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Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis

Long-Term Treatment Study of Ocrelizumab for Rheumatoid Arthritis

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp

Chugai Pharmaceutical Co., Ltd.

clinical-trials@chugai-pharm.co.jp

Interventional

Open-labelled, multicenter study

3

-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.

Both

Rheumatoid Arthritis

investigational material(s)
Generic name etc : Ocrelizumab
INN of investigational material :
Therapeutic category code : 399 Agents affecting metabolism, n.e.c.
Dosage and Administration for Investigational material : 500 mg will be administered by intravenous infusion on Day 1 and Day 15. Repeat courses of therapy with ocrelizumab may be administered basically every 24 weeks, a minimum interval of 12 weeks, between courses.

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)
Changes of endpoints from the beginning of the treatment in the previous study