Status:
COMPLETED
Study Evaluating the Efficacy and Safety of Etanercept and Methotrexate in Japanese Subjects With Rheumatoid Arthritis
Lead Sponsor:
Pfizer
Conditions:
Arthritis, Rheumatoid
Eligibility:
All Genders
20-75 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to examine the effects of etanercept (10 mg and 25 mg) compared with methotrexate (up to 8 mg per week) on the slowing of joint destruction.
Eligibility Criteria
Inclusion
- Must be Japanese and live in Japan
- Must be age 20 to 75 years
- Diagnosed less than or equal to 10 years from time of first visit
Exclusion
- Anyone who has received etanercept or TNF-inhibitors such as infliximab or adalimumab in the past
- Patient with other rheumatic diseases or conditions that could predispose the patient to infection
- Pregnant or lactating women
Key Trial Info
Start Date :
July 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2010
Estimated Enrollment :
550 Patients enrolled
Trial Details
Trial ID
NCT00445770
Start Date
July 1 2006
End Date
July 1 2010
Last Update
August 15 2011
Active Locations (41)
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1
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan, 460-0001
2
Pfizer Investigational Site
Nagoya, Aichi-ken, Japan, 4678602
3
Pfizer Investigational Site
Goshogawara, Aomori, Japan, 037-0053
4
Pfizer Investigational Site
Asahi, Chiba, Japan, 289-2511