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Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis

CompletedPhase 2

Sponsor: Tanabe Pharma Corporation

Conditions: Rheumatoid Arthritis

Interventions: MP-435(dose1) + Methotrexate, Placebo + Methotrexate

Countries: Japan

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 overview

Sex: ALL

Age: 20 Years to 75 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* 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 Criteria:

* 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.

Locations (1)

Osaka, Japan