PREventative Study Against URate-lowering Drug-induced Gout Exacerbations 1
NCT ID: NCT00829829
Last Updated: 2017-04-28
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
241 participants
INTERVENTIONAL
2009-02-28
2010-06-30
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 15.
Placebo
Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.
Rilonacept 80 mg
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 15.
Rilonacept 80 mg
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 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 15.
Rilonacept 160 mg
Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 weeks.
Interventions
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Placebo
Placebo loading dose followed by placebo injections (2 mL) qw for 16 weeks.
Rilonacept 80 mg
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 16 weeks.
Rilonacept 160 mg
Rilonacept 320 mg loading dose followed by Rilonacept 160 mg/2 mL injections qw for 16 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;
* Serum uric acid greater than or equal to 7.5 mg/dL at 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;
* Previous exposure to Rilonacept;
* Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 3 months prior to the screening visit.
18 Years
80 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Locations
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Birmingham, Alabama, United States
Gilbert, Arizona, United States
Peoria, Arizona, United States
Searcy, Arkansas, United States
Concord, California, United States
San Diego, California, United States
Santa Maria, California, United States
Trumball, Connecticut, United States
Washington D.C., District of Columbia, United States
Daytona Beach, Florida, United States
Delray Beach, Florida, United States
Jacksonville, Florida, United States
Jupiter, Florida, United States
Naples, Florida, United States
St. Petersburg, Florida, United States
Gainsville, Georgia, United States
Rome, Georgia, United States
Tucker, Georgia, United States
Woodstock, Georgia, United States
Boise, Idaho, United States
Avon, Indiana, United States
Evansville, Indiana, United States
South Bend, Indiana, United States
Wichita, Kansas, United States
Bowling Green, Kentucky, United States
Owensboro, Kentucky, United States
Baltimore, Maryland, United States
Ellicott City, Maryland, United States
Resistertown, Maryland, United States
Troy, Michigan, United States
Jackson, Mississippi, United States
Florissant, Missouri, United States
Las Vegas, Nevada, United States
Las Vegas, Nevada, United States
Berkeley Heights, New Jersey, United States
Freehold, New Jersey, United States
Brooklyn, New York, United States
Greensboro, North Carolina, United States
Hickory, North Carolina, United States
Morehead City, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Akron, Ohio, United States
Cincinnati, Ohio, United States
Middleburg Heights, Ohio, United States
Perrysburg, Ohio, United States
Duncansville, Pennsylvania, United States
Fountain Hill, Pennsylvania, United States
Huntingdon Valley, Pennsylvania, United States
Lancaster, Pennsylvania, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greer, South Carolina, United States
North Charleston, South Carolina, United States
Rock Hill, South Carolina, United States
Memphis, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Longview, Texas, United States
Richardson, Texas, United States
San Antonio, Texas, United States
Burke, Virginia, United States
Richmond, Virginia, United States
Spokane, Washington, United States
Tacoma, Washington, United States
Calgary, Alberta, Canada
Burnaby, British Columbia, Canada
Kamloops, British Columbia, Canada
Kelowna, British Columbia, Canada
Quesnel, British Columbia, Canada
Victoria, British Columbia, Canada
Mount Pearl, Newfoundland and Labrador, Canada
St. John's, Newfoundland and Labrador, Canada
Brampton, Ontario, Canada
Corunna, Ontario, Canada
Fort Erie, Ontario, Canada
Greater Sudbury, Ontario, Canada
Kitchener, Ontario, Canada
Listowel, Ontario, Canada
London, Ontario, Canada
London, Ontario, Canada
Mississauga, Ontario, Canada
Newmarket, Ontario, Canada
Toronto, Ontario, Canada
Windsor, Ontario, Canada
Montreal, Quebec, Canada
Québec, Quebec, Canada
Trois-Rivières, Quebec, Canada
Saskatoon, Saskatchewan, Canada
Countries
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References
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Schumacher HR Jr, Evans RR, Saag KG, Clower J, Jennings W, Weinstein SP, Yancopoulos GD, Wang J, Terkeltaub R. Rilonacept (interleukin-1 trap) for prevention of gout flares during initiation of uric acid-lowering therapy: results from a phase III randomized, double-blind, placebo-controlled, confirmatory efficacy study. Arthritis Care Res (Hoboken). 2012 Oct;64(10):1462-70. doi: 10.1002/acr.21690.
Related Links
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Other Identifiers
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IL1T-GA-0810
Identifier Type: -
Identifier Source: org_study_id
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