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

Condition(s) targeted: Rheumatoid Arthritis

Intervention: Etanercept, Methotrexate (Drug)

Phase: Phase 4

Status: Active, not recruiting

Sponsored by: Wyeth

Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Wyeth

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.

Official title: A 24-Month,Randomized,Double-Blind,Two-Period Study to Evaluate the Efficacy and Safety of the Combination of Etanercept and Methotrexate and Methotrexate Alone in Subjects With Early Rheumatoid Arthritis

Study design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study

Primary outcome:

To compare the effects of the combination of etanercept and methotrexate to methotrexate alone on radiographic change

To compare the effects of the combination of etanercept and methotrexate to methotrexate alone on clinical disease activity

Secondary outcome: Evaluate the safety of each treatment group

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

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

Denver, Colorado 80230, United States

Starting date: October 2004
Ending date: February 2008
Last updated: December 21, 2007