Study of the Safety and Effectiveness of Rilonacept for the Prevention of Gout Flares - Full Text View

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:

MedlinePlus related topics: Gout

Drug Information available for: Rilonacept

U.S. FDA Resources

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

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

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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):

Schumacher HR Jr, Sundy JS, Terkeltaub R, Knapp HR, Mellis SJ, Stahl N, Yancopoulos GD, Soo Y, King-Davis S, Weinstein SP, Radin AR; 0619 Study Group. Rilonacept (interleukin-1 trap) in the prevention of acute gout flares during initiation of urate-lowering therapy: results of a phase II randomized, double-blind, placebo-controlled trial. Arthritis Rheum. 2012 Mar;64(3):876-84. doi: 10.1002/art.33412.

Khanna D, Sarkin AJ, Khanna PP, Shieh MM, Kavanaugh AF, Terkeltaub RA, Lee SJ, Singh JA, Hirsch JD. Minimally important differences of the gout impact scale in a randomized controlled trial. Rheumatology (Oxford). 2011 Jul;50(7):1331-6. Epub 2011 Mar 3.

Responsible Party:	Robert Evans, PharmD/ Director of Clinical Sciences, Regeneron Pharmaceuticals, Inc
ClinicalTrials.gov Identifier:	NCT00610363 History of Changes
Other Study ID Numbers:	IL1T-GA-0619
Study First Received:	January 24, 2008
Last Updated:	June 1, 2011
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 May 23, 2013