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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
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
Ocrelizumab IV
IV Injection
Ocrelizumab SC
SC Injection
Methylprednisolone IV
Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion
Diphenhydramine IV
Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab infusion
Dexamethasone given orally
Participants will receive mandatory (corticosteroids and antihistamine) and optional (analgesic) prophylactic treatment before the start of each ocrelizumab injection
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)