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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00144521
Recruitment Status : Completed
First Posted : September 5, 2005
Last Update Posted : February 2, 2009
Information provided by:
Chugai Pharmaceutical

Brief Summary:
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 or disease Intervention/treatment Phase
Rheumatoid Arthritis Drug: MRA(Tocilizumab) Drug: MRA placebo Drug: MTX Drug: MTX placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 127 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : February 2004
Actual Primary Completion Date : August 2004
Actual Study Completion Date : April 2006

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
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

Primary Outcome Measures :
  1. Frequency of ACR 20% improvement [ Time Frame: week 24 ]

Secondary Outcome Measures :
  1. Frequency and severity of adverse events and adverse drug reactions [ Time Frame: throughout study ]
  2. Time course of DAS28 [ Time Frame: throughout study ]
  3. time course of the frequency of ACR 20%, 50% and 70% [ Time Frame: throughout study ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00144521

Sponsors and Collaborators
Chugai Pharmaceutical
Study Director: Takahiro Kakehi Chugai Pharmaceutical

Responsible Party: Chugai Pharmaceutical Identifier: NCT00144521     History of Changes
Other Study ID Numbers: MRA213JP
First Posted: September 5, 2005    Key Record Dates
Last Update Posted: February 2, 2009
Last Verified: January 2009

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