NCT00144508
Completed
Phase 3
An Open-Label, Phase III Study to Evaluate the Efficacy and Safety of MRA in Patients With RA
Overview
- Phase
- Phase 3
- Intervention
- MRA (Tocilizumab)
- Conditions
- Rheumatoid Arthritis
- Sponsor
- Chugai Pharmaceutical
- Enrollment
- 306
- Primary Endpoint
- Change in the erosion score, as determined by the modified Sharp method.
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Arms & Interventions
1
Intervention: MRA (Tocilizumab)
2
continue current treatment
Intervention: current treatment
Outcomes
Primary Outcomes
Change in the erosion score, as determined by the modified Sharp method.
Time Frame: week 52
Frequency and severity of adverse events and adverse drug reactions
Time Frame: throughout study
Secondary Outcomes
- Change in the erosion score(week 28)
- Changes in the joint space narrowing score and total Sharp score(week 28, 52)
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