Systemic Juvenile Idiopathic Arthritis
Conditions
Brief summary
This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.
Interventions
DRUGMRA(Tocilizumab)
Sponsors
Chugai Pharmaceutical
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 19 Years
Healthy volunteers
No
Inclusion criteria
* Patients who are diagnosed with rheumatoid factor (RF) positive or negative polyarthritic or oligoarthritic JIA according to the ILAR standards (1997) * Patients aged at least 2 years old and less than 20. * Patients aged less than 16 years old at time of onset
Exclusion criteria
* Patients with Class IV Steinbrocker functional disorder at evaluation within 2 weeks before initiation of treatment with the investigational product * Patients who have been treated for the underlying disease with a biological agent, such as infliximab or etanercept, within 12 weeks before initiation of treatment with the investigational product
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS | whole period |
| Safety:Incidence and severity of adverse events and adverse drug reactions | whole period |
| Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration | whole period |
Secondary
| Measure | Time frame |
|---|---|
| Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS | whole period |
Outcome results
None listed