An Open-Label, Phase III Study to Evaluate the Efficacy, Safety and PK of MRA in Patients With pJIA

Chugai Pharmaceutical0 sites19 target enrollmentNovember 2004

Overview

Phase: Phase 3
Intervention: MRA(Tocilizumab)
Conditions: Systemic Juvenile Idiopathic Arthritis
Sponsor: Chugai Pharmaceutical
Enrollment: 19
Primary Endpoint: Efficacy:Percentage of patients showing 30% improvement in the JIA core set on LOBS
Status: Completed
Last Updated: 17 years ago

This is an open-label, Phase III study to evaluate the efficacy, safety and PK of MRA in patients with pJIA.

Registry

clinicaltrials.gov

Start Date

November 2004

End Date

October 2005

Last Updated

17 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Sponsor

MRA(Tocilizumab)

Intervention: MRA(Tocilizumab)

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

Time Frame: whole period

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

Time Frame: whole period

Pharmacokinetics:The Cmax, trough values, AUC, Kel, CL, Vd, Vdss, and t1/2 for serum MRA concentration

Time Frame: whole period

Efficacy:The time course of the percentage of patients showing 30%, 50%, and 70% improvement in the JIA core set, each evaluation endpoint in the JIA core set, CRP, pain up to LOBS(whole period)