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)	Phase III

Further Study Details: 

Primary Outcomes: Efficacy:; Frequency of ACR 20% improvement at the final visit; Safety:; Frequency and severity of adverse events and adverse drug reactions
Secondary Outcomes: Efficacy:; Time course of DAS28 to the final visit, time course of the frequency of ACR 20%, 50% and 70% improvement
Expected Total Enrollment:  120

Ages Eligible for Study:  20 Years   -   75 Years,  Genders Eligible for Study:  Both

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.)

Study chairs or principal investigators

Takahiro Kakehi,  Study Director,  Chugai Pharmaceutical Co., Ltd.   

Study ID Numbers:  MRA213JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144521
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13