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Sponsored by: |
Novartis Pharmaceuticals |
---|---|
Information provided by: | Novartis |
ClinicalTrials.gov Identifier: | NCT00819585 |
A 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled study to evaluate canakinumab (ACZ885) for prophylaxis of signs and symptoms of acute flares in chronic gout patients initiating allopurinol therapy
Condition | Intervention | Phase |
---|---|---|
Gout |
Drug: ACZ885 Drug: Colchicine |
Phase II |
Study Type: | Interventional |
Study Design: | Prevention, Randomized, Double Blind (Subject, Investigator), Parallel Assignment |
Official Title: | A 24-Week, Dose-Ranging, Multi-Center, Double-Blind, Double-Dummy, Active-Controlled Study to Evaluate Canakinumab (ACZ885) for Prophylaxis of Signs and Symptoms of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy |
Estimated Enrollment: | 440 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | January 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Canakinumab 25 mg s.c. once on Day 1: Experimental | Drug: ACZ885 |
Canakinumab 50 mg s.c. once on Day 1: Experimental | Drug: ACZ885 |
Canakinumab 50 mg s.c. followed by canakinumab 25 mg s.c.: Experimental | Drug: ACZ885 |
Canakinumab 300 mg s.c. once on Day 1: Experimental | Drug: ACZ885 |
Colchicine 0.5 mg capsule orally once daily for 16 weeks: Active Comparator | Drug: Colchicine |
Canakinumab 100 mg s.c. once on Day 1: Experimental | Drug: ACZ885 |
Canakinumab 200 mg s.c. once on Day 1: Experimental | Drug: ACZ885 |
Ages Eligible for Study: | 18 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Other protocol-defined inclusion/exclusion criteria may apply
Contact: Novartis Pharmaceuticals | 862-778-8300 |
United States, California | |
Talbert Medical Group | Not yet recruiting |
Huntington Beach, California, United States, 92646 | |
United States, Florida | |
Health Awareness | Not yet recruiting |
Jupiter, Florida, United States, 33458 | |
United States, Hawaii | |
East-West Medical Research institute | Recruiting |
Honolulu, Hawaii, United States, 96814 | |
United States, Kansas | |
Pinnacle Medical Research | Not yet recruiting |
Overland Park, Kansas, United States, 66215 | |
United States, Louisiana | |
The Family Doctors | Not yet recruiting |
Shreveport, Louisiana, United States, 71115 | |
Dolby Research, LLC | Not yet recruiting |
Baton Rouge, Louisiana, United States, 70809 | |
United States, Maryland | |
Good Samaritan Hospital of Maryland | Not yet recruiting |
Baltimore, Maryland, United States, 21239 | |
United States, Michigan | |
Shores Rheumatology | Not yet recruiting |
St. Clair Shores, Michigan, United States, 48081 | |
United States, New York | |
Rochester clinical Research | Not yet recruiting |
Rochester, New York, United States, 14609 | |
United States, Oklahoma | |
Health Research of Oklahoma, PLLC | Not yet recruiting |
Oklahoma City, Oklahoma, United States, 73103 | |
Castlerock Clinical Research Consultants, LLC | Not yet recruiting |
Tulsa, Oklahoma, United States, 74136 | |
United States, Pennsylvania | |
Altoona Center for Clinical Research | Recruiting |
Duncansville, Pennsylvania, United States, 16635 | |
United States, South Carolina | |
Columbia Clinical Research | Not yet recruiting |
Columbia, South Carolina, United States, 29201 | |
Upstate Pharmaceutical Research | Not yet recruiting |
Greenville, South Carolina, United States, 29615 | |
United States, Texas | |
iMED Internal medicine, PA | Not yet recruiting |
San Antonio, Texas, United States, 78228 | |
Belgium | |
Novartis Investigative Site | Not yet recruiting |
Gozée, Belgium | |
Novartis Investigative site | Not yet recruiting |
Oostham, Belgium | |
Novartis Investigative Site | Recruiting |
Brussels, Belgium | |
Guatemala | |
Novartis Investigative site | Not yet recruiting |
Guatemala City, Guatemala | |
Singapore | |
Novartis Investigative site | Not yet recruiting |
Singapore, Singapore |
Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals ( External Affairs ) |
Study ID Numbers: | CACZ885H2251, EudraCT : 2008-005876-28 |
Study First Received: | January 8, 2009 |
Last Updated: | January 8, 2009 |
ClinicalTrials.gov Identifier: | NCT00819585 History of Changes |
Health Authority: | Argentina: Ministry of Health; Belgium: Federal Agency for Medicinal Products and Health Products; Colombia: National Institutes of Health; Czech Republic: State Institute for Drug Control; Finland: National Agency for Medicines; Germany: Federal Institute for Drugs and Medical Devices; Guatemala: Ministry of Health; Hungary: National Institute of Pharmacy; Portugal: National Pharmacy and Medicines Institute; Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products; Russia: Pharmacological Committee, Ministry of Health; Singapore: Health Sciences Authority; Slovakia: State Institute for Drug Control; South Africa: Medicines Control Council; Spain: Spanish Agency of Medicines; Switzerland: Federal Office of Public Health; Taiwan: Department of Health; Turkey: Ministry of Health; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration; Venezuela: Nacional de Higiene Rafael Rangel |
Gout Chronic Gout Gouty arthritis Gout flares |
Antimetabolites Allopurinol Antioxidants Metabolic Diseases Joint Diseases Antimitotic Agents Rheumatic Diseases Gout Purine-Pyrimidine Metabolism, Inborn Errors Arthritis, Gouty |
Signs and Symptoms Metabolism, Inborn Errors Musculoskeletal Diseases Genetic Diseases, Inborn Arthritis Tubulin Modulators Colchicine Antirheumatic Agents Metabolic Disorder |
Antimetabolites Allopurinol Antioxidants Molecular Mechanisms of Pharmacological Action Antineoplastic Agents Physiological Effects of Drugs Gout Suppressants Purine-Pyrimidine Metabolism, Inborn Errors Metabolism, Inborn Errors Musculoskeletal Diseases Arthritis Therapeutic Uses Free Radical Scavengers |
Colchicine Metabolic Diseases Joint Diseases Mitosis Modulators Enzyme Inhibitors Rheumatic Diseases Antimitotic Agents Protective Agents Gout Pharmacologic Actions Genetic Diseases, Inborn Tubulin Modulators Antirheumatic Agents |