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Comparative Study (Double-Blind) of MRA for Rheumatoid Arthritis (RA)

This study has been completed.
Sponsor:
Information provided by:
Chugai Pharmaceutical
ClinicalTrials.gov Identifier:
NCT00144521
First received: September 2, 2005
Last updated: January 30, 2009
Last verified: January 2009
History of Changes
  Purpose

The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.


Condition Intervention Phase
Rheumatoid Arthritis
 Drug: MRA(Tocilizumab)
Drug: MRA placebo
Drug: MTX
Drug: MTX placebo
 Phase 3

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 Double-Blind, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA

Resource links provided by NLM:

Drug Information available for: Tocilizumab
U.S. FDA Resources

Further study details as provided by Chugai Pharmaceutical:

Primary Outcome Measures:
  • Frequency of ACR 20% improvement [ Time Frame: week 24 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency and severity of adverse events and adverse drug reactions [ Time Frame: throughout study ] [ Designated as safety issue: Yes ]
  • Time course of DAS28 [ Time Frame: throughout study ] [ Designated as safety issue: No ]
  • time course of the frequency of ACR 20%, 50% and 70% [ Time Frame: throughout study ] [ Designated as safety issue: No ]

Enrollment: 127
Study Start Date: February 2004
Study Completion Date: April 2006
Primary Completion Date: August 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: MRA(Tocilizumab)
8mg/kg/4week(i.v.)for 24 weeks
Drug: MTX placebo
0mg/week(p.o.) for 24 weeks
Active Comparator: 2 Drug: MRA placebo
0mg/kg/4week(i.v.) for 24 weeks
Drug: MTX
8mg/week(p.o.) for 24 weeks

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria

  • Diagnosis of RA based on the 1987 classification criteria of the American College of Rheumatology (ACR)
  • Disease duration of 6 months or more
  • Treated with 8 mg/week of MTX for at least 8 weeks immediately preceding enrollment, and continued on this treatment up to initiation of the study drug
  • Active disease at enrollment (less than 2 weeks before initiating treatment with a study drug), Which is defined as having at least 6 tender and 6 swollen joints among 49 and 46 joints stipulated by the Japanese Rheumatism Foundation's Drug Evaluation Committee and ESR at least 30 mm/hr and CRP not less than 1.0 mg/dL

Exclusion criteria

  • Assessed as having Class IV Steinbrocker functional activity in the 4 weeks preceding treatment with the study drug
  • Treated with infliximab, etanercept or leflunomide in the 12 weeks preceding treatment with the study drug

  • Received any of the following therapies in the 2 weeks preceding initiation of treatment with the study drug.

    1. Administration of any DMARD or immunosuppressant other than MTX
    2. Administration of corticosteroids exceeding 10 mg/day as prednisolone
    3. Dose escalation or initiation of corticosteroids

  • Received any of the following therapies in the 4 weeks preceding treatment with the study drug

    1. Plasma exchange therapy
    2. Surgical treatment (operation, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00144521

Sponsors and Collaborators
Chugai Pharmaceutical
Investigators
Study Director: Takahiro Kakehi Chugai Pharmaceutical
  More Information

No publications provided

Responsible Party: Chugai Pharmaceutical
ClinicalTrials.gov Identifier: NCT00144521     History of Changes
Other Study ID Numbers: MRA213JP
Study First Received: September 2, 2005
Last Updated: January 30, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013