A SINGLE ARM, OPEN LABEL MULTICENTRE EXTENSION STUDY TO EVALUATE THE EFFECTIVENESS AND SAFETY OF OCRELIZUMAB INPATIENTS WITH MULTIPLE SCLEROSIS PREVIOUSLY ENROLLED IN A F. HOFFMANN-LA ROCHE SPONSORED OCRELIZUMAB PHASE IIIb/IV CLINICAL TRIA

F. Hoffmann-La Roche Ltd0 个研究点目标入组 750 人开始时间: 2018年4月18日最近更新: 2018年9月24日

适应症

试验速览

暂无简介。

•- Able to comply with the study protocol, in the investigator’s judgment
•- Completed the treatment period of Roche sponsored ocrelizumab Parent-trial (exception for female patients who were pregnant during MA30005 study and are still in the safety follow up period) and who in the opinion of the investigator may benefit from treatment with ocrelizumab and so are eligible for ocrelizumab re-treatment
•- Meet re-treatment criteria with ocrelizumab
•- For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug
•Are the trial subjects under 18? no
•Number of subjects for this age range:
•F.1.2 Adults (18-64 years) yes
•F.1.2.1 Number of subjects for this age range 750
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•- Hypersensitivity to ocrelizumab or to any of its excipients
•- Patients in a severely immunocompromised state until the condition resolves
•- Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation
•- Existence of a contra-indication as per SmPC
•- Patients who discontinued ocrelizumab, exemption made for treatment discontinuation because of pregnancy and breastfeeding and continued clinical study assessments

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