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Clinical Trials/NCT00144586
NCT00144586
Completed
Phase 3

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 MRA220JP or MRA221JP

Chugai Pharmaceutical0 sites42 target enrollmentMarch 2005
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ConditionsRheumatoid Arthritis
InterventionsMRA(Tocilizumab)
DrugsMRA(Tocilizumab)

Overview

Phase
Phase 3
Intervention
MRA(Tocilizumab)
Conditions
Rheumatoid Arthritis
Sponsor
Chugai Pharmaceutical
Enrollment
42
Primary Endpoint
20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.
Status
Completed
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaArms & InterventionsOutcomesSimilar 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 MRA220JP or MRA221JP.

Registry
clinicaltrials.gov
Start Date
March 2005
End Date
June 2009
Last Updated
12 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Intervention: MRA(Tocilizumab)

Outcomes

Primary Outcomes

20% improvement based on the American College of Rheumatology (ACR) criteria compared with the baseline value in the previous study.

Time Frame: throughout study

Secondary Outcomes

  • Time courses for DAS28, for ACR20%, 50%, and 70% improvement, and for each ACR core set variable.(Week 0, then every 4 Week)

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