Study Comparing Etanercept and Methotrexate vs. Methotrexate Alone in Rheumatoid Arthritis
Information source: Wyeth
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
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
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.
Clinical Details
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 changeTo 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
Eligibility
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
Locations and Contacts
Denver, Colorado 80230, United States
Additional Information
Starting date: October 2004
Ending date: February 2008
Last updated: December 21, 2007
|
