ONG-TERM EFFECTIVENESS AND SAFETY EVALUATION OF OCRELIZUMAB IN FRENCH PATIENTS WITH PROGRESSIVE MS: CONSONANCE EXTENSION STUDY - CONSONANCE EXTENSION STUDY

niversity Nice Hospital0 个研究点目标入组 90 人开始时间: 2021年12月2日最近更新: 2024年4月22日

试验速览

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•Signed informed consent form (ICF)
•Able to comply with the study protocol, in the investigator’s judgment
•Affiliation to the social security system
•Completed the treatment period of Roche-sponsored ocrelizumab trial (CONSONANCE) and who in the opinion of the investigator may benefit from treatment with ocrelizumab. Only patients enrolled under Protocol version 1 (approval date: 18 February 2018) will be eligible.
•Meet re-treatment criteria with ocrelizumab (please see section 6.11)
•Patients who became pregnant by chance between the last visit of the CONSONANCE study and screening of this study, as confirmed by pregnancy tests at screening, will enter the study but will only re-start treatment with ocrelizumab after birth or after breastfeeding is stopped, as per re-treatment criteria in section 6.11
•Women of childbearing potential* (WOCBP):
•oMust have a negative urine pregnancy test at Visit 1 (Screening) and Visit 2 (Baseline)
•oMust agree 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 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 90
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•Patients who meet any of the following criteria will be excluded from study entry:
•Hypersensitivity to ocrelizumab or any of its excipients
•Patients in a severely immunocompromised state, until the condition resolves
•Evidence of any AE potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation
•Existence of a contra-indication as per the SmPC
•Prohibited concomitant medication as specified in section 6.7
•Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug in CONSONANCE
•Patients who had early ocrelizumab discontinuation in CONSONANCE (exemption made for treatment discontinuation due to unplanned pregnancy and breastfeeding for patients who continued clinical study assessments in CONSONANCE)

发起方

niversity Nice Hospital