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
  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:


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
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: 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 August 28, 2014