Study Comparing Enbrel (Etanercept) Plus Methotrexate Versus Enbrel Alone in Active Rheumatoid Arthritis Despite Current Methotrexate Therapy

Phase 4

Completed

• Conditions: Rheumatoid Arthritis

• Registration Number: NCT00244556
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To investigate the changes in MRI-derived markers of joint inflammation and destruction and in biochemical markers of connective tissue metabolism and angiogenesis in rheumatoid arthritis patients treated with Enbrel and Enbrel+methotrexate.

Detailed Description

Not available

Study Timeline

• Study Start: 2003-03
• Primary Completion: 2004-05
• Study Completion: 2004-05
• Study First Submitted: 2005-10-12
• Study First Submitted QC: 2005-10-25
• Study First Posted: 2005-10-26
• Status Verified: 2013-02
• Last Update Submitted: 2013-02-20
• Last Update Posted: 2013-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

Inclusion Criteria

• In the case of contra-indications for MRI, the patient may participate in the remaining part of the project.

Exclusion Criteria

• N/A

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
To assess the efficacy and safety of substituting ENBREL versus adding ENBREL to Methotrexate in patients with active Rheumatoid Arthritis despite adequate Methotrexate therapy.

Secondary Outcome Measures

Name	Time	Method
To evaluate the effect of combination therapy with ENBREL plus Methotrexate versus ENBREL alone on health-related quality of life measures.