Study Evaluating the Efficacy and Safety of Etanercept

Phase 4

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00546533
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To assess the efficacy of etanercept 25 mg administered subcutaneously twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-01
• Study Completion: 2005-02
• Status Verified: 2007-10
• Study First Submitted: 2007-10-18
• Study First Submitted QC: 2007-10-18
• Last Update Submitted: 2007-10-18
• Study First Posted: 2007-10-19
• Last Update Posted: 2007-10-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

• A negative serum or urine pregnancy test at screening and a medically acceptable form of contraception starting at screening and continuing throughout the study is required for all females of childbearing potential (defined as an oral, injectable, or implantable contraceptive, intrauterine device, or barrier method combined with a spermicide).
• Failed therapy with at least one DMARD (DMARD failure is defined as a discontinuation because of lack of clinical efficacy).
• Meet the 1987 American Rheumatism Association (ARA) revised criteria for rheumatoid arthritis.

Exclusion Criteria

• Uncooperative patients with a history of poor compliance.
• Known hypersensitivity to etanercept or any of its components.
• Known significant concurrent medical disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
To assess the clinical efficacy of etanercept 25 mg administered twice-weekly for 12 weeks in patients with active RA for whom classical antirheumatic therapy is insufficient or inappropriate.