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MS drug ocrelizumab tested for Long-Term safety and effectiveness

NCT ID NCT03599245

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study followed over 1,000 people with multiple sclerosis who had already taken ocrelizumab in earlier trials. Participants received a 600-mg infusion every 24 months for two years. Researchers tracked disability progression, relapse rates, and safety to see if the drug remains effective and safe over the long term.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ocrelizumab
What this could lead to
If successful, this could confirm ocrelizumab as a safe, long-term treatment option to control multiple sclerosis and slow disability progression.
What could go wrong
This is an extension study without a placebo group, so results may be less definitive. Long-term risks like infections or infusion reactions remain possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

1,055 people

The number who actually took part.

Started

Jul 2018

Finished

Jul 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • A. O. U. Federico II

    Naples, Campania, 80131, Italy

  • AO Ospedali Riuniti Villa Sofia-Cervello

    Palermo, Sicily, 90146, Italy

  • AO di Perugia - Ospedale S. Maria della Misericordia

    Perugia, Umbria, 06156, Italy

  • AOU Careggi

    Florence, Tuscany, 50134, Italy

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

    Ancona, The Marches, 60100, Italy

  • AOU Policlinico Giaccone

    Palermo, Sicily, 90129, Italy

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

    Catania, Sicily, 95123, Italy

  • AOU Senese - Presidio Ospedaliero Le Scotte

    Siena, Tuscany, 53100, Italy

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

    Bergamo, Lombardy, 24127, Italy

  • AZ Sint Jan

    Bruges, 8000, Belgium

  • Aalborg Universitetshospital

    Aalborg, 9000, Denmark

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • Amphia Ziekenhuis

    Breda, 4819 EV, Netherlands

  • Amsterdam UMC Location VUMC

    Amsterdam, 1081 HV, Netherlands

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189, Italy

  • Azienda Ospedaliera di Padova

    Padova, Veneto, 35128, Italy

  • Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet

    Budapest, 1204, Hungary

  • CH de Gonesse

    Gonesse, 95503, France

  • CHU Tivoli

    La Louvière, 7100, Belgium

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, 25030, France

  • CHU de Grenoble

    La Tronche, 38700, France

  • CHU de Liège (Sart Tilman)

    Liège, 4000, Belgium

  • CHU de Nîmes Hopital Caremeau

    Nîmes, 30900, France

  • CHU de Rouen Hopital

    Rouen, 76031, France

  • CHU de la Timone - Hopital d Adultes

    Marseille, 13005, France

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

    Gdansk, 80-803, Poland

  • Care Clinic

    Katowice, 40-568, Poland

  • Centralsjukhuset

    Karlstad, 65185, Sweden

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    Ciudad Autonoma Buenos Aires, C1061ABD, Argentina

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Centrum för Neurologi

    Stockholm, 113 41, Sweden

  • Charing Cross Hospital

    London, W6 8RF, United Kingdom

  • Clinical Hospital Centre Zagreb

    Zagreb, 10000, Croatia

  • Clinique NeuroOutaouais

    Gatineau, Quebec, J8Y 1W2, Canada

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006, Spain

  • Complejo Hospitalario Universitario de Vigo - Xeral Cies

    Vigo, Pontevedra, 36312, Spain

  • East Tallinn Central Hospital

    Tallinn, 10138, Estonia

  • Elisabeth-TweeSteden Ziekenhuis

    Tilburg, 5022 GC, Netherlands

  • Fakultna nemocnica Trnava

    Trnava, 917 75, Slovakia

  • Fakultni nemocnice u sv. Anny

    Brno, 656 91, Czechia

  • Fakultni nemocnice v Motole

    Prague, 150 06, Czechia

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133, Italy

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122, Italy

  • Fondazione Istituto S. Raffaele - Giglio

    Cefalù, Sicily, 90015, Italy

  • Fundacion Rosarina de Neurorehabilitacion

    Rosario, 2000, Argentina

  • Gazi University Medical Faculty

    Ankara, 06500, Turkey (Türkiye)

  • Groene Hart Ziekenhuis

    Gouda, 2803 HH, Netherlands

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • Groupe Hospitalier Pitié- Salpétrière

    Paris, 75651, France

  • HIA de Toulon hôpital militaire

    Toulon, 83041, France

  • HUC

    Coimbra, 3000-075, Portugal

  • Hacettepe University Medical Faculty

    Ankara, 06100, Turkey (Türkiye)

  • Haukeland universitetssykehus

    Bergen, 5021, Norway

  • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

    Sønderborg, 6400, Denmark

  • Hopital Central - CHU de Nancy

    Nancy, 54035, France

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • Hopital Gui de Chauliac

    Montpellier, 34295, France

  • Hopital Roger Salengro Service de Neurologie

    Lille, 59037, France

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677, France

  • Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC

    Culiacán, Sinaloa, 80020, Mexico

  • Hospital Beatriz Angelo

    Loures, 2674-514, Portugal

  • Hospital Churruca Visca

    Buenos Aires, C1437JCP, Argentina

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010, Spain

  • Hospital General de Castellon

    Castellon, Castellon, 12004, Spain

  • Hospital General de México

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

  • Hospital Geral de Santo Antonio

    Porto, 4099-001, Portugal

  • Hospital Puerta del Mar

    Cadiz, 11009, Spain

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Sao Lucas - PUCRS

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

  • Hospital Universitari Arnau de Vilanova de Lleida

    Lleida, Lerida, 25198, Spain

  • Hospital Universitari de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hospital Universitari de Girona Dr. Josep Trueta

    Girona, 17007, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, Spain

  • Hospital Universitario Clínico San Carlos

    Madrid, 28040, Spain

  • Hospital Universitario La Paz

    Madrid, 28046, Spain

  • Hospital Universitario Virgen de Arrixaca

    Murcia, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital das Clinicas - FMUSP

    São Paulo, São Paulo, 05403-900, Brazil

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hôpital Pasteur

    Nice, 06002, France

  • Hôpital de Poissy

    Poissy, 78300, France

  • Höpital Hautepierre

    Strasbourg, 67098, France

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

    Pavia, Lombardy, 27100, Italy

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077, Italy

  • IRCCS Ospedale Casa Sollievo Della Sofferenza

    San Giovanni Rotondo, Apulia, 71013, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Ibn Sina Hospital

    Kuwait City, 10002, Kuwait

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

    Lublin, 20-410, Poland

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warsaw, 02-957, Poland

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132, Italy

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

    Istanbul, 34098, Turkey (Türkiye)

  • Istanbul University Istanbul School of Medicine

    Istanbul, 34093, Turkey (Türkiye)

  • Jeroen Bosch Ziekenhuis

    's-Hertogenbosch, 5223 GZ, Netherlands

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon, 61080, Turkey (Türkiye)

  • Kings College Hospital

    London, SE5 9RS, United Kingdom

  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

    Warsaw, 02-097, Poland

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7AU, United Kingdom

  • London Health Sciences Centre Uni Campus

    London, Ontario, N6A 5A5, Canada

  • Maasstadziekenhuis

    NL -rotterdam, 3079 DZ, Netherlands

  • Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

    Krakow, 31-637, Poland

  • Mehiläinen Neo Turku

    Turku, 20520, Finland

  • Montreal Neurological Institute and Hospital

    Montreal, Quebec, H3A 2B4, Canada

  • Morriston Hospital

    Swansea, SA6 6NL, United Kingdom

  • Multiprofile Hosp. for Active Treatment

    Sofia, 1309, Bulgaria

  • Mustafa Kemal Ataturk UTF

    Hatay, 31001, Turkey (Türkiye)

  • National Hospital for Neurology and Neurosurgery,

    London, WC1 3BG, United Kingdom

  • Nemocnice Jihlava

    Jihlava, 58633, Czechia

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796, Poland

  • Odense Universitetshospital, Neurologisk Afdeling N

    Odense C, 5000, Denmark

  • Ondokuz Mayis University School of Medicine

    Samsun, 55139, Turkey (Türkiye)

  • Ospedale Bellaria

    Bologna, Emilia-Romagna, 40139, Italy

  • Ospedale Binaghi

    Cagliari, Sardinia, 09126, Italy

  • Ospedale Civile di Montichiari

    Montichiari, Lombardy, 25018, Italy

  • Ospedale S.Antonio Abate

    Gallarate, Lombardy, 21013, Italy

  • Ospedale S.Camillo Forlanini

    Rome, Lazio, 00152, Italy

  • Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

    Chieti, Abruzzo, 66013, Italy

  • Ospedale San Salvatore

    L’Aquila, Abruzzo, 67100, Italy

  • Policlinico G.B. Rossi

    Verona, Veneto, 37134, Italy

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

    Rome, Lazio, 00133, Italy

  • Policlinico Universitario A. Gemelli

    Rome, Lazio, 00168, Italy

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF, United Kingdom

  • Raigmore Hospital

    Inverness, IV2 3UV, United Kingdom

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2, Canada

  • Revalidatie en MS Centrum

    Overpelt, 3900, Belgium

  • Rigshospitalet Glostrup

    Glostrup Municipality, 2600, Denmark

  • Royal Cornwall Hospital

    Truro, TR1 3LQ, United Kingdom

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW, United Kingdom

  • Royal Free Hospital

    London, NW3 2QS, United Kingdom

  • Royal Hallamshire Hospita

    Sheffield, S10 2JF, United Kingdom

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP, United Kingdom

  • Sahlgrenska Sjukhuset

    Gothenburg, 413 45, Sweden

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD, United Kingdom

  • Selcuk University Medical Faculty

    Konya, 42131, Turkey (Türkiye)

  • Shat Np Sveti Naum

    Sofia, 1113, Bulgaria

  • St George's Hospital

    London, SW17 0QT, United Kingdom

  • St Vincents University Hospital

    Dublin, Ireland

  • Stavanger Universitetssykehus, Helse Stavanger HF

    Stavanger, 4011, Norway

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario, M4N 3M5, Canada

  • Sykehuset Buskerud HF

    Drammen, 3004, Norway

  • Tartu University Hospital

    Tartu, 51014, Estonia

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6, Canada

  • The Royal London Hospital

    London, E1 1BB, United Kingdom

  • UZ Antwerpen

    Edegem, 2650, Belgium

  • Unidad de investigacion en salud (UIS)

    Mexico City, 14050, Mexico

  • Universitario de La Princesa

    Madrid, 28006, Spain

  • University Medical Centre

    Ljubljana, 1000, Slovenia

  • University Medical Centre Maribor

    Maribor, 2000, Slovenia

  • University of British Columbia

    Vancouver, British Columbia, V6T 1Z4, Canada

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80131, Italy

  • Univerzitna nemocnica Bratislava

    Bratislava, 813 69, Slovakia

  • Univerzitna nemocnica Bratislava Nemocnica Ruzinov

    Bratislava, 826 06, Slovakia

  • VALEOMED Diagnosztikai Központ

    Esztergom, 2500, Hungary

  • VFN Praha Poliklinika Rs Centrum - Budova A

    Prague, 12808, Czechia

  • West Tallinn Central Hospital

    Tallinn, 10617, Estonia

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG, Netherlands

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