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

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

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.

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.