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Completed

NCT Number: NCT01143337

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

20 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site

Osaka, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

MP-435(dose1) + Methotrexate

Drug

MP-435 dose1 + stable weekly dose of Methotrexate

Placebo + Methotrexate

Drug

Placebo + stable weekly dose of Methotrexate

Primary outcomes

  1. Percentage of Participants Achieving American College of Rheumatology 20 (ACR 20) Response

    Time frame: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)

    ACR 20 response is a decrease of at least 20 per cent in both tender and swollen joint count [TJC and SJC] and in 3 to 5 assessments (participant's assessment of pain visual analog scale [VAS] with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; Health Assessment Questionnaire [HAQ-DI]: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; C-reactive protein[CRP]).

Secondary outcomes

  1. Percentage of Participants Achieving ACR 50 Response

    Time frame: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)

    ACR 50 response is a decrease of at least 50 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).

  2. Percentage of Participants Achieving American College of Rheumatology 70 (ACR 70) Response

    Time frame: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time)

    ACR 70 response is a decrease of at least 70 per cent in both tender and swollen joint count and in 3 to 5 assessments (participant's assessment of pain VAS with 0, no pain to 10, worst pain; patient's and physician's global assessment of disease activity VAS scales: overall disease activity [0, very well to 10, very poor and 0, no arthritis activity to 10, extremely active, respectively]; HAQ-DI: 20-questions on life activities [0, no difficulty to 3, inability to perform a task]; CRP).

  3. Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components

    Time frame: LOCF (Week 12 or discontinuation time)

    DAS28 (CRP) is calculated using TJC, SJC C-Reactive Protein ( CRP in mg/dL ), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.36 x log (CRP+1) + 0.014 x Global Assessment of Arthritis + 0.96 where 28 joints are examined and a lower score indicates less disease activity.

    DAS28 (ESR) is calculated using TJC, SJC erythrocyte sedimentation rate (ESR in mm/hour), and the Patient's Global Assessment of Disease Activity - Visual Analog Scale (VAS in mm) using the following formula: 0.56 x √(TJC) + 0.28 x √(SJC) + 0.70 x log (ESR) + 0.014 x Global Assessment of Arthritis where 28 joints are examined and a lower score indicates less disease activity.

    A negative change score indicates improvement. Higher score indicated more disease activity. DAS28 =<3.2 implied low disease activity, >3.2 to 5.1 implied moderate disease activity, >5.1 implied high disease activity.

  4. Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components

    Time frame: LOCF (Week 12 or discontinuation time)

    ACR components are tender joints count (TJC), swollen joints count (SJC), participant assessment of pain, participant global assessment of disease activity, physician global assessment of disease activity, self-assessed disability (disability index of the Health Assessment Questionnaire [HAQ-DI]); and C-Reactive Protein (CRP) or erythrocyte sedimentation rate (ESR).

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study title

A Multicenter Randomized, Double-blind, Placebo-controlled Study of MP-435 in Combination With MTX in Patients With Rheumatoid Arthritis - Exploratory Study

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Jun 14, 2010
Registry last updated
Jan 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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