Study of the Safety and Efficacy of Long-Term Rilonacept Treatment for the Prevention of Gout Flares
NCT ID: NCT01459796
Last Updated: 2017-07-18
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE3
220 participants
INTERVENTIONAL
2011-11-30
2013-06-30
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
TRIPLE
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 51.
Placebo
Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
Allopurinol
Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
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 51.
Rilonacept
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
Allopurinol
Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
Interventions
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Rilonacept
Rilonacept 160 mg loading dose followed by Rilonacept 80 mg/2 mL injections qw for 52 weeks.
Placebo
Placebo loading dose followed by placebo injections (2 mL) qw for 52 weeks.
Allopurinol
Allopurinol 50 or 100 mg, orally daily for 52 weeks as background treatment.
Eligibility Criteria
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Inclusion Criteria
* Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout;
* Serum uric acid greater than or equal to 7.5 mg/dL at the screening visit;
* A self-reported history of at least 2 gout flares in the year prior to screening.
Exclusion Criteria
* Participants requiring dialysis;
* Participants who had had an organ transplant;
* Persistent chronic or active infections;
* Previous exposure to rilonacept;
* Use of allopurinol, benzbromarone, febuxostat, probenecid or sulfinpyrazone within 84 days 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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Principal Investigators
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Clinical Trial Management
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Sierra Vista, Arizona, United States
Tucson, Arizona, United States
Searcy, Arkansas, United States
Concord, California, United States
La Jolla, California, United States
Long Beach, California, United States
Whittier, California, United States
Denver, Colorado, United States
Trumbull, Connecticut, United States
Washington D.C., District of Columbia, United States
Clearwater, Florida, United States
DeLand, Florida, United States
Delray Beach, Florida, United States
New Port Richey, Florida, United States
Ocala, Florida, United States
Orlando, Florida, United States
St. Petersburg, Florida, United States
Tampa, Florida, United States
Venice, Florida, United States
Atlanta, Georgia, United States
Boise, Idaho, United States
Coeur d'Alene, Idaho, United States
Meridian, Idaho, United States
Avon, Indiana, United States
Brownsburg, Indiana, United States
Evansville, Indiana, United States
Bowling Green, Kentucky, United States
Elizabethtown, Kentucky, United States
Owensboro, Kentucky, United States
New Orleans, Louisiana, United States
Cumberland, Maryland, United States
Hagerstown, Maryland, United States
Wheaton, Maryland, United States
Fall River, Massachusetts, United States
Edina, Minnesota, United States
St Louis, Missouri, United States
Kalispell, Montana, United States
Omaha, Nebraska, United States
Brooklyn, New York, United States
Cary, North Carolina, United States
Charlotte, North Carolina, United States
Greensboro, North Carolina, United States
Greenville, North Carolina, United States
Raleigh, North Carolina, United States
Salisbury, North Carolina, United States
Statesville, North Carolina, United States
Winston-Salem, North Carolina, United States
Akron, Ohio, United States
Carlisle, Ohio, United States
Portland, Oregon, United States
Huntingdon Valley, Pennsylvania, United States
Johnstown, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Reading, Pennsylvania, United States
Anderson, South Carolina, United States
Charleston, South Carolina, United States
Columbia, South Carolina, United States
Greenville, South Carolina, United States
Rock Hill, South Carolina, United States
Simpsonville, South Carolina, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Houston, Texas, United States
Lake Jackson, Texas, United States
North Richland Hills, Texas, United States
San Antonio, Texas, United States
Sugar Land, Texas, United States
Salt Lake City, Utah, United States
Arlington, Virginia, United States
Spokane, Washington, United States
Countries
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Other Identifiers
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IL1T-GA-1101
Identifier Type: -
Identifier Source: org_study_id
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