A Study to Evaluate the Efficacy, Safety and Pharmacokinetics (PK) of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
NCT ID: NCT04544436
Last Updated: 2025-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
864 participants
INTERVENTIONAL
2020-11-26
2028-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Ocrelizumab Higher Dose
Participants will be randomized to receive a minimum of 5 higher treatment doses based on their body weight at baseline: 1200 mg (participant's body weight \<75 kilograms \[kg\]) or 1800 mg (participant's body weight ≥ 75 kg) of ocrelizumab administered by IV infusion Q24W in the DBT phase. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Ocrelizumab
The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (body weight \<75 kg) or 1800 mg (body weight ≥ 75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion Q24W. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total).
Antihistamine
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Methylprednisolone
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
Ocrelizumab Approved Dose
Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by IV infusion Q24W in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Ocrelizumab
Ocrelizumab will be administered at a dose of 600 mg Q24W. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion Q24W.
Antihistamine
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Methylprednisolone
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
Interventions
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Ocrelizumab
The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (body weight \<75 kg) or 1800 mg (body weight ≥ 75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion Q24W. During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total).
Ocrelizumab
Ocrelizumab will be administered at a dose of 600 mg Q24W. The first dose of ocrelizumab will be administered as two 300 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion Q24W.
Antihistamine
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Methylprednisolone
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening. No relapse 30 days prior to screening and at baseline
* Participants must be neurologically stable for at least 30 days prior to randomization and baseline
* EDSS score, at screening and baseline, from 0 to 5.5 inclusive
* Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
* Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds
* Documented magnetic resonance imaging (MRI) of brain with abnormalities consistent with MS at screening
* Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization
* Females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods
* Female participants without reproductive potential may be enrolled e.g. if post-menopausal or if surgically sterile
Exclusion Criteria
* Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening
* History of confirmed or suspected progressive multifocal leukoencephalopathy
* History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening
* Immunocompromised state
* Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization
* Inability to complete an MRI or contraindication to gadolinium administration
* Contraindications to mandatory pre-medications for infusion-related reaction (IRRs)
* Known presence of other neurologic disorders that 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
* Significant, uncontrolled disease that may preclude participant from participating in the study
* History of or currently active primary or secondary, non-drug-related, immunodeficiency
* Pregnant or breastfeeding or intending to become pregnant
* Lack of peripheral venous access
* History of alcohol or other drug abuse within 12 months prior to screening
* Treatment with any investigational agent within 24 weeks prior to screening or treatment with any experimental procedure for MS
* Previous use of anti- cluster of differentiation 20 (CD20s) (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy
* Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
* Previous treatment with natalizumab within 4.5 months of baseline
* Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
* Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab - Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication
* Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation
* Any previous history of transplantation or anti-rejection therapy
* Treatment with IV immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization
* Systemic corticosteroid therapy within 4 weeks prior to screening
* Positive screening tests for active, latent, or inadequately treated hepatitis B
* Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab
* Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above
18 Years
55 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Maine Medical Center
Scarborough, Maine, United States
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
North Central Neurology Associates
Cullman, Alabama, United States
Alabama Neurology Associates
Homewood, Alabama, United States
21st Century Neurology
Phoenix, Arizona, United States
Profound Research, LLC
Carlsbad, California, United States
Stanford University Medical Center
Stanford, California, United States
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States
Neurology Associates, PA
Maitland, Florida, United States
University of South Florida
Tampa, Florida, United States
American Health Network Institute, LLC
Avon, Indiana, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
The NeuroMedical Clinic of Central Louisiana
Alexandria, Louisiana, United States
Dragonfly Research, LLC
Wellesley, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
Cleveland Clinic Lou Ruvo
Las Vegas, Nevada, United States
Dent Neurological Institute
Amherst, New York, United States
UC Health Neurology
Dayton, Ohio, United States
Oklahoma Medical Research Foundation
Oklahoma City, Oklahoma, United States
Abington Neurological Associates
Willow Grove, Pennsylvania, United States
Tri-State Mountain Neurology
Johnson City, Tennessee, United States
Hope Neurology
Knoxville, Tennessee, United States
Bhupesh Dihenia M.D. P.A.
Lubbock, Texas, United States
Lone Star Neurology of San Antonio
San Antonio, Texas, United States
Evergreen MS Center
Kirkland, Washington, United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
Buenos Aires, , Argentina
CEMIC
Buenos Aires, , Argentina
Centro de Investigaciones Médicas Tucuman
San Miguel de Tucumán, , Argentina
Austin Hospital
Heidelberg, Victoria, Australia
Hospital Erasme
Brussels, , Belgium
Revalidatie en MS Centrum
Overpelt, , Belgium
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
IMV Pesquisa Neurológica
Porto Alegre, Rio Grande do Sul, Brazil
Clinica Neurologica
Joinville, Santa Catarina, Brazil
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, Brazil
Recherche Sepmus Inc.
Greenfield Park, Quebec, Canada
Hotel-Dieu de Levis
Lévis, Quebec, Canada
Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Groupe Hospitalier Pellegrin
Bordeaux, , France
CHU Hopital Gabriel Montpied
Clermont-Ferrand, , France
CH St Vincent de Paul
Lille, , France
Hôpital Charles Nicolle
Rouen, , France
Charite - Universitätsmedizin Berlin
Berlin, , Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, , Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, , Germany
Universitätsklinikum Schleswig-Holstein
Kiel, , Germany
Universität Leipzig
Leipzig, , Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
Deutsche Klinik für Diagnostik
Wiesbaden, , Germany
401 Military Hospital of Athens
Athens, , Greece
S-Medicon Egeszsegugyi Szolgaltato Kft.
Budapest, , Hungary
UNO Medical Trials Kft.
Budapest, , Hungary
Somogy Vármegyei Kaposi Mór Oktató Kórház
Kaposvár, , Hungary
Universita? G. D'Annunzio
Chieti, Abruzzo, Italy
AOU Seconda Università degli Studi
Napoli, Campania, Italy
AOU Seconda Università degli Studi
Napoli, Campania, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, Italy
NCL Institute Neuroscience
Rome, Lazio, Italy
Policlinico Umberto I
Rome, Lazio, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, Italy
Hospital IV Alberto Sabogal Sologuren
Bellavista, , Peru
Clinica Internacional
Lima, , Peru
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo
Lima, , Peru
Hospital Maria Auxiliadora
Lima, , Peru
Hospital Nacional Dos de Mayo
Lima, , Peru
Clinica Sanchez Ferrer
Trujillo, , Peru
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz, , Poland
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
Gdansk, , Poland
MA-LEK Clinical Sp. Z o.o.
Katowice, , Poland
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM
Lodz, , Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, , Poland
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
Plewiska, , Poland
EMC Instytut Medyczny SA
Późna, , Poland
Nmedis sp. z o.o.
Rzeszów, , Poland
Osrodek Badan Klinicznych Euromedis
Szczecin, , Poland
Centrum Medyczne NeuroProtect
Warsaw, , Poland
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Warsaw, , Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, , Poland
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz
Lisbon, , Portugal
Hospital de Santa Maria
Lisbon, , Portugal
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Krasnoyarsk Krai, Russia
Neiro Clinica LLC
Moscow, Moscow Oblast, Russia
Research Center of Neurology of RAMS
Moscow, Moscow Oblast, Russia
Federal center of brain research and neurotechnologies
Moskva, Moscow Oblast, Russia
City Clinical Hospital #24
Moskva, Moscow Oblast, Russia
National Center of Social Significant Disease
Saint Petersburg, Sankt-Peterburg, Russia
N.P. Bechtereva Institute of the Human Brain
Saint Petersburg, Sankt-Peterburg, Russia
City Hospital #40 of Kurortniy Administrative District
Saint Petersburg, Sankt-Peterburg, Russia
SHI Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Sverdlovsk Oblast, Russia
Vertebronevrologiya LLC
Kazan', Tatarstan Republic, Russia
KSMU Interregional Clinical Diagnostic Centre
Kazan', Tatarstan Republic, Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Ulyanovsk Oblast, Russia
Saratov State Medical University of RosZdrav
Saratov, , Russia
Nebbiolo Center for Clinical Trials
Tomsk, , Russia
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, Spain
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, Spain
Hospital Universitari Vall d'Hebron
Barcelona, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, , Spain
Universitätsspital Basel Medizin Neurologie
Basel, , Switzerland
Inselspital Bern Medizin Neurologie
Bern, , Switzerland
Ospedale Regionale di Lugano - Civico
Lugano, , Switzerland
Kocaeli University Hospital
Kocaeli, , Turkey (Türkiye)
5th Cherkasy City Center of Primary Health Care
Cherkasy, , Ukraine
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?
Chernihiv, , Ukraine
Bukovinsky SMU RMI Chernivtsi RCH
Chernivtsi, , Ukraine
SI USSRI of Medical and Social Problems of Disabilities of MOHU
Dnipro, , Ukraine
Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
Kharkiv, , Ukraine
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU
Kharkiv, , Ukraine
Medical Center of Private Execution First Private Clinic
Kyiv, , Ukraine
Medical Center Dopomoga Plus
Kyiv, , Ukraine
Lvivska oblasna tsentralna likarnia
Lviv, , Ukraine
LCC "Medical center "Unimed"
Zaporizhzhia, , Ukraine
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
Zaporizhzhia, , Ukraine
Derriford Hospital
Plymouth, , United Kingdom
Countries
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Other Identifiers
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2020-000893-69
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506467-34-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
BN42082
Identifier Type: -
Identifier Source: org_study_id
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