Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-05-27
60
Participants Needed
17
Research Sites
6 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of ocrelizumab in people with relapsing multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS). The study aims to measure how well ocrelizumab works in these groups and to understand its pharmacodynamic profile, especially in Chinese participants with PPMS. This study is a Phase 4, open-label, single-arm trial sponsored by Hoffmann-La Roche. Participants with RMS will receive intravenous infusions of ocrelizumab at a dose of 300 mg on Days 1 and 15 of the first 24-week cycle. Subsequent cycles involve single 600 mg infusions every 24 weeks. Participants with PPMS receive the same initial dosing schedule, followed by 600 mg infusions at Week 24. One cycle equals 24 weeks for both groups. During the study, participants will undergo various assessments including monitoring relapse rates for RMS, measuring B-cell levels in blood, and brain MRI scans to observe lesion changes. Other evaluations include disability status, walking tests, and quality of life questionnaires. The study will also monitor drug concentration, adverse events, and suicidal ideation over approximately 1.6 to 1.8 years. Safety and efficacy data will be collected up to Week 48 and beyond.
CONDITIONS
Brief 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 (RMS) or primary progressive multiple sclerosis (PPMS) according to the revised 2017 McDonald Criteria
- Expanded Disability Status Scale (EDSS) score between 0 and 5.5 for RMS, or between 3.0 and 6.5 for PPMS, at screening and baseline
- Documented brain MRI showing abnormalities consistent with multiple sclerosis before screening
- Age between 18 and 55 years
You will not qualify if you...
- Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) for RMS participants
- History of relapsing remitting multiple sclerosis (RRMS) or SPMS for PPMS participants
- Disease duration over 10 years in participants with an EDSS score of 2.0 or less at screening for RMS
- History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)
- Inability to complete MRI or contraindication to gadolinium administration
- Contraindications to required pre-medications such as corticosteroids and antihistamines
- Other neurological disorders interfering with diagnosis or assessments
- Any chronic disease requiring systemic corticosteroids or immunosuppressants during the study
- Known HIV infection
- Lack of peripheral venous access
- Previous treatment with B-cell targeted therapies within 6 months before screening
- Positive screening tests for hepatitis B or C virus infection
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to approximately 1.6 years
Participants receive intravenous infusions of ocrelizumab following a specific schedule: 300 mg on Days 1 and 15 of Cycle 1, then 600 mg every 24 weeks thereafter.
Infusions on Days 1 and 15 of Cycle 1, then every 24 weeks
Duration - Up to approximately 1.8 years
Participants are monitored for safety, efficacy, and other health assessments following treatment.
Assessments at Week 24, Week 48, and ongoing monitoring visits
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/
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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