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NCT03599245CompletedPhase 3

This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)

A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

Source: ClinicalTrials.gov · Last updated 25 Sept 2026

Brief summary (registry, in English)

This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

Status (registry)
Completed
Phase (registry)
Phase 3
Study type
Interventional
Enrollment
1055 (actual)
First submitted
25 Jun 2018
Start date
12 Jul 2018
Primary completion date
17 Jul 2025
Lead sponsor
Hoffmann-La Roche
NCT number
NCT03599245
EU CT number
2023-506543-41-00
EudraCT number
2017-004886-29

What you commit to

  • Study type: Interventional · Phase 3
  • Participants enrolled: 1055
  • From 12 Jul 2018 to the primary completion date, 17 Jul 2025
  • 121 sites in 26 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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

Other illness

  • Hypersensitivity to ocrelizumab or to any of its excipients.
  • Participantss in a severely immunocompromised state until the condition resolves.

Other

  • 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

Who the study is looking for

  • Signed Informed Consent Form
  • Able to comply with the study protocol, in the investigator's judgment
  • Completed the treatment period of Roche sponsored ocrelizumab P-trials

Age in the registry: 18 years to 65 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (121)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Hospital Churruca Visca
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Buenos AiresArgentinaUnknown status
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
Coordinator of this site? Confirm its status
Ciudad Autonoma Buenos AiresArgentinaUnknown status
Fundacion Rosarina de Neurorehabilitacion
Coordinator of this site? Confirm its status
RosarioArgentinaUnknown status
Az St-Jan Brugge-Oostende A.V.
Coordinator of this site? Confirm its status
BruggeBelgiumCompleted
Antwerp University Hospital
Coordinator of this site? Confirm its status
EdegemBelgiumCompleted
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes
Coordinator of this site? Confirm its status
La LouviereBelgiumCompleted
CHU de Liège
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LiègeBelgiumCompleted
Noorderhart
Coordinator of this site? Confirm its status
PeltBelgiumCompleted
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD
Coordinator of this site? Confirm its status
SofiaBulgariaCompleted
MHAT National Heart Hospital EAD
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SofiyaBulgariaCompleted
Instituto de Neurologia de Curitiba
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CuritibaBrazilUnknown status
Hospital Sao Lucas - PUCRS
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Porto AlegreBrazilUnknown status
Hospital das Clinicas FMUSP
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São PauloBrazilUnknown status
Clinique NeuroOutaouais
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GatineauCanadaUnknown status
Recherche Sepmus Inc.
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Greenfield ParkCanadaUnknown status
London Health Sciences Centre Uni Campus
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LondonCanadaUnknown status
Montreal Neurological Institute and Hospital
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MontrealCanadaUnknown status
The Ottawa Hospital - General Campus
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OttawaCanadaUnknown status
Sunnybrook Health Sciences Centre
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TorontoCanadaUnknown status
University of British Columbia
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VancouverCanadaUnknown status
Fakultni nemocnice u sv. Anny
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BrnoCzechiaUnknown status
Nemocnice Jihlava
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JihlavaCzechiaUnknown status
VFN Praha Poliklinika Rs Centrum - Budova A
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PragueCzechiaUnknown status
Fakultni nemocnice v Motole
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PragueCzechiaUnknown status
Aalborg University Hospital
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AalborgDenmarkCompleted
Aarhus Universitetshospital
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Aarhus NDenmarkCompleted
Rigshospitalet
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GlostrupDenmarkCompleted
West Tallinn Central Hospital
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TallinnEstoniaUnknown status
East Tallinn Central Hospital
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TallinnEstoniaUnknown status
Tartu University Hospital
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TartuEstoniaUnknown status
Complejo Hospitalario Universitario A Coruña (CHUAC)
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A CoruñaSpainUnknown status
Hospital Vall d'Hebron
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BarcelonaSpainUnknown status
Hospital Puerta del Mar
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CadizSpainUnknown status
Hospital General de Castellon
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CastellonSpainUnknown status
Hospital Universitari de Girona Dr Josep Trueta
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GironaSpainUnknown status
Hospital Universitari de Bellvitge
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L'Hospitalet de LlobregatSpainUnknown status
Hospital Universitari Arnau De Vilanova De Lleida
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LleidaSpainUnknown status
Hospital Universitario Clínico San Carlos
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MadridSpainUnknown status
Universitario de La Princesa
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MadridSpainUnknown status
Hospital Universitario La Paz
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MadridSpainUnknown status
Hospital Universitario 12 de Octubre
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MadridSpainUnknown status
Hospital Universitario Virgen de Arrixaca
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MurciaSpainUnknown status
Hospital Universitario Central De Asturias
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OviedoSpainUnknown status
Hospital Quiron de Madrid
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Pozuelo de AlarcónSpainUnknown status
Hospital Universitario Virgen Macarena
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SevilleSpainUnknown status
Hospital Universitario la Fe
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ValenciaSpainUnknown status
Hospital Clinico Universitario de Valencia
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ValenciaSpainUnknown status
Complejo Hospitalario Universitario de Vigo - Xeral Cies
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VigoSpainUnknown status
Mehiläinen Neo Turku
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TurkuFinlandUnknown status
Besancon University Hospital Center
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Besancon CedexFranceCompleted
Centre hospitalier Universitaire de Bordeaux
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BordeauxFranceCompleted
Hospices Civils de Lyon
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BronFranceCompleted
Chu Gabriel Montpied
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Clermont-FerrandFranceCompleted
Centre Hospitalier General
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GonesseFranceCompleted
Centre Hospitalier Universitaire Grenoble Alpes
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Grenoble Cedex 9FranceCompleted
Centre Hospitalier Universitaire De Lille
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Lille CedexFranceCompleted
CHRU de Nancy
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NancyFranceCompleted
Centre Hospitalier Universitaire de Nice
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NiceFranceCompleted
Centre Hospitalier Universitaire De Nimes
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Nimes Cedex 9FranceCompleted
Centre Hospitalier Intercommunal De Poissy Saint Germain
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PoissyFranceCompleted
CHU De Rouen
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Rouen CedexFranceCompleted
Centre Hospitalier Universitaire de Nantes
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Saint-HerblainFranceCompleted
HIA Sainte Anne
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Toulon Cedex 9FranceCompleted
Royal Devon and Exeter Hospital (Wonford)
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ExeterUnited KingdomUnknown status
Queen Elizabeth University Hospital
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GlasgowUnited KingdomUnknown status
Raigmore Hospital
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InvernessUnited KingdomUnknown status
Leeds Teaching Hospitals NHS Trust
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LeedsUnited KingdomUnknown status
The Royal London Hospital
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LondonUnited KingdomUnknown status
National Hospital For Neurology and Neurosurgery
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LondonUnited KingdomUnknown status
Charing Cross Hospital
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LondonUnited KingdomUnknown status
St. George's Hospital
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LondonUnited KingdomUnknown status
Kings College Hospital
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LondonUnited KingdomUnknown status
Royal Free Hospital
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LondonUnited KingdomUnknown status
Royal Victoria Infirmary
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Newcastle upon TyneUnited KingdomUnknown status
Salford Royal NHS Foundation Trust
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SalfordUnited KingdomUnknown status
Royal Hallamshire Hospita
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SheffieldUnited KingdomUnknown status
Morriston Hospital
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SwanseaUnited KingdomUnknown status
Royal Cornwall Hospital
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TruroUnited KingdomUnknown status
KBC Zagreb
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Grad ZagrebCroatiaCompleted
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
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BudapestHungaryCompleted
VALEOMED Diagnosztikai Központ
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EsztergomHungaryCompleted
St Vincents University Hospital
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DublinIrelandUnknown status
Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di Catania
Coordinator of this site? Confirm its status
CataniaItalyCompleted
Azienda Ospedaliero-Universitaria Sant Andre
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RomeItalyCompleted
Azienda Ospedaliera Policlinico Universitario Tor Vergata
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RomeItalyCompleted
Ibn Sina Hospital
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Kuwait CityKuwaitUnknown status
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
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CuliacánMexicoUnknown status
Unidad de investigacion en salud (UIS)
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Mexico CityMexicoUnknown status
Hospital General de Mexico
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Mexico CityMexicoUnknown status
Amsterdam UMC
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AmsterdamNetherlandsCompleted
Zuyderland Medisch Centrum Stichting
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GeleenNetherlandsCompleted
Groene Hart Ziekenhuis
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GoudaNetherlandsCompleted
Jeroen Bosch Ziekenhuis
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's-HertogenboschNetherlandsCompleted
Helse Stavanger HF
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StavangerNorwayCompleted
Neurocentrum Bydgoszcz sp. z o.o
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BydgoszczPolandCompleted
Malopolskie Centrum Diagnostyczne Medical Sp. z o.o.
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CracowPolandCompleted
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandCompleted
Care Clinic Sp. Z O.O.
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KatowicePolandCompleted
Centrum Neurologii Krzysztof Selmaj
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ŁódźPolandCompleted
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
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LublinPolandCompleted
Instytut Psychiatrii I Neurologii
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WarsawPolandCompleted
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
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WarsawPolandCompleted
CCAB Centro Clinico Academico Braga Associacao
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BragaPortugalCompleted
Centro Hospitalar E Universitărio de Coimbra E.P.E.
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CoimbraPortugalCompleted
Hospital Beatriz Ângelo
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LouresPortugalCompleted
Centro Hospitalar Universitário de Santo Antonio,E.P.E.
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PortoPortugalCompleted
Sahlgrenska University Hospital-Vastra Gotalandsregionen
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GoteborgSwedenCompleted
Region Vaermland
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KarlstadSwedenCompleted
Region Stockholm – SLSO
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StockholmSwedenCompleted
University Medical Center Ljubljana
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LjubljanaSloveniaCompleted
Univerzitetni klinični center Maribor
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MariborSloveniaCompleted
University Hospital Bratislava
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BratislavaSlovakiaCompleted
Fakultna nemocnica Trnava
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TrnavaSlovakiaCompleted
Gazi University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Hacettepe University Medical Faculty
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AnkaraTurkey (Türkiye)Unknown status
Mustafa Kemal Ataturk UTF
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HatayTurkey (Türkiye)Unknown status
Istanbul University Istanbul School of Medicine
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IstanbulTurkey (Türkiye)Unknown status
Istanbul Universitesi Cerrahpasa-Cerrahpasa Tip Fakultesi
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IstanbulTurkey (Türkiye)Unknown status
Selcuk University Medical Faculty
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KonyaTurkey (Türkiye)Unknown status
Ondokuz Mayis University School of Medicine
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SamsunTurkey (Türkiye)Unknown status
Karadeniz Tecnical Uni Med Fac
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TrabzonTurkey (Türkiye)Unknown status

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.