A Post-Marketing Surveillance Looking at Safety of Enbrel (Etanercept) in Adults With Active Rheumatoid Arthritis (RA) and Children With Juvenile Rheumatoid Arthritis (JRA).

Wyeth is now a wholly owned subsidiary of Pfizer0 sites100 target enrollmentMarch 2004

ConditionsRheumatoid Arthritis

DrugsEnbrel (Etanercept)

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Rheumatoid Arthritis
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Enrollment: 100
Status: Completed
Last Updated: 18 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

This postmarketing surveillance study will evaluate the safety profile of Enbrel (etanercept) in an Indian population. It will provide surveillance on a currently approved indication for Enbrel of reducing symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis.

Registry

clinicaltrials.gov

Start Date

March 2004

End Date

February 2006

Last Updated

18 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

Wyeth is now a wholly owned subsidiary of Pfizer

Eligibility Criteria

Inclusion Criteria

•Inclusion in this study will be as per the approved indications in the package insert.
•Patients with moderately to severely active RA.
•Children with JRA who have had an inadequate response to one or more DMARDs.

Exclusion Criteria

•Known hypersensitivity to etanercept or any of its components.
•Known significant concurrent medical disease, including:
•Congestive heart failure, uncontrolled angina pectoris, recent history of myocardial infarction
•Cancer or history of cancer
•Active infection
•Sepsis or risk of sepsis
•Active tuberculosis or a past history of tuberculosis
•Pancytopenia
•Females who are pregnant, breast feeding or at risk of pregnancy and not using a medically acceptable form of contraception.
•Patients who are planning to undergo elective surgery during the study period.