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| Tracking Information | |||||||||
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| First Received Date ICMJE | January 4, 2006 | ||||||||
| Last Updated Date | December 19, 2007 | ||||||||
| Start Date ICMJE | January 2006 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00273858 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Study Evaluating Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis | ||||||||
| Official Title ICMJE | 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 | ||||||||
| Brief Summary | 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. |
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| Detailed Description | |||||||||
| Study Phase | Phase IV | ||||||||
| Study Type ICMJE | Observational | ||||||||
| Study Design ICMJE | Other, Prospective | ||||||||
| Condition ICMJE |
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| Intervention ICMJE | Drug: etanercept | ||||||||
| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 1000 | ||||||||
| Estimated Completion Date | December 2009 | ||||||||
| Estimated Primary Completion Date | December 2009 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria: · Clinical diagnosis of Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis. Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | Greece | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00273858 | ||||||||
| Responsible Party | Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth | ||||||||
| Study ID Numbers ICMJE | 0881A-101695 | ||||||||
| Study Sponsor ICMJE | Wyeth | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | Wyeth | ||||||||
| Verification Date | December 2007 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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