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

Tanabe Pharma Corporation

Status and phase: Completed; Phase 2

Conditions: Rheumatoid Arthritis

Treatments: Drug: Placebo + Methotrexate; Drug: MP-435(dose1) + Methotrexate

Study type: Interventional

Funder types: Industry

Identifiers

NCT01143337

MP-435-J04

Details and patient eligibility

About

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.

Enrollment: 112 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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112 participants in 2 patient groups, including a placebo group

1

Experimental group

Description:

dose1

Treatment:

Drug: MP-435(dose1) + Methotrexate

2

Placebo Comparator group

Description:

Placebo

Treatment:

Drug: Placebo + Methotrexate