Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
225 participants
INTERVENTIONAL
2009-03-31
2010-02-28
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 (for Rilonacept) and Indomethacin
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Indomethacin
Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Placebo (for Rilonacept)
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
Rilonacept and Indomethacin
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Rilonacept
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
Indomethacin
Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Rilonacept and Placebo (for Indomethacin)
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Rilonacept
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
Placebo (for Indomethacin)
Placebo (for Indomethacin) orally TID for 12 days.
Interventions
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Rilonacept
Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline).
Indomethacin
Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days).
Placebo (for Indomethacin)
Placebo (for Indomethacin) orally TID for 12 days.
Placebo (for Rilonacept)
Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).
Eligibility Criteria
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Inclusion Criteria
2. Previously met the preliminary criteria of ARA for the classification of the acute arthritis of primary gout
3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and pain of at least moderate severity
4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessments of the gouty index joint
5. Current presentation of acute gout flare in 3 joints or less
Exclusion Criteria
2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatment with topical analgesics within 12 hours before baseline assessments
3. History of NSAID intolerance
4. Participants with history of chronic, gouty arthritis
18 Years
70 Years
ALL
No
Sponsors
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Regeneron Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Evans, PharmD
Role: STUDY_DIRECTOR
Regeneron Pharmaceuticals
Locations
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Birmingham, Alabama, United States
Huntsville, Alabama, United States
Mesa, Arizona, United States
Phoenix, Arizona, United States
Sierra Vista, Arizona, United States
Burbank, California, United States
Whittier, California, United States
Clearwater, Florida, United States
DeBary, Florida, United States
DeLand, Florida, United States
Jupiter, Florida, United States
Orange Park, Florida, United States
Orlando, Florida, United States
Oviedo, Florida, United States
Boise, Idaho, United States
Elizabethtown, Kentucky, United States
Baltimore, Maryland, United States
Wheaton, Maryland, United States
Detroit, Michigan, United States
Stevenville, Michigan, United States
Billings, Montana, United States
Albuquerque, New Mexico, United States
Albany, New York, United States
Burlington, North Carolina, United States
Cary, North Carolina, United States
Raleigh, North Carolina, United States
Raleigh, North Carolina, United States
Wilmington, North Carolina, United States
Willoughby Hills, Ohio, United States
Oklahoma City, Oklahoma, United States
Lake Oswego, Oregon, United States
Portland, Oregon, United States
Johnstown, Pennsylvania, United States
Limerick, Pennsylvania, United States
Norristown, Pennsylvania, United States
Greenville, South Carolina, United States
Bristol, Tennessee, United States
Dallas, Texas, United States
Forth Worth, Texas, United States
Houston, Texas, United States
Irving, Texas, United States
Mesquite, Texas, United States
North Richland Hills, Texas, United States
San Antonio, Texas, United States
Countries
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References
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Terkeltaub RA, Schumacher HR, Carter JD, Baraf HS, Evans RR, Wang J, King-Davis S, Weinstein SP. Rilonacept in the treatment of acute gouty arthritis: a randomized, controlled clinical trial using indomethacin as the active comparator. Arthritis Res Ther. 2013 Feb 1;15(1):R25. doi: 10.1186/ar4159.
Related Links
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Other Identifiers
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IL1T-GA-0814
Identifier Type: -
Identifier Source: org_study_id
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