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Набира участници Фаза 4 NCT07483450

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

Фаза 4 – наблюдение след одобрението на пазара
Заболявания: Relapsing Multiple Sclerosis Primary Progressive Multiple Sclerosis

Спонсор: Hoffmann-La Roche

Налично на: БГ
Обобщение
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).
Кой може да участва
Inclusion Criteria: * 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 Exclusion Criteria: * Diagnosis of PPMS or non-active secondary progressive multiple sclerosis (SPMS) (only for RMS cohort) * 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) * Inability to complete an MRI scan or contraindication to Gd administration * Contraindications to mandatory pre-medications (i.e., corticosteroids and antihistamines) * 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 * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * Known history of human immunodeficiency virus (HIV) infection * Lack of peripheral venous access * 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 * Positive screening tests for hepatitis B virus (HBV) and/or hepatitis C virus (HCV)
Интервенции
Ocrelizumab
DRUG
Места на провеждане 17
Китай (17)
Peking Union Medical College Hospital
Beijing
Peking University First Hospital
Beijing
Beijing Hospital of Ministry of Health
Beijing
Xiangya Hospital Central South University
Changsha
West China Hospital of Sichuan University
Chengdu
The First Affiliated Hospital, Chongqing Medical University
Chongqing
The First Affiliated Hospital of Sun Yat-sen University
Guangzhou
The Third Affiliated Hospital of Sun Yat-Sen University
Guangzhou
The First Affiliated Hospital of College of Medicine, Zhejiang University
Hangzhou
Inner Mongolia Autonomous Region People's Hospital
Hohhot
Lanzhou University Second Hospital
Lanzhou
The First Affiliated Hospital of Nanchang University
Nanchang , Jiangxi
The First Hospital of China Medical University
Shenyang
The Second Hospital of Hebei Medical University
Shijiazhuang
ACTIVE_NOT_RECRUITING
1st Affiliated Hospital of Shanxi Medical University
Taiyuan
Xinjiang People Hospital
Ürümqi
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan
Технически детайли
Статус
Набира участници
Фаза
Фаза 4
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
18 Years
Максимална възраст
55 Years
Здрави доброволци
Не
Начална дата
04.07.2025
Крайна дата
23.04.2027
Регистрационен номер
NCT07483450
Източник
clinicaltrials.gov
Запитване за медицински туризъм

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