Polyarticular Juvenile Idiopathic Arthritis
Conditions
Brief summary
This is an open-label, extension, Phase III study to evaluate the long-term safety, efficacy and PK of MRA in patients with pJIA who participated in Study MRA318JP.
Interventions
DRUGMRA(Tocilizumab)
8mg/kg/4weeks
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
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS | every 3 months |
| Safety:Incidence and severity of adverse events and adverse drug reactions | whole period |
| Pharmacokinetics:The time course of the trough values for the 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 variable of the JIA core set, CRP, pain every 3M, LOBS | every 3 months |
Outcome results
None listed