An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With sJIA Who Participated in Studies MRA011JP or MRA316JP

Chugai Pharmaceutical0 sites60 target enrollmentJuly 2004

ConditionsSystemic Juvenile Idiopathic Arthritis

InterventionsMRA(Tocilizumab)

DrugsMRA(Tocilizumab)

Overview

Phase: Phase 3
Intervention: MRA(Tocilizumab)
Conditions: Systemic Juvenile Idiopathic Arthritis
Sponsor: Chugai Pharmaceutical
Enrollment: 60
Primary Endpoint: Efficacy:Percentage of patients showing 30% improvement in the JIA core set compared with before the first infusion of the investigational product (including the previous study)
Status: Completed
Last Updated: 16 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

An open-label, extension, Phase III study to evaluate the long-term safety and efficacy of MRA in patients with sJIA who were participated in Studies MRA011JP or MRA316JP

Registry

clinicaltrials.gov

Start Date

July 2004

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 compared with before the first infusion of the investigational product (including the previous study)

Time Frame: whole period

Safety:Incidence and severity of adverse events and adverse reactions

Time Frame: whole period

Pharmacokinetics:The time profile of the trough serum MRA concentration at 0W, then every 2Wks

Time Frame: 0 week and every 2 weeks

Secondary Outcomes

Efficacy:Time profiles of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, corticosteroid dose at 0W, then every 2Wks(0 week and every 2 weeks)