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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00503503
Enrollment
Unknown
Registered
2007-07-18
Start date
2005-03-31
Completion date
2007-10-31
Last updated
2007-12-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rheumatoid Arthritis

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.

Interventions

Sponsors

Wyeth is now a wholly owned subsidiary of Pfizer
Lead SponsorINDUSTRY

Study design

Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
11 Years to 90 Years
Healthy volunteers
No

Inclusion criteria

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Apr 3, 2026