A PHASE IIIB MULTICENTER, RANDOMIZED, DOUBLE-BLIND, CONTROLLED STUDY TO EVALUATE THE EFFICACY, SAFETY AND PHARMACOKINETICS OF A HIGHER DOSE OF OCRELIZUMAB IN ADULTS WITH RELAPSING MULTIPLE SCLEROSIS

F. HOFFMANN-LA ROCHE LTD.,0 个研究点目标入组 0 人开始时间: 2020年10月8日最近更新: 2024年8月20日

适应症

试验速览

暂无简介。

•Patients must meet the following criteria for study entry:
•Signed ICF
•Ages 1855 years at time of signing ICF
•Ability to comply with the study protocol
•Diagnosis of RMS in accordance with the revised McDonald Criteria 2017
•(Thompson et al. 2018)
•At least two documented clinical attacks within the last 2 years prior to screening, or
•one clinical attack in the year prior to screening (with no relapse 30 days prior to
•screening and at baseline)
•Patients must be neurologically stable for at least 30 days prior to randomization
•and baseline assessments
•EDSS, at screening and baseline, from 0 to 5.5 inclusive
•Documented MRI of brain with abnormalities consistent with MS prior to screening
•Patients requiring symptomatic treatment for MS (e.g., fampridine, cannabis) and/or
•physiotherapy must be treated at a stable dose during the screening period prior to
•the initiation of study drug on Day 1 and must have a plan to remain at a stable dose
•for the duration of study treatment
•Patients must not initiate symptomatic treatment for MS or physiotherapy
•within 4 weeks of randomization.
•For more details, review the protocol.

•Patients who meet any of the following criteria will be excluded from study entry:
•History of primary progressive MS at screening
•Any known or suspected active infection at screening or baseline (except nailbed
•infections), or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with
•oral anti microbials within 2 weeks prior to and during screening
•History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
•History of cancer, including hematologic malignancy and solid tumors, within
•10 years of screening
•Basal or squamous cell carcinoma of the skin that has been excised and is
•considered cured and in situ carcinoma of the cervix treated with apparent
•success by curative therapy >1year prior to screening is not exclusionary.
•For more details, review the protocol.

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