Study Evaluating Etanercept in Patients With Rheumatoid Arthritis(RA), Juvenile Idiopathic Arthritis (JIA), or Psoriatic Arthritis (PsA) in Spain
NCT00195377
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Adult Trials: 18+ Years
- 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 | ||||
|---|---|---|---|---|
| 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 |
| |||
| 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:
| |||
| Sex/Gender |
| |||
| 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 |
| |||
| PRS Account | Wyeth is now a wholly owned subsidiary of Pfizer | |||
| Verification Date | June 2009 | |||