RecruitingPhase 4NCT07483450

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


Sponsor

Hoffmann-La Roche

Enrollment

60 participants

Start Date

Jul 4, 2025

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 YearsMax Age: 55 Years

Plain Language Summary

Simplified for easier understanding

This study is evaluating ocrelizumab — an approved medication for multiple sclerosis (MS) — in patients with either relapsing MS (where symptoms come and go) or primary progressive MS (where symptoms gradually worsen from the start). The study is collecting data on how well the drug works in a broader, real-world population and tracking safety over time. **You may be eligible if...** - You have been diagnosed with relapsing MS or primary progressive MS using established diagnostic criteria - Your disability level falls within a defined range (EDSS 0–5.5 for relapsing MS, or 3.0–6.5 for primary progressive MS) - You have had a brain MRI showing changes consistent with MS **You may NOT be eligible if...** - You have progressive MS of a non-active type (for the relapsing MS group) - You have a history of relapsing-remitting or secondary progressive MS (for the primary progressive MS group) - You have a history of a rare brain infection called PML (progressive multifocal leukoencephalopathy) - You cannot have an MRI or tolerate contrast dye - You have another neurological disorder that could be confused with MS - You have HIV, hepatitis B, or hepatitis C infection - You recently received B-cell–targeting therapies (within 6 months) - You require long-term steroids or immune-suppressing drugs for another condition Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOcrelizumab

Ocrelizumab will be administered as per the schedule specified in the respective arms.


Locations(17)

The First Affiliated Hospital of Nanchang University

Nanchang, Jiangxi, China

Peking Union Medical College Hospital

Beijing, China

Peking University First Hospital

Beijing, China

Beijing Hospital of Ministry of Health

Beijing, China

Xiangya Hospital Central South University

Changsha, China

West China Hospital of Sichuan University

Chengdu, China

The First Affiliated Hospital, Chongqing Medical University

Chongqing, China

The First Affiliated Hospital of Sun Yat-sen University

Guangzhou, China

The Third Affiliated Hospital of Sun Yat-Sen University

Guangzhou, China

The First Affiliated Hospital of College of Medicine, Zhejiang University

Hangzhou, China

Inner Mongolia Autonomous Region People's Hospital

Hohhot, China

Lanzhou University Second Hospital

Lanzhou, China

The First Hospital of China Medical University

Shenyang, China

The Second Hospital of Hebei Medical University

Shijiazhuang, China

1st Affiliated Hospital of Shanxi Medical University

Taiyuan, China

Xinjiang People Hospital

Ürümqi, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

View Full Details on ClinicalTrials.gov

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NCT07483450


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