Phase III Comparative Study(Open-Label) of MRA for Rheumatoid Arthritis(RA)
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: MRA (Tocilizumab)Other: current treatment
- Registration Number
- NCT00144508
- Lead Sponsor
- Chugai Pharmaceutical
- Brief Summary
To evaluate clinical efficacy and tolerability of MRA, patients with RA are randomized to receive either MRA or conventional DMARDs.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 306
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 MRA (Tocilizumab) - 2 current treatment continue current treatment
- Primary Outcome Measures
Name Time Method Change in the erosion score, as determined by the modified Sharp method. week 52 Frequency and severity of adverse events and adverse drug reactions throughout study
- Secondary Outcome Measures
Name Time Method Change in the erosion score week 28 Changes in the joint space narrowing score and total Sharp score week 28, 52