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 TRIAL - A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis

F. HOFFMANN - LA ROCHE LTD.0 个研究点目标入组 1,224 人开始时间: 2021年6月17日最近更新: 2021年8月17日

适应症

试验速览

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•- Able to comply with the study protocol, in the investigator’s judgment
•- Completed the treatment period of Roche sponsored ocrelizumab Parent-trial (including the female patients who were pregnant during study and are still in the safety follow up period) and who in the opinion of the investigator may benefit from treatment with ocrelizumab
•-Patient who became pregnant by chance between the last visit of the parent study and screening of this study, as confirmed by pregnancy tests at screening, will enter the safety follow-up immediately and re-start the treatment after birth and breastfeeding are over, as per re-treatment criteria
•- Meet re-treatment criteria with ocrelizumab
•- For women of childbearing potential: agreement to remain abstinent or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the final dose of ocrelizumab, as applicable in the local ocrelizumab package leaflet.
•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 1224
•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 ocrelizumab package leaflet
•- Prohibited concomitant medication use
•- Patient intending to become pregnant during the study or within 6 month after the last dose of the study drug in the parent study
•- Patients who discontinued ocrelizumab, exemption made for treatment discontinuation due to pregnancy and breastfeeding for patients who
•continued clinical study assessments in the safety follow-up of the parent study.

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