Study of MRA for Systemic Juvenile Idiopathic Arthritis (sJIA)

Study Overview
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Brief Summary
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This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Official Title
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A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA

Conditions
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Systemic Juvenile Idiopathic Arthritis

Intervention / Treatment
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* Drug: MRA(Tocilizumab)
* Drug: placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Patients diagnosed as having systemic JIA based on the International League of Associations for Rheumatology criteria (1997) Patients between 2 and 19 years of age Patients who are under 16 years of age at onset Patients who have been treated with corticosteroids (continued treatment for 3 months or longer at a dose of ≥0.2 mg/kg as prednisolone equivalent) but who failed to respond adequately or in whom treatment could not be continued or the dose could not be increased due to adverse drug reactions Exclusion criteria Patients who have been treated with infliximab or etanercept within 12 weeks before treatment with the investigational product Patients who have received the following treatments within 4 weeks before treatment with the investigational product Surgical treatment (e.g., operation) Plasma exchange therapy

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: MRA(Tocilizumab)<br> <br> |
| Placebo Comparator: 2<br> | Drug: placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS |  | open-label period | 
| Efficacy:Percentage of patients in whom effects were maintained |  | Blind period | 
| Safety:Incidence and severity of adverse events and adverse drug reactions |  | whole period | 
| Pharmacokinetics:The time course of the trough serum MRA concentration |  | whole period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score |  | Open-label period | 
| Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS |  | Blind Period |