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

Chugai Pharmaceutical0 sites19 target enrollmentFebruary 2005

ConditionsPolyarticular Juvenile Idiopathic Arthritis

InterventionsMRA(Tocilizumab)

DrugsMRA(Tocilizumab)

Overview

Phase: Phase 3
Intervention: MRA(Tocilizumab)
Conditions: Polyarticular Juvenile Idiopathic Arthritis
Sponsor: Chugai Pharmaceutical
Enrollment: 19
Primary Endpoint: Efficacy:Percentage of patients showing 30% improvement in the JIA core set every 3M, LOBS
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 2005

End Date

June 2009

Last Updated

16 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chugai Pharmaceutical

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: MRA(Tocilizumab)

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(every 3 months)