Study Utilizing Rilonacept in Gout Exacerbations

Phase

Condition

Arthritis And Arthritic Pain (Pediatric)

Collagen Vascular Diseases

Joint Injuries

Treatment

N/A

Clinical Study ID

NCT00855920

IL1T-GA-0814

Ages 18-70
All Genders

Study Summary

This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Eligibility Criteria

Inclusion

Inclusion Criteria:

Male or female 18 - 70 years of age
Previously met the preliminary criteria of ARA for the classification of the acutearthritis of primary gout
Presenting with an acute attack (flare) of gout within 48 hours of pain onset and painof at least moderate severity
Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessmentsof the gouty index joint
Current presentation of acute gout flare in 3 joints or less

Exclusion

Exclusion Criteria:

Treatment with any non-steroidal anti-inflammatory drug (NSAIDs) or opiates within 48hours prior to baseline assessments. Treatment with long-acting NSAIDs within 1 monthprior to baseline visit. Treatment with naproxen, meloxicam, nabumetone, celecoxib andindomethacin SR within 5 days prior to baseline visit.
Treatment with oral analgesics within 6 hours before baseline assessments. Treatmentwith topical analgesics within 12 hours before baseline assessments
History of NSAID intolerance
Participants with history of chronic, gouty arthritis

Study Design

March 01, 2009

February 28, 2010

Connect with a study center

Birmingham, Alabama
United States
Site Not Available
Huntsville, Alabama
United States
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Mesa, Arizona
United States
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Phoenix, Arizona
United States
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Sierra Vista, Arizona
United States
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Burbank, California
United States
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Whittier, California
United States
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Clearwater, Florida
United States
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Debary, Florida
United States
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Deland, Florida
United States
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Jupiter, Florida
United States
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Orange Park, Florida
United States
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Orlando, Florida
United States
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Oviedo, Florida
United States
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Boise, Idaho
United States
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Elizabethtown, Kentucky
United States
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Baltimore, Maryland
United States
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Wheaton, Maryland
United States
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Detroit, Michigan 48221
United States
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Stevenville, Michigan
United States
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Billings, Montana
United States
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Albuquerque, New Mexico
United States
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Albany, New York
United States
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Burlington, North Carolina
United States
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Cary, North Carolina
United States
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Raleigh, North Carolina
United States
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Wilmington, North Carolina
United States
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Willoughby Hills, Ohio
United States
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Oklahoma City, Oklahoma
United States
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Lake Oswego, Oregon
United States
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Portland, Oregon
United States
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Johnstown, Pennsylvania
United States
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Limerick, Pennsylvania
United States
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Norristown, Pennsylvania
United States
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Greenville, South Carolina
United States
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Bristol, Tennessee
United States
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Dallas, Texas
United States
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Forth Worth, Texas
United States
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Houston, Texas
United States
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Irving, Texas
United States
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Mesquite, Texas
United States
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North Richland Hills, Texas
United States
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San Antonio, Texas
United States
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