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Sponsored by: |
Amgen |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00433875 |
Twelve week treatment of AMG 714 in RA patients who failed at least one DMARD, followed by a 3 month observational period.
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: AMG 714 |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double-Blind, Parallel Assignment |
Official Title: | A Double-Blind, Placebo Controlled, Randomized, Parallel-Group Clinical Trial With Multiple Dose Treatment of Anti-IL 15 Human Monoclonal Antibody (AMG 714) in Patients With Active Rheumatoid Arthritis Who Have Previously Failed One or More Disease Modifying Anti-Rheumatic Drugs |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Inclusion Criteria: Diagnosis of RA -
Exclusion Criteria: No prior biologic treatment for RA
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Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20030210 |
Study First Received: | February 8, 2007 |
Last Updated: | December 20, 2007 |
ClinicalTrials.gov Identifier: | NCT00433875 |
Health Authority: | Denmark: Ministry of Health; Germany: Federal Institute for Drugs and Medical Devices; Poland: Drug Institut; South Africa: Department of Health; Sweden: Medical Products Agency; United Kingdom: Medicines and Healthcare Products Regulatory Agency; United States: Food and Drug Administration |
Antibodies, Monoclonal Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases |
Arthritis Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases Immunoglobulins |
Immune System Diseases |