A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis

Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-55
SponsorHoffmann-La Roche

About this trial

The main purpose of this study is to evaluate the efficacy of ocrelizumab in participants with relapsing multiple sclerosis (RMS) and to characterize the ocrelizumab pharmacodynamic (PD) profile in Chinese participants with primary progressive multiple sclerosis (PPMS).

Eligibility criteria

Qualifiers

Diagnosis of RMS/PPMS in accordance with the revised 2017 McDonald Criteria

EDSS score from 0-5.5 (RMS) or 3.0-6.5 (PPMS), inclusive, at screening and baseline

Documented MRI of brain with abnormalities consistent with MS before screening

Disqualifiers

Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)

History of relapsing remitting multiple sclerosis (RRMS) or SPMS at screening (only for PPMS cohort)

Disease duration of more than 10 years in participants with an EDSS ≤ 2.0 at screening (only for RMS cohort)

History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)

Trial design

Treatments tested in this trial

  • Ocrelizumab

Treatment groups

60 Participants
are divided into 2 treatment groups

Sponsors and collaborators