Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis

Phase 4

Completed

• Conditions: Rheumatoid Arthritis
• Interventions: Drug: Etanercept; Drug: Methotrexate; Drug: Placebo

• Registration Number: NCT00195494
• Lead Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer

Brief Summary

To compare the effects of the combination of ETN and MTX to MTX alone on radiographic change and clinical disease activity in subjects with early RA over 12 months.

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Primary Completion: 2008-03
• Study Completion: 2008-03
• Results First Submitted: 2009-03-31
• Status Verified: 2012-08
• Results First Submitted QC: 2012-08-01
• Last Update Submitted: 2012-08-01
• Results First Posted: 2012-09-05
• Last Update Posted: 2012-09-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 542

Inclusion Criteria

• Satisfies the 1987 ACR Revised Criteria for Rheumatoid Arthritis
• Has RA greater than or equal to 3 months and less than or equal to 2 years

Exclusion Criteria

• Received any previous treatment with MTX
• Received any previous treatment with ETN or other tumour necrosis factor antagonist

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1b	Placebo	Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
2a	Etanercept	Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
2a	Placebo	Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
1a	Etanercept	Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
1a	Methotrexate	Etanercept + Methorexate for Period 1 (first 12 months) and Period 2 (Second 12 months)
1b	Etanercept	Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
1b	Methotrexate	Etanercept + Methotrexate for Period 1 (First 12 months) and Etanercept alone for Period 2 (Second 12 months)
2a	Methotrexate	Methotrexate alone in Period 1 (First 12 months) and etanercept + Methotrexate in Period 2 (Second 12 months)
2b	Methotrexate	Methotrexate alone in Period 1 (First 12 months) and Methotrexate alone in Period 2 (Second 12 months)

Primary Outcome Measures

Name	Time	Method
The Number of Participants Achieving Remission As Measured by a Disease Activity Score for 28 Joints (DAS 28) < 2.6.	12 months	Effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity. DAS28 scale 0 - 10, 3.2 or lower showing controlled disease while 5.1 implies active disease.
Year 1 Participants Having an Annualized Modified Total Sharp Score (mTSS) < 0.5.	12 months	The (van der Heijde) modified total Sharp score (mTSS) is the sum of scores for erosions (range 0-280) and joint space narrowings (range 0-168) and thus has a total range of (0 - 448 ), where zero is the best score , indicating no damage.

Secondary Outcome Measures

Name	Time	Method
Safety Measured by Number of Participants Reporting a Serious Adverse Event That Led to Death	12 and 24 months	Safety report for entire trial where participants reported a serious adverse event that led to death.