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 MRA213JP

Chugai Pharmaceutical0 sites115 target enrollmentJune 2004

ConditionsRheumatoid Arthritis

InterventionsMRA (Tocilizumab)

DrugsMRA (Tocilizumab)

Overview

Phase: Phase 3
Intervention: MRA (Tocilizumab)
Conditions: Rheumatoid Arthritis
Sponsor: Chugai Pharmaceutical
Enrollment: 115
Primary Endpoint: Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
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 and efficacy of MRA in patients with RA who participated in Study MRA213JP.

Registry

clinicaltrials.gov

Start Date

June 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:the frequency of amelioration of at least 20% in terms of the ACR criteria

Time Frame: throughout study

Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions

Time Frame: throughout study

Pharmacokinetics of the serum MRA concentration

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

Secondary Outcomes

Efficacy: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)