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

NCT ID: NCT01143337

Last Updated: 2026-01-06

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

112 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-06-30

Study Completion Date

2012-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Rheumatoid Arthritis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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1

dose1

Group Type EXPERIMENTAL

MP-435(dose1) + Methotrexate

Intervention Type DRUG

MP-435 dose1 + stable weekly dose of Methotrexate

2

Placebo

Group Type PLACEBO_COMPARATOR

Placebo + Methotrexate

Intervention Type DRUG

Placebo + stable weekly dose of Methotrexate

Interventions

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MP-435(dose1) + Methotrexate

MP-435 dose1 + stable weekly dose of Methotrexate

Intervention Type DRUG

Placebo + Methotrexate

Placebo + stable weekly dose of Methotrexate

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanabe Pharma Corporation

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Investigational site

Osaka, , Japan

Site Status

Countries

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Japan

Other Identifiers

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MP-435-J04

Identifier Type: -

Identifier Source: org_study_id

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