Long-term Treatment Study of MRA for Polyarticular Juvenile Idiopathic Arthritis (pJIA)

Chugai Pharmaceutical19 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

NON_RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Polyarticular Juvenile Idiopathic Arthritis

Interventions

MRA(Tocilizumab)DRUG

8mg/kg/4weeks

Eligibility

Sex: ALLMin age: 2 YearsMax age: 19 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS

Time frame: every 3 months

Safety:Incidence and severity of adverse events and adverse drug reactions

Time frame: whole period

Pharmacokinetics:The time course of the trough values for the serum MRA concentration

Time frame: whole period

Secondary Outcomes

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

Time frame: every 3 months

Data from ClinicalTrials.gov

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