Clinical trial • Phase III • Neurology

OCRELIZUMAB for Primary progressive multiple sclerosis

Phase III trial of OCRELIZUMAB for Primary progressive multiple sclerosis.

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Primary progressive multiple sclerosis
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
18-12-2023
First CTIS Authorization Date
08-02-2024

Trial design

Randomised, placebo ocrelizumab (placebo) and approved dose of ocrelizumab (ocrevus 300 mg concentrate for solution for infusion); investigational arm is a higher dose of ocrelizumab. specific dosing and schedule not specified in provided data.-controlled Phase III trial in Greece, Hungary, Italy and others.

Randomised
Yes
Comparator
Placebo Ocrelizumab (placebo) and approved dose of ocrelizumab (Ocrevus 300 mg concentrate for solution for infusion); investigational arm is a higher dose of ocrelizumab. Specific dosing and schedule not specified in provided data.
Target Sample Size
459
Trial Duration For Participant
1344

Eligibility

Recruits 459 adults.

Inclusion criteria

  • {"criterion_text":"- 1. Ages 18-55 years at time of screening"}
  • {"criterion_text":"- 2. Diagnosis of PPMS, in accordance with the revised McDonald criteria 2017"}
  • {"criterion_text":"- 3. Expanded disability status scale (EDSS) score at screening and baseline 3- 6.5, inclusive"}
  • {"criterion_text":"- 4. Score of ≥ 2.0 on the Functional Systems (FS) scale for the pyramidal system that was due to lower extremity findings at screening and baseline"}
  • {"criterion_text":"- 5. Documented MRI of brain with abnormalities consistent with MS"}
  • {"criterion_text":"- 6. Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments"}

Exclusion criteria

  • {"criterion_text":"- 1. History of relapsing remitting or secondary progressive MS at screening"}
  • {"criterion_text":"- 2. Any known or suspected active infection at screening or baseline, or any major episode of infection requiring hospitalization or treatment with IV anti microbials within 8 weeks prior to and during screening or treatment with oral anti microbials within 2 weeks prior to and during screening"}
  • {"criterion_text":"- 3. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening"}
  • {"criterion_text":"- 4. Immunocompromised state"}
  • {"criterion_text":"- 5. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study"}
  • {"criterion_text":"- 6. History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)"}

Endpoints

Primary endpoints

  • {"endpoint_text":"- 1. Time to onset of cCDP sustained for at least 12 weeks. Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT","definition_or_measurement_approach":"Time to onset of cCDP sustained for at least 12 weeks; defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT"}

Secondary endpoints

  • {"endpoint_text":"- 1. Time to onset of 24 week cCDP (cCDP24)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 2. Time to onset of cCDP12 independent of protocol-defined relapses (PDR), also termed progression independent of relapse activity (PIRA) as per Kappos et al.2020","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 3. Time to onset of 12-week CDP (CDP12)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 4. Time to ≥ 20% increase in 12 week confirmed T25FWT","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 5. Annual rate of percent change from baseline in total brain volume","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 6. Annual rate of percent change from baseline in thalamic volume","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 7. Time to 12-week confirmed 4-point worsening in Symbol Digit Modalities Test (SDMT)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 8. Change in NfL (i.e. ratio to baseline) at Week 96","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 9.Time to 12-week confirmed 8-point increase in 12-Item Multiple Sclerosis Walking Scale (MSWS12)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 10. Change in NfL (i.e. ratio to baseline) at Week 96 for patients in the higher dose ocrelizumab group","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 11. Change in NfL (i.e. ratio to baseline) at Week 96 for patients in the approved dose ocrelizumab group","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 12. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version 5.0","definition_or_measurement_approach":"Severity determined according to NCI CTCAE Version 5.0"}
  • {"endpoint_text":"- 13. Change from baseline in clinical laboratory test results (including hematology, chemistry, and Ig levels)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 14. Change from baseline in vital signs (including systolic and diastolic blood pressure, and pulse rate) following study treatment administration","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 15. Serum concentration of ocrelizumab at specified timepoints","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 16. B-cell levels in blood (including comparing the degree of B-cell depletion between the doses)","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 17. Proportion of participants achieving 5 or less B-cells per microliter of blood","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 18. Proportion of participants achieving 5 or less B-cells per microliter of blood in participants with the high versus low affinity Fcgamma Receptor 3A (FcγR3A) genotype per arm","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 19. Change from Baseline in the anti-drug antibodies (ADAs) levels","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 20. Levels of Neurofilament Light Chain (NfL) in blood","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 21. Levels of Interleukin-6 (IL-6) in blood","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 22. Levels of blood B-cells","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 23. Levels of Lymphocytes in blood","definition_or_measurement_approach":""}
  • {"endpoint_text":"- 24. Proportion of participants with different DNA genotypes","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
459
Recruitment Window Months
103
Consent Approach
Informed consent is obtained from participants (adults). Multiple subject information and informed consent forms (ICFs) and localized versions are provided (examples in English, Greek, Bulgarian, Spanish, Portuguese, Hungarian, French, Polish, Italian, German, Dutch among others). Optional/ancillary consents are available for CSF biomarker substudy, open-label extension (OLE), MRI, genetic substudies, infant health questionnaire and other optional procedures as evidenced by multiple ICF documents titled for these optional components. Participants are adults (18-55) and consent is provided by the participant; no assent procedures for minors are specified.

Geography

Total Number Of Sites
57
Total Number Of Participants
310

Greece

Latest Decision Or Authorization Date
27-03-2026
Number Of Sites
2
Number Of Participants
6

Sites

Site Name
401 General Military Hospital Of Athens
Department Name
Neurology Clinic
Contact Person Name
Nikolaos Fakas
Contact Person Email
drfakas@yahoo.gr
Site Name
Eginitio Hospital
Department Name
A’ Neurology Clinic
Contact Person Name
Leonidas Stefanis
Contact Person Email
lstefanis@bioacademy.gr

Hungary

Latest Decision Or Authorization Date
25-03-2026
Number Of Sites
5
Number Of Participants
13

Sites

Site Name
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Department Name
Neurologiai Osztaly Stroke Reszleg
Contact Person Name
Attila Csanyi
Contact Person Email
csanyia@petz.gyor.hu
Site Name
Uno Medical Trials Kft.
Department Name
Neurologia
Contact Person Name
Krisztina Kovacs
Contact Person Email
kovacs.krisztina@otvkft.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Neurologiai Osztaly
Contact Person Name
Istvan Dema
Contact Person Email
deme.istvan@kmmk.hu
Site Name
Orszagos Mentalis Ideggyogyaszati Es Idegsebeszeti Intezet
Department Name
Neurologiai Osztaly
Contact Person Name
Adrienne Jori Birkas
Contact Person Email
dradricamino@yahoo.com
Site Name
Pest Megyei Flor Ferenc Korhaz
Department Name
Neurologia és Stroke Osztaly
Contact Person Name
Zita Biro
Contact Person Email
birozitamaria@gmail.com

Italy

Latest Decision Or Authorization Date
27-03-2026
Number Of Sites
7
Number Of Participants
20

Sites

Site Name
Azienda Socio Sanitaria Territoriale Della Valle Olona
Department Name
Neurologia 2 – Sclerosi Multipla e Recupero Neurologico
Contact Person Name
Pietro Annovazzi
Site Name
Azienda Ospedaliera Universitaria Federico II Di Napoli
Department Name
Dipartimento Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Contact Person Name
Vincenzo Brescia Morra
Site Name
Ospedale San Raffaele S.r.l.
Department Name
Unità Operativa di Neurologia
Contact Person Name
Massimo Filippi
Contact Person Email
filippi.massimo@hsr.it
Site Name
Azienda Ospedaliera Universitaria Citta' Della Salute E Della Scienza Di Torino
Department Name
S.C. Neurologia 1
Contact Person Name
Paola Cavalla
Contact Person Email
paola.cavalla@unito.it
Site Name
Neurological Institute Foundation Casimiro Mondino
Department Name
Dipartimento Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Contact Person Name
Roberto Bergamaschi
Contact Person Email
roberto.bergamaschi@mondino.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
I Clinica Neurologica
Contact Person Name
Antonio Gallo
Contact Person Email
antonio.gallo@unicampania.it
Site Name
Azienda Ospedaliero-Universitaria Sant Andre
Department Name
UOC Neurologia
Contact Person Name
Marco Salvetti
Contact Person Email
marco.salvetti@uniroma1.it

Spain

Latest Decision Or Authorization Date
11-05-2026
Number Of Sites
4
Number Of Participants
25

Sites

Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurologia
Contact Person Name
Mar Tintoré Subirana
Contact Person Email
mtintore@cem-cat.org
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurologia
Contact Person Name
Rafael Arroyo
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
University Clinical Hospital Virgen De La Arrixaca
Department Name
Neurologia
Contact Person Name
José Meca Lallana
Contact Person Email
jose.meca@carm.es
Site Name
Hospital Universitario Puerta De Hierro De Majadahonda
Department Name
Neurologia
Contact Person Name
Maria Rosario Blasco Quilez
Contact Person Email
charoblascoquilez@yahoo.es

France

Latest Decision Or Authorization Date
25-03-2026
Number Of Sites
7
Number Of Participants
24

Sites

Site Name
CHRU De Nancy
Department Name
Neurology
Contact Person Name
Guillaume Mathey
Contact Person Email
g.mathey@chru-nancy.fr
Site Name
Centre Hospitalier Regional Et Universitaire De Brest
Department Name
Neurology
Contact Person Name
Aurore Jourdain
Contact Person Email
Aurore.jourdain@chu-brest.fr
Site Name
Les Hopitaux Universitaires De Strasbourg
Department Name
Neurology
Contact Person Name
Jérome De Seze
Site Name
Besancon University Hospital Center
Department Name
Neurology
Contact Person Name
Eric Berger
Contact Person Email
ccappe@chu-besancon.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Neurology
Contact Person Name
Arnaud kwi atkowski
Contact Person Email
kwiatkowski.arnaud@ghicl.net
Site Name
Centre Hospitalier Universitaire De Caen Normandie
Department Name
Neurology
Contact Person Name
Pierre Branger
Contact Person Email
branger-p@chu-caen.fr
Site Name
CHU Gabriel-Montpied
Department Name
Neurology
Contact Person Name
Pierre Clavelou

Bulgaria

Latest Decision Or Authorization Date
27-03-2026
Number Of Sites
2
Number Of Participants
13

Sites

Site Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Department Name
Department of Movement Disorders, Multiple Sclerosis
Contact Person Name
Ivan Milanov
Contact Person Email
ubalnp@yahoo.com
Site Name
University Multiprofile Hospital For Active Treatment Dr. Georgi Stranski EAD
Department Name
Neurology Clinic
Contact Person Name
Maya Danovska-Mladenova
Contact Person Email
mdanovska@yahoo.com

Belgium

Latest Decision Or Authorization Date
25-03-2026
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Noorderhart
Department Name
Revalidatie en MS Centrum
Contact Person Name
Veronica Popescu

Portugal

Latest Decision Or Authorization Date
26-03-2026
Number Of Sites
4
Number Of Participants
11

Sites

Site Name
Centro Hospitalar De Lisboa Ocidental E.P.E.
Department Name
Serviço de Neurologia
Contact Person Name
Manuel Salavisa
Contact Person Email
mtteixeira@chlo.min-saude.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Unidade de Investigação Clínica
Contact Person Name
João Cerqueira
Contact Person Email
jcerqueira@ecsaude.uminho.pt
Site Name
Centro Hospitalar Universitario Lisboa Central E.P.E.
Department Name
Serviço de Neurologia
Contact Person Name
João Sequeira
Contact Person Email
joaospsequeira@gmail.com
Site Name
Centro Hospitalar Universitario De Santo Antonio E.P.E.
Department Name
Serviço Neurologia/Departament Neurociências
Contact Person Name
Raquel Samões
Contact Person Email
araquelfsamoes@hotmail.com

Denmark

Latest Decision Or Authorization Date
21-04-2026
Number Of Sites
2
Number Of Participants
9

Sites

Site Name
Aalborg University Hospital
Department Name
Neurologisk Afdeling
Contact Person Name
Inga Urbonaviciute
Contact Person Email
i.urbonaviciute@rn.dk
Site Name
Rigshospitalet
Department Name
Neurologisk Klinik
Contact Person Name
Finn Sellebjerg

Germany

Latest Decision Or Authorization Date
25-03-2026
Number Of Sites
9
Number Of Participants
31

Sites

Site Name
Universitaetsklinikum Ulm AöR
Department Name
Neurology
Contact Person Name
Makbule Senel
Contact Person Email
makbule.senel@uni-ulm.de
Site Name
Medizinische Hochschule Hannover
Department Name
Neurology
Contact Person Name
Thomas Skripuletz
Site Name
Universitaet Leipzig
Department Name
Neurology
Contact Person Name
Florian Then Bergh
Site Name
Universitaetsmedizin Greifswald KöR
Department Name
Neurology
Contact Person Name
Matthias Grothe
Site Name
DKD HELIOS Klinik Wiesbaden GmbH
Department Name
Neurology
Contact Person Name
Ann-Sophie Lauenstein
Site Name
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
Department Name
Zentrum für Klinische Neurowissenschaften
Contact Person Name
Tjalf Ziemssen
Site Name
Universitaet Muenster
Department Name
Neurology
Contact Person Name
Luisa Klotz
Contact Person Email
luisa.klotz@ukmuenster.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Neurology
Contact Person Name
Markus Kowarik
Site Name
Universitaetsklinikum Ulm AöR (additional/contact entry)
Department Name
Neurology

Poland

Latest Decision Or Authorization Date
24-03-2026
Number Of Sites
14
Number Of Participants
155

Sites

Site Name
Instytut Psychiatrii I Neurologii
Department Name
II Klinika Neurologiczna
Principal Investigator Name
Iwona Kurkowska-Jastrzębska
Principal Investigator Email
neuro2@ipin.edu.pl
Contact Person Name
Iwona Kurkowska-Jastrzębska
Contact Person Email
neuro2@ipin.edu.pl
Site Name
Euromedis Sp. z o.o.
Department Name
Centrum Medyczne EUROMEDIS
Principal Investigator Name
Marcin Ratajczak
Principal Investigator Email
rejestracjabk@euromedis.pl
Contact Person Name
Marcin Ratajczak
Contact Person Email
rejestracjabk@euromedis.pl
Site Name
Copernicus Podmiot Leczniczy Sp. z o.o.
Principal Investigator Name
Waldemar Fryze
Principal Investigator Email
jlewandowska@wss.gda.pl
Contact Person Name
Waldemar Fryze
Contact Person Email
jlewandowska@wss.gda.pl
Site Name
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Specjalistyczny Nr 3 W Rybniku
Department Name
Oddział Neurologiczny z Pododdziałem Udarowym
Principal Investigator Name
Maciej Świat
Principal Investigator Email
sekretariat@szpital.rybnik.pl
Contact Person Name
Maciej Świat
Contact Person Email
sekretariat@szpital.rybnik.pl
Site Name
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. S.K.
Department Name
KLINIKA NEUROLOGII I MEDYCYNY REGENERACYJNEJ
Principal Investigator Name
Magdalena Boczarska-Jedynak
Principal Investigator Email
info@instytutboczarska.pl
Contact Person Name
Magdalena Boczarska-Jedynak
Contact Person Email
info@instytutboczarska.pl
Site Name
Indywidualna Praktyka Lekarska Prof. dr hab. n. med. Konrad Rejdak
Principal Investigator Name
Konrad Rejdak
Principal Investigator Email
indywidualnapraktykakr@gmail.com
Contact Person Name
Konrad Rejdak
Site Name
Szpital Specjalistyczny Im. Ludwika Rydygiera W Krakowie Sp. z o.o.
Department Name
Oddział Neurologii i Udarów Mózgu z Pododdziałem Udarów Mózgu
Principal Investigator Name
Stanisław Rusek
Principal Investigator Email
badaniakliniczne@rydygierkrakow.pl
Contact Person Name
Stanisław Rusek
Site Name
Ma-Lek Clinical Sp. z o.o.
Principal Investigator Name
Maciej Maciejowski
Principal Investigator Email
m.m@ctsm.pl
Contact Person Name
Maciej Maciejowski
Contact Person Email
m.m@ctsm.pl
Site Name
Centrum Medyczne Neuroprotect
Principal Investigator Name
Maciej Czarnecki
Principal Investigator Email
marta.biel@neuroprotect.pl
Contact Person Name
Maciej Czarnecki
Contact Person Email
marta.biel@neuroprotect.pl
Site Name
EMC Instytut Medyczny S.A.
Principal Investigator Name
Alicja Kalinowska-Łyszczarz
Principal Investigator Email
alicjakal@yahoo.com
Contact Person Name
Alicja Kalinowska-Łyszczarz
Contact Person Email
alicjakal@yahoo.com
Site Name
Nmedis Sp. z o.o.
Principal Investigator Name
Iwona Rościszewska-Żukowska
Principal Investigator Email
iwona.rosciszewska@op.pl
Contact Person Name
Iwona Rościszewska-Żukowska
Contact Person Email
iwona.rosciszewska@op.pl
Site Name
Neurocentrum Bydgoszcz Sp. z o.o.
Principal Investigator Name
Robert Bonek
Principal Investigator Email
rejestracja@ncbydgoszcz.pl
Contact Person Name
Robert Bonek
Contact Person Email
rejestracja@ncbydgoszcz.pl
Site Name
Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
Principal Investigator Name
Justyna Hryniewicz
Principal Investigator Email
j.dhryniewicz@gmail.com
Contact Person Name
Justyna Hryniewicz
Contact Person Email
j.dhryniewicz@gmail.com

Sponsor

Primary sponsor

Full Name
F. Hoffmann-La Roche AG
Organisation Type
Pharmaceutical company
Country Of Registered Address
Switzerland

Contract research organisations

Name
IQVIA RDS Hellas Single Member S.A.
Responsibilities
[{"id":1004049,"code":"1"}]
Name
IQVIA Limited
Responsibilities
[{"id":1004046,"code":"15","value":"Monitoring"}]
Name
PPD Development LP
Responsibilities
[{"id":1004052,"code":"4"}]
Name
Syneos Health Inc.
Responsibilities
[{"id":1004053,"code":"4"}]

Third parties

  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"[{\"id\":1004050,\"code\":\"3\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"[{\"id\":1004049,\"code\":\"1\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"[{\"id\":1004047,\"code\":\"15\",\"value\":\"Other Third Party Duty\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Denmark","full_name":"Unilabs A/S","duties_or_roles":"[{\"id\":1004044,\"code\":\"4\"}]","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"[{\"id\":1004055,\"code\":\"15\",\"value\":\"Study materials, patient materials\"}]","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"[{\"id\":1004056,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"[{\"id\":1004051,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Roland Henry Lab UCSF; UCSF Department of Neurology, Sandler Neurosciences Center","duties_or_roles":"[{\"id\":1004054,\"code\":\"15\",\"value\":\"Other Third Party Duty\"}]","organisation_type":"Health care"}
  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"[{\"id\":1004052,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"[{\"id\":1004048,\"code\":\"15\",\"value\":\"Other Third Party Duty\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"[{\"id\":1004053,\"code\":\"4\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"[{\"id\":1004045,\"code\":\"15\",\"value\":\"Study Material Supply\"}]","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"[{\"id\":1004046,\"code\":\"15\",\"value\":\"Monitoring\"}]","organisation_type":"Pharmaceutical company"}

Investigational products

Investigational Product Name
Ocrevus 300 mg concentrate for solution for infusion
Active Substance
OCRELIZUMAB
Modality
Monoclonal antibody
Routes Of Administration
INTRAVENOUS INFUSION
Route
Intravenous infusion
Authorisation Status
Authorised (marketing authorisation present: EU/1/17/1231)
Maximum Dose
1800 mg
Investigational Product Name
Placebo Ocrelizumab
Modality
Other
Authorisation Status
Not applicable

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