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
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