This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
NCT ID: NCT03599245
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
1055 participants
INTERVENTIONAL
2018-07-12
2025-07-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ocrelizumab
Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
Ocrelizumab
Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.
Interventions
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Ocrelizumab
Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.
Eligibility Criteria
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Inclusion Criteria
* Able to comply with the study protocol, in the investigator's judgment
* Completed the treatment period of Roche sponsored ocrelizumab P-trials
Exclusion Criteria
* Participantss in a severely immunocompromised state until the condition resolves.
* Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
* Existence of a contra-indication as per SmPC
* Prohibited concomitant medication as specified in protocol
* Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Hospital Churruca Visca
Buenos Aires, , Argentina
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
Ciudad Autonoma Buenos Aires, , Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario, , Argentina
AZ Sint Jan
Bruges, , Belgium
UZ Antwerpen
Edegem, , Belgium
CHU Tivoli
La Louvière, , Belgium
CHU de Liège (Sart Tilman)
Liège, , Belgium
Revalidatie en MS Centrum
Overpelt, , Belgium
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, Brazil
Shat Np Sveti Naum
Sofia, , Bulgaria
Multiprofile Hosp. for Active Treatment
Sofia, , Bulgaria
University of British Columbia
Vancouver, British Columbia, Canada
London Health Sciences Centre Uni Campus
London, Ontario, Canada
The Ottawa Hospital - General Campus
Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Clinique NeuroOutaouais
Gatineau, Quebec, Canada
Recherche Sepmus Inc.
Greenfield Park, Quebec, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, Canada
Clinical Hospital Centre Zagreb
Zagreb, , Croatia
Fakultni nemocnice u sv. Anny
Brno, , Czechia
Nemocnice Jihlava
Jihlava, , Czechia
VFN Praha Poliklinika Rs Centrum - Budova A
Prague, , Czechia
Fakultni nemocnice v Motole
Prague, , Czechia
Aalborg Universitetshospital
Aalborg, , Denmark
Aarhus Universitetshospital
Aarhus N, , Denmark
Rigshospitalet Glostrup
Glostrup Municipality, , Denmark
Odense Universitetshospital, Neurologisk Afdeling N
Odense C, , Denmark
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
Sønderborg, , Denmark
East Tallinn Central Hospital
Tallinn, , Estonia
West Tallinn Central Hospital
Tallinn, , Estonia
Tartu University Hospital
Tartu, , Estonia
Mehiläinen Neo Turku
Turku, , Finland
CHU de Besancon Hopital Jean Minjoz
Besançon, , France
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon
Bron, , France
Hopital Gabriel Montpied CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CH de Gonesse
Gonesse, , France
CHU de Grenoble
La Tronche, , France
Hopital Roger Salengro Service de Neurologie
Lille, , France
CHU de la Timone - Hopital d Adultes
Marseille, , France
Hopital Gui de Chauliac
Montpellier, , France
Hopital Central - CHU de Nancy
Nancy, , France
Hôpital Pasteur
Nice, , France
CHU de Nîmes Hopital Caremeau
Nîmes, , France
Groupe Hospitalier Pitié- Salpétrière
Paris, , France
Hôpital de Poissy
Poissy, , France
CHU de Rouen Hopital
Rouen, , France
Höpital Hautepierre
Strasbourg, , France
HIA de Toulon hôpital militaire
Toulon, , France
Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
Budapest, , Hungary
VALEOMED Diagnosztikai Központ
Esztergom, , Hungary
St Vincents University Hospital
Dublin, , Ireland
Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
Chieti, Abruzzo, Italy
Ospedale San Salvatore
L’Aquila, Abruzzo, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza
San Giovanni Rotondo, Apulia, Italy
A. O. U. Federico II
Napoli, Campania, Italy
Università degli Studi della Campania Luigi Vanvitelli
Napoli, Campania, Italy
Ospedale Bellaria
Bologna, Emilia-Romagna, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, Italy
Ospedale S.Camillo Forlanini
Rome, Lazio, Italy
Policlinico Universitario A. Gemelli
Rome, Lazio, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, Italy
Irccs A.O.U.San Martino Ist
Genoa, Liguria, Italy
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
Bergamo, Lombardy, Italy
Ospedale S.Antonio Abate
Gallarate, Lombardy, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Lombardy, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy
Ospedale Civile di Montichiari
Montichiari, Lombardy, Italy
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Pavia, Lombardy, Italy
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, Italy
Ospedale Binaghi
Cagliari, Sardinia, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
Catania, Sicily, Italy
Fondazione Istituto S. Raffaele - Giglio
Cefalù, Sicily, Italy
AOU Policlinico Giaccone
Palermo, Sicily, Italy
AO Ospedali Riuniti Villa Sofia-Cervello
Palermo, Sicily, Italy
AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi
Ancona, The Marches, Italy
AOU Careggi
Florence, Tuscany, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
AOU Senese - Presidio Ospedaliero Le Scotte
Siena, Tuscany, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
Perugia, Umbria, Italy
Azienda Ospedaliera di Padova
Padua, Veneto, Italy
Policlinico G.B. Rossi
Verona, Veneto, Italy
Ibn Sina Hospital
Kuwait City, , Kuwait
Hospital General de México
Mexico City, Mexico CITY (federal District), Mexico
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
Culiacán, Sinaloa, Mexico
Unidad de investigacion en salud (UIS)
Mexico City, , Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, , Netherlands
Amsterdam UMC Location VUMC
Amsterdam, , Netherlands
Amphia Ziekenhuis
Breda, , Netherlands
Groene Hart Ziekenhuis
Gouda, , Netherlands
Maasstadziekenhuis
NL -rotterdam, , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, , Netherlands
Elisabeth-TweeSteden Ziekenhuis
Tilburg, , Netherlands
Haukeland universitetssykehus
Bergen, , Norway
Sykehuset Buskerud HF
Drammen, , Norway
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger, , Norway
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz, , Poland
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
Gdansk, , Poland
Care Clinic
Katowice, , Poland
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
Krakow, , Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, , Poland
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Warsaw, , Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, , Poland
Hospital de Braga
Braga, , Portugal
HUC
Coimbra, , Portugal
Hospital Beatriz Angelo
Loures, , Portugal
Hospital Geral de Santo Antonio
Porto, , Portugal
Univerzitna nemocnica Bratislava
Bratislava, , Slovakia
Univerzitna nemocnica Bratislava Nemocnica Ruzinov
Bratislava, , Slovakia
Fakultna nemocnica Trnava
Trnava, , Slovakia
University Medical Centre
Ljubljana, , Slovenia
University Medical Centre Maribor
Maribor, , Slovenia
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Castellon
Castellon, Castellon, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, Spain
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Lerida, Spain
Hospital Quiron de Madrid
Pozuelo de Alarcón, Madrid, Spain
Complejo Hospitalario Universitario de Vigo - Xeral Cies
Vigo, Pontevedra, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Puerta del Mar
Cadiz, , Spain
Hospital Universitari de Girona Dr. Josep Trueta
Girona, , Spain
Universitario de La Princesa
Madrid, , Spain
Hospital Universitario Clínico San Carlos
Madrid, , Spain
Hospital Universitario 12 de Octubre
Madrid, , Spain
Hospital Universitario La Paz
Madrid, , Spain
Hospital Universitario Virgen de Arrixaca
Murcia, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Sahlgrenska Sjukhuset
Gothenburg, , Sweden
Centralsjukhuset
Karlstad, , Sweden
Centrum för Neurologi
Stockholm, , Sweden
Hacettepe University Medical Faculty
Ankara, , Turkey (Türkiye)
Gazi University Medical Faculty
Ankara, , Turkey (Türkiye)
Mustafa Kemal Ataturk UTF
Hatay, , Turkey (Türkiye)
Istanbul University Istanbul School of Medicine
Istanbul, , Turkey (Türkiye)
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
Istanbul, , Turkey (Türkiye)
Selcuk University Medical Faculty
Konya, , Turkey (Türkiye)
Ondokuz Mayis University School of Medicine
Samsun, , Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.
Trabzon, , Turkey (Türkiye)
Royal Devon and Exeter Hospital (Wonford)
Exeter, , United Kingdom
Queen Elizabeth University Hospital
Glasgow, , United Kingdom
Raigmore Hospital
Inverness, , United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, , United Kingdom
The Royal London Hospital
London, , United Kingdom
Royal Free Hospital
London, , United Kingdom
Kings College Hospital
London, , United Kingdom
St George's Hospital
London, , United Kingdom
Charing Cross Hospital
London, , United Kingdom
National Hospital for Neurology and Neurosurgery,
London, , United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, , United Kingdom
Salford Royal NHS Foundation Trust
Salford, , United Kingdom
Royal Hallamshire Hospita
Sheffield, , United Kingdom
Morriston Hospital
Swansea, , United Kingdom
Royal Cornwall Hospital
Truro, , United Kingdom
Countries
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Other Identifiers
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2017-004886-29
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MN39158
Identifier Type: -
Identifier Source: org_study_id