A double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA

Condition	Intervention	Phase
systemic juvenile idiopathic arthritis	Drug: MRA(Tocilizumab)	Phase III

Further Study Details: 

Primary Outcomes: Efficacy:; Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study); Safety:; Incidence and severity of adverse events and adverse reactions; Pharmacokinetics:; The time profile of the trough serum MRA concentration; at 0W, then every 2Wks
Secondary Outcomes: Efficacy:; Time profiles of CRP and ESR, Time profile of percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, Time profiles of JIA core set variables, Time profile of pain, Time profile of corticosteroid dose; at 0W, then every 2Wks
Expected Total Enrollment:  55

Ages Eligible for Study:  2 Years   -   19 Years,  Genders Eligible for Study:  Both

Criteria

Inclusion criteria (MRA011JP patients)

• Of the patients who received the three infusions of MRA at the same dose in the main evaluation period in the previous study and are currently in the continued treatment period
• the patients in whom it is confirmed that the drug is effective and there are no problems with safety (MRA316JP patients)
• Patients who proceed to the blind period and in whom the last observations are done after study completion or withdrawal
• Patients who receive the three infusions in the open-label period and do not meet the criteria for transition to the blind period

Exclusion criteria

• Patients who were not enrolled by 3 months after completion of the previous study
• Patients who have been treated with infliximab or etanercept from completion of the previous study until the start of treatment in this study

Study chairs or principal investigators

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

Study ID Numbers:  MRA317JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144612
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13