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| Sponsor: | Wyeth |
|---|---|
| Information provided by: | Wyeth |
| ClinicalTrials.gov Identifier: | NCT00273858 |
Purpose
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) |
Eligibility| 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:
Contacts and Locations| 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 |
More Information
| 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 History of Changes |
| Health Authority: | Greece: National Organization of Medicines |
|
Rheumatoid Arthritis Ankylosing Spondylitis Psoriatic Arthritis |
|
Anti-Inflammatory Agents Immunologic Factors Physiological Effects of Drugs Arthritis, Rheumatoid Infection TNFR-Fc fusion protein Bone Diseases Musculoskeletal Diseases Sensory System Agents Psoriasis Therapeutic Uses Arthritis Connective Tissue Diseases Spondylitis, Ankylosing Anti-Inflammatory Agents, Non-Steroidal |
Analgesics Spondylarthritis Spondylitis Spondylarthropathies Ankylosis Spinal Diseases Autoimmune Diseases Skin Diseases Immune System Diseases Arthritis, Psoriatic Joint Diseases Gastrointestinal Agents Rheumatic Diseases Immunosuppressive Agents Pharmacologic Actions |
