An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with RA who were participated in Study MRA213JP.

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

Further Study Details: 

Primary Outcomes: Efficacy:; The frequency of amelioration of at least 20% in terms of the ACR criteria; Safety:; Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions; Pharmacokinetics:; The serum MRA concentration; at 0W,4W,8W,12W,LOBS
Secondary Outcomes: Efficacy:; Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set; at 0W,4W,8W,12W,LOBS
Expected Total Enrollment:  300

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

Criteria

Inclusion criteria

• Either MRA or placebo was administered at least 3 times in the preceding study, and there were confirmed to be no problems with respect to safety.
• In the case of Patients whose participation in the current study was judged to be inappropriate because of problems in the preｃｅｄｉｎｇ study with respect to safety, these Patients must have been in the methotrexate dose group in the preceding study.

Exclusion criteria

• Administered drugs such as infliximab, etanercept, and leflunomide within 12 weeks before administration of the study drug
• Evaluated as belonging to Steinbrocker’s class IV within 4 weeks before administration of the study drug
• Have not been registered by 3 months after the full code-breaking of the preceding study
• Were administered plasma exchange therapy between initiation of the preceding study and the initial administration in the current study
• Treated surgically (except for local surgery) within 4 weeks before administration of the study drug

Study chairs or principal investigators

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

Study ID Numbers:  MRA215JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144534
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13