Study Utilizing Rilonacept in Gout Exacerbations

Last updated: March 20, 2017
Sponsor: Regeneron Pharmaceuticals
Overall Status: Completed

Phase

3

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:

  1. Male or female 18 - 70 years of age

  2. Previously met the preliminary criteria of ARA for the classification of the acutearthritis of primary gout

  3. Presenting with an acute attack (flare) of gout within 48 hours of pain onset and painof at least moderate severity

  4. Must have at least 1 on the 0-3 scale for the swelling and the tenderness assessmentsof the gouty index joint

  5. Current presentation of acute gout flare in 3 joints or less

Exclusion

Exclusion Criteria:

  1. 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.

  2. Treatment with oral analgesics within 6 hours before baseline assessments. Treatmentwith topical analgesics within 12 hours before baseline assessments

  3. History of NSAID intolerance

  4. Participants with history of chronic, gouty arthritis

Study Design

Total Participants: 225
Study Start date:
March 01, 2009
Estimated Completion Date:
February 28, 2010

Connect with a study center

  • Birmingham, Alabama
    United States

    Site Not Available

  • Huntsville, Alabama
    United States

    Site Not Available

  • Mesa, Arizona
    United States

    Site Not Available

  • Phoenix, Arizona
    United States

    Site Not Available

  • Sierra Vista, Arizona
    United States

    Site Not Available

  • Burbank, California
    United States

    Site Not Available

  • Whittier, California
    United States

    Site Not Available

  • Clearwater, Florida
    United States

    Site Not Available

  • Debary, Florida
    United States

    Site Not Available

  • Deland, Florida
    United States

    Site Not Available

  • Jupiter, Florida
    United States

    Site Not Available

  • Orange Park, Florida
    United States

    Site Not Available

  • Orlando, Florida
    United States

    Site Not Available

  • Oviedo, Florida
    United States

    Site Not Available

  • Boise, Idaho
    United States

    Site Not Available

  • Elizabethtown, Kentucky
    United States

    Site Not Available

  • Baltimore, Maryland
    United States

    Site Not Available

  • Wheaton, Maryland
    United States

    Site Not Available

  • Detroit, Michigan 48221
    United States

    Site Not Available

  • Stevenville, Michigan
    United States

    Site Not Available

  • Billings, Montana
    United States

    Site Not Available

  • Albuquerque, New Mexico
    United States

    Site Not Available

  • Albany, New York
    United States

    Site Not Available

  • Burlington, North Carolina
    United States

    Site Not Available

  • Cary, North Carolina
    United States

    Site Not Available

  • Raleigh, North Carolina
    United States

    Site Not Available

  • Wilmington, North Carolina
    United States

    Site Not Available

  • Willoughby Hills, Ohio
    United States

    Site Not Available

  • Oklahoma City, Oklahoma
    United States

    Site Not Available

  • Lake Oswego, Oregon
    United States

    Site Not Available

  • Portland, Oregon
    United States

    Site Not Available

  • Johnstown, Pennsylvania
    United States

    Site Not Available

  • Limerick, Pennsylvania
    United States

    Site Not Available

  • Norristown, Pennsylvania
    United States

    Site Not Available

  • Greenville, South Carolina
    United States

    Site Not Available

  • Bristol, Tennessee
    United States

    Site Not Available

  • Dallas, Texas
    United States

    Site Not Available

  • Forth Worth, Texas
    United States

    Site Not Available

  • Houston, Texas
    United States

    Site Not Available

  • Irving, Texas
    United States

    Site Not Available

  • Mesquite, Texas
    United States

    Site Not Available

  • North Richland Hills, Texas
    United States

    Site Not Available

  • San Antonio, Texas
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.