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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Study Classification

OBSERVATIONAL

Study Start Date

2005-03-31

Study Completion Date

2007-10-31

Brief Summary

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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

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Conditions

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Rheumatoid Arthritis

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Enbrel (etanercept)

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Minimum Eligible Age

11 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Wyeth

Principal Investigators

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Medical Monitor

Role: STUDY_DIRECTOR

Wyeth is now a wholly owned subsidiary of Pfizer

References

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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.

Reference Type DERIVED

PMID: 19332630 (View on PubMed)

Other Identifiers

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0881Y1-4460

Identifier Type: -

Identifier Source: org_study_id