Date of first enrolment: 01-07-2009
• Target sample size: 80
• Recruitment status: Open to Recruitment
• URL: http://www.ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=996
• Study type: Interventional
• Study design: Randomized, Parallel Group, Placebo Controlled Trial; Method of generating randomization sequence:Computer generated randomization Method of allocation concealment:Centralized Blinding and masking:Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded

Countries of recruitment

India, Indonesia

Contacts

• Name: Suneela Thatte
• Affiliation: Director Regulatory Affairs

• Name: Dr Sanghamitra Patnaik
• Affiliation: Director Regulatory Affairs

Key inclusion & exclusion criteria

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


Age minimum:
Age maximum:
Gender:

Health Condition(s) or Problem(s) studied

Gout

Intervention(s)

Intervention1: Matching Placebo: Matching
Intervention2: Rilonacept: 160 mg and 80mg s.c.
Control Intervention1: Allopurinol: 100 mg and 300 mg tablets

Primary Outcome(s)

The number of gout flares per subject assessed from Day 1 to Week 16.Timepoint: number of gout flares

Secondary Outcome(s)

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 16Timepoint: number of gout flares

Secondary ID(s)

IL1T-GA-0816

NCT00958438

Source(s) of Monetary Support

Regeneron Pharmaceuticals, Inc. 777 Old Saw Mill River Road Tarrytown, NY 10591

Secondary Sponsor(s)

Quintiles Research (India) Pvt. Limited 8, M.G. Road, 4th Floor, Nitesh Time Square, Bangalore 560001 Telephone: [phone] Fax : [phone]