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Sponsors and Collaborators: |
Amgen Immunex Corporation |
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Information provided by: | Amgen |
ClinicalTrials.gov Identifier: | NCT00249041 |
The purpose of this study is to assess the antibody formation to Enbrel liquid in subjects with Rheumatoid Arthritis
Condition | Intervention | Phase |
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Rheumatoid Arthritis |
Drug: 50 mg Etanercept Drug: Enbrel liquid |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Open Label, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Open-Label Study to Assess the Antibody Response to Etanercept Liquid in Subjects With Rheumatoid Arthritis (RA) |
Enrollment: | 447 |
Study Start Date: | October 2005 |
Study Completion Date: | March 2007 |
Primary Completion Date: | December 2006 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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Etanercept liquid: Experimental |
Drug: 50 mg Etanercept
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
Drug: Enbrel liquid
50 mg Etanercept liquid injected SC once weekly using prefilled syringes
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The purpose of this study is to assess the rate of anti-etanercept antibody formation in a larger sample of subjects on liquid etanercept than the previous study, 20020378, in a minimum of 400 subjects receiving etanercept liquid for the first time, with and without concomitant MTX therapy. The rate of neutralizing antibodies to liquid etanercept will also be assessed.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Responsible Party: | Amgen Inc. ( Global Development Leader ) |
Study ID Numbers: | 20050145 |
Study First Received: | November 3, 2005 |
Last Updated: | December 4, 2008 |
ClinicalTrials.gov Identifier: | NCT00249041 History of Changes |
Health Authority: | United States: Food and Drug Administration |
Rheumatoid Arthritis, Enbrel liquid, antibodies |
Anti-Inflammatory Agents Autoimmune Diseases Immunologic Factors Joint Diseases Arthritis, Rheumatoid Rheumatic Diseases TNFR-Fc fusion protein Immunosuppressive Agents Antibodies |
Musculoskeletal Diseases Analgesics, Non-Narcotic Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Immunoglobulins |
Anti-Inflammatory Agents Autoimmune Diseases Immunologic Factors Immune System Diseases Joint Diseases Physiological Effects of Drugs Gastrointestinal Agents Arthritis, Rheumatoid Rheumatic Diseases TNFR-Fc fusion protein Immunosuppressive Agents Pharmacologic Actions |
Musculoskeletal Diseases Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Arthritis Connective Tissue Diseases Anti-Inflammatory Agents, Non-Steroidal Peripheral Nervous System Agents Analgesics Antirheumatic Agents Central Nervous System Agents |