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Sponsored by: |
Wyeth |
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Information provided by: | Wyeth |
ClinicalTrials.gov Identifier: | NCT00273858 |
This is a Phase 4 open label, non-interventional, multi-center study to evaluate the safety of Enbrel (etanercept) treatment in patients receiving etanercept 25mg sc twice weekly or 50mg of etanercept once weekly. The improvement of health-related quality of life will also be evaluated.
Condition | Intervention | Phase |
---|---|---|
Ankylosing Spondylitis Arthritis, Psoriatic Arthritis, Rheumatoid Spondylitis, Ankylosing |
Drug: etanercept |
Phase IV |
Study Type: | Observational |
Study Design: | Prospective |
Official Title: | Open Label Study to Evaluate the Safety Profile and the Quality of Life in Patients Receiving Etanercept for the Treatment of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis |
Estimated Enrollment: | 1000 |
Study Start Date: | January 2006 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients
Inclusion Criteria:
· Clinical diagnosis of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis.
Exclusion Criteria:
Contact: Trial Manager | clintrialparticipation@wyeth.com |
Greece | |
Recruiting | |
Thessaloniki, Greece, 546 42 | |
Recruiting | |
Athens, Greece, 115 27 | |
Not yet recruiting | |
Karditsa, Greece, 43100 | |
Recruiting | |
Athens, Greece, 184 54 | |
Recruiting | |
Athens, Greece, 115 26 | |
Recruiting | |
Larissa, Greece, 411 10 | |
Recruiting | |
Ioannina, Greece, 45500 | |
Recruiting | |
Thessaloniki, Greece, 551 34 | |
Greece, Asvestohori | |
Recruiting | |
Thessaloniki, Asvestohori, Greece, 570 10 | |
Greece, Goudi | |
Not yet recruiting | |
Athens, Goudi, Greece, 115 27 | |
Greece, Maroussi | |
Recruiting | |
Athens, Maroussi, Greece, 145 61 | |
Greece, Voula | |
Not yet recruiting | |
Athens, Voula, Greece, 16673 |
Study Director: | Medical Monitor | Wyeth |
Principal Investigator: | Trial Manager | For Greece, decregwyeth.com |
Responsible Party: | Wyeth ( Wyeth (Registry Contact: Clinical Trial Registry Specialist) ) |
Study ID Numbers: | 0881A-101695 |
Study First Received: | January 4, 2006 |
Last Updated: | December 19, 2007 |
ClinicalTrials.gov Identifier: | NCT00273858 |
Health Authority: | Greece: National Organization of Medicines |
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis |
Spinal Diseases Autoimmune Diseases Skin Diseases Arthritis, Psoriatic Spondylarthropathy Joint Diseases Arthritis, Rheumatoid Quality of Life Rheumatic Diseases TNFR-Fc fusion protein Bone Diseases |
Musculoskeletal Diseases Psoriasis Arthritis Connective Tissue Diseases Spondylitis, Ankylosing Skin Diseases, Papulosquamous Spondylarthritis Spondylitis Ankylosis Spondylarthropathies |
Anti-Inflammatory Agents Immunologic Factors Immune System Diseases Physiological Effects of Drugs Gastrointestinal Agents Infection Immunosuppressive Agents Pharmacologic Actions Bone Diseases, Infectious |
Analgesics, Non-Narcotic Sensory System Agents Therapeutic Uses Anti-Inflammatory Agents, Non-Steroidal Analgesics Peripheral Nervous System Agents Antirheumatic Agents Central Nervous System Agents |