Actively Recruiting

Phase 4
Age: 18Years - 55Years
All Genders
NCT07483450

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

Led by Hoffmann-La Roche · Updated on 2026-04-24

60

Participants Needed

17

Research Sites

94 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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).

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years - 55Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of relapsing multiple sclerosis or primary progressive multiple sclerosis according to the revised 2017 McDonald Criteria
  • EDSS score from 0 to 5.5 for RMS or 3.0 to 6.5 for PPMS at screening and baseline
  • Documented MRI of brain with abnormalities consistent with multiple sclerosis before screening
Not Eligible

You will not qualify if you...

  • Diagnosis of primary progressive multiple sclerosis or non-active secondary progressive multiple sclerosis for RMS cohort
  • History of relapsing remitting multiple sclerosis or secondary progressive multiple sclerosis for PPMS cohort
  • Disease duration over 10 years with EDSS score 2.0 or less for RMS cohort
  • History of confirmed or suspected progressive multifocal leukoencephalopathy
  • Inability to complete MRI or contraindication to gadolinium administration
  • Contraindications to corticosteroids or antihistamines used as pre-medications
  • Presence of other neurological disorders interfering with MS diagnosis or study assessments
  • Any chronic disease requiring systemic corticosteroids or immunosuppressants during the study
  • Known HIV infection
  • Lack of peripheral venous access
  • Previous B-cell targeted therapy within 6 months of screening
  • Positive screening for hepatitis B or hepatitis C virus infection

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China, 330209

Actively Recruiting

2

Peking Union Medical College Hospital

Beijing, China, 100032

Actively Recruiting

3

Peking University First Hospital

Beijing, China, 100034

Actively Recruiting

4

Beijing Hospital of Ministry of Health

Beijing, China, 100730

Actively Recruiting

5

Xiangya Hospital Central South University

Changsha, China, 410008

Actively Recruiting

6

West China Hospital of Sichuan University

Chengdu, China, 610041

Actively Recruiting

7

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China, 400016

Actively Recruiting

8

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China, 510080

Actively Recruiting

9

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China, 510630

Actively Recruiting

10

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, China, 310003

Actively Recruiting

11

Inner Mongolia Autonomous Region People's Hospital

Hohhot, China, 010011

Actively Recruiting

12

Lanzhou University Second Hospital

Lanzhou, China, 730030

Actively Recruiting

13

The First Hospital of China Medical University

Shenyang, China, DUMMY_VALUE

Actively Recruiting

14

The Second Hospital of Hebei Medical University

Shijiazhuang, China, 050000

Active, Not Recruiting

15

1st Affiliated Hospital of Shanxi Medical University

Taiyuan, China, 030000

Actively Recruiting

16

Xinjiang People Hospital

Ürümqi, China, 830000

Actively Recruiting

17

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China, 430030

Actively Recruiting

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Research Team

R

Reference Study ID Number: YN44938 https://forpatients.roche.com/

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NON_RANDOMIZED

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

2

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