Extension Study of Tocilizumab Long Term Treatment of Moderate to Severe Rheumatoid Arthritis Patients
- Sponsor
- Chugai Pharma Taiwan
- Study ID
- NCT01347983
- Phase
- PHASE3
- Status
- Completed
Conditions
Eligibility Criteria
- Sex
- ALL
- Age
- 20 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Tocilizumab+Methotrexate(MTX) — DRUGTocilizumab: 8 mg/kg every 4 weeks, IV infusion Methotrexate: 10-20 mg/week
Study Details
24 week open-labeled extension study to continue monitoring the same group of patients in the previous MRA230TW phase IIIb trial in order to evaluate the long term efficacy and safety of tocilizumab.
Key Dates
- Start date
- May 31, 2011
- Status verified
- Apr 2013
- Primary completion
- Mar 31, 2013
- Completion
- Apr 30, 2013
Study Design
- Enrollment
- 72 participants (actual)
- Allocation
- NON_RANDOMIZED
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Primary Outcome Measure
Proportion of patients with an American College of Rheumatology 70 (ACR70) response [ Time Frame: at week 24 ]
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