Study Evaluating Enbrel in Patients With Rheumatoid Arthritis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on March 21, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rheumatoid Arthritis
Intervention: Enbrel (Drug)
Phase: N/A
Status: Completed
Sponsored by: Wyeth Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth
Trial Manager, Principal Investigator, Affiliation: For Germany, MedinfoDEU@wyeth.com
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.
Clinical Details
Official title: Observational Study With Enbrel in Patients With Rheumatoid Arthritis
Study design: Prospective
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Proven diagnosis of rheumatoid arthritis
Exclusion Criteria:
- 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
Locations and Contacts
Additional Information
Starting date: June 2003
Ending date: July 2005
Last updated: December 12, 2007
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