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

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Wyeth

Status

Completed

Conditions

Rheumatoid Arthritis

Treatments

Drug: Enbrel (etanercept)

Study type

Observational

Funder types

Industry

Identifiers

NCT00503503
0881Y1-4460

Details and patient eligibility

About

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.

Sex

All

Ages

11 to 90 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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