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

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NCT00503503

Last updated on April 11, 2018
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FOR MORE INFORMATION
Study Location
Contact
1-800-718-1021
[email protected]
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Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Rheumatoid Arthritis
Sex
Females and Males
Age
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]

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

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

NCT00503503
Pfizer
Completed
Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan

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Study Evaluating the Efficacy of Enbrel (Etanercept) in Subjects in Japan
Safety and Efficacy From Large Scale All Cases Surveillance for Etanercept in Japan
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.
Not Provided
Observational
Time Perspective: Prospective
Not Provided
Not Provided
Not Provided
Not Provided
Rheumatoid Arthritis
Drug: Enbrel (etanercept)
Not Provided
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 ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
Not Provided
October 2007
October 2007   (Final data collection date for primary outcome measure)

Inclusion Criteria

· Patients with rheumatoid arthritis [only those refractory to the previous treatment]
Sexes Eligible for Study: All
11 Years to 90 Years   (Child, Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
 
NCT00503503
0881Y1-4460
Not Provided
Not Provided
Not Provided
Wyeth (Registry Contact: Clinical Trial Registry Specialist), Wyeth
Wyeth is now a wholly owned subsidiary of Pfizer
Not Provided
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Wyeth is now a wholly owned subsidiary of Pfizer
December 2007

FOR MORE INFORMATION

Contact a representative by phone, email, or visiting thte study website. To get updates and notications about this trail, sign up using the form below.

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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Contact

[email protected]



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