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

Wyeth

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Drug: Enbrel (Etanercept)

Study type: Observational

Funder types: Industry

Identifiers

NCT00484809

0881A-101511

Details and patient eligibility

About

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.

Sex: All

Ages: 4+ years old

Volunteers: No Healthy Volunteers

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.