Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares
NCT ID: NCT00610363
Last Updated: 2017-05-02
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
83 participants
INTERVENTIONAL
2007-11-30
2008-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Placebo
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 16.
Placebo (for Rilonacept)
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
Rilonacept 160 mg
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 16.
Rilonacept
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
Interventions
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Rilonacept
Rilonacept 320 mg loading dose on Day 1 followed by Rilonacept 160 mg/2 mL injections qw for 17 weeks.
Placebo (for Rilonacept)
Placebo loading dose on Day 1 followed by single placebo injections (2 mL) qw for 17 weeks.
Eligibility Criteria
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Inclusion Criteria
* Previously met the preliminary criteria of the American Rheumatism Association (ARA) for the classification of the acute arthritis of primary gout;
* At least 2 gout flares in the year prior to the screening visit.
Exclusion Criteria
* Persistent chronic or active infections;
* History of an allergic reaction to allopurinol;
* History or presence of cancer within 5 years of the screening visit.
18 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Shirletta King-Davis
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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San Diego, California, United States
Santa Maria, California, United States
Whittier, California, United States
Colorado Srings, Colorado, United States
DeLand, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Tampa, Florida, United States
Dunwoody, Georgia, United States
Honolulu, Hawaii, United States
Boise, Idaho, United States
Indianapolis, Indiana, United States
South Bend, Indiana, United States
Owensboro, Kentucky, United States
Wheaton, Maryland, United States
Billings, Montana, United States
Omaha, Nebraska, United States
Reno, Nevada, United States
Albany, New York, United States
Plainview, New York, United States
Roslyn, New York, United States
Monroe, North Carolina, United States
Raleigh, North Carolina, United States
Cincinnati, Ohio, United States
Mayfield Village, Ohio, United States
Oklahoma City, Oklahoma, United States
Duncansville, Pennsylvania, United States
West Reading, Pennsylvania, United States
Charleston, South Carolina, United States
Grenville, South Carolina, United States
Dallas, Texas, United States
Spokane, Washington, United States
Countries
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References
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Schumacher HR Jr, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR; 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876-84. doi: 10.1002/art.33412.
Khanna D, Sarkin AJ, Khanna PP, Shieh MM, Kavanaugh AF, Terkeltaub RA, Lee SJ, Singh JA, Hirsch JD. Minimally important differences of the gout impact scale in a randomized controlled trial. Rheumatology (Oxford). 2011 Jul;50(7):1331-6. doi: 10.1093/rheumatology/ker023. Epub 2011 Mar 3.
Other Identifiers
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IL1T-GA-0619
Identifier Type: -
Identifier Source: org_study_id
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