To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.

Condition	Intervention	Phase
Rheumatoid Arthritis	Drug: MRA(Tocilizumab)	Phase III

Further Study Details: 

Primary Outcomes: Efficacy:Change in the erosion score 52 weeks, as determined by the modified Sharp method.; Safety:Frequency and severity of adverse events and adverse drug reactions
Secondary Outcomes: Efficacy:Change in the erosion score 28 weeks, Changes in the joint space narrowing score and total Sharp score 28 and 52 weeks
Expected Total Enrollment:  300

Ages Eligible for Study:  20 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria

• Diagnosed as having RA, on the basis of the criteria stipulated by the American Conference on Rheumatism (ACR) in 1987.
• With RA that has continued for at least 6 months but less than 5 years, with the date of first appearance being taken as the date of RA diagnosis.
• Active RA despite at least one DMARDs or immunosuppressantns. Active disease 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 2.0mg/dL.

Exclusion criteria

• Shown to have class-IV Steinbrocker’s functional activity in an evaluation carried out within 4 weeks before administration of the study drug.
• Treated with drugs that delay joint destruction (infliximab, etanercept, leflunomide, etc.) within 3 months before administration of the study drug.
• The oral corticosteroid dose (prednisolone equivalent of up to 10 mg/day)has not been fixed 2 weeks before administration of the study drug.
• Subjected to any of the following within 4 weeks before administration of the study drug: (i) Change in dosage of currently administered DMARDs and/or immunosuppressive agents. (ii) Plasma exchange method. (iii) Surgical treatment (operations, etc.).

Study chairs or principal investigators

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

Study ID Numbers:  MRA012JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144508
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13