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

NCT03599245 | Completed Phase 3 FDA Drug

• 2 other identifiers: MN391582017-004886-29
• Study Type: interventional
• Target: 1,055
• Locations: 24 countries
• Sites: 153

Brief Summary

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).

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (20)

• 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

  Up to 2 Years

Study Arms (1)

Ocrelizumab

EXPERIMENTAL

Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.

Ocrelizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (159)

Hospital Churruca Visca

Buenos Aires, C1437JCP, Argentina

Location

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

Ciudad Autonoma Buenos Aires, C1061ABD, Argentina

Location

Fundacion Rosarina de Neurorehabilitacion

Rosario, 2000, Argentina

Location

AZ Sint Jan

Bruges, 8000, Belgium

Location

UZ Antwerpen

Edegem, 2650, Belgium

Location

CHU Tivoli

La Louvière, 7100, Belgium

Location

CHU de Liège (Sart Tilman)

Liège, 4000, Belgium

Location

Revalidatie en MS Centrum

Overpelt, 3900, Belgium

Location

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

Location

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

Location

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, 05403-900, Brazil

Location

Shat Np Sveti Naum

Sofia, 1113, Bulgaria

Location

Multiprofile Hosp. for Active Treatment

Sofia, 1309, Bulgaria

Location

University of British Columbia

Vancouver, British Columbia, V6T 1Z4, Canada

Location

London Health Sciences Centre Uni Campus

London, Ontario, N6A 5A5, Canada

Location

The Ottawa Hospital - General Campus

Ottawa, Ontario, K1H 8L6, Canada

Location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Clinique NeuroOutaouais

Gatineau, Quebec, J8Y 1W2, Canada

Location

Recherche Sepmus Inc.

Greenfield Park, Quebec, J4V 2J2, Canada

Location

Montreal Neurological Institute and Hospital

Montreal, Quebec, H3A 2B4, Canada

Location

Clinical Hospital Centre Zagreb

Zagreb, 10000, Croatia

Location

Fakultni nemocnice u sv. Anny

Brno, 656 91, Czechia

Location

Nemocnice Jihlava

Jihlava, 58633, Czechia

Location

VFN Praha Poliklinika Rs Centrum - Budova A

Prague, 12808, Czechia

Location

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

Location

Aalborg Universitetshospital

Aalborg, 9000, Denmark

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

Rigshospitalet Glostrup

Glostrup Municipality, 2600, Denmark

Location

Odense Universitetshospital, Neurologisk Afdeling N

Odense C, 5000, Denmark

Location

Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

Sønderborg, 6400, Denmark

Location

East Tallinn Central Hospital

Tallinn, 10138, Estonia

Location

West Tallinn Central Hospital

Tallinn, 10617, Estonia

Location

Tartu University Hospital

Tartu, 51014, Estonia

Location

Mehiläinen Neo Turku

Turku, 20520, Finland

Location

CHU de Besancon Hopital Jean Minjoz

Besançon, 25030, France

Location

Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Hopital neurologique Pierre Wertheimer - CHU Lyon

Bron, 69677, France

Location

Hopital Gabriel Montpied CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

CH de Gonesse

Gonesse, 95503, France

Location

CHU de Grenoble

La Tronche, 38700, France

Location

Hopital Roger Salengro Service de Neurologie

Lille, 59037, France

Location

CHU de la Timone - Hopital d Adultes

Marseille, 13005, France

Location

Hopital Gui de Chauliac

Montpellier, 34295, France

Location

Hopital Central - CHU de Nancy

Nancy, 54035, France

Location

Hôpital Pasteur

Nice, 06002, France

Location

CHU de Nîmes Hopital Caremeau

Nîmes, 30900, France

Location

Groupe Hospitalier Pitié- Salpétrière

Paris, 75651, France

Location

Hôpital de Poissy

Poissy, 78300, France

Location

CHU de Rouen Hopital

Rouen, 76031, France

Location

Höpital Hautepierre

Strasbourg, 67098, France

Location

HIA de Toulon hôpital militaire

Toulon, 83041, France

Location

Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet

Budapest, 1204, Hungary

Location

VALEOMED Diagnosztikai Központ

Esztergom, 2500, Hungary

Location

St Vincents University Hospital

Dublin, Ireland

Location

Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

Chieti, Abruzzo, 66013, Italy

Location

Ospedale San Salvatore

L’Aquila, Abruzzo, 67100, Italy

Location

IRCCS Ospedale Casa Sollievo Della Sofferenza

San Giovanni Rotondo, Apulia, 71013, Italy

Location

A. O. U. Federico II

Napoli, Campania, 80131, Italy

Location

Università degli Studi della Campania Luigi Vanvitelli

Napoli, Campania, 80131, Italy

Location

Ospedale Bellaria

Bologna, Emilia-Romagna, 40139, Italy

Location

Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

Rome, Lazio, 00133, Italy

Location

Ospedale S.Camillo Forlanini

Rome, Lazio, 00152, Italy

Location

Policlinico Universitario A. Gemelli

Rome, Lazio, 00168, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, 00189, Italy

Location

Irccs A.O.U.San Martino Ist

Genoa, Liguria, 16132, Italy

Location

ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

Bergamo, Lombardy, 24127, Italy

Location

Ospedale S.Antonio Abate

Gallarate, Lombardy, 21013, Italy

Location

Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

Milan, Lombardy, 20122, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Fond. Istituto Neurologico C.Besta

Milan, Lombardy, 20133, Italy

Location

Ospedale Civile di Montichiari

Montichiari, Lombardy, 25018, Italy

Location

IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

Pavia, Lombardy, 27100, Italy

Location

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, 86077, Italy

Location

Ospedale Binaghi

Cagliari, Sardinia, 09126, Italy

Location

AOU Policlinico V. Emanuele - P.O G. Rodolico

Catania, Sicily, 95123, Italy

Location

Fondazione Istituto S. Raffaele - Giglio

Cefalù, Sicily, 90015, Italy

Location

AOU Policlinico Giaccone

Palermo, Sicily, 90129, Italy

Location

AO Ospedali Riuniti Villa Sofia-Cervello

Palermo, Sicily, 90146, Italy

Location

AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi

Ancona, The Marches, 60100, Italy

Location

AOU Careggi

Florence, Tuscany, 50134, Italy

Location

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

AOU Senese - Presidio Ospedaliero Le Scotte

Siena, Tuscany, 53100, Italy

Location

AO di Perugia - Ospedale S. Maria della Misericordia

Perugia, Umbria, 06156, Italy

Location

Azienda Ospedaliera di Padova

Padua, Veneto, 35128, Italy

Location

Policlinico G.B. Rossi

Verona, Veneto, 37134, Italy

Location

Ibn Sina Hospital

Kuwait City, 10002, Kuwait

Location

Hospital General de México

Mexico City, Mexico CITY (federal District), 06726, Mexico

Location

Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

Culiacán, Sinaloa, 80020, Mexico

Location

Unidad de investigacion en salud (UIS)

Mexico City, 14050, Mexico

Location

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, 5223 GZ, Netherlands

Location

Amsterdam UMC Location VUMC

Amsterdam, 1081 HV, Netherlands

Location

Amphia Ziekenhuis

Breda, 4819 EV, Netherlands

Location

Groene Hart Ziekenhuis

Gouda, 2803 HH, Netherlands

Location

Maasstadziekenhuis

NL -rotterdam, 3079 DZ, Netherlands

Location

Zuyderland Medisch Centrum - Sittard Geleen

Sittard-Geleen, 6162 BG, Netherlands

Location

Elisabeth-TweeSteden Ziekenhuis

Tilburg, 5022 GC, Netherlands

Location

Haukeland universitetssykehus

Bergen, 5021, Norway

Location

Sykehuset Buskerud HF

Drammen, 3004, Norway

Location

Stavanger Universitetssykehus, Helse Stavanger HF

Stavanger, 4011, Norway

Location

Neurocentrum Bydgoszcz sp. z o.o

Bydgoszcz, 85-796, Poland

Location

COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika

Gdansk, 80-803, Poland

Location

Care Clinic

Katowice, 40-568, Poland

Location

Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

Krakow, 31-637, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, 90-324, Poland

Location

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, 20-410, Poland

Location

Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

Warsaw, 02-097, Poland

Location

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

Warsaw, 02-957, Poland

Location

Hospital de Braga

Braga, 4710-243, Portugal

Location

HUC

Coimbra, 3000-075, Portugal

Location

Hospital Beatriz Angelo

Loures, 2674-514, Portugal

Location

Hospital Geral de Santo Antonio

Porto, 4099-001, Portugal

Location

Univerzitna nemocnica Bratislava

Bratislava, 813 69, Slovakia

Location

Univerzitna nemocnica Bratislava Nemocnica Ruzinov

Bratislava, 826 06, Slovakia

Location

Fakultna nemocnica Trnava

Trnava, 917 75, Slovakia

Location

University Medical Centre

Ljubljana, 1000, Slovenia

Location

University Medical Centre Maribor

Maribor, 2000, Slovenia

Location

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital General de Castellon

Castellon, Castellon, 12004, Spain

Location

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, 15006, Spain

Location

Hospital Universitari Arnau de Vilanova de Lleida

Lleida, Lerida, 25198, Spain

Location

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Complejo Hospitalario Universitario de Vigo - Xeral Cies

Vigo, Pontevedra, 36312, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Puerta del Mar

Cadiz, 11009, Spain

Location

Hospital Universitari de Girona Dr. Josep Trueta

Girona, 17007, Spain

Location

Universitario de La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Clínico San Carlos

Madrid, 28040, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Hospital Universitario La Paz

Madrid, 28046, Spain

Location

Hospital Universitario Virgen de Arrixaca

Murcia, Spain

Location

Hospital Clinico Universitario de Valencia

Valencia, 46010, Spain

Location

Hospital Universitario la Fe

Valencia, 46026, Spain

Location

Sahlgrenska Sjukhuset

Gothenburg, 413 45, Sweden

Location

Centralsjukhuset

Karlstad, 65185, Sweden

Location

Centrum för Neurologi

Stockholm, 113 41, Sweden

Location

Hacettepe University Medical Faculty

Ankara, 06100, Turkey (Türkiye)

Location

Gazi University Medical Faculty

Ankara, 06500, Turkey (Türkiye)

Location

Mustafa Kemal Ataturk UTF

Hatay, 31001, Turkey (Türkiye)

Location

Istanbul University Istanbul School of Medicine

Istanbul, 34093, Turkey (Türkiye)

Location

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

Istanbul, 34098, Turkey (Türkiye)

Location

Selcuk University Medical Faculty

Konya, 42131, Turkey (Türkiye)

Location

Ondokuz Mayis University School of Medicine

Samsun, 55139, Turkey (Türkiye)

Location

Karadeniz Tecnical Uni. Med. Fac.

Trabzon, 61080, Turkey (Türkiye)

Location

Royal Devon and Exeter Hospital (Wonford)

Exeter, EX2 5DW, United Kingdom

Location

Queen Elizabeth University Hospital

Glasgow, G51 4TF, United Kingdom

Location

Raigmore Hospital

Inverness, IV2 3UV, United Kingdom

Location

Leeds Teaching Hospitals NHS Trust

Leeds, LS9 7AU, United Kingdom

Location

The Royal London Hospital

London, E1 1BB, United Kingdom

Location

Royal Free Hospital

London, NW3 2QS, United Kingdom

Location

Kings College Hospital

London, SE5 9RS, United Kingdom

Location

St George's Hospital

London, SW17 0QT, United Kingdom

Location

Charing Cross Hospital

London, W6 8RF, United Kingdom

Location

National Hospital for Neurology and Neurosurgery,

London, WC1 3BG, United Kingdom

Location

Royal Victoria Infirmary

Newcastle upon Tyne, NE1 4LP, United Kingdom

Location

Salford Royal NHS Foundation Trust

Salford, M6 8HD, United Kingdom

Location

Royal Hallamshire Hospita

Sheffield, S10 2JF, United Kingdom

Location

Morriston Hospital

Swansea, SA6 6NL, United Kingdom

Location

Royal Cornwall Hospital

Truro, TR1 3LQ, United Kingdom

Location

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 25, 2018
• First Posted: July 26, 2018
• Study Start: July 12, 2018
• Primary Completion: July 17, 2025
• Study Completion: July 17, 2025
• Last Updated: November 12, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share

Locations

TU (8); BU (2); HU (2); CZ (4); BR (3); ME (3); AR (3); NL (7); DK (5); BE (5); CR (1); PT (4); IE (1); KU (1); SL (2); CA (7); ES (17); FI (1); SE (3); NO (3); GB (15); FR (17); IT (31); PL (8)