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Sponsored by: |
UCB |
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Information provided by: | UCB |
ClinicalTrials.gov Identifier: | NCT00152386 |
Patients will be assigned to one of three treatment groups. Study medication is administered over a 52 week study duration.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: Certolizumab pegol (CDP870) |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Double-Blind, Placebo Control, Parallel Assignment |
Official Title: | A Phase III Multicentre, Double Blind, Placebo-Controlled, Parallel Group 52-Week Study to Assess the Efficacy and Safety of 2 Dose Regimens of Lyophilised CDP870 as Additional Medication to Methotrexate in the Treatment of Signs and Symptoms and Preventing Structural Damage in Patients With Active Rheumatoid Arthritis Who Have an Incomplete Response to Methotrexate |
Estimated Enrollment: | 950 |
Study Start Date: | February 2005 |
Study Completion Date: | October 2006 |
Primary Completion Date: | October 2006 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria:
Active RA disease at Screening and Baseline as defined by:
Exclusion Criteria:
Study Director: | Jeff White, MD | UCB |
Study ID Numbers: | C87027 |
Study First Received: | September 7, 2005 |
Last Updated: | March 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00152386 History of Changes |
Health Authority: | Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica; Australia: Department of Health and Ageing Therapeutic Goods Administration; Belgium: Directorate general for the protection of Public health: Medicines; Bulgaria: Bulgarian Drug Agency; Canada: Health Canada; Chile: Instituto de Salud Publica de Chile; Croatia: Ministry of Health and Social Care; Czech Republic: State Institute for Drug Control; Estonia: The State Agency of Medicine; Finland: National Agency for Medicines; France: Afssaps - French Health Products Safety Agency; Germany: Paul-Ehrlich-Institut; Hungary: National Institute of Pharmacy; Israel: Israeli Health Ministry Pharmaceutical Administration; Latvia: State Agency of Medicines; Lithuania: State Medicine Control Agency - Ministry of Health; Mexico: Federal Commission for Protection Against Health Risks; Netherlands: Medicines Evaluation Board (MEB); New Zealand: Food Safety Authority; Russia: Pharmacological Committee, Ministry of Health; Serbia and Montenegro: Agency for Drugs and Medicinal Devices; Slovakia: State Institute for Drug Control; United Kingdom: Medicines and Healthcare Products Regulatory Agency; Ukraine: State Pharmacological Center - Ministry of Health; United States: Food and Drug Administration |
Rheumatoid Arthritis, CDP870 Certolizumab pegol, Cimzia |
Immunoglobulin Fab Fragments Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases Signs and Symptoms |
Antibodies Musculoskeletal Diseases Arthritis Connective Tissue Diseases Methotrexate Immunoglobulins |
Immunoglobulin Fab Fragments Autoimmune Diseases Immunologic Factors Immune System Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Physiological Effects of Drugs Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Pharmacologic Actions |