An open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who were participated in Study MRA318JP.

Condition	Intervention	Phase
polyarticular 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; every 3M, LOBS; Safety:; Incidence and severity of adverse events and adverse drug reactions; Pharmacokinetics:; The time course of the trough values for the serum MRA concentration
Secondary Outcomes: Efficacy:; The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, The time course of each variable of the JIA core set, The time course of CRP, The time course of pain; every 3M, LOBS
Expected Total Enrollment:  15

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

Criteria

Inclusion criteria

• Of the patients who received three infusions with MRA in the previous study and for whom a last observation was conducted
• the patients who did not have problems with safety in the previous study"

Exclusion criteria

• Patients who were not enrolled by 3 months after completion of the previous study

• Patients who received any of the following since completion of the previous study until initiation of treatment in the present study

  1. DMARDs or immunosuppressants
  2. Intravenous and intramuscular injection of corticosteroids
  3. Plasma exchange therapy
  4. Other drugs and therapies that may affect evaluation of drug efficacy

Study chairs or principal investigators

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

Study ID Numbers:  MRA319JP
Last Updated:  September 2, 2005
Record first received:  September 2, 2005
ClinicalTrials.gov Identifier:  NCT00144625
Health Authority: Japan: Ministry of Health, Labor and Welfare
ClinicalTrials.gov processed this record on 2005-09-13