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COMPLETED
NCT05232825
PHASE3

A Phase III, Non-Inferiority, Randomized, Open-Label, Parallel Group, Multicenter Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

This study will evaluate the pharmacokinetics, pharmacodynamics, safety, immunogenicity, and radiological and clinical effects of subcutaneous (SC) administration of ocrelizumab compared with the intravenous (IV) infusion of ocrelizumab in patients with either relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS).

Official title: A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

236

Start Date

2022-05-03

Completion Date

2025-06-06

Last Updated

2026-08-11

Healthy Volunteers

No

Interventions

DRUG

Ocrelizumab IV

IV Injection

DRUG

Ocrelizumab SC

SC Injection

DRUG

Methylprednisolone IV

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion

DRUG

Diphenhydramine IV

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion

DRUG

Dexamethasone given orally

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab injection

DRUG

Desloratadine given orally

Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab injection

Locations (37)

Neurology Associates PA

Maitland, Florida, United States

University of South Florida

Tampa, Florida, United States

Johns Hopkins Hospital

Baltimore, Maryland, United States

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis

Owosso, Michigan, United States

UC Health Neurology

Dayton, Ohio, United States

Premier Neurology

Greenville, South Carolina, United States

Neurology Clinic PC

Cordova, Tennessee, United States

CEDOES - Diagnóstico e Pesquisa

Vitória, Espírito Santo, Brazil

Clinica Amo Assistencia Medica Em Oncologia

Salvador, Estado de Bahia, Brazil

Fakultni nemocnice u sv. Anny

Brno, Czechia

Charles University, Medical faculty, Hradec Kralove

Hradec Králové, Czechia

Nemocnice Jihlava

Jihlava, Czechia

Fakultni nemocnice Ostrava

Ostrava-Poruba, Czechia

Pardubicka Krajska Nemocnice

Pardubice, Czechia

Fakultni poliklinika VFN

Prague, Czechia

Fakultni nemocnice Motol

Prague, Czechia

Krajska zdravotni a.s Nemocnice Teplice o.z.

Teplice, Czechia

Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

Rome, Lazio, Italy

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, Italy

Ospedale Civile di Montichiari

Montichiari, Lombardy, Italy

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, Italy

Optimal Clinical Trials

Auckland, New Zealand

Hawkes Bay Hospital

Hastings, New Zealand

Neurocentrum Bydgoszcz sp. z o.o

Bydgoszcz, Poland

Care Clinic

Katowice, Poland

Centrum Neurologii Krzysztof Selmaj

Lodz, Poland

Przychodnia EuroMediCare

Wroc?aw, Poland

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario Virgen Macarena

Seville, Sevilla, Spain

Complejo Hospitalario Nuestra Señora de la Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Universitari Vall d'Hebron

Barcelona, Spain

Hospital Universitario Reina Sofia

Córdoba, Spain

Bakirkoy State Mental Hospital

Istanbul, Turkey (Türkiye)

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

Istanbul, Turkey (Türkiye)

Katip Celebi University Ataturk Training and Research Hospital

Izmir, Turkey (Türkiye)

Kocaeli University Hospital

Kocaeli, Turkey (Türkiye)

Namik Kemal Universitesi Sagli Uygulama ve Arastirma Hastanesi

Süleymanpa?a, Turkey (Türkiye)