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Clinical Trials/NCT00144534
NCT00144534CompletedPhase 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 MRA213JP

Chugai Pharmaceutical0 sites115 target enrollmentStarted: June 2004Last updated:
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Conditions
Interventions
Drugs

Trial Snapshot

Phase
Phase 3
Status
Completed
Enrollment
115
Primary Endpoint
Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsRecords & IdentifiersSimilar Trials

Study 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.

Study Design

Study Type
Interventional
Allocation
Non Randomized
Intervention Model
Single Group
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
20 Years to 75 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Arms & Interventions

1

Experimental

Intervention: MRA (Tocilizumab) (Drug)

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)

Investigators

Sponsor Class
Industry

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