Study Evaluating the Tolerance and Safety of Enbrel (Etanercept) in Adults and Children

• Status: Completed
• Trial end date: 2006-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
• Treatments: Etanercept

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.