Clinical trial • Phase III • Neurology|Immunology
OCRELIZUMAB for Primary progressive multiple sclerosis
Phase III trial of OCRELIZUMAB for Primary progressive multiple sclerosis.
Overview
- Trial Therapeutic Area
- Neurology|Immunology
- Trial Disease
- Primary progressive multiple sclerosis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 12-12-2023
- First CTIS Authorization Date
- 31-01-2024
Trial design
Randomised, arm a: ocrelizumab (ocrevus 300 mg concentrate for solution for infusion; intravenous infusion; specific dosing schedule not specified in the available data). arm b: placebo (placebo ocrevus).-controlled Phase III trial in France, Italy, Romania and others.
- Randomised
- Yes
- Comparator
- Arm A: Ocrelizumab (Ocrevus 300 mg concentrate for solution for infusion; intravenous infusion; specific dosing schedule not specified in the available data). Arm B: Placebo (Placebo Ocrevus).
- Target Sample Size
- 637
- Trial Duration For Participant
- 1008
Eligibility
Recruits 637 Vulnerable population selected. Subject information and informed consent forms include infant/infant-health and pregnancy-related authorization forms (e.g. L1_WA40404_Infant-Health_ICF and Pregnancy Outcome ICF documents). Informed consent is obtained using subject information and ICFs provided in multiple languages; infant authorization forms are provided for infant assessments..
- Vulnerable Population
- Vulnerable population selected. Subject information and informed consent forms include infant/infant-health and pregnancy-related authorization forms (e.g. L1_WA40404_Infant-Health_ICF and Pregnancy Outcome ICF documents). Informed consent is obtained using subject information and ICFs provided in multiple languages; infant authorization forms are provided for infant assessments.
Inclusion criteria
- {"criterion_text":"- 1. Diagnosis of PPMS in accordance with the McDonald criteria (Thompson et al. 2017)\n- 2. EDSS score at screening and baseline ≥ 3.0 to 8.0, inclusive\n- 3. Disease duration from the onset of multiple sclerosis (MS) symptoms relative to randomization date: o Less than 20 years in patients with an EDSS score at screening 7.0-8.0 o Less than 15 years in patients with an EDSS at screening 5.5-6.5 o Less than 10 years in patients with an EDSS at screening ≤ 5.0\n- 4. Documented history or presence at screening of at least one of the following laboratory findings in a cerebrospinal fluid specimen o Elevated IgG index o One or more IgG oligoclonal bands detected by isoelectric focusing\n- 5. Screening and baseline 9-HPT completed in > 25 seconds (average of the two hands)\n- 6. Neurological stability for ≥ 30 days prior to baseline"}
Exclusion criteria
- {"criterion_text":"- 1. History of relapsing-remitting or secondary progressive MS at screening\n- 2. Confirmed serious opportunistic infection\n- 3. Patients who have or have had confirmed or a high degree of suspicion of progressive multifocal leukoencephalopathy\n- 4. Known active malignancy or are being actively monitored for recurrence of malignancy\n- 5. Immunocompromised state defined as one or more of the following: CD4 count < 250/μL, absolute neutrophil count <1.5 x 103/μL, Serum IgG < 4.6 g/L\n- 6. Receipt of a live-attenuated vaccine within 6 weeks prior to randomization"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Time to onset of composite 12-week CDP defined as the time from randomization to the first occurrence of either 12-week CDP in 9-HPT, or 12-week CDP in EDSS","definition_or_measurement_approach":"Composite 12-week confirmed disability progression (CDP): time from randomization to first occurrence of at least one of: 12-week CDP in 9-HPT (defined as a 20% worsening from baseline in 9-HPT confirmed for at least 12 weeks) OR 12-week CDP in EDSS (defined as an increase of ≥1.0 point from baseline EDSS in patients with baseline EDSS ≤5.5, or an increase of ≥0.5 point in patients with baseline EDSS >5.5, confirmed for at least 12 weeks). MRI activity subgroup defined as presence of T1 Gd+ lesion(s) and/or new/enlarging T2 lesion(s) during screening."}
Secondary endpoints
- {"endpoint_text":"- 1. Time to 12-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 12 weeks","definition_or_measurement_approach":"Pre-defined increase in EDSS score confirmed for at least 12 weeks (see primary endpoint EDSS definition)."}
- {"endpoint_text":"- 2. Time to 24-week CDP in 9-HPT","definition_or_measurement_approach":"Time to 24-week confirmed disability progression in 9-HPT (24-week confirmation)."}
- {"endpoint_text":"- 3. Time to 24-week CDP in EDSS, as a pre-defined increase in EDSS score confirmed for at least 24 weeks","definition_or_measurement_approach":"Pre-defined increase in EDSS score confirmed for at least 24 weeks."}
- {"endpoint_text":"- 4. Annual rate of percent change from baseline in total volume of T2 lesions","definition_or_measurement_approach":"Annual rate of percent change from baseline in total T2 lesion volume measured by MRI."}
- {"endpoint_text":"- 5. Annual rate of percent change from Week 24 in total brain volume","definition_or_measurement_approach":"Annual rate of percent change in total brain volume using MRI, referenced from Week 24."}
- {"endpoint_text":"- 6. Incidence and nature of adverse events, serious adverse events, adverse events leading to study treatment withdrawal","definition_or_measurement_approach":"Safety assessed by proportion and characterization of adverse events (AEs), serious adverse events (SAEs), and AEs leading to treatment withdrawal."}
- {"endpoint_text":"- 7. Change from baseline in laboratory test results for hematology and chemistry association of decrease in certain laboratory parameters, and serious infections","definition_or_measurement_approach":"Change from baseline for hematology and chemistry parameters; monitoring for decreases in specified laboratory values and occurrence of serious infections."}
- {"endpoint_text":"- 8. Presence of ADA during the study relative to baseline","definition_or_measurement_approach":"Detection of anti-drug antibodies (ADA) relative to baseline."}
- {"endpoint_text":"- 9. Total plasma clearances (CL) of ocrelizumab","definition_or_measurement_approach":"Pharmacokinetic measurement: total plasma clearance (CL) of ocrelizumab."}
- {"endpoint_text":"- 10. Volumes of distribution(Vd) of ocrelizumab","definition_or_measurement_approach":"Pharmacokinetic measurement: volume(s) of distribution (Vd) for ocrelizumab."}
- {"endpoint_text":"- 11. Area under the concentration-time curve (AUC) of ocrelizumab","definition_or_measurement_approach":"Pharmacokinetic measurement: AUC (area under the concentration-time curve) for ocrelizumab."}
Recruitment
- Digital Remote Recruitment
- Yes
- Planned Sample Size
- 637
- Recruitment Window Months
- 130
- Consent Approach
- Informed consent obtained via subject information and ICF documents (Main ICF and optional/addenda) provided in multiple languages (examples in the public documents: English, Spanish, French, Portuguese, Italian, Polish, Croatian, Bulgarian, Romanian, Dutch, Russian, Ukrainian). Infant authorization and pregnancy outcome ICFs are provided for infant and pregnancy-related assessments. Consent is obtained from adult participants using these language-specific ICFs; infant authorization forms are provided where infant assessments are involved.
Methods
- Patient outreach letter — patient-facing letters used for recruitment; country-specific versions available (e.g. ES, IT, PT, HR, BE, RO, PL, FR, BG).
- Posters — study posters for site-based recruitment (country-specific versions available).
- Study-specific brochures and brochure stickers — printed materials for patients and HCPs (country-specific).
- Physician referral communication / GP cover letters — materials to engage and inform referring physicians / GPs (country-specific).
- Site guidance and study-specific presentations — materials for site staff to support recruitment and retention.
- Mini social media toolkit (HCP-facing) — digital/HCP-targeted social media materials to support awareness among healthcare professionals.
- Study guide / handy reference cards / scientific slide decks — educational materials used at sites to facilitate recruitment discussions.
Geography
- Total Number Of Sites
- 62
- Total Number Of Participants
- 363
France
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 774
- Number Of Sites
- 8
- Number Of Participants
- 12
Sites
- Site Name
- University Hospital Of Clermont-Ferrand
- Department Name
- Service de Neurologie
- Principal Investigator Name
- Pierre CLAVELOU
- Principal Investigator Email
- pclavelou@chu-clermontferrand.fr
- Contact Person Name
- Pierre CLAVELOU
- Contact Person Email
- pclavelou@chu-clermontferrand.fr
- Site Name
- CHRU De Nancy
- Department Name
- Neurology Department
- Principal Investigator Name
- Guillaume Mathey
- Principal Investigator Email
- g.mathey@chu-nancy.fr
- Contact Person Name
- Guillaume Mathey
- Contact Person Email
- g.mathey@chu-nancy.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Centre d’Investigation clinique
- Principal Investigator Name
- Jérôme DE SEZE
- Principal Investigator Email
- jerome.de.seze@chru-strasbourg.fr
- Contact Person Name
- Jérôme DE SEZE
- Contact Person Email
- jerome.de.seze@chru-strasbourg.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Neurology Department
- Principal Investigator Name
- David Laplaud
- Principal Investigator Email
- david.laplaud@chu-nantes.fr
- Contact Person Name
- David Laplaud
- Contact Person Email
- david.laplaud@chu-nantes.fr
- Site Name
- Hospices Civils De Lyon
- Department Name
- Service de Neurologie - sclérose en plaques, pathologie de la myéline et neuroinflammation
- Principal Investigator Name
- Sandra Vukusic
- Principal Investigator Email
- sandra.vukusic@chu-lyon.fr
- Contact Person Name
- Sandra Vukusic
- Contact Person Email
- sandra.vukusic@chu-lyon.fr
- Site Name
- Pellegrin Hospital
- Department Name
- Neurology Department
- 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
- Centre Hospitalier Universitaire De Nimes
- Department Name
- Neurology Department
- Principal Investigator Name
- Giovanni Castelnovo
- Principal Investigator Email
- giovanni.castelnovo@chu-nimes.fr
- Contact Person Name
- Giovanni Castelnovo
- Contact Person Email
- giovanni.castelnovo@chu-nimes.fr
- Site Name
- Assistance Publique Hopitaux De Marseille
- Department Name
- Neurology Department
- Principal Investigator Name
- Jean Pelletier
- Principal Investigator Email
- jean.pelletier@ap-hm.fr
- Contact Person Name
- Jean Pelletier
- Contact Person Email
- jean.pelletier@ap-hm.fr
Italy
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 773
- Number Of Sites
- 8
- Number Of Participants
- 45
Sites
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Centro Regionale Sclerosi Multipla (CRESM)
- Principal Investigator Name
- Simona Malucchi
- Principal Investigator Email
- simona.malucchi@gmail.com
- Contact Person Name
- Simona Malucchi
- Contact Person Email
- simona.malucchi@gmail.com
- Site Name
- Fondazione Istituto G. Giglio Di Cafalu
- Department Name
- Unità Operativa Neurologia
- Principal Investigator Name
- Luigi Grimaldi
- Principal Investigator Email
- luigi.grimaldi@hsrgiglio.it
- Contact Person Name
- Luigi Grimaldi
- Contact Person Email
- luigi.grimaldi@hsrgiglio.it
- Site Name
- Neurological Institute Foundation Casimiro Mondino
- Department Name
- Centro Sclerosi Multipla
- Principal Investigator Name
- Roberto Bergamaschi
- Principal Investigator Email
- roberto.bergamaschi@mondino.it
- Contact Person Name
- Roberto Bergamaschi
- Contact Person Email
- roberto.bergamaschi@mondino.it
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Dipartimento di Neurologia
- Principal Investigator Name
- Massimo Filippi
- Principal Investigator Email
- filippi.massimo@hsr.it
- Contact Person Name
- Massimo Filippi
- Contact Person Email
- filippi.massimo@hsr.it
- Site Name
- Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
- Department Name
- Centro Sclerosi Multipla
- Principal Investigator Name
- Elisabetta Signoriello
- Principal Investigator Email
- elisabetta.signoriello@gmail.com
- Contact Person Name
- Elisabetta Signoriello
- Contact Person Email
- elisabetta.signoriello@gmail.com
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Dip_Neuroscienze, Riabilitazione,Oftalmologia, Genetica_Scienze Materno-infantili_AOU S Martino
- Principal Investigator Name
- Matilde Inglese
- Principal Investigator Email
- m.inglese@unige.it
- Contact Person Name
- Matilde Inglese
- Contact Person Email
- m.inglese@unige.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- Unità Operativa di Neurologia
- Principal Investigator Name
- Giovanni Ristori
- Principal Investigator Email
- giovanni.ristori@uniroma1.it
- Contact Person Name
- Giovanni Ristori
- Contact Person Email
- giovanni.ristori@uniroma1.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- Dipartimento di Medicina dei Sistemi UOSD Centro di riferimento regionale per la SM
- Principal Investigator Name
- Girolama Alessandra Marfia
- Principal Investigator Email
- marfia@med.uniroma2.it
- Contact Person Name
- Girolama Alessandra Marfia
- Contact Person Email
- marfia@med.uniroma2.it
Romania
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 774
- Number Of Sites
- 4
- Number Of Participants
- 17
Sites
- Site Name
- Spitalul Judetean De Urgenta Deva
- Department Name
- Neurology
- Principal Investigator Name
- Cecilia-Laura Albu
- Principal Investigator Email
- albu.cecilia@yahoo.com
- Contact Person Name
- Cecilia-Laura Albu
- Contact Person Email
- albu.cecilia@yahoo.com
- Site Name
- Spitalul Clinic Cai Ferate Constanta
- Department Name
- Neurology
- Principal Investigator Name
- Ana-Maria Ionescu
- Principal Investigator Email
- anaiulius@yahoo.com
- Contact Person Name
- Ana-Maria Ionescu
- Contact Person Email
- anaiulius@yahoo.com
- Site Name
- Spitalul Clinic Judetean De Urgenta Targu Mures
- Department Name
- Neurology
- Principal Investigator Name
- Rodica-Ioana Balasa
- Principal Investigator Email
- rodica.balasa@umfst.ro
- Contact Person Name
- Rodica-Ioana Balasa
- Contact Person Email
- rodica.balasa@umfst.ro
- Site Name
- Clubul Sanatatii S.R.L.
- Department Name
- Neurology
- Principal Investigator Name
- Emilian-Silviu Manescu
- Principal Investigator Email
- clubul.sanatatii@yahoo.com
- Contact Person Name
- Emilian-Silviu Manescu
- Contact Person Email
- clubul.sanatatii@yahoo.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 774
- Number Of Sites
- 3
- Number Of Participants
- 18
Sites
- Site Name
- Multiprofile Hospital For Active Treatment Avis Medika OOD
- Department Name
- Department of neurological diseases
- Principal Investigator Name
- Hristo Lilovski
- Principal Investigator Email
- hristolilovski@gmail.com
- Contact Person Name
- Hristo Lilovski
- Contact Person Email
- hristolilovski@gmail.com
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Clinic of Neurological Diseases for Movement Disorders
- Principal Investigator Name
- Ivan Milanov
- Principal Investigator Email
- ubalnp@yahoo.com
- Contact Person Name
- Ivan Milanov
- Contact Person Email
- ubalnp@yahoo.com
- Site Name
- Military Medical Academy
- Department Name
- Department of Neurological Diseases
- Principal Investigator Name
- Plamen Tsvetanov
- Principal Investigator Email
- tzvetanovplamen@hotmail.com
- Contact Person Name
- Plamen Tsvetanov
- Contact Person Email
- tzvetanovplamen@hotmail.com
Portugal
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 773
- Number Of Sites
- 5
- Number Of Participants
- 15
Sites
- Site Name
- CNS Saude Lda.
- Department Name
- Campus Neurológico Sénior
- Principal Investigator Name
- Joaquim Ferreira
- Principal Investigator Email
- joaquimjferreira@gmail.com
- Contact Person Name
- Joaquim Ferreira
- Contact Person Email
- joaquimjferreira@gmail.com
- Site Name
- Unidade Local De Saude De Santo Antonio E.P.E.
- Department Name
- Neurology
- Principal Investigator Name
- Ernestina Santos
- Principal Investigator Email
- ernestina.santos@gmail.com
- Contact Person Name
- Ernestina Santos
- Contact Person Email
- ernestina.santos@gmail.com
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Neurology
- Principal Investigator Name
- João Cerqueira
- Principal Investigator Email
- jcerqueira@med.uminho.pt
- Contact Person Name
- João Cerqueira
- Contact Person Email
- jcerqueira@med.uminho.pt
- Site Name
- Unidade Local De Saude De Loures-Odivelas EPE
- Department Name
- Neurology
- Principal Investigator Name
- José Vale
- Principal Investigator Email
- josevale.neuro@gmail.com
- Contact Person Name
- José Vale
- Contact Person Email
- josevale.neuro@gmail.com
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Neurology
- Principal Investigator Name
- Irene Mendes
- Principal Investigator Email
- maria.irene.mendes@hgo.min-saude.pt
- Contact Person Name
- Irene Mendes
- Contact Person Email
- maria.irene.mendes@hgo.min-saude.pt
Poland
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 773
- Number Of Sites
- 17
- Number Of Participants
- 195
Sites
- Site Name
- MCBK Iwona Czajkowska Anna Podrażka- Szczepaniak s.c.
- Principal Investigator Name
- Marzena Tomaszewska
- Principal Investigator Email
- mt@mcbk.pl
- Contact Person Name
- Marzena Tomaszewska
- Contact Person Email
- mt@mcbk.pl
- Site Name
- Samodzielny Publiczny Zaklad Opieki Zdrowotnej Wojewodzki Szpital Specjalistyczny Nr 3 W Rybniku
- Department Name
- Oddział Neurologii z Pododdziałem Udarowym
- Principal Investigator Name
- Maciej Świat
- Principal Investigator Email
- mswiat@szpital.rybnik.pl
- Contact Person Name
- Maciej Świat
- Contact Person Email
- mswiat@szpital.rybnik.pl
- Site Name
- Szpital Uniwersytecki w Krakowie
- Department Name
- Zespół Poradni Specjalistycznych Botaniczna 3, Poradnia Neurologiczna
- Principal Investigator Name
- Agnieszka Słowik
- Principal Investigator Email
- neurologiabk@su.krakow.pl
- Contact Person Name
- Agnieszka Słowik
- Contact Person Email
- neurologiabk@su.krakow.pl
- Site Name
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Department Name
- Szpital im. M. Kopernika, Oddział Neurologiczny
- Principal Investigator Name
- Waldemar Fryze
- Principal Investigator Email
- sekretariat.neurologia.kopernik@copernicus.gda.pl
- Contact Person Name
- Waldemar Fryze
- Contact Person Email
- sekretariat.neurologia.kopernik@copernicus.gda.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
- Contact Person Email
- indywidualnapraktykakr@gmail.com
- Site Name
- EMC Instytut Medyczny S.A.
- Principal Investigator Name
- Monika Susz-Kołodyńska
- Principal Investigator Email
- jasuszka@poczta.onet.pl
- Contact Person Name
- Monika Susz-Kołodyńska
- Contact Person Email
- jasuszka@poczta.onet.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
- Med Polonia Sp. z o.o.
- Principal Investigator Name
- Karolina Piasecka-Stryczyńska
- Principal Investigator Email
- badania.kliniczne@medpolonia.pl
- Contact Person Name
- Karolina Piasecka-Stryczyńska
- Contact Person Email
- badania.kliniczne@medpolonia.pl
- Site Name
- Uniwersytecki Szpital Kliniczny W Bialymstoku
- Department Name
- Klinika Neurologii
- Principal Investigator Name
- Alina Kułakowska
- Principal Investigator Email
- alina.kulakowska@umb.edu.pl
- Contact Person Name
- Alina Kułakowska
- Contact Person Email
- alina.kulakowska@umb.edu.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
- Resmedica Sp. z o.o.
- Department Name
- Poradnia Neurologiczna
- Principal Investigator Name
- Elżbieta Jasińska
- Principal Investigator Email
- elzbieta.jasinska@resmedicakielce.pl
- Contact Person Name
- Elżbieta Jasińska
- Contact Person Email
- elzbieta.jasinska@resmedicakielce.pl
- Site Name
- Galen Clinic
- Principal Investigator Name
- Urszula Chyrchel-Paszkiewicz
- Principal Investigator Email
- pgluchyrchel@gmail.com
- Contact Person Name
- Urszula Chyrchel-Paszkiewicz
- Contact Person Email
- pgluchyrchel@gmail.com
- Site Name
- Neuro-Medic Sp. z o.o.
- Principal Investigator Name
- Janusz Zbrojkiewicz
- Principal Investigator Email
- neuromedic@op.pl
- Contact Person Name
- Janusz Zbrojkiewicz
- Contact Person Email
- neuromedic@op.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny W Olsztynie
- Department Name
- Oddział Kliniczny Neurologiczny Oddział Udarowy
- Principal Investigator Name
- Andrzej Tutaj
- Principal Investigator Email
- atutaj@wss.olsztyn.pl
- Contact Person Name
- Andrzej Tutaj
- Contact Person Email
- atutaj@wss.olsztyn.pl
- Site Name
- Euromedis Sp. z o.o.
- Principal Investigator Name
- Marcin Ratajczak
- Principal Investigator Email
- marcin.ratajczak@euromedis.pl
- Contact Person Name
- Marcin Ratajczak
- Contact Person Email
- marcin.ratajczak@euromedis.pl
- Site Name
- Novo-Med Zielinski I Wspolnicy Sp. j.
- Principal Investigator Name
- Tomasz Zieliński
- Principal Investigator Email
- tzielinski@op.pl
- Contact Person Name
- Tomasz Zieliński
- Contact Person Email
- tzielinski@op.pl
Croatia
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 03-02-2026
- Processing Time Days
- 774
- Number Of Sites
- 4
- Number Of Participants
- 28
Sites
- Site Name
- Klinicki Bolnicki Centar Osijek
- Department Name
- Neurology clinic
- Principal Investigator Name
- Tea Mirosevic Zubonja
- Principal Investigator Email
- tmirosevic@gmail.com
- Contact Person Name
- Tea Mirosevic Zubonja
- Contact Person Email
- tmirosevic@gmail.com
- Site Name
- KBC Zagreb
- Department Name
- Neurology clinic
- Principal Investigator Name
- Mario Habek
- Principal Investigator Email
- mario.habek@mef.hr
- Contact Person Name
- Mario Habek
- Contact Person Email
- mario.habek@mef.hr
- Site Name
- Opca Bolnica Varazdin
- Department Name
- Department of Neurology
- Principal Investigator Name
- Spomenka Kidemet - Piskac
- Principal Investigator Email
- spiskac@gmail.com
- Contact Person Name
- Spomenka Kidemet - Piskac
- Contact Person Email
- spiskac@gmail.com
- Site Name
- Klinicki bolnicki centar Sestre milosrdnice
- Department Name
- Neurology clinic
- Principal Investigator Name
- Vanja Basic Kes
- Principal Investigator Email
- kesvanja@gmail.com
- Contact Person Name
- Vanja Basic Kes
- Contact Person Email
- kesvanja@gmail.com
Belgium
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 29-01-2026
- Processing Time Days
- 769
- Number Of Sites
- 3
- Number Of Participants
- 5
Sites
- Site Name
- Antwerp University Hospital
- Department Name
- Multiple Sclerosis and CNS Neuroimmune Disorders
- Principal Investigator Name
- Barbara Willekens
- Principal Investigator Email
- barbara.willekens@uza.be
- Contact Person Name
- Barbara Willekens
- Contact Person Email
- barbara.willekens@uza.be
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Service de neurologie
- Principal Investigator Name
- Vincent Van Pesch
- Principal Investigator Email
- vincent.vanpesch@uclouvain.be
- Contact Person Name
- Vincent Van Pesch
- Contact Person Email
- vincent.vanpesch@uclouvain.be
- Site Name
- Noorderhart
- Department Name
- Revalidatie & MS
- Principal Investigator Name
- Veronica Popescu
- Principal Investigator Email
- veronica.popescu@noorderhart.be
- Contact Person Name
- Veronica Popescu
- Contact Person Email
- veronica.popescu@noorderhart.be
Spain
- Earliest CTIS Part Ii Submission Date
- 22-12-2023
- Latest Decision Or Authorization Date
- 02-02-2026
- Processing Time Days
- 773
- Number Of Sites
- 10
- Number Of Participants
- 28
Sites
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Julia Sabin Muñoz
- Principal Investigator Email
- julia.sabin.m@gmail.com
- Contact Person Name
- Julia Sabin Muñoz
- Contact Person Email
- julia.sabin.m@gmail.com
- Site Name
- University Clinical Hospital Virgen De La Arrixaca
- Department Name
- Servicio de neurología
- Principal Investigator Name
- José Eustasio Meca Lallana
- Principal Investigator Email
- pmecal@gmail.com
- Contact Person Name
- José Eustasio Meca Lallana
- Contact Person Email
- pmecal@gmail.com
- Site Name
- Hospital Universitario Virgen De La Macarena
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Sara Eichau
- Principal Investigator Email
- saraeichau@gmail.com
- Contact Person Name
- Sara Eichau
- Contact Person Email
- saraeichau@gmail.com
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Lucienne Costa-Frossard França
- Principal Investigator Email
- lufrossard@yahoo.es
- Contact Person Name
- Lucienne Costa-Frossard França
- Contact Person Email
- lufrossard@yahoo.es
- Site Name
- Hospital Universitario De Salamanca
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Yasmina El Berdei Montero
- Principal Investigator Email
- yberdei@saludcastillayleon.es
- Contact Person Name
- Yasmina El Berdei Montero
- Contact Person Email
- yberdei@saludcastillayleon.es
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Xabier Montalban
- Principal Investigator Email
- xavier.montalban@cem-cat.org
- Contact Person Name
- Xabier Montalban
- Contact Person Email
- xavier.montalban@cem-cat.org
- Site Name
- Hospital Clinic De Barcelona
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Yolanda Blanco Morgado
- Principal Investigator Email
- yblanco@clinic.cat
- Contact Person Name
- Yolanda Blanco Morgado
- Contact Person Email
- yblanco@clinic.cat
- Site Name
- Complexo Hospitalario Universitario De Vigo
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Ines Gonzalez Suarez
- Principal Investigator Email
- igonsua@gmail.com
- Contact Person Name
- Ines Gonzalez Suarez
- Contact Person Email
- igonsua@gmail.com
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Bonaventura Casanova Estruch
- Principal Investigator Email
- casanova.bonaventura@gmail.com
- Contact Person Name
- Bonaventura Casanova Estruch
- Contact Person Email
- casanova.bonaventura@gmail.com
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Servicio de neurología
- Principal Investigator Name
- Rafael Arroyo
- Principal Investigator Email
- rafaelarroyo09@gmail.com
- Contact Person Name
- Rafael Arroyo
- Contact Person Email
- rafaelarroyo09@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
- Pharmaceutical Product Development LLC
- Responsibilities
- Global CRO
- Name
- Eresearchtechnology Inc.
- Responsibilities
- ePRO and eCOA management system
- Name
- Almac Clinical Technologies LLC
Third parties
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"ePRO and eCOA management system","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Labcorp Central Laboratory Services S.a.r.l.","duties_or_roles":"Central laboratory services","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Regents of the University of California - UCSF; Industry Contracts Division","duties_or_roles":"Special MRIs; MRI-related support","organisation_type":"Industry"}
- {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"Laboratory/sample handling support","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"Global CRO","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Unilabs A/S","duties_or_roles":"Laboratory services","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"Neurostatus EDSS training and EDSS scores review by UHB Neurologist","organisation_type":"Laboratory/Research/Testing facility"}
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
- Marketing authorisation EU/1/17/1231/002
- Dose Levels
- Product presentation 300 mg; max daily dose 600 mg; max total dose amount 6 g
- Maximum Dose
- Max daily dose 600 mg; max total dose amount 6 g
- Investigational Product Name
- Placebo Ocrevus
- Modality
- Other
- Investigational Product Name
- DIPHENHYDRAMINE HYDROCHLORIDE
- Active Substance
- DIPHENHYDRAMINE HYDROCHLORIDE
- Modality
- Small molecule
- Routes Of Administration
- ORAL
- Route
- Oral
- Authorisation Status
- euSubstNumber SUB01769MIG
- Dose Levels
- Max daily dose amount 50 mg
- Maximum Dose
- 50 mg daily
- Investigational Product Name
- METHYLPREDNISOLONE SODIUM SUCCINATE
- Active Substance
- METHYLPREDNISOLONE SODIUM SUCCINATE
- Modality
- Small molecule
- Routes Of Administration
- INTRAVENOUS INFUSION
- Route
- Intravenous infusion
- Authorisation Status
- euSubstNumber SUB14562MIG
- Dose Levels
- Max daily dose amount 100 mg; max total dose amount 1200 mg
- Maximum Dose
- 100 mg daily; total up to 1200 mg
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