Clinical trial • Phase III • Neurology

OCRELIZUMAB for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Secondary progressive multiple sclerosis (active)

Phase III trial of OCRELIZUMAB for Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Secondary progressive multiple sclerosis (activ…

Overview

Trial Therapeutic Area
Neurology
Trial Disease
Relapsing multiple sclerosis | Relapsing-remitting multiple sclerosis | Secondary progressive multiple sclerosis (active)
Trial Stage
Phase III
Drug Modality
Monoclonal antibody

Key dates

Initial CTIS Submission Date
21-12-2023
First CTIS Authorization Date
08-02-2024

Trial design

Randomised, open-label, higher dose ocrelizumab versus approved dose ocrelizumab (control); placebo ocrelizumab also listed as placebo control. specific dosing regimens not specified in the ctis data provided (product listed as ocrevus 300 mg concentrate for solution for infusion). Phase III trial across 51 sites in Denmark, Poland, Belgium and others.

Randomised
Yes
Open Label
Yes
Comparator
Higher dose ocrelizumab versus approved dose ocrelizumab (control); placebo ocrelizumab also listed as placebo control. Specific dosing regimens not specified in the CTIS data provided (product listed as Ocrevus 300 mg concentrate for solution for infusion).
Target Sample Size
507
Trial Duration For Participant
1218

Eligibility

Recruits 507 Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms (ICFs) and specific ICFs are provided (including infant/pregnant partner/infant and other optional ICFs). Consent is obtained via subject information and informed consent forms available in multiple language versions (documents available in EN, FR, NL, GR, RU, PT, PL, ES, HU, DE, IT as per document list)..

Vulnerable Population
Vulnerable population selected (isVulnerablePopulationSelected = true). Subject information and informed consent forms (ICFs) and specific ICFs are provided (including infant/pregnant partner/infant and other optional ICFs). Consent is obtained via subject information and informed consent forms available in multiple language versions (documents available in EN, FR, NL, GR, RU, PT, PL, ES, HU, DE, IT as per document list).

Inclusion criteria

  • {"criterion_text":"- 1. Ages 18−55 years at time of screening\n- 2. Diagnosis of RMS (i.e., RRMS or aSPMS where patients still experience relapses) in accordance with the revised McDonald Criteria 2017\n- 3. At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening (with no relapse 30 days prior to screening and at baseline)\n- 4. Patients must be neurologically stable for at least 30 days prior to randomization and baseline assessments\n- 5. Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive\n- 6. Documented MRI of brain with abnormalities consistent with MS"}

Exclusion criteria

  • {"criterion_text":"- 1. History of primary progressive MS at screening\n- 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\n- 3. History of confirmed or suspected progressive multifocal leukoencephalopathy (PML)\n- 4. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening\n- 5. Immunocompromised state\n- 6. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study"}

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 is 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)\n- 2. Time to onset of 48-week cCDP (cCDP48)\n- 3. 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\n- 4. Time to ≥ 20% increase in 12 week confirmed T25FWT\n- 5. Time to ≥ 20% increase in 24 week confirmed T25FWT\n- 6. Annual rate of percent change from baseline in total brain volume\n- 7. Time to 12-week confirmed 4-point worsening in Symbol Digit Modalities test (SDMT)\n- 8. Time to 12-week confirmed 8-point increase in 12-Item Multiple Sclerosis Walking Scale (MSWS-12)\n- 9. Change in NfL (i.e. ratio to baseline) at Week 48 for patients assigned to the higher dose ocrelizumab group\n- 10. Change in NfL (i.e ratio to baseline) at Week 48 for patients assigned to the approved dose ocrelizumab group\n- 11. 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\n- 12. Change from baseline in clinical laboratory test results (including hematology, chemistry, and Ig levels)\n- 13. Change from baseline in vital signs (including systolic and diastolic blood pressure, and pulse rate) following study treatment administration\n- 14. Serum concentration of ocrelizumab at specified timepoints\n- 15. B-cell levels in blood (including comparing the degree of B-cell depletion between the doses)\n- 16. Proportion of participant achieving 5 or less B-cells per microliter of blood\n- 17. 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\n- 18. Change from Baseline in the anti-drug antibodies (ADAs) levels\n- 19. Levels of Neurofilament Light Chain (NfL) in blood\n- 20. Levels of interleukin-6 (IL-6) in blood\n- 21. Levels of blood B cells\n- 22. Levels of Lymphocytes in blood\n- 23. Proportion of participants with different DNA genotypes","definition_or_measurement_approach":""}

Recruitment

Planned Sample Size
507
Recruitment Window Months
93
Consent Approach
Informed consent obtained using subject information and informed consent forms (ICFs). Multiple ICFs and addenda are provided (Main ICF, RBR ICF, MRI ICF, Optional CSF Substudy ICF, OLE ICF, COVID-19 addenda, genetic ICF, infant/pregnant partner ICFs, etc.). Documents available in multiple languages (EN, FR, NL, GR, RU, PT, PL, ES, HU, DE, IT as per document list). For infants/pregnant participants specific information/consent documents are available.

Geography

Total Number Of Sites
51
Total Number Of Participants
357

Denmark

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
25-03-2025
Processing Time Days
432
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
Rigshospitalet
Department Name
Neurologisk Klinik
Principal Investigator Name
Finn Sellebjerg
Principal Investigator Email
finn.thorup.sellebjerg@regionh.dk
Contact Person Name
Finn Sellebjerg

Poland

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
31-03-2025
Processing Time Days
438
Number Of Sites
13
Number Of Participants
183

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
Copernicus Podmiot Leczniczy Sp. z o.o.
Department Name
Oddział Neurologiczny
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
Uniwersytecki Szpital Kliniczny Nr 1 Im Norberta Barlickiego Uniwersytetu Medycznego W Lodzi SPZOZ
Department Name
Oddział Kliniczny Neurologii
Principal Investigator Name
Mariusz Stasiołek
Principal Investigator Email
oddzial.neurologii@barlicki.pl
Contact Person Name
Mariusz Stasiołek
Contact Person Email
oddzial.neurologii@barlicki.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
Centrum Neurologii Krzysztof Selmaj
Principal Investigator Name
Krzysztof Selmaj
Principal Investigator Email
centrum.neurologii.k.selmaj@gmail.com
Contact Person Name
Krzysztof Selmaj
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
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Department Name
Klinika Neurologii
Principal Investigator Name
Anna Kostera-Pruszczyk
Principal Investigator Email
kn.csk@uck.wum.pl
Contact Person Name
Anna Kostera-Pruszczyk
Contact Person Email
kn.csk@uck.wum.pl
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
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
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
Euromedis Sp. z o.o.
Principal Investigator Name
Marcin Ratajczak
Principal Investigator Email
rejestracjabk@euromedis.pl
Contact Person Name
Marcin Ratajczak
Contact Person Email
rejestracjabk@euromedis.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

Belgium

Earliest CTIS Part Ii Submission Date
18-03-2024
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
371
Number Of Sites
2
Number Of Participants
8

Sites

Site Name
Hopital Erasme
Department Name
Neurology
Principal Investigator Name
Sophie Elands
Principal Investigator Email
sophie.elands@hubruxelles.be
Contact Person Name
Sophie Elands
Contact Person Email
sophie.elands@hubruxelles.be
Site Name
Noorderhart
Department Name
Revalidatie en MS Centrum
Principal Investigator Name
Veronica Popescu
Principal Investigator Email
veronica.popescu@noorderhart.be
Contact Person Name
Veronica Popescu

Portugal

Earliest CTIS Part Ii Submission Date
19-02-2024
Latest Decision Or Authorization Date
24-03-2025
Processing Time Days
399
Number Of Sites
4
Number Of Participants
10

Sites

Site Name
Centro Hospitalar De Lisboa Ocidental E.P.E.
Department Name
Serviço de Neurologia
Principal Investigator Name
Manuel Salavisa
Principal Investigator Email
mtteixeira@chlo.min-saude.pt
Contact Person Name
Manuel Salavisa
Contact Person Email
mtteixeira@chlo.min-saude.pt
Site Name
Hospital Beatriz Angelo
Department Name
Neurologia - HBA
Principal Investigator Name
José Vale
Principal Investigator Email
jose.santos2@hbeatrizangelo.pt
Contact Person Name
José Vale
Contact Person Email
jose.santos2@hbeatrizangelo.pt
Site Name
CCAB Centro Clinico Academico Braga Associacao
Department Name
Unidade de Investigação Clínica
Principal Investigator Name
João Cerqueira
Principal Investigator Email
jcerqueira@ecsaude.uminho.pt
Contact Person Name
João Cerqueira
Contact Person Email
jcerqueira@ecsaude.uminho.pt
Site Name
Centro Hospitalar Universitario De Lisboa Norte E.P.E.
Department Name
Serviço de Neurologia
Principal Investigator Name
João Ferreira
Principal Investigator Email
jnuno.d.ferreira@gmail.com
Contact Person Name
João Ferreira
Contact Person Email
jnuno.d.ferreira@gmail.com

France

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
27-03-2025
Processing Time Days
434
Number Of Sites
4
Number Of Participants
6

Sites

Site Name
Centre Hospitalier Universitaire De Bordeaux
Department Name
Neurology
Principal Investigator Name
Aurélie Ruet
Principal Investigator Email
aurelie.ruet@chu-bordeaux.fr
Contact Person Name
Aurélie Ruet
Contact Person Email
aurelie.ruet@chu-bordeaux.fr
Site Name
Groupement Des Hopitaux De L'Institut Catholique De Lille
Department Name
Neurology
Principal Investigator Name
Arnaud kwiatkowski
Principal Investigator Email
kwiatkowski.arnaud@ghicl.net
Contact Person Name
Arnaud kwiatkowski
Contact Person Email
kwiatkowski.arnaud@ghicl.net
Site Name
CHU Gabriel-Montpied
Department Name
Neurology
Principal Investigator Name
Pierre Clavenou
Principal Investigator Email
pclavelou@chu-clermontferrand.fr
Contact Person Name
Pierre Clavenou
Site Name
CHU De Rouen
Department Name
Neurology
Principal Investigator Name
Bertrand Bourre
Principal Investigator Email
bertrand.bourre@chu-rouen.fr
Contact Person Name
Bertrand Bourre
Contact Person Email
bertrand.bourre@chu-rouen.fr

Greece

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
28-03-2025
Processing Time Days
435
Number Of Sites
1
Number Of Participants
3

Sites

Site Name
401 General Military Hospital Of Athens
Department Name
Neurology Clinic
Principal Investigator Name
Nikolaos Fakas
Principal Investigator Email
drfakas@yahoo.gr
Contact Person Name
Nikolaos Fakas
Contact Person Email
drfakas@yahoo.gr

Germany

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
18-06-2025
Processing Time Days
517
Number Of Sites
8
Number Of Participants
47

Sites

Site Name
Universitaetsklinikum Schleswig-Holstein
Department Name
Klinik für Neurologie
Principal Investigator Name
Klarissa Stürner
Principal Investigator Email
Klarissa.Stuerner@uksh.de
Contact Person Name
Klarissa Stürner
Contact Person Email
Klarissa.Stuerner@uksh.de
Site Name
DKD HELIOS Klinik Wiesbaden GmbH
Department Name
Neurologie
Principal Investigator Name
Ann-Sophie Lauenstein
Principal Investigator Email
ann-sophie.lauenstein@helios-gesundheit.de
Contact Person Name
Ann-Sophie Lauenstein
Site Name
St. Josef-Hospital
Department Name
Klinik für Neurologie
Principal Investigator Name
Simon Faissner
Principal Investigator Email
Simon.Faissner@ruhr-uni-bochum.de
Contact Person Name
Simon Faissner
Site Name
Universitaetsklinikum Ulm AöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Makbule Senel
Principal Investigator Email
makbule.senel@uni-ulm.de
Contact Person Name
Makbule Senel
Contact Person Email
makbule.senel@uni-ulm.de
Site Name
Universitaetsklinikum Tuebingen AöR
Department Name
Zentrum für Neurologie
Principal Investigator Name
Markus Kowarik
Principal Investigator Email
markus.kowarik@med.uni-tuebingen.de
Contact Person Name
Markus Kowarik
Site Name
Charite Universitaetsmedizin Berlin KöR
Department Name
Klinik für Neurologie
Principal Investigator Name
Carolin Otto
Principal Investigator Email
carolin.otto@charite.de
Contact Person Name
Carolin Otto
Contact Person Email
carolin.otto@charite.de
Site Name
Universitaet Leipzig
Department Name
Neurologie
Principal Investigator Name
Florian Then Bergh
Principal Investigator Email
Florian.ThenBergh@medizin.uni-leipzig.de
Contact Person Name
Florian Then Bergh
Site Name
Technische Universitat Dresden
Department Name
Zentrum für klinische Neurowissenschaften
Principal Investigator Name
Tjalf Ziemssen
Principal Investigator Email
tjalf.ziemssen@uniklinikum-dresden.de
Contact Person Name
Tjalf Ziemssen

Hungary

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
29-10-2025
Processing Time Days
650
Number Of Sites
3
Number Of Participants
21

Sites

Site Name
Uno Medical Trials Kft.
Department Name
Neurologia
Principal Investigator Name
Krisztina Kovacs
Principal Investigator Email
kovacs.krisztina@otvkft.hu
Contact Person Name
Krisztina Kovacs
Contact Person Email
kovacs.krisztina@otvkft.hu
Site Name
Somogy Varmegyei Kaposi Mor Oktato Korhaz
Department Name
Neurologiai Osztaly
Principal Investigator Name
Istvan Deme
Principal Investigator Email
deme.istvan@kmmk.hu
Contact Person Name
Istvan Deme
Contact Person Email
deme.istvan@kmmk.hu
Site Name
S-Medicon Kft.
Department Name
Neurologia
Principal Investigator Name
Maria Satori
Principal Investigator Email
satori.maria@gmail.com
Contact Person Name
Maria Satori
Contact Person Email
satori.maria@gmail.com

Italy

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
17-11-2025
Processing Time Days
669
Number Of Sites
8
Number Of Participants
33

Sites

Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
II Clinica Neurologica
Principal Investigator Name
Elisabetta Signoriello
Principal Investigator Email
elisabetta.signoriello@gmail.com
Contact Person Name
Elisabetta Signoriello
Site Name
Neurological Centre Of Latium Istituto Di Neuroscienze O In Breve N.C.L. Istituto Di Neuroscienze S.r.l.
Department Name
Centro sperimentazioni cliniche di NCL
Principal Investigator Name
Carlo Pozzilli
Principal Investigator Email
carlo.pozzilli@uniroma1.it
Contact Person Name
Carlo Pozzilli
Contact Person Email
carlo.pozzilli@uniroma1.it
Site Name
IRCCS Foundation Istituto Neurologico Carlo Besta
Department Name
UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Principal Investigator Name
Laura Brambilla
Principal Investigator Email
laura.brambilla@istituto-besta.it
Contact Person Name
Laura Brambilla
Site Name
Istituto Neurologico Mediterraneo Neuromed S.p.A.
Department Name
Dipartimento di Neurologia
Principal Investigator Name
Diego Centonze
Principal Investigator Email
centonze@uniroma2.it
Contact Person Name
Diego Centonze
Contact Person Email
centonze@uniroma2.it
Site Name
Azienda Ospedaliero-Universitaria Policlinico Umberto I
Department Name
Dipartimento di Neuroscienze Umane
Principal Investigator Name
Antonella Conte
Principal Investigator Email
antonella.conte@uniroma1.it
Contact Person Name
Antonella Conte
Contact Person Email
antonella.conte@uniroma1.it
Site Name
Azienda Ospedaliera Policlinico Universitario Tor Vergata
Department Name
UOSD Sclerosi Multipla
Principal Investigator Name
Girolama Marfia
Principal Investigator Email
marfia@uniroma2.it
Contact Person Name
Girolama Marfia
Contact Person Email
marfia@uniroma2.it
Site Name
Universita' Degli Studi G. D'annunzio Di Chieti
Department Name
Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
Principal Investigator Name
Valentina Tomassini
Principal Investigator Email
valentina.tomassini@unich.it
Contact Person Name
Valentina Tomassini
Contact Person Email
valentina.tomassini@unich.it
Site Name
Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Department Name
I Clinica Neurologica
Principal Investigator Name
Antonio Gallo
Principal Investigator Email
antonio.gallo@unicampania.it
Contact Person Name
Antonio Gallo
Contact Person Email
antonio.gallo@unicampania.it

Spain

Earliest CTIS Part Ii Submission Date
18-01-2024
Latest Decision Or Authorization Date
11-05-2026
Processing Time Days
844
Number Of Sites
7
Number Of Participants
43

Sites

Site Name
Hospital Alvaro Cunqueiro
Department Name
Neurologia
Principal Investigator Name
Inés González Suárez
Principal Investigator Email
Ines.Maria.Gonzalez.Suarez@sergas.es
Contact Person Name
Inés González Suárez
Site Name
Hospital Universitario Puerta Del Mar
Department Name
Neurologia
Principal Investigator Name
Raul Espinosa Rosso
Principal Investigator Email
r.espinosarosso@hotmail.com
Contact Person Name
Raul Espinosa Rosso
Contact Person Email
r.espinosarosso@hotmail.com
Site Name
Hospital Universitario Quironsalud Madrid
Department Name
Neurologia
Principal Investigator Name
Rafael Arroyo González
Principal Investigator Email
rafaelarroyo09@gmail.com
Contact Person Name
Rafael Arroyo González
Contact Person Email
rafaelarroyo09@gmail.com
Site Name
Hospital Universitario Regional De Malaga
Department Name
Neurologia
Principal Investigator Name
Ana maría Alonso Torres
Principal Investigator Email
a.alonso.eecc@gmail.com
Contact Person Name
Ana maría Alonso Torres
Contact Person Email
a.alonso.eecc@gmail.com
Site Name
Hospital Universitari Vall D Hebron
Department Name
Neurologia
Principal Investigator Name
Mar Tintoré Subirana
Principal Investigator Email
mtintore@cem-cat.org
Contact Person Name
Mar Tintoré Subirana
Contact Person Email
mtintore@cem-cat.org
Site Name
Complexo Hospitalario Universitario A Coruna
Department Name
Neurologia
Principal Investigator Name
Ana López Real
Principal Investigator Email
Ana.maria.Lopez.Real@sergas.es
Contact Person Name
Ana López Real
Contact Person Email
Ana.maria.Lopez.Real@sergas.es
Site Name
Hospital Universitario Puerta Del Mar (additional site listed)
Department Name
Neurologia

Sponsor

Primary sponsor

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

Contract research organisations

Name
PPD Development LP
Responsibilities
code: 4
Name
IQVIA Limited
Responsibilities
Monitoring
Name
Syneos Health Inc.
Responsibilities
code: 4

Third parties

  • {"country":"United States","full_name":"PPD Development LP","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"Denmark","full_name":"Unilabs A/S","duties_or_roles":"code: 4","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"United Kingdom","full_name":"IQVIA Limited","duties_or_roles":"Monitoring","organisation_type":"Pharmaceutical company"}
  • {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"Study Material Supply","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Other Third Party Duty","organisation_type":"Pharmaceutical company"}
  • {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United States","full_name":"Syneos Health Inc.","duties_or_roles":"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":"code: 4","organisation_type":"Industry"}
  • {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"Other Third Party Duty","organisation_type":"Laboratory/Research/Testing facility"}
  • {"country":"Greece","full_name":"IQVIA RDS Hellas Single Member S.A.","duties_or_roles":"code: 1","organisation_type":"Non-Pharmaceutical company"}
  • {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"code: 4","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom (Northern Ireland)","full_name":"Almac Group Limited","duties_or_roles":"code: 3","organisation_type":"Pharmaceutical company"}
  • {"country":"United Kingdom","full_name":"Publicis Healthcare Communications Group Limited","duties_or_roles":"Study Material, Patient Material","organisation_type":"Non-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 (EU/1/17/1231/002)
Maximum Dose
1800 mg (max daily); 23.4 g (max total)
Investigational Product Name
Placebo ocrelizumab
Modality
Other

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