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

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).

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Ocrelizumab

Detailed Description

This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.

• Study Type: Interventional
• Enrollment (Actual): 1055
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Buenos Aires, Argentina, C1437JCP
    • Hospital Churruca Visca
  • Ciudad Autonoma Buenos Aires, Argentina, C1061ABD
    • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • Rosario, Argentina, 2000
    • Fundacion Rosarina de Neurorehabilitacion
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint Jan
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • La Louvière, Belgium, 7100
    • Chu Tivoli
  • Liège, Belgium, 4000
    • CHU de Liège (Sart Tilman)
  • Overpelt, Belgium, 3900
    • Revalidatie en MS Centrum
• Brazil
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
  • São Paulo
    • São Paulo, São Paulo, Brazil, 05403-900
      • Hospital das Clinicas - FMUSP
• Bulgaria
  • Sofia, Bulgaria, 1113
    • Shat Np Sveti Naum
  • Sofia, Bulgaria, 1309
    • Multiprofile Hosp. for Active Treatment
• Canada
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 1Z4
      • University of British Columbia
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre Uni Campus
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital - General Campus
    • Toronto, Ontario, Canada, M4N 3M5
      • Sunnybrook Health Sciences Centre
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 1W2
      • Clinique NeuroOutaouais
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Recherche Sepmus Inc.
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
• Croatia
  • Zagreb, Croatia, 10000
    • Clinical Hospital Centre Zagreb
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny
  • Jihlava, Czechia, 58633
    • Nemocnice Jihlava
  • Prague, Czechia, 12808
    • VFN Praha Poliklinika Rs Centrum - Budova A
  • Prague, Czechia, 150 06
    • Fakultni nemocnice v Motole
• Denmark
  • Aalborg, Denmark, 9000
    • Aalborg Universitetshospital
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital
  • Glostrup Municipality, Denmark, 2600
    • Rigshospitalet Glostrup
  • Odense C, Denmark, 5000
    • Odense Universitetshospital, Neurologisk Afdeling N
  • Sønderborg, Denmark, 6400
    • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
• Estonia
  • Tallinn, Estonia, 10138
    • East Tallinn Central Hospital
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tartu, Estonia, 51014
    • Tartu University Hospital
• Finland
  • Turku, Finland, 20520
    • Mehiläinen Neo Turku
• France
  • Besançon, France, 25030
    • CHU de Besancon Hopital Jean Minjoz
  • Bordeaux, France, 33076
    • Groupe Hospitalier Pellegrin
  • Bron, France, 69677
    • Hopital neurologique Pierre Wertheimer - CHU Lyon
  • Clermont-Ferrand, France, 63003
    • Hopital Gabriel Montpied CHU de Clermont-Ferrand
  • Gonesse, France, 95503
    • CH de Gonesse
  • La Tronche, France, 38700
    • CHU de Grenoble
  • Lille, France, 59037
    • Hopital Roger Salengro Service de Neurologie
  • Marseille, France, 13005
    • CHU de la Timone - Hopital d Adultes
  • Montpellier, France, 34295
    • Hôpital Gui de Chauliac
  • Nancy, France, 54035
    • Hopital Central - CHU de Nancy
  • Nice, France, 06002
    • Hôpital Pasteur
  • Nîmes, France, 30900
    • CHU de Nîmes Hopital Caremeau
  • Paris, France, 75651
    • Groupe Hospitalier Pitié- Salpétrière
  • Poissy, France, 78300
    • Hôpital de Poissy
  • Rouen, France, 76031
    • CHU de Rouen Hopital
  • Strasbourg, France, 67098
    • Hôpital Hautepierre
  • Toulon, France, 83041
    • HIA de Toulon hôpital militaire
• Hungary
  • Budapest, Hungary, 1204
    • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
  • Esztergom, Hungary, 2500
    • VALEOMED Diagnosztikai Központ
• Ireland
  • Dublin, Ireland
    • St Vincents University Hospital
• Italy
  • Abruzzo
    • Chieti, Abruzzo, Italy, 66013
      • Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
    • L’Aquila, Abruzzo, Italy, 67100
      • Ospedale San Salvatore
  • Apulia
    • San Giovanni Rotondo, Apulia, Italy, 71013
      • IRCCS Ospedale Casa Sollievo della Sofferenza
  • Campania
    • Napoli, Campania, Italy, 80131
      • Università degli studi della Campania Luigi Vanvitelli
    • Napoli, Campania, Italy, 80131
      • A. O. U. Federico II
  • Emilia-Romagna
    • Bologna, Emilia-Romagna, Italy, 40139
      • Ospedale Bellaria
  • Lazio
    • Rome, Lazio, Italy, 00168
      • Policlinico Universitario A. Gemelli
    • Rome, Lazio, Italy, 00189
      • Azienda Ospedaliera Sant'Andrea
    • Rome, Lazio, Italy, 00152
      • Ospedale S.Camillo Forlanini
    • Rome, Lazio, Italy, 00133
      • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • Irccs A.O.U.San Martino Ist
  • Lombardy
    • Bergamo, Lombardy, Italy, 24127
      • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
    • Gallarate, Lombardy, Italy, 21013
      • Ospedale S.Antonio Abate
    • Milan, Lombardy, Italy, 20132
      • Irccs Ospedale San Raffaele
    • Milan, Lombardy, Italy, 20133
      • Fond. Istituto Neurologico C.Besta
    • Milan, Lombardy, Italy, 20122
      • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
    • Montichiari, Lombardy, Italy, 25018
      • Ospedale Civile di Montichiari
    • Pavia, Lombardy, Italy, 27100
      • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • IRCCS Istituto Neurologico Neuromed
  • Sardinia
    • Cagliari, Sardinia, Italy, 09126
      • Ospedale Binaghi
  • Sicily
    • Catania, Sicily, Italy, 95123
      • AOU Policlinico V. Emanuele - P.O G. Rodolico
    • Cefalù, Sicily, Italy, 90015
      • Fondazione Istituto S. Raffaele - Giglio
    • Palermo, Sicily, Italy, 90129
      • AOU Policlinico Giaccone
    • Palermo, Sicily, Italy, 90146
      • AO Ospedali Riuniti Villa Sofia-Cervello
  • The Marches
    • Ancona, The Marches, Italy, 60100
      • AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi
  • Tuscany
    • Florence, Tuscany, Italy, 50134
      • AOU Careggi
    • Florence, Tuscany, Italy, 50134
      • AOUC Azienda Ospedaliero-Universitaria Careggi
    • Siena, Tuscany, Italy, 53100
      • AOU Senese - Presidio Ospedaliero Le Scotte
  • Umbria
    • Perugia, Umbria, Italy, 06156
      • AO di Perugia - Ospedale S. Maria della Misericordia
  • Veneto
    • Padua, Veneto, Italy, 35128
      • Azienda Ospedaliera Di Padova
    • Verona, Veneto, Italy, 37134
      • Policlinico G.B. Rossi
• Kuwait
  • Kuwait City, Kuwait, 10002
    • Ibn Sina Hospital
• Mexico
  • Mexico City, Mexico, 14050
    • Unidad de investigacion en salud (UIS)
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06726
      • Hospital General de Mexico
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
• Netherlands
  • 's-Hertogenbosch, Netherlands, 5223 GZ
    • Jeroen Bosch Ziekenhuis
  • Amsterdam, Netherlands, 1081 HV
    • Amsterdam UMC Location VUMC
  • Breda, Netherlands, 4819 EV
    • Amphia Ziekenhuis
  • Gouda, Netherlands, 2803 HH
    • Groene Hart Ziekenhuis
  • NL -rotterdam, Netherlands, 3079 DZ
    • Maasstadziekenhuis
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard Geleen
  • Tilburg, Netherlands, 5022 GC
    • Elisabeth-Tweesteden Ziekenhuis
• Norway
  • Bergen, Norway, 5021
    • Haukeland Universitetssykehus
  • Drammen, Norway, 3004
    • Sykehuset Buskerud HF
  • Stavanger, Norway, 4011
    • Stavanger Universitetssykehus, Helse Stavanger HF
• Poland
  • Bydgoszcz, Poland, 85-796
    • Neurocentrum Bydgoszcz sp. z o.o
  • Gdansk, Poland, 80-803
    • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
  • Katowice, Poland, 40-568
    • CaRe Clinic
  • Krakow, Poland, 31-637
    • Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
  • Lodz, Poland, 90-324
    • Centrum Neurologii Krzysztof Selmaj
  • Lublin, Poland, 20-410
    • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Warsaw, Poland, 02-097
    • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
  • Warsaw, Poland, 02-957
    • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
• Portugal
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal, 3000-075
    • HUC
  • Loures, Portugal, 2674-514
    • Hospital Beatriz Ângelo
  • Porto, Portugal, 4099-001
    • Hospital Geral de Santo Antonio
• Slovakia
  • Bratislava, Slovakia, 813 69
    • Univerzitna nemocnica Bratislava
  • Bratislava, Slovakia, 826 06
    • Univerzitna nemocnica Bratislava Nemocnica Ruzinov
  • Trnava, Slovakia, 917 75
    • Fakultna nemocnica Trnava
• Slovenia
  • Ljubljana, Slovenia, 1000
    • University Medical Centre
  • Maribor, Slovenia, 2000
    • University Medical Centre Maribor
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Girona, Spain, 17007
    • Hospital Universitari de Girona Dr. Josep Trueta
  • Madrid, Spain, 28041
    • Hospital Universitario 12 de Octubre
  • Madrid, Spain, 28046
    • Hospital Universitario La Paz
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Madrid, Spain, 28006
    • Universitario de La Princesa
  • Murcia, Spain
    • Hospital Universitario Virgen de Arrixaca
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia
  • Valencia, Spain, 46026
    • Hospital Universitario La Fe
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Castellon
    • Castellon, Castellon, Spain, 12004
      • Hospital General de Castellón
  • LA Coruna
    • A Coruña, LA Coruna, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC)
  • Lerida
    • Lleida, Lerida, Spain, 25198
      • Hospital Universitari Arnau de Vilanova de Lleida
  • Madrid
    • Pozuelo de Alarcón, Madrid, Spain, 28223
      • Hospital Quiron de Madrid
  • Pontevedra
    • Vigo, Pontevedra, Spain, 36312
      • Complejo Hospitalario Universitario de Vigo - Xeral Cies
  • Principality of Asturias
    • Oviedo, Principality of Asturias, Spain
      • Hospital Universitario Central de Asturias
• Sweden
  • Gothenburg, Sweden, 413 45
    • Sahlgrenska Sjukhuset
  • Karlstad, Sweden, 65185
    • Centralsjukhuset
  • Stockholm, Sweden, 113 41
    • Centrum för neurologi
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06500
    • Gazi University Medical Faculty
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe University Medical Faculty
  • Hatay, Turkey (Türkiye), 31001
    • Mustafa Kemal Ataturk UTF
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul University Istanbul School of Medicine
  • Konya, Turkey (Türkiye), 42131
    • Selcuk University Medical Faculty
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayis University School of Medicine
  • Trabzon, Turkey (Türkiye), 61080
    • Karadeniz Tecnical Uni. Med. Fac.
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital (Wonford)
  • Glasgow, United Kingdom, G51 4TF
    • Queen Elizabeth University Hospital
  • Inverness, United Kingdom, IV2 3UV
    • Raigmore Hospital
  • Leeds, United Kingdom, LS9 7AU
    • Leeds Teaching Hospitals NHS Trust
  • London, United Kingdom, SW17 0QT
    • St George's Hospital
  • London, United Kingdom, W6 8RF
    • Charing Cross Hospital
  • London, United Kingdom, SE5 9RS
    • Kings College Hospital
  • London, United Kingdom, E1 1BB
    • The Royal London Hospital
  • London, United Kingdom, NW3 2QS
    • Royal Free Hospital
  • London, United Kingdom, WC1 3BG
    • National Hospital for Neurology and Neurosurgery,
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Salford, United Kingdom, M6 8HD
    • Salford Royal NHS Foundation Trust
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospita
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital
  • Truro, United Kingdom, TR1 3LQ
    • Royal Cornwall Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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

Exclusion Criteria:

• Hypersensitivity to ocrelizumab or to any of its excipients.
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ocrelizumab; Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.	Drug: Ocrelizumab; Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks		Up to 2 Years
Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment		Up to 2 years
Percentage of participants who have improved, stable or worsened disability compared with baseline	Improved, stable or worsened disability is measured by expanded disability status scale (EDSS) (annually/by epoch and over duration of the study) Stable EDSS is defined as EDSS change +/- 0.5. Worsening is > 0.5 increase of EDSS, Improvement is >0.5 decrease of EDSS	Up to 2 years
Mean change from inclusion in parent study in EDSS score over the course of the treatment		Up to 2 years
Time to 20% increase in timed 25-foot walk test (T25FWT)	Time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end treatment	Up to 2 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to first protocol-defined event of disease activity		Up to 2 Years
Time to first relapse		Up to 2 Years
Annualized relapse rate		Up to 2 Years
Percentage of participants relapse free, yearly and over the course of the treatment		Up to 2 Years
Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment	Disease activity is defined as at least one the following events: protocol-defined relapse; 24 weeks CDP based on increases in EDSS; a T1 Gadolinium (Gd)-enhanced lesion; or a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI).	Up to 2 Years
Percentage of participants with no evidence of progression (NEP)	NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20% increase in timed T25FWT; 20% increase in timed 9HPT yearly and over the course of the treatment	Up to 2 Years
Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)	NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion yearly and over the course of the treatment	Up to 2 Years
Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)		Up to 2 Years
Total number of T1 Gd-enhancing lesions as detected by brain MRI over time		Up to 2 Years
Total number of new and/or enlarging T2 lesion as detected by brain MRI over time		Up to 2 Years
Change in total T1 hypointense lesion volume over time		Up to 2 Years
Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time		Up to 2 Years
Change in brain volume (grey and white matter) as detected by brain MRI over time		Up to 2 Years
Presence and evolution of leptomeningeal follicles as detected by MRI		Up to 2 Years
Time to treatment discontinuation/switch		Up to 2 Years
Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])		Up to 2 Years
Participant reported outcomes: SymptoMScreen Score		Up to 2 Years
Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)		Up to 2 Years
Percentage of Participants with Adverse Events		Up to 2 Years
Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period		Up to 2 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): July 12, 2018
• Primary Completion (Actual): July 17, 2025
• Study Completion (Actual): July 17, 2025

Study Registration Dates

• First Submitted: June 25, 2018
• First Submitted That Met QC Criteria: July 23, 2018
• First Posted (Actual): July 26, 2018

Study Record Updates

• Last Update Posted (Actual): November 12, 2025
• Last Update Submitted That Met QC Criteria: November 11, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Immunologic Factors; Physiological Effects of Drugs; ocrelizumab
• Other Study ID Numbers: MN39158; 2017-004886-29 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No