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NCT07483450Active, not recruitingPhase 4

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

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

Source: ClinicalTrials.gov · Last updated 30 Sept 2026

Brief summary (registry, in English)

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).

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
60 (estimated)
First submitted
16 Mar 2026
Start date
4 Jul 2025
Primary completion date
31 Dec 2027
Lead sponsor
Hoffmann-La Roche
NCT number
NCT07483450

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 60
  • From 4 Jul 2025 to the primary completion date, 31 Dec 2027
  • 17 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines)
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • 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

Other illness

  • 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)
  • 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
  • Known history of human immunodeficiency virus (HIV) infection
  • Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)

Other

  • Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort)
  • Inability to complete an MRI scan or contraindication to Gd administration
  • Lack of peripheral venous access

Who the study is looking for

  • 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

Age in the registry: 18 years to 55 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (17)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Beijing Hospital of Ministry of Health
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BeijingChinaUnknown status
Peking University First Hospital
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BeijingChinaUnknown status
Peking Union Medical College Hospital
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BeijingChinaUnknown status
Xiangya Hospital Central South University
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ChangshaChinaUnknown status
West China Hospital of Sichuan University
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ChengduChinaUnknown status
The First Affiliated Hospital, Chongqing Medical University
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ChongqingChinaUnknown status
The Third Affiliated Hospital of Sun Yat-Sen University
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GuangzhouChinaUnknown status
the First Affiliated Hospital of Sun Yat-sen University
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GuangzhouChinaUnknown status
The First Affiliated Hospital of College of Medicine,Zhejiang University
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HangzhouChinaUnknown status
Inner Mongolia Autonomous Region People's Hospital
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HohhotChinaUnknown status
Lanzhou University Second Hospital
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LanzhouChinaUnknown status
The First Affiliated Hospital of NanChang University
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NanchangChinaUnknown status
The First Hospital of China Medical University
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ShenyangChinaUnknown status
The Second Hospital of Hebei Medical University
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ShijiazhuangChinaUnknown status
1st Affiliated Hospital of Shanxi Medical University
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TaiyuanChinaUnknown status
Xinjiang People Hospital
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ÜrümqiChinaUnknown status
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
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WuhanChinaUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.