Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain
NCT00195377
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- RA or PsA in whom DMARDs/antiTNF antibodies/anti IL1 has been insufficient or inappropriate
- Children from 4 to 17 years old with JIA polyarticular
- Clinically significant abnormal screening lab values
- Patients who are planning to undergo elective surgery during the study period.
- Other current autoimmune connective tissue diseases
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Descriptive Information | ||||
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Brief Title | Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain | |||
Official Title | Evaluating Safety and QoL in Patients Treated With Etanercept: an Open Multicenter Study | |||
Brief Summary | The purpose of this study is to assess the safety of etanercept in patients with rheumatoid arthritis (RA), juvenile idiopathic arthritis (JIA) or psoriatic arthritis (PsA) in Spain | |||
Detailed Description | Not Provided | |||
Study Type | Observational | |||
Study Design | Observational Model: Cohort Time Perspective: Prospective | |||
Target Follow-Up Duration | Not Provided | |||
Biospecimen | Not Provided | |||
Sampling Method | Probability Sample | |||
Study Population | Patients with rheumatoid arthritis, psoriatic arthritis or AIJ, treated with etanercept in rheumatology units | |||
Condition |
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Intervention | Drug: Etanercept | |||
Study Groups/Cohorts | Not Provided | |||
Publications * | Not Provided | |||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | ||||
Recruitment Information | ||||
Recruitment Status | Completed | |||
Enrollment | 1000 | |||
Original Enrollment | Same as current | |||
Actual Study Completion Date | April 2006 | |||
Actual Primary Completion Date | April 2006 (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 | 4 Years and older (Child, Adult, Older Adult) | |||
Accepts Healthy Volunteers | No | |||
Contacts | Contact information is only displayed when the study is recruiting subjects | |||
Listed Location Countries | Spain | |||
Removed Location Countries | ||||
Administrative Information | ||||
NCT Number | NCT00195377 | |||
Other Study ID Numbers | 101393 | |||
Has Data Monitoring Committee | Not Provided | |||
U.S. FDA-regulated Product | Not Provided | |||
IPD Sharing Statement | Not Provided | |||
Responsible Party | Not Provided | |||
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 | June 2009 |