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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: March 20, 2012
Last verified: March 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • The American College of Rheumatology 20 (ACR 20) Responder rate at Week 12 [ Time Frame: 12 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The American College of Rheumatology 20, 50 and 70 (ACR 20, 50 and 70) Responder rates [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]
  • Changes from the pretreatment values in the Disease Activity Score (DAS) 28, and ACR components [ Time Frame: up to 12 weeks ] [ Designated as safety issue: No ]

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
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
Last Updated: March 20, 2012
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 June 17, 2013