Actively Recruiting
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
Eligibility Criteria
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
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
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
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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