A Double-Blind, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With sJIA

Chugai Pharmaceutical0 sites56 target enrollmentMay 2004

ConditionsSystemic Juvenile Idiopathic Arthritis

Interventionsplacebo MRA(Tocilizumab)

DrugsMRA(Tocilizumab)placebo

Overview

Phase: Phase 3
Intervention: placebo
Conditions: Systemic Juvenile Idiopathic Arthritis
Sponsor: Chugai Pharmaceutical
Enrollment: 56
Primary Endpoint: Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

This is a double-blind, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with sJIA.

Registry

clinicaltrials.gov

Start Date

May 2004

End Date

October 2005

Last Updated

17 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Chugai Pharmaceutical

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

2

Intervention: placebo

1

Intervention: MRA(Tocilizumab)

Outcomes

Primary Outcomes

Efficacy:Percentage of patients showing 30% improvement in the JIA core set, Percentage of patients showing improvement in CRP on LOBS

Time Frame: open-label period

Efficacy:Percentage of patients in whom effects were maintained

Time Frame: Blind period

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

Time Frame: whole period

Pharmacokinetics:The time course of the trough serum MRA concentration

Time Frame: whole period

Secondary Outcomes

Efficacy:Time courses of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, JIA core set variables, pain, maximum body temperature, systemic feature score(Open-label period)
Period for which effects, Time course of CRP and ESR, percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set,JIA core set variables,pain, maximum body temperature,systemic feature score up to LOBS(Blind Period)