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Sponsored by: |
Regeneron Pharmaceuticals |
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Information provided by: | Regeneron Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00829829 |
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are beginning allopurinol treatment for gout. Subjects will participate in this study for approximately 22 weeks. Rilonacept is being studied for use in preventing allopurinol-induced gout flares.
Condition | Intervention | Phase |
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Intercritical Gout |
Drug: rilonacept |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety/Efficacy Study |
Official Title: | A Multi-Center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of Rilonacept for the Prophylaxis of Gout Flares During the Initiation of Allopurinol Therapy |
Estimated Enrollment: | 240 |
Study Start Date: | February 2009 |
Estimated Study Completion Date: | April 2010 |
Estimated Primary Completion Date: | March 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1: Placebo Comparator
Placebo
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Drug: rilonacept
Placebo loading dose followed by placebo SC injections (2 mL) once a week for 16 weeks
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2: Active Comparator
rilonacept 80 mg
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Drug: rilonacept
rilonacept 160 mg SC loading dose followed by rilonacept 80 mg/2 mL SC injections once a week for 16 weeks
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3: Active Comparator
rilonacept 160 mg
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Drug: rilonacept
rilonacept 320 mg SC loading dose followed by rilonacept 160 mg/2 mL SC injections once a week for 16 weeks
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Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Connie Seitz | 512-416-5027 | connie.seitz@quintiles.com |
United States, California | |
Recruiting | |
San Diego, California, United States, 92103 | |
Recruiting | |
Santa Maria, California, United States, 93454 | |
United States, Connecticut | |
Recruiting | |
Trumball, Connecticut, United States, 06611 | |
United States, Florida | |
Recruiting | |
Jacksonville, Florida, United States, 32205 | |
Recruiting | |
St. Petersburg, Florida, United States, 33702 | |
Recruiting | |
Jupiter, Florida, United States, 33458 | |
United States, Georgia | |
Recruiting | |
Woodstock, Georgia, United States, 30188 | |
United States, Idaho | |
Recruiting | |
Boise, Idaho, United States, 83713 | |
United States, New York | |
Recruiting | |
Brooklyn, New York, United States, 11201 | |
United States, North Carolina | |
Recruiting | |
Morehead City, North Carolina, United States, 28516 | |
Recruiting | |
Greensboro, North Carolina, United States, 27408 | |
United States, Ohio | |
Recruiting | |
Perrysburg, Ohio, United States, 43551 | |
United States, Pennsylvania | |
Recruiting | |
Bethlehem, Pennsylvania, United States, 18105 | |
Recruiting | |
Huntingdon, Pennsylvania, United States, 19006 | |
Recruiting | |
Reading, Pennsylvania, United States, 19606 | |
United States, South Carolina | |
Recruiting | |
Rock Hill, South Carolina, United States, 29732 | |
United States, Tennessee | |
Recruiting | |
Germantown, Tennessee, United States, 38138 | |
United States, Texas | |
Recruiting | |
Houston, Texas, United States, 77074 | |
United States, Washington | |
Recruiting | |
Spokane, Washington, United States, 99204 |
Responsible Party: | Regeneron Pharmaceuticals, Inc ( Robert Evans, PharmD / Director of Clinical Sciences ) |
Study ID Numbers: | IL1T-GA-0810 |
Study First Received: | January 23, 2009 |
Last Updated: | March 20, 2009 |
ClinicalTrials.gov Identifier: | NCT00829829 History of Changes |
Health Authority: | United States: Food and Drug Administration; Canada: Health Canada; Canada: Ethics Review Committee |
Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases |
Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout |
Metabolism, Inborn Errors Uric Acid Allopurinol Metabolic Diseases Musculoskeletal Diseases Genetic Diseases, Inborn |
Arthritis Joint Diseases Rheumatic Diseases Metabolic Disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout |
Metabolism, Inborn Errors Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases |
Arthritis Rheumatic Diseases Purine-Pyrimidine Metabolism, Inborn Errors Gout |