Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT00610363
First received: January 24, 2008
Last updated: September 27, 2013
Last verified: June 2011
  Purpose

This is a clinical research study to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning another additional treatment. Subjects will participate in this study for approximately 24 weeks. Rilonacept is being studied for use in preventing gout attacks in patients who have gout.


Condition Intervention Phase
Gout
Biological: rilonacept
Other: placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study, Tolerability, and Efficacy of Rilonacept for the Prevention of Gout Flares During Initiation of Allopurinol Therapy

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • number of flares during the treatment period [ Time Frame: 16 weeks ] [ Designated as safety issue: Yes ]

Enrollment: 83
Study Start Date: November 2007
Study Completion Date: October 2008
Primary Completion Date: October 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
rilonacept
Biological: rilonacept
160mg sc once a week
Placebo Comparator: 2
placebo
Other: placebo
placebo sc once a week

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Male or female greater than 18 years of age
  • Previously met the preliminary criteria of the ARA for the classification of the acute arthritis of primary gout
  • At least 2 gout flares in the year prior to the Screening Visit

Exclusion Criteria:

  • Acute gout flare within 2 weeks of the Screening visit and during Screening
  • Persistent chronic or active infections
  • History of an allergic reaction to allopurinol
  • History or presence of cancer within 5 years of the Screening Visit
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00610363

  Hide Study Locations
Locations
United States, California
San Diego, California, United States, 92108
Santa Maria, California, United States, 93454
Whittier, California, United States, 90601
United States, Colorado
Colorado Srings, Colorado, United States, 80910
United States, Florida
DeLand, Florida, United States, 32720
Ocala, Florida, United States, 34471
Orlando, Florida, United States, 32804
St. Petersburg, Florida, United States, 33710
Tampa, Florida, United States
Tampa, Florida, United States, 33614
United States, Georgia
Dunwoody, Georgia, United States, 30338
United States, Hawaii
Honolulu, Hawaii, United States, 96814
United States, Idaho
Boise, Idaho, United States, 83702
United States, Indiana
Indianapolis, Indiana, United States, 46268
South Bend, Indiana, United States, 46601
United States, Kentucky
Owensboro, Kentucky, United States, 42303
United States, Maryland
Wheaton, Maryland, United States, 20902
United States, Montana
Billings, Montana, United States, 59101
United States, Nebraska
Omaha, Nebraska, United States, 68114
United States, Nevada
Reno, Nevada, United States, 89502
United States, New York
Albany, New York, United States, 12206
Plainview, New York, United States, 11803
Roslyn, New York, United States, 11576
United States, North Carolina
Monroe, North Carolina, United States, 28112
Raleigh, North Carolina, United States, 27612
United States, Ohio
Cincinnati, Ohio, United States, 45242
Mayfield Village, Ohio, United States, 44143
United States, Oklahoma
Oklahoma City, Oklahoma, United States, 73112
United States, Pennsylvania
Duncansville, Pennsylvania, United States, 16635
West Reading, Pennsylvania, United States, 19611
United States, South Carolina
Charleston, South Carolina, United States, 29406
Grenville, South Carolina, United States, 29601
United States, Texas
Dallas, Texas, United States, 75235
United States, Washington
Spokane, Washington, United States, 99204
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Shirletta King-Davis Regeneron Pharmaceuticals
  More Information

No publications provided by Regeneron Pharmaceuticals

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00610363     History of Changes
Other Study ID Numbers: IL1T-GA-0619
Study First Received: January 24, 2008
Last Updated: September 27, 2013
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Gout
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases

ClinicalTrials.gov processed this record on July 22, 2014