ong-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis
- Conditions
- Rheumatoid Arthritis
- Registration Number
- JPRN-jRCT2080220736
- Lead Sponsor
- Chugai Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 200
Subjects who have completed the week 24 visit in the previous study
-Treatment with methotrexate (MTX) 6-8mg/week (administered orally) has continued from the previous study.
-Functional Class 4 as defined by the ACR Classification of Functional Status in rheumatoid arthritis.
-Cardiac or pulmonary function worsens markedly from the week 24 visit in the previous study to enrolment in this study.
-Primary or secondary immunodeficiency, including HIV infection occurs from the week 24 visit in the previous study to enrolment in this study.
-Hepatitis B, hepatitis C or tuberculosis infection occurs from the week 24 visit in the previous study to enrolment in this study.
-Malignancy occurs from the week 24 visit in the previous study to enrolment in this study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy (the frequency of achievement of 20%, 50% and 70% in terms of the ACR criteria, DAS28, EULAR response rate, HAQ-DI score, FACIT-Fatigue scale, persistence rate), Safety (incidence of adverse events)<br>Changes of endpoints from the beginning of the treatment in the previous study
- Secondary Outcome Measures
Name Time Method