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Study Evaluating the Safety and Efficacy of Enbrel (Etanercept) in Japan

Information source: Wyeth
Information obtained from ClinicalTrials.gov on February 12, 2009
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Enbrel (etanercept) (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

Overall contact:
Trial Manager, Email: clintrialparticipation@wyeth.com

Summary

The special use-results surveillance is conducted in patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted in the actual setting of use after marketing with the following objectives: 1. To examine the safety of long-term use of Enbrel including the occurrence of malignant tumors. 2. To confirm the efficacy of Enbrel in the long-term use.

Clinical Details

Official title: Long Term Safety and Efficacy From Special Surveillance for Etanercept in Japan

Study design: Natural History, Longitudinal, Convenience Sample, Prospective Study

Eligibility

Minimum age: N/A. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria Patients with rheumatoid arthritis(RA) who fulfill all of the following

1. Patients who are refractory to the treatment.

2. Patients who have never been treated with Enbrel and in whom its long-term therapy may be instituted.

3. Patients without a history of or concurrent malignant tumors.

Locations and Contacts

Trial Manager, Email: clintrialparticipation@wyeth.com

Multiple Cities, Japan; Recruiting
Additional Information

Starting date: June 2007
Ending date: March 2008
Last updated: July 16, 2007

Page last updated: February 12, 2009

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