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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 EnbrelĀ®

- Treatment with EnbrelĀ® 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

Page last updated: March 21, 2008

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