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A Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Participants With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
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Autoimmune Disorder -
Multiple Sclerosis (MS) -
Relapsing Multiple Sclerosis (RMS) -
Primary Progressive Multiple Sclerosis (PPMS)
- For Medical Professional
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Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 4
Study Identifier
NCT07483450, YN44938
Condition
Relapsing Multiple Sclerosis, Primary Progressive Multiple Sclerosis
Official Title
A Multicenter, Open-label, Single-arm Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Ocrelizumab in Chinese Patients With Relapsing Multiple Sclerosis and Primary Progressive Multiple Sclerosis
Study Summary
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
All
≥18 Years & ≤ 55 Years
No
Inclusion Criteria
- 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
Exclusion Criteria
- 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)
- Inability to complete an MRI scan or contraindication to Gd administration
- Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)
- Known presence of other neurologic disorders if they could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
- Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
- Known history of human immunodeficiency virus (HIV) infection
- Lack of peripheral venous access
- Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab), unless the last infusion was at least 6 months prior to screening
- Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
This page summarises information from public registry websites, such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc. To learn more about this study, see the For Medical Professional tab or visit one of those websites.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com