Long-term Treatment Study of MRA for Rheumatoid Arthritis (RA) From Study MRA213JP
Phase 3
Completed
- Conditions
- Rheumatoid Arthritis
- Interventions
- Drug: MRA (Tocilizumab)
- Registration Number
- NCT00144534
- Lead Sponsor
- Chugai Pharmaceutical
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 115
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 MRA (Tocilizumab) -
- Primary Outcome Measures
Name Time Method Efficacy:the frequency of amelioration of at least 20% in terms of the ACR criteria throughout study Frequency and degree (severity and seriousness) of adverse events and adverse drug reactions throughout study Pharmacokinetics of the serum MRA concentration 0W,4W,8W,12W,LOBS
- Secondary Outcome Measures
Name Time Method 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