Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan


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Eligibility Criteria
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Females and Males
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
11-90 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

· Patients with rheumatoid arthritis [only those refractory to the previous treatment]


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Advanced Information
Descriptive Information
Brief Title Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Official Title Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan
Brief Summary The objective of this surveillance is to determine the following items in all patients receiving Enbrel for a certain period after marketing: 1) unlabeled adverse events, 2) onset (frequency, severity and other details) of adverse events, 3) factors considered to affect the safety, and 4) the efficacy of Enbrel. Moreover, the onset (frequency, severity and other details) of the followings will be key issues of this surveillance:Infection (tuberculosis, opportunistic infection, etc.), autoimmune diseases, cardiac failure, malignant tumor, interstitial pneumonia, demyelinating disorders, pancytopenia, aplastic anemia and application site reactions.
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 (etanercept)
Study Groups/Cohorts Not Provided
Publications * Koike T, Harigai M, Inokuma S, Inoue K, Ishiguro N, Ryu J, Takeuchi T, Tanaka Y, Yamanaka H, Fujii K, Freundlich B, Suzukawa M. Postmarketing surveillance of the safety and effectiveness of etanercept in Japan. J Rheumatol. 2009 May;36(5):898-906. doi: 10.3899/jrheum.080791. Epub 2009 Mar 30.

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Enrollment Not Provided
Original Enrollment Not Provided
Actual Study Completion Date October 2007
Actual Primary Completion Date October 2007   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria

· Patients with rheumatoid arthritis [only those refractory to the previous treatment]

Sexes Eligible for Study:All
Ages 11 Years to 90 Years   (Child, 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 NCT00503503
Other Study ID Numbers 0881Y1-4460
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Study Sponsor Wyeth is now a wholly owned subsidiary of Pfizer
Collaborators Not Provided
Study Director:Medical MonitorWyeth is now a wholly owned subsidiary of Pfizer
PRS Account Wyeth is now a wholly owned subsidiary of Pfizer
Verification Date December 2007