Status:
COMPLETED
Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis
Lead Sponsor:
Tanabe Pharma Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-75 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to determine the Efficacy, Safety, and Pharmacokinetics of MP-435 administered for 12 weeks in subjects with rheumatoid arthritis (RA) on stable doses of Methotrexate.
Eligibility Criteria
Inclusion
- Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987) for at least 6 months.
- Subjects who inadequately response for stable dose of MTX.
Exclusion
- Patients with Class IV functional activity by the Steinbrocker's scale.
- Patients who have received a biological agent in the past.
- Patients who have other rheumatic diseases, or who have other diseases with joint symptoms.
- Patients with severe or uncontrolled endocrine, psychiatric, cardiac, hematological, pulmonary, hepatic, kidney, gastrointestinal, or thyroid disease.
Key Trial Info
Start Date :
June 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2012
Estimated Enrollment :
112 Patients enrolled
Trial Details
Trial ID
NCT01143337
Start Date
June 1 2010
End Date
March 1 2012
Last Update
January 6 2026
Active Locations (1)
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1
Investigational site
Osaka, Japan