An Open-label, Extension, Phase III Study to Evaluate the Long-term Safety and Efficacy of MRA in Patients With RA Who Participated in Study MRA012JP

Chugai Pharmaceutical0 sites241 target enrollmentApril 2004

ConditionsRheumatoid Arthritis

InterventionsMRA(Tocilizumab)

DrugsMRA(Tocilizumab)

Overview

Phase: Phase 3
Intervention: MRA(Tocilizumab)
Conditions: Rheumatoid Arthritis
Sponsor: Chugai Pharmaceutical
Enrollment: 241
Primary Endpoint: Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)
Status: Completed
Last Updated: 12 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 and efficacy of MRA in patients with RA who participated in Study MRA012JP.

Registry

clinicaltrials.gov

Start Date

April 2004

End Date

June 2009

Last Updated

12 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Chugai Pharmaceutical

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arms & Interventions

1

Intervention: MRA(Tocilizumab)

Outcomes

Primary Outcomes

Patients fron MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria compared to the beginning of the treatment in previous study(MRA012JP)

Time Frame: 0W,4W,8W,12W,LOBS

Patients fron non-MRA Group of previous study:The frequency of amelioration of at least 20% in terms of the ACR criteria

Time Frame: 0W,4W,8W,12W,LOBS

Secondary Outcomes

Time courses of DAS28, frequencies of amelioration of at least 20%, 50%, and 70% in terms of the ACR criteria, each item in the ACR core set(0W,4W,8W,12W,LOBS)
Frequency, severity, and seriousness of adverse events and adverse drug reactions(Throughout study)