Trial record 1 of 1 for:    MP-435-J04
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Efficacy and Safety Study of MP-435 in Combination With Methotrexate (MTX) in Patients With Rheumatoid Arthritis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01143337
First received: June 9, 2010
Last updated: October 7, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Rheumatoid Arthritis
Drug: MP-435(dose1) + Methotrexate
Drug: Placebo + Methotrexate
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized, Double-blind, Placebo-controlled Study of MP-435 in Combination With MTX in Patients With Rheumatoid Arthritis - Exploratory Study

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    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 Outcome Measures:
  • Percentage of Participants Achieving ACR 50 Response [ Time Frame: Week 2, 4, 6, 8, 12, LOCF (Week 12 or discontinuation time) ] [ Designated as safety issue: No ]
    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).

  • 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) ] [ Designated as safety issue: No ]
    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).

  • Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components [ Time Frame: LOCF (Week 12 or discontinuation time) ] [ Designated as safety issue: No ]

    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.


  • Percent Changes From the Pretreatment Values in the Disease Activity Score (DAS) 28, and ACR Components [ Time Frame: LOCF (Week 12 or discontinuation time) ] [ Designated as safety issue: No ]
    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).


Enrollment: 112
Study Start Date: June 2010
Study Completion Date: March 2012
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
dose1
Drug: MP-435(dose1) + Methotrexate
MP-435 dose1 + stable weekly dose of Methotrexate
Placebo Comparator: 2
Placebo
Drug: Placebo + Methotrexate
Placebo + stable weekly dose of Methotrexate

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01143337

Locations
Japan
Investigational site
Osaka, Japan
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01143337     History of Changes
Other Study ID Numbers: MP-435-J04
Study First Received: June 9, 2010
Results First Received: September 10, 2014
Last Updated: October 7, 2014
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Rheumatoid Arthritis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Folic Acid Antagonists
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors

ClinicalTrials.gov processed this record on October 19, 2014