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COMPLETED
NCT03599245
PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

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).

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

1055

Start Date

2018-07-12

Completion Date

2025-07-17

Last Updated

2026-09-25

Healthy Volunteers

No

Interventions

DRUG

Ocrelizumab

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

Locations (161)

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 Guillaume et René Laënnec

Nantes, 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

Naples, Campania, Italy

Università degli Studi della Campania Luigi Vanvitelli

Naples, 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

Padova, 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 Universitario Virgen Macarena

Seville, 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