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

PHASE3CompletedINTERVENTIONAL
Enrollment

236

Participants

Timeline

Start Date

May 3, 2022

Primary Completion Date

March 10, 2023

Study Completion Date

June 6, 2025

Conditions
Relapsing Multiple SclerosisPrimary Progressive Multiple Sclerosis
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

Trial Locations (37)

1010

Optimal Clinical Trials, Auckland

4120

Hawkes Bay Hospital, Hastings

14011

Hospital Universitario Reina Sofia, Córdoba

21287

Johns Hopkins Hospital, Baltimore

25018

Ospedale Civile di Montichiari, Montichiari

28222

Hospital Universitario Puerta de Hierro Majadahonda, Majadahonda

29605

Premier Neurology, Greenville

32751

Neurology Associates PA, Maitland

33612

University of South Florida, Tampa

34000

Bakirkoy State Mental Hospital, Istanbul

34098

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi, Istanbul

35360

Katip Celebi University Ataturk Training and Research Hospital, Izmir

38010

Complejo Hospitalario Nuestra Señora de la Candelaria, Santa Cruz de Tenerife

38018

Neurology Clinic PC, Cordova

41071

Hospital Universitario Virgen Macarena, Seville

41380

Kocaeli University Hospital, Kocaeli

45417

UC Health Neurology, Dayton

48867

Memorial Healthcare Institute for Neurosciences and Multiple Sclerosis, Owosso

58633

Nemocnice Jihlava, Jihlava

59100

Namik Kemal Universitesi Sagli Uygulama ve Arastirma Hastanesi, Süleymanpa?a

86077

IRCCS Istituto Neurologico Neuromed, Pozzilli

41950640

Clinica Amo - Assistencia Medica Em Oncologia, Salvador

29055-450

CEDOES - Diagnóstico e Pesquisa, Vitória

656 91

Fakultni nemocnice u sv. Anny, Brno

500 05

Charles University, Medical faculty, Hradec Kralove, Hradec Králové

708 52

Fakultni nemocnice Ostrava, Ostrava-Poruba

532 03

Pardubicka Krajska Nemocnice, Pardubice

128 08

Fakultni poliklinika VFN, Prague

150 06

Fakultni nemocnice Motol, Prague

415 01

Krajska zdravotni a.s Nemocnice Teplice o.z., Teplice

00133

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

00189

Azienda Ospedaliera Sant'Andrea, Rome

85-796

Neurocentrum Bydgoszcz sp. z o.o, Bydgoszcz

40-568

Care Clinic, Katowice

90-324

Centrum Neurologii Krzysztof Selmaj, Lodz

50-220

Przychodnia EuroMediCare, Wroc?aw

08035

Hospital Universitari Vall d'Hebron, Barcelona

All Listed Sponsors
lead

Hoffmann-La Roche

INDUSTRY