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

Chugai Pharmaceutical0 sites127 target enrollmentFebruary 2004

ConditionsRheumatoid Arthritis

InterventionsMRA(Tocilizumab)MTX placebo MRA placebo MTX

DrugsMRA(Tocilizumab)MRA placebo MTX MTX placebo

Overview

Phase: Phase 3
Intervention: MRA(Tocilizumab)
Conditions: Rheumatoid Arthritis
Sponsor: Chugai Pharmaceutical
Enrollment: 127
Primary Endpoint: Frequency of ACR 20% improvement
Status: Completed
Last Updated: 17 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Similar Trials

Overview

Brief Summary

The purpose of this study is to investigate the clinical efficacy and safety of MRA in a double-blind, parallel-group, controlled study using MRA or methotrexate (MTX) in rheumatoid arthritis (RA) patients with MTX administered.

Registry

clinicaltrials.gov

Start Date

February 2004

End Date

April 2006

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

1

Intervention: MRA(Tocilizumab)

1

Intervention: MTX placebo

2

Intervention: MRA placebo

2

Intervention: MTX

Outcomes

Primary Outcomes

Frequency of ACR 20% improvement

Time Frame: week 24

Secondary Outcomes

Frequency and severity of adverse events and adverse drug reactions(throughout study)
Time course of DAS28(throughout study)
time course of the frequency of ACR 20%, 50% and 70%(throughout study)