Study Evaluating Enbrel in Patients With Rheumatoid Arthritis
NCT00245934
ABOUT THIS STUDY
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Adult Trials: 18+ Years
- Proven diagnosis of rheumatoid arthritis
- Contraindications according to Summary of Product Characteristic (SmPC)of Enbrel® the
following points will prevent or restrict participation:
- Patients who suffer from hypersensitivity to the active substance Etanercept or
to any of the excipients of Enbrel®
- Treatment with Enbrel® should not be initiated in patients with active infections
including chronic or localized infections
- Patients with sepsis or risk of sepsis should not be treated
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| Descriptive Information | |||||||
|---|---|---|---|---|---|---|---|
| Brief Title | Study Evaluating Enbrel in Patients With Rheumatoid Arthritis | ||||||
| Official Title | Observational Study With Enbrel in Patients With Rheumatoid Arthritis | ||||||
| Brief Summary | The purpose of this study is to investigate the incidence of adverse events for patients with rheumatoid arthritis treated with Enbrel under usual care settings. In addition, differences in injection site reactions based on whether health care professionals or patients administer Enbrel will be assessed and evaluated. | ||||||
| Detailed Description | Not Provided | ||||||
| Study Type | Observational | ||||||
| Study Design | Time Perspective: Prospective | ||||||
| Target Follow-Up Duration | Not Provided | ||||||
| Biospecimen | Not Provided | ||||||
| Sampling Method | Not Provided | ||||||
| Study Population | Not Provided | ||||||
| Condition | Rheumatoid Arthritis | ||||||
| Intervention | Drug: Enbrel | ||||||
| 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 | 1500 | ||||||
| Original Enrollment | Same as current | ||||||
| Actual Study Completion Date | July 2005 | ||||||
| Primary Completion Date | Not Provided | ||||||
| Eligibility Criteria | Inclusion Criteria:
Exclusion Criteria:
| ||||||
| Sex/Gender |
| ||||||
| 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 | Not Provided | ||||||
| Removed Location Countries | |||||||
| Administrative Information | |||||||
| NCT Number | NCT00245934 | ||||||
| Other Study ID Numbers | 101354 | ||||||
| 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 | December 2007 | ||||||