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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00459706 |
The purpose of this study is to explore and compare the perceptions and satisfaction for two different delivery mechanisms for Etanercept (Etanercept Auto-injector and the Etanercept prefilled syringe) in patients with rheumatoid arthritis (RA).
Condition | Intervention | Phase |
---|---|---|
Active Rheumatoid Arthritis |
Device: Etanercept Prefilled Syringe Device: Etanercept Autoinjector |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment |
Official Title: | A 3-Month, Randomised, Open Label, Parallel Group, Descriptive Study To Explore and Compare Perceptions and Satisfaction For Two Different Delivery Mechanisms For Etanercept (Etanercept Autoinjector and The Etanercept Prefilled Syringe) in Patients With Rheumatoid Arthritis |
Estimated Enrollment: | 534 |
Study Start Date: | September 2007 |
Estimated Study Completion Date: | January 2009 |
Estimated Primary Completion Date: | January 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
Arm 1: Enbrel 50 mg Prefilled Syringe
|
Device: Etanercept Prefilled Syringe
Enbrel 50 mg Prefilled Syringe once weekly
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2: Active Comparator
Arm 2: Enbrel 50 mg Autoinjector
|
Device: Etanercept Autoinjector
Enbrel 50 mg Autoinjector once weekly
|
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion:
Exclusion:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Study Director: | Medical Monitor | Wyeth |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0881K1-6000 |
Study First Received: | April 11, 2007 |
Last Updated: | July 7, 2008 |
ClinicalTrials.gov Identifier: | NCT00459706 |
Health Authority: | European Union: European Medicines Agency |
Rheumatoid Arthritis |
Antibodies Autoimmune Diseases Musculoskeletal Diseases Joint Diseases Arthritis Immunoglobulin G |
Connective Tissue Diseases Arthritis, Rheumatoid Rheumatic Diseases TNFR-Fc fusion protein Immunoglobulins |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases Physiological Effects of Drugs Gastrointestinal Agents Immunosuppressive Agents Pharmacologic Actions Analgesics, Non-Narcotic |
Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |