Clinical trial • Phase III • Neurology|Musculoskeletal
Ocrelizumab for Multiple sclerosis
Phase III trial of Ocrelizumab for Multiple sclerosis. open-label. 1110 participants.
Overview
- Trial Therapeutic Area
- Neurology|Musculoskeletal
- Trial Disease
- Multiple sclerosis
- Trial Stage
- Phase III
- Drug Modality
- Monoclonal antibody
Key dates
- Initial CTIS Submission Date
- 05-06-2024
- First CTIS Authorization Date
- 08-07-2024
Trial design
open-label Phase III trial in Slovakia, Latvia, Romania and others.
- Open Label
- Yes
- Target Sample Size
- 1110
Eligibility
Recruits 1110 Vulnerable population selected. Study submission includes infant/child-related documentation (e.g. documents titled 'L1_SIS and ICF Infant Authorization Form', 'L2_Other subject information material_Infant Health Questionnaire', 'L1_SIS and ICF_Baby Health Information'), indicating provision of infant/child information and authorization forms..
- Pregnancy Exclusion
- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet
- Vulnerable Population
- Vulnerable population selected. Study submission includes infant/child-related documentation (e.g. documents titled 'L1_SIS and ICF Infant Authorization Form', 'L2_Other subject information material_Infant Health Questionnaire', 'L1_SIS and ICF_Baby Health Information'), indicating provision of infant/child information and authorization forms.
Inclusion criteria
- {"criterion_text":"- Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation"}
- {"criterion_text":"- For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet"}
Exclusion criteria
- {"criterion_text":"- Concurrent participation in any clinical trial (other than the Parent study)"}
- {"criterion_text":"- Unable or unwilling to comply with the requirements of the protocol"}
Endpoints
Primary endpoints
- {"endpoint_text":"- 1. Incidence and severity of adverse events, with severity determined according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 5.0 (NCI CTCAE v5.0)","definition_or_measurement_approach":"Severity determined according to NCI CTCAE v5.0"}
Secondary endpoints
- {"endpoint_text":"- 1. Change in Expanded Disability Status Scale (EDSS) score over time","definition_or_measurement_approach":"Change in EDSS score measured over time (EDSS instrument)"}
- {"endpoint_text":"- 2. Change in 9-Hole Peg Test (9HPT) and Timed 25-Foot Walk Test (T25FWT) over time","definition_or_measurement_approach":"Change over time in 9HPT and T25FWT performance measures"}
- {"endpoint_text":"- 3. The number of new, hypointense T1 lesions and number of new or enlarging T2 lesions","definition_or_measurement_approach":"MRI lesion counts: new hypointense T1 lesions and new/enlarging T2 lesions"}
- {"endpoint_text":"- 4. The change in total volume of T2 lesions and in total T1 lesion volume","definition_or_measurement_approach":"Change in MRI measured total T2 lesion volume and total T1 lesion volume"}
Recruitment
- Planned Sample Size
- 1110
- Recruitment Window Months
- 43
- Consent Approach
- Participant information sheets and informed consent forms (ICFs) are provided; infant/authorization forms are included where relevant (e.g. 'Infant Authorization Form', 'Infant Health Questionnaire', 'Baby Health Information'). ICFs and related materials are submitted in multiple country/language versions (examples in the submission include English, Latvian, Russian, Romanian, French, Spanish, Italian, Dutch, Hungarian, Polish, Swedish, Portuguese, Lithuanian), indicating country-specific language materials and specific infant/authorization documentation.
Geography
- Total Number Of Sites
- 105
- Total Number Of Participants
- 809
Slovakia
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 18
- Number Of Sites
- 3
- Number Of Participants
- 12
Sites
- Site Name
- MUDr. Beata Dupejova neurologicka ambulancia s.r.o.
- Department Name
- Neurologicka ambulancia
- Principal Investigator Name
- Beata Dupejova
- Principal Investigator Email
- dupejova@gmail.com
- Contact Person Name
- Beata Dupejova
- Contact Person Email
- dupejova@gmail.com
- Site Name
- Fakultna Nemocnica S Poliklinikou Zilina
- Department Name
- Neurologicke oddelenie
- Principal Investigator Name
- Juraj Vyletelka
- Principal Investigator Email
- vyletelka@nextra.sk
- Contact Person Name
- Juraj Vyletelka
- Contact Person Email
- vyletelka@nextra.sk
- Site Name
- University Hospital Bratislava
- Department Name
- Neurologicka klinika SZU a UNB
- Principal Investigator Name
- Viera Hancinova
- Principal Investigator Email
- dr.hancinova@gmail.com
- Contact Person Name
- Viera Hancinova
- Contact Person Email
- dr.hancinova@gmail.com
Latvia
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 18
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Latvijas Juras medicinas centrs AS
- Department Name
- Neurology
- Principal Investigator Name
- Jolanta Kalnina
- Principal Investigator Email
- jolanta@ljmc.lv
- Contact Person Name
- Jolanta Kalnina
- Contact Person Email
- jolanta@ljmc.lv
- Site Name
- Pauls Stradins Clinical University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Alina Flintere-Flinte
- Principal Investigator Email
- alina-medi@inbox.lv
- Contact Person Name
- Alina Flintere-Flinte
- Contact Person Email
- alina-medi@inbox.lv
Romania
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 11-07-2024
- Processing Time Days
- 21
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Clubul Sanatatii S.R.L.
- Department Name
- Compartiment Cercetare, Secţia de Neurologie
- Principal Investigator Name
- Emilian-Silviu Manescu
- Principal Investigator Email
- silviumanescu@yahoo.com
- Contact Person Name
- Emilian-Silviu Manescu
- Contact Person Email
- silviumanescu@yahoo.com
Bulgaria
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 18
- Number Of Sites
- 7
- Number Of Participants
- 25
Sites
- Site Name
- Tokuda Hospital
- Department Name
- Clinic of Neurology and Sleep Medicine
- Principal Investigator Name
- Ivan Staikov
- Principal Investigator Email
- ivanstaikov@hotmail.com
- Contact Person Name
- Ivan Staikov
- Contact Person Email
- ivanstaikov@hotmail.com
- Site Name
- Universitetska Parva Mnogoprofilna Bolnitsa Za Aktivno Lechenie Sofia Sv. Yoan Krastitel
- Department Name
- Clinic of Neurology
- Principal Investigator Name
- Dimitar Maslarov
- Principal Investigator Email
- maslarovdb@abv.bg
- Contact Person Name
- Dimitar Maslarov
- Contact Person Email
- maslarovdb@abv.bg
- Site Name
- MHAT National Heart Hospital EAD
- Department Name
- Clinic of Neurology
- Principal Investigator Name
- Lyubomir Haralanov
- Principal Investigator Email
- haralanovl@yahoo.com
- Contact Person Name
- Lyubomir Haralanov
- Contact Person Email
- haralanovl@yahoo.com
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Clinic of neurology diseases for movement disorders
- Principal Investigator Name
- Sonya Hristova-Chakmakova
- Principal Investigator Email
- ivanovasonia@gmail.com
- Contact Person Name
- Sonya Hristova-Chakmakova
- Contact Person Email
- ivanovasonia@gmail.com
- Site Name
- Military Medical Academy
- Department Name
- Clinic of Neurology
- Principal Investigator Name
- Hristina Dimitrova
- Principal Investigator Email
- drhrisi@abv.bg
- Contact Person Name
- Hristina Dimitrova
- Contact Person Email
- drhrisi@abv.bg
- Site Name
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
- Department Name
- Clinic for intensive treatment of neurology diseases
- Principal Investigator Name
- Milena Milanova
- Principal Investigator Email
- milanova_m@dir.bg
- Contact Person Name
- Milena Milanova
- Contact Person Email
- milanova_m@dir.bg
- Site Name
- Multiprofile Hospital For Active Treatment Avis Medika OOD
- Department Name
- Department of Neurology
- Principal Investigator Name
- Hristo Lilovski
- Principal Investigator Email
- hristolilovski@gmail.com
- Contact Person Name
- Hristo Lilovski
- Contact Person Email
- hristolilovski@gmail.com
Croatia
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 09-07-2024
- Processing Time Days
- 19
- Number Of Sites
- 2
- Number Of Participants
- 14
Sites
- Site Name
- KBC Zagreb
- Department Name
- Neurology
- 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
- Neurology
- Principal Investigator Name
- Spomenka Kidjemet-Piskac
- Principal Investigator Email
- spiskac@gmail.com
- Contact Person Name
- Spomenka Kidjemet-Piskac
- Contact Person Email
- spiskac@gmail.com
Spain
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 11-07-2024
- Processing Time Days
- 21
- Number Of Sites
- 11
- Number Of Participants
- 78
Sites
- Site Name
- Complexo Hospitalario Universitario De Santiago
- Department Name
- Neurology
- Principal Investigator Name
- José María Prieto González
- Principal Investigator Email
- josemaoscar.prieto@usc.es
- Contact Person Name
- José María Prieto González
- Contact Person Email
- josemaoscar.prieto@usc.es
- Site Name
- Hospital Universitario Ramon Y Cajal
- Department Name
- Neurology
- Principal Investigator Name
- Lucienne Costa-Frossard Franca
- Principal Investigator Email
- lufrossard@yahoo.es
- Contact Person Name
- Lucienne Costa-Frossard Franca
- Contact Person Email
- lufrossard@yahoo.es
- Site Name
- Hospital Santa Caterina Ias
- Department Name
- Neurology
- Principal Investigator Name
- Gary Alvarez Bravo
- Principal Investigator Email
- garinho29@icloud.com
- Contact Person Name
- Gary Alvarez Bravo
- Contact Person Email
- garinho29@icloud.com
- Site Name
- Hospital Universitario Puerta De Hierro De Majadahonda
- Department Name
- Neurology
- Principal Investigator Name
- Julia Sabin Muñon
- Principal Investigator Email
- julia.sabin.m@gmail.com
- Contact Person Name
- Julia Sabin Muñon
- Contact Person Email
- julia.sabin.m@gmail.com
- Site Name
- Hospital Universitario De La Princesa
- Department Name
- Neurology
- Principal Investigator Name
- Virginia Meca Lallana
- Principal Investigator Email
- virmeca@hotmail.com
- Contact Person Name
- Virginia Meca Lallana
- Contact Person Email
- virmeca@hotmail.com
- Site Name
- Hospital Clinico San Carlos
- Department Name
- Neurology
- Principal Investigator Name
- Celia Oreja Guevara
- Principal Investigator Email
- orejacbn@gmail.com
- Contact Person Name
- Celia Oreja Guevara
- Contact Person Email
- orejacbn@gmail.com
- Site Name
- Hospital Universitari Vall D Hebron
- Department Name
- Neurology
- Principal Investigator Name
- Xavier Montalban Gairin
- Principal Investigator Email
- xavier.montalban@cem-cat.org
- Contact Person Name
- Xavier Montalban Gairin
- Contact Person Email
- xavier.montalban@cem-cat.org
- Site Name
- Bellvitge University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Sergio Martínez Yelamos
- Principal Investigator Email
- smartinezy@bellvitgehospital.cat
- Contact Person Name
- Sergio Martínez Yelamos
- Contact Person Email
- smartinezy@bellvitgehospital.cat
- Site Name
- Hospital Universitario Basurto
- Department Name
- Neurology
- Principal Investigator Name
- Cristina Llarena González
- Principal Investigator Email
- mariacristina.llarenagonzalez@osakidetza.net
- Contact Person Name
- Cristina Llarena González
- Contact Person Email
- mariacristina.llarenagonzalez@osakidetza.net
- Site Name
- Hospital Universitario Regional De Malaga
- Department Name
- Neurology
- 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 Universitario Virgen De La Macarena
- Department Name
- Neurology
- Principal Investigator Name
- Sara Eichau Madueno
- Principal Investigator Email
- saraeichau@gmail.com
- Contact Person Name
- Sara Eichau Madueno
- Contact Person Email
- saraeichau@gmail.com
Sweden
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 09-07-2024
- Processing Time Days
- 19
- Number Of Sites
- 3
- Number Of Participants
- 9
Sites
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Department of Neurology
- Principal Investigator Name
- Clas Malmeström
- Principal Investigator Email
- jan.lycke@neuro.gu.se
- Contact Person Name
- Clas Malmeström
- Contact Person Email
- jan.lycke@neuro.gu.se
- Site Name
- Karolinska University Hospital
- Department Name
- Department of Clinical Neuroscience
- Principal Investigator Name
- Virginija Karrenbauer
- Principal Investigator Email
- virginija.karrenbauer@ki.se
- Contact Person Name
- Virginija Karrenbauer
- Contact Person Email
- virginija.karrenbauer@ki.se
- Site Name
- Region Stockholm – SLSO
- Department Name
- Department of Neurology
- Principal Investigator Name
- Tomas Olsson
- Principal Investigator Email
- tomas.olsson@ki.se
- Contact Person Name
- Tomas Olsson
- Contact Person Email
- tomas.olsson@ki.se
Belgium
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 10-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 5
- Number Of Participants
- 21
Sites
- Site Name
- Cliniques Universitaires Saint-Luc
- Department Name
- Neurology
- Principal Investigator Name
- Vincent Van Pesh
- Principal Investigator Email
- vincent.vanpesch@saintluc.uclouvain.be
- Contact Person Name
- Vincent Van Pesh
- Contact Person Email
- vincent.vanpesch@saintluc.uclouvain.be
- Site Name
- Algemeen Ziekenhuis Delta
- Department Name
- Neurology
- Principal Investigator Name
- Maarten Buyle
- Principal Investigator Email
- maarten.buyle@azdelta.be
- Contact Person Name
- Maarten Buyle
- Contact Person Email
- maarten.buyle@azdelta.be
- Site Name
- Algemeen Ziekenhuis Alma
- Department Name
- Neurology
- Principal Investigator Name
- Danny Decoo
- Principal Investigator Email
- danny.decoo@azalma.be
- Contact Person Name
- Danny Decoo
- Contact Person Email
- danny.decoo@azalma.be
- Site Name
- Az St-Jan Brugge-Oostende A.V.
- Department Name
- Neurology
- Principal Investigator Name
- Melissa Cambron
- Principal Investigator Email
- melissa.cambron@azsintjan.be
- Contact Person Name
- Melissa Cambron
- Contact Person Email
- melissa.cambron@azsintjan.be
- Site Name
- Antwerp University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Barbara Willekens
- Principal Investigator Email
- barbara.willekens@uza.be
- Contact Person Name
- Barbara Willekens
- Contact Person Email
- barbara.willekens@uza.be
France
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 12-07-2024
- Processing Time Days
- 22
- Number Of Sites
- 10
- Number Of Participants
- 40
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
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Service de neurologie
- 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 Intercommunal De Poissy Saint Germain
- Department Name
- Service de neurologie
- Principal Investigator Name
- Olivier HEINZLEF
- Principal Investigator Email
- olivier.heinzlef@ght-yvelinesnord.fr
- Contact Person Name
- Olivier HEINZLEF
- Contact Person Email
- olivier.heinzlef@ght-yvelinesnord.fr
- Site Name
- Les Hopitaux Universitaires De Strasbourg
- Department Name
- Service de neurologie
- Principal Investigator Name
- Jerome DE SEZE
- Principal Investigator Email
- jerome.deseze@chru-strasbourg.fr
- Contact Person Name
- Jerome DE SEZE
- Contact Person Email
- jerome.deseze@chru-strasbourg.fr
- Site Name
- CHRU De Nancy
- Department Name
- Service de neurologie
- Principal Investigator Name
- Guillaume MATHEY
- Principal Investigator Email
- g.mathey@chru-nancy.fr
- Contact Person Name
- Guillaume MATHEY
- Contact Person Email
- g.mathey@chru-nancy.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- Service de neurologie D
- Principal Investigator Name
- Patrick VERMERSCH
- Principal Investigator Email
- patrick.vermersch@univ-lille.fr
- Contact Person Name
- Patrick VERMERSCH
- Contact Person Email
- patrick.vermersch@univ-lille.fr
- Site Name
- Centre Hospitalier Universitaire De Nantes
- Department Name
- Service de neurologie, CIC de neurologie
- Principal Investigator Name
- David LAPLAUD
- Principal Investigator Email
- david.laplaud@univ-nantes.fr
- Contact Person Name
- David LAPLAUD
- Contact Person Email
- david.laplaud@univ-nantes.fr
- Site Name
- Centre Hospitalier Universitaire De Caen Normandie
- Department Name
- Service de neurologie
- Principal Investigator Name
- Pierre BRANGER
- Principal Investigator Email
- branger-p@chu-caen.fr
- Contact Person Name
- Pierre BRANGER
- Contact Person Email
- branger-p@chu-caen.fr
- Site Name
- Hospital Pierre Wertheimer
- Department Name
- Service de neurologie, sclérose en plaques, pathologies 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
- Centre Hospitalier Universitaire De Nice
- Department Name
- Services des neurosciences
- Principal Investigator Name
- Christine LEBRUN FRENAY
- Principal Investigator Email
- lebrun-frenay.c@chu-nice.fr
- Contact Person Name
- Christine LEBRUN FRENAY
- Contact Person Email
- lebrun-frenay.c@chu-nice.fr
Portugal
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 10-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 4
- Number Of Participants
- 10
Sites
- Site Name
- Unidade Local De Saude De Almada-Seixal E.P.E.
- Department Name
- Neurologia
- Principal Investigator Name
- Maria Irene Mendes
- Principal Investigator Email
- maria.irene.mendes@hgo.min-saude.pt
- Contact Person Name
- Maria Irene Mendes
- Contact Person Email
- maria.irene.mendes@hgo.min-saude.pt
- Site Name
- Unidade Local De Saude De Coimbra E.P.E.
- Department Name
- Neurologia
- Principal Investigator Name
- Carla Cecilia Nunes
- Principal Investigator Email
- carlacecilianunes@gmail.com
- Contact Person Name
- Carla Cecilia Nunes
- Contact Person Email
- carlacecilianunes@gmail.com
- Site Name
- Unidade Local De Saude De Santa Maria E.P.E.
- Department Name
- 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
- Site Name
- CCAB Centro Clinico Academico Braga Associacao
- Department Name
- Neurologia
- Principal Investigator Name
- João José Cerqueira
- Principal Investigator Email
- jcerqueira@med.uminho.pt
- Contact Person Name
- João José Cerqueira
- Contact Person Email
- jcerqueira@med.uminho.pt
Estonia
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 19-07-2024
- Processing Time Days
- 29
- Number Of Sites
- 2
- Number Of Participants
- 7
Sites
- Site Name
- Laane-Tallinna Keskhaigla AS
- Department Name
- Neurology
- Principal Investigator Name
- Katrin Gross-Paju
- Principal Investigator Email
- katrin.gross-paju@keskhaigla.ee
- Contact Person Name
- Katrin Gross-Paju
- Contact Person Email
- katrin.gross-paju@keskhaigla.ee
- Site Name
- Tartu University Hospital
- Department Name
- Neurology
- Principal Investigator Name
- Irja Kalbe
- Principal Investigator Email
- irja.kalbe@kliinikum.ee
- Contact Person Name
- Irja Kalbe
- Contact Person Email
- irja.kalbe@kliinikum.ee
Czechia
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 10-07-2024
- Processing Time Days
- 20
- Number Of Sites
- 7
- Number Of Participants
- 83
Sites
- Site Name
- Krajska zdravotni a.s.
- Department Name
- Neurology
- Principal Investigator Name
- Marta Vachová
- Principal Investigator Email
- marta.vachova@kzcr.eu
- Contact Person Name
- Marta Vachová
- Contact Person Email
- marta.vachova@kzcr.eu
- Site Name
- Fakultni Nemocnice U Sv Anny V Brne
- Department Name
- Neurology
- Principal Investigator Name
- Michal Dufek
- Principal Investigator Email
- michal.dufek@fnusa.cz
- Contact Person Name
- Michal Dufek
- Contact Person Email
- michal.dufek@fnusa.cz
- Site Name
- Fakultni Nemocnice Hradec Kralove
- Department Name
- Neurology
- Principal Investigator Name
- Zbyšek Pavelek
- Principal Investigator Email
- zbysekpavelekr@email.cz
- Contact Person Name
- Zbyšek Pavelek
- Contact Person Email
- zbysekpavelekr@email.cz
- Site Name
- Vseobecna Fakultni Nemocnice V Praze
- Department Name
- Neurology
- Principal Investigator Name
- Eva Kubala Havrdová
- Principal Investigator Email
- eva.kubalahavrdova@vfn.cz
- Contact Person Name
- Eva Kubala Havrdová
- Contact Person Email
- eva.kubalahavrdova@vfn.cz
- Site Name
- Nemocnice Jihlava prispevkova organizace
- Department Name
- Neurology
- Principal Investigator Name
- Ondřej Škoda
- Principal Investigator Email
- skodao@nemji.cz
- Contact Person Name
- Ondřej Škoda
- Contact Person Email
- skodao@nemji.cz
- Site Name
- Neurospol s.r.o.
- Department Name
- Neurology
- Principal Investigator Name
- Pavel Hradílek
- Principal Investigator Email
- pavel.hradilek@seznam.cz
- Contact Person Name
- Pavel Hradílek
- Contact Person Email
- pavel.hradilek@seznam.cz
- Site Name
- Fakultni Nemocnice Brno
- Department Name
- Neurology
- Principal Investigator Name
- Yvonne Benešová
- Principal Investigator Email
- benesova.yvonne@fnbrno.cz
- Contact Person Name
- Yvonne Benešová
- Contact Person Email
- benesova.yvonne@fnbrno.cz
Poland
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 25
- Number Of Sites
- 12
- Number Of Participants
- 170
Sites
- Site Name
- Neuroprotect Sp. z o.o.
- Principal Investigator Name
- Maciej Czarnecki
- Principal Investigator Email
- maciej.czarnecki@neuroprotect.pl
- Contact Person Name
- Maciej Czarnecki
- Contact Person Email
- maciej.czarnecki@neuroprotect.pl
- Site Name
- Centrum Neurologii Krzysztof Selmaj
- Principal Investigator Name
- Krzysztof Selmaj
- Principal Investigator Email
- kselmaj@gmail.com
- Contact Person Name
- Krzysztof Selmaj
- Contact Person Email
- kselmaj@gmail.com
- Site Name
- Vitamed Galaj I Cichomski Sp. j.
- Principal Investigator Name
- Maciej Binek
- Principal Investigator Email
- binek.maciej@wp.pl
- Contact Person Name
- Maciej Binek
- Contact Person Email
- binek.maciej@wp.pl
- Site Name
- Copernicus Podmiot Leczniczy Sp. z o.o.
- Department Name
- Oddział Neurologiczny
- Principal Investigator Name
- Waldemar Fryze
- Principal Investigator Email
- w.fryze@wp.pl
- Contact Person Name
- Waldemar Fryze
- Contact Person Email
- w.fryze@wp.pl
- Site Name
- Uniwersytecki Szpital Kliniczny Nr 4 W Lublinie
- Department Name
- Kliniczny Oddział Neurologii Oddział Udarowy i Wczesnej Rehabilitacji Poudarowej
- Principal Investigator Name
- Konrad Rejdak
- Principal Investigator Email
- rejdakk@gmail.com
- Contact Person Name
- Konrad Rejdak
- Contact Person Email
- rejdakk@gmail.com
- Site Name
- Neuro-Medic Sp. z o.o.
- Principal Investigator Name
- Janusz Zbrojkiewicz
- Principal Investigator Email
- jzbrojkiewicz@op.pl
- Contact Person Name
- Janusz Zbrojkiewicz
- Contact Person Email
- jzbrojkiewicz@op.pl
- Site Name
- Specjalistyczna Praktyka Lekarska prof. Grzegorz Opala
- Principal Investigator Name
- Grzegorz Opala
- Principal Investigator Email
- opala.praktyka@gmail.com
- Contact Person Name
- Grzegorz Opala
- Contact Person Email
- opala.praktyka@gmail.com
- Site Name
- Neuro-Care Sp. z o.o. sp.k.
- Principal Investigator Name
- Gabriela Kłodowska
- Principal Investigator Email
- g.klodowska@neuro-care.pl
- Contact Person Name
- Gabriela Kłodowska
- Contact Person Email
- g.klodowska@neuro-care.pl
- Site Name
- Krakowska Akademia Neurologii Sp. z o.o.
- Principal Investigator Name
- Andrzej Szczudlik
- Principal Investigator Email
- andrzej.szczudlik@neurologia.org.pl
- Contact Person Name
- Andrzej Szczudlik
- Contact Person Email
- andrzej.szczudlik@neurologia.org.pl
- Site Name
- Wojewodzki Szpital Specjalistyczny W Olsztynie
- Department Name
- Oddział Neurologiczny
- Principal Investigator Name
- Andrzej Tutaj
- Principal Investigator Email
- tutajandrzej@poczta.onet.pl
- Contact Person Name
- Andrzej Tutaj
- Contact Person Email
- tutajandrzej@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
- Neurologiczny NZOZ Centrum Leczenia SM Ośrodek Badań Klinicznych im. dr n. med. Hanki Hertmanowskiej
- Principal Investigator Name
- Adriana Chełminiak
- Principal Investigator Email
- ada-neta@wp.pl
- Contact Person Name
- Adriana Chełminiak
- Contact Person Email
- ada-neta@wp.pl
Lithuania
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 23-07-2024
- Processing Time Days
- 33
- Number Of Sites
- 2
- Number Of Participants
- 9
Sites
- Site Name
- Vilniaus Universiteto Ligonine Santaros Klinikos Vsi
- Department Name
- Department of Neurology
- Principal Investigator Name
- Kizlaitiene Rasa
- Principal Investigator Email
- rasa.kizlaitiene@santa.lt
- Contact Person Name
- Kizlaitiene Rasa
- Contact Person Email
- rasa.kizlaitiene@santa.lt
- Site Name
- Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos
- Department Name
- Department of Neurology
- Principal Investigator Name
- Antanas Vaitkus
- Principal Investigator Email
- antanas.vaitkus@kaunoklinikos.lt
- Contact Person Name
- Antanas Vaitkus
- Contact Person Email
- antanas.vaitkus@kaunoklinikos.lt
Italy
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 05-08-2024
- Processing Time Days
- 46
- Number Of Sites
- 11
- Number Of Participants
- 103
Sites
- Site Name
- Ospedale San Raffaele S.r.l.
- Department Name
- Neurology
- 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 Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Neurology
- Principal Investigator Name
- Simona Malucchi
- Principal Investigator Email
- s.malucchi@sanluigi.piemonte.it
- Contact Person Name
- Simona Malucchi
- Contact Person Email
- s.malucchi@sanluigi.piemonte.it
- Site Name
- Azienda Ospedaliera Policlinico Universitario Tor Vergata
- Department Name
- Neurology
- Principal Investigator Name
- Alessandra Girolama Marfia
- Principal Investigator Email
- marfia@uniroma2.it
- Contact Person Name
- Alessandra Girolama Marfia
- Contact Person Email
- marfia@uniroma2.it
- Site Name
- IRCCS Ospedale Policlinico San Martino
- Department Name
- Neurology
- Principal Investigator Name
- Antonio Uccelli
- Principal Investigator Email
- auccelli@neurologia.unige.it
- Contact Person Name
- Antonio Uccelli
- Contact Person Email
- auccelli@neurologia.unige.it
- Site Name
- Azienda Socio Sanitaria Territoriale Della Valle Olona
- Department Name
- Neurology
- Principal Investigator Name
- Pietro Annovazzi
- Principal Investigator Email
- pietro.annovazzi@gmail.com
- Contact Person Name
- Pietro Annovazzi
- Contact Person Email
- pietro.annovazzi@gmail.com
- Site Name
- Azienda Sanitaria Locale Della Provincia Di Biella
- Department Name
- Neurology
- Principal Investigator Name
- Graziano Gusmaroli
- Principal Investigator Email
- graziano.gusmaroli@aslbi.piemonte.it
- Contact Person Name
- Graziano Gusmaroli
- Contact Person Email
- graziano.gusmaroli@aslbi.piemonte.it
- Site Name
- Azienda Socio Sanitaria Territoriale Degli Spedali Civili Di Brescia
- Department Name
- Neurology
- Principal Investigator Name
- Cinzia Cordioli
- Principal Investigator Email
- cinzia.cordioli@gmail.com
- Contact Person Name
- Cinzia Cordioli
- Contact Person Email
- cinzia.cordioli@gmail.com
- Site Name
- Azienda Ospedaliero-Universitaria Delle Marche
- Department Name
- Neurology
- Principal Investigator Name
- Raffaella Cerqua
- Principal Investigator Email
- raffaella.cerqua@ospedaliriuniti.marche.it
- Contact Person Name
- Raffaella Cerqua
- Contact Person Email
- raffaella.cerqua@ospedaliriuniti.marche.it
- Site Name
- Fondazione Istituto G. Giglio Di Cafalu
- Department Name
- Neurology
- 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
- IRCCS Foundation Istituto Neurologico Carlo Besta
- Department Name
- Neurology
- Principal Investigator Name
- Carlo Giuseppe Antozzi
- Principal Investigator Email
- carlo.antozzi@istituto-besta.it
- Contact Person Name
- Carlo Giuseppe Antozzi
- Contact Person Email
- carlo.antozzi@istituto-besta.it
- Site Name
- Azienda Ospedaliero-Universitaria Sant Andre
- Department Name
- Neurology
- Principal Investigator Name
- Giovanni Ristori
- Principal Investigator Email
- giovanni.ristori@uniroma1.it
- Contact Person Name
- Giovanni Ristori
- Contact Person Email
- giovanni.ristori@uniroma1.it
Finland
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 1
Sites
- Site Name
- Suomen Terveystalo Oy
- Department Name
- Terveystalo Tampere
- Principal Investigator Name
- Marja-Liisa Sumelahti
- Principal Investigator Email
- marja-liisa.sumelahti@terveystalo.com
- Contact Person Name
- Marja-Liisa Sumelahti
- Contact Person Email
- marja-liisa.sumelahti@terveystalo.com
Hungary
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 18
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- University Of Pecs
- Department Name
- Neurológiai Klinika
- Principal Investigator Name
- Péter Ács
- Principal Investigator Email
- acspeterdr@gmail.com
- Contact Person Name
- Péter Ács
- Contact Person Email
- acspeterdr@gmail.com
- Site Name
- S-Medicon Egészségügyi Szolgáltató Kft.
- Department Name
- Neurológia
- Principal Investigator Name
- Mária Sátori
- Principal Investigator Email
- satori.maria@gmail.com
- Contact Person Name
- Mária Sátori
- Contact Person Email
- satori.maria@gmail.com
- Site Name
- Jahn Ferenc Del-Pesti Korhaz Es Rendelointezet
- Department Name
- Neurológiai Osztály
- Principal Investigator Name
- Csilla Rózsa
- Principal Investigator Email
- rozsa.csilla@delpestikorhaz.hu
- Contact Person Name
- Csilla Rózsa
- Contact Person Email
- rozsa.csilla@delpestikorhaz.hu
Germany
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 12-07-2024
- Processing Time Days
- 22
- Number Of Sites
- 15
- Number Of Participants
- 184
Sites
- Site Name
- Universitaetsklinikum Ulm AöR
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Hayrettin Tumani
- Principal Investigator Email
- hayrettin.tumani@uni-ulm.de
- Contact Person Name
- Hayrettin Tumani
- Contact Person Email
- hayrettin.tumani@uni-ulm.de
- Site Name
- Juedisches Krankenhaus Berlin Stiftung Des Buergerlichen Rechts
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Juliane Klehmet
- Principal Investigator Email
- juliane.klehmet@jkb-online.de
- Contact Person Name
- Juliane Klehmet
- Contact Person Email
- juliane.klehmet@jkb-online.de
- Site Name
- Universitaet Leipzig
- Department Name
- Klinik und Poliklinik fuer Neurologie
- Principal Investigator Name
- Florian Then Bergh
- Principal Investigator Email
- florian.thenbergh@medizin.uni-leipzig.de
- Contact Person Name
- Florian Then Bergh
- Contact Person Email
- florian.thenbergh@medizin.uni-leipzig.de
- Site Name
- Universitaetsklinikum Duesseldorf AöR
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Norbert Goebels
- Principal Investigator Email
- norbert.goebels@med.uni-duesseldorf.de
- Contact Person Name
- Norbert Goebels
- Contact Person Email
- norbert.goebels@med.uni-duesseldorf.de
- Site Name
- Charite Universitaetsmedizin Berlin KöR
- Department Name
- Neurology
- 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
- Neurologie in Bonn
- Department Name
- Neurologie
- Principal Investigator Name
- Stephan Schmidt
- Principal Investigator Email
- schmidt@neurologie-in-bonn.de
- Contact Person Name
- Stephan Schmidt
- Contact Person Email
- schmidt@neurologie-in-bonn.de
- Site Name
- Universitaetsklinikum Tuebingen AöR
- Department Name
- Abteilung fuer Neurodegenerative Erkrankungen
- Principal Investigator Name
- Ulf Ziemann
- Principal Investigator Email
- ulf.ziemann@med.uni-tuebingen.de
- Contact Person Name
- Ulf Ziemann
- Contact Person Email
- ulf.ziemann@med.uni-tuebingen.de
- Site Name
- Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR
- Department Name
- Klinik und Poliklinik fuer Neurologie
- Principal Investigator Name
- Tjalf Ziemssen
- Principal Investigator Email
- tjalf.ziemssen@ukdd.de
- Contact Person Name
- Tjalf Ziemssen
- Contact Person Email
- tjalf.ziemssen@ukdd.de
- Site Name
- Pharmakologisches Studienzentrum Chemnitz GmbH
- Principal Investigator Name
- Ralf Bodenschatz
- Principal Investigator Email
- ralf.bodenschatz.sz@studienzentrum-chemnitz.de
- Contact Person Name
- Ralf Bodenschatz
- Contact Person Email
- ralf.bodenschatz.sz@studienzentrum-chemnitz.de
- Site Name
- Universitaetsklinikum Muenster AöR
- Department Name
- Klinik f. Neurologie mit Institut f.Transl. Neurol
- Principal Investigator Name
- Luisa Koltz
- Principal Investigator Email
- luisa.klotz@ukmuenster.de
- Contact Person Name
- Luisa Koltz
- Contact Person Email
- luisa.klotz@ukmuenster.de
- Site Name
- NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH
- Department Name
- Studienzentrum
- Principal Investigator Name
- Daniela Rau
- Principal Investigator Email
- rau@neurologie-ulm.de
- Contact Person Name
- Daniela Rau
- Contact Person Email
- rau@neurologie-ulm.de
- Site Name
- University Of Regensburg
- Department Name
- Klinik und Poliklinik fuer Neurologie
- Principal Investigator Name
- Klemens Angstwurm
- Principal Investigator Email
- klemens.angstwurm@medbo.de
- Contact Person Name
- Klemens Angstwurm
- Contact Person Email
- klemens.angstwurm@medbo.de
- Site Name
- Studienzentrum Nord-West
- Principal Investigator Name
- Wolfgang Schwarz
- Principal Investigator Email
- wschwarz@studienzentrum-nordwest.de
- Contact Person Name
- Wolfgang Schwarz
- Contact Person Email
- wschwarz@studienzentrum-nordwest.de
- Site Name
- Zentrum fuer ambulante Neurologie
- Department Name
- Neurotransdata GmbH
- Principal Investigator Name
- Harald Landefeld
- Principal Investigator Email
- haraldlandefeld@web.de
- Contact Person Name
- Harald Landefeld
- Contact Person Email
- haraldlandefeld@web.de
- Site Name
- Klinikum Bayreuth GmbH
- Department Name
- Klinik fuer Neurologie
- Principal Investigator Name
- Patrick Oschmann
- Principal Investigator Email
- patrick.oschmann@klinikum-bayreuth.de
- Contact Person Name
- Patrick Oschmann
- Contact Person Email
- patrick.oschmann@klinikum-bayreuth.de
Netherlands
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 08-07-2024
- Processing Time Days
- 18
- Number Of Sites
- 1
- Number Of Participants
- 6
Sites
- Site Name
- Zuyderland Medisch Centrum Stichting
- Department Name
- Department of Neurology
- Principal Investigator Name
- Stephanie Knippenberg
- Principal Investigator Email
- s.knippenberg@zuyderland.nl
- Contact Person Name
- Stephanie Knippenberg
- Contact Person Email
- s.knippenberg@zuyderland.nl
Austria
- Earliest CTIS Part Ii Submission Date
- 20-06-2024
- Latest Decision Or Authorization Date
- 15-07-2024
- Processing Time Days
- 25
- Number Of Sites
- 3
- Number Of Participants
- 10
Sites
- Site Name
- Konvent Der Barmherzigen Brueder
- Department Name
- Abteilung für Neurologie
- Principal Investigator Name
- Thomas Hofer
- Principal Investigator Email
- thomas.hofer@bblinz.at
- Contact Person Name
- Thomas Hofer
- Contact Person Email
- thomas.hofer@bblinz.at
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Universitätsklinik für Neurologie
- Principal Investigator Name
- Florian Deisenhammer
- Principal Investigator Email
- florian.deisenhammer@tirol-kliniken.at
- Contact Person Name
- Florian Deisenhammer
- Contact Person Email
- florian.deisenhammer@tirol-kliniken.at
- Site Name
- Medical University Of Vienna
- Department Name
- Universitätsklinik für Neurologie
- Principal Investigator Name
- Walter Rinner
- Principal Investigator Email
- walter.rinner@meduniwien.ac.at
- Contact Person Name
- Walter Rinner
- Contact Person Email
- walter.rinner@meduniwien.ac.at
Sponsor
Primary sponsor
- Full Name
- F. Hoffmann-La Roche AG
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- Switzerland
Contract research organisations
- Name
- Almac Clinical Technologies LLC
- Responsibilities
- sponsorDuties codes: ["3"]
- Name
- Labcorp Central Laboratory Services LP
- Responsibilities
- sponsorDuties codes: ["4"]
- Name
- Unilabs A/S
- Responsibilities
- sponsorDuties codes: ["4"]
Third parties
- {"country":"Canada","full_name":"Neurorx Research Inc.","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"Denmark","full_name":"Unilabs A/S","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Laboratory/Research/Testing facility"}
- {"country":"United States","full_name":"Almac Clinical Technologies LLC","duties_or_roles":"sponsorDuties codes: [\"3\"]","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"sponsorDuties codes: [\"4\"]","organisation_type":"Pharmaceutical company"}
- {"country":"Switzerland","full_name":"Neurostatus-UHB AG","duties_or_roles":"EDSS licencing, EDSS e-test and training, EDSS score consultation","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
- Authorised (marketing authorisation number EU/1/17/1231/001)
- Starting Dose
- 300 mg (product name indicates 300 mg concentrate for solution for infusion)
- Maximum Dose
- 600 mg (maxDailyDoseAmount 600 mg)
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