Trial record 1 of 1 for:
NCT00273858
Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis
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ClinicalTrials.gov Identifier: NCT00273858 |
Recruitment Status :
Terminated
(The study was terminated because at least one year follow-up was achieved for each patient and the achievement of 965 exposure years to the drug.)
First Posted : January 9, 2006
Results First Posted : July 28, 2011
Last Update Posted : September 12, 2011
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Sponsor:
Wyeth is now a wholly owned subsidiary of Pfizer
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
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Tracking Information | ||||
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First Submitted Date | January 4, 2006 | |||
First Posted Date | January 9, 2006 | |||
Results First Submitted Date | June 30, 2011 | |||
Results First Posted Date | July 28, 2011 | |||
Last Update Posted Date | September 12, 2011 | |||
Study Start Date | March 2006 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Current Primary Outcome Measures |
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Original Primary Outcome Measures | Not Provided | |||
Change History | ||||
Current Secondary Outcome Measures |
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Original Secondary Outcome Measures | Not Provided | |||
Current Other Pre-specified Outcome Measures | Not Provided | |||
Original Other Pre-specified Outcome Measures | Not Provided | |||
Descriptive Information | ||||
Brief Title | Study Evaluating the Safety of Etanercept in Rheumatoid Arthritis, Ankylosing Spondylitis and Psoriatic Arthritis | |||
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 | |||
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. | |||
Detailed Description | Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC). Patients have been recruited sequentially based on eligibility criteria up to the number limit assigned to each site. |
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Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Non-Probability Sample | |||
Study Population | Rheumatoid Arthritis Patients, Psoriatic Arthritis Patients, Ankylosing Spondylitis Patients | |||
Condition |
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Intervention | Other: There is no Intervention. The study is observational.
The study is observational and the prescription follows the SmPC of etanercept.
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Study Groups/Cohorts | etanercept
Patients already prescribed to receive etanercept for the first time for treatment of Rheumatoid Arthritis, Ankylosing Spondylitis or Psoriatic Arthritis according to the Summary of Product Characteristics (SmPC).
Intervention: Other: There is no Intervention. The study is observational.
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Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | ||||
Recruitment Status | Terminated | |||
Actual Enrollment |
880 | |||
Original Enrollment |
400 | |||
Actual Study Completion Date | July 2010 | |||
Actual Primary Completion Date | July 2010 (Final data collection date for primary outcome measure) | |||
Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender |
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Ages | 18 Years and older (Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Greece | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00273858 | |||
Other Study ID Numbers | 0881A-101695 B1801106 |
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Has Data Monitoring Committee | No | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Study Sponsor | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Collaborators | Not Provided | |||
Investigators |
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PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
Verification Date | September 2011 |