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

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00484809
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-03
• Study Completion: 2006-02
• Study First Submitted: 2007-06-08
• Study First Submitted QC: 2007-06-08
• Study First Posted: 2007-06-11
• Status Verified: 2007-12
• Last Update Submitted: 2007-12-11
• Last Update Posted: 2007-12-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified