Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis

NCT ID: NCT03593590

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Total Enrollment: 1710 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2018-11-12
• Study Completion Date: 2026-01-23

Brief Summary

This is a multicentre non-interventional study aimed at evaluating the real-world effectiveness and safety of ocrelizumab treatment in participants with relapsing multiple sclerosis (RMS) or primary progressive multiple sclerosis (PPMS), who have been prescribed ocrelizumab as per routine practice. This study will use a comprehensive combination of participant reported outcomes and conventional multiple sclerosis (MS) endpoints that measure clinical domains commonly affected by MS (e.g. fatigue, hand function, gait, cognition), and their impact on employment, activities of daily living, quality of life and healthcare resource utilization. The incidence, type, and pattern of serious adverse events (SAEs), and of adverse events (AEs) leading to treatment discontinuation will also be determined.

Conditions

Multiple Sclerosis

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Ocrelizumab

Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.

Interventions

Ocrelizumab

Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.

Intervention Type: DRUG

Other Intervention Names

Ocrevus

Eligibility Criteria

Inclusion Criteria

• Must have a definite diagnosis of RMS or PPMS and in whom a decision to initiate ocrelizumab has been taken as part of routine clinical practice
• Must be prescribed ocrelizumab in line with the SmPC
• Must have provided signed informed consent
• Must be able and willing to complete the PROs as per clinical practice

Exclusion Criteria

• Previously treated with ocrelizumab (including phase II, phase III and phase IIIB clinical trials, local trials and investigator initiated study (IIS) as well as a pre-approval access or compassionate use programmes or local registries that are not compatible with the MuSicalE study design)
• Not receiving ocrelizumab in line with the SmPC

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Landesklinikum Amstetten

Amstetten, , Austria

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

Innsbruck, , Austria

Kepler Universitätsklinikum GmbH - Neuromed Campus

Linz, , Austria

Kepler Universitätskliniken GmbH - Med Campus III

Linz, , Austria

Multiple Sklerose Zentrum

Melk, , Austria

Klinik Floridsdorf

Vienna, , Austria

Imeldaziekenhuis

Bonheiden, , Belgium

AZ KLINA

Brasschaat, , Belgium

Hospital Erasme

Brussels, , Belgium

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires St-Luc

Brussels, , Belgium

CHU de Charleroi

Charleroi, , Belgium

UZ Antwerpen

Edegem, , Belgium

CNRF - Centre Neurologique et Réadaptation Fonctionnelle

Fraiture, , Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, , Belgium

AZ Groeninge

Kortrijk, , Belgium

CHU Tivoli

La Louvière, , Belgium

CHC MontLégia

Liège, , Belgium

Nationaal MS Centrum

Melsbroek, , Belgium

CHU UCL Mont-Godinne

Mont-godinne, , Belgium

AZ Oostende

Ostend, , Belgium

Revalidatie en MS Centrum

Overpelt, , Belgium

AZ Delta (Campus Rumbeke)

Roeselare, , Belgium

Clinica Amo - Assistencia Medica Em Oncologia

Salvador, Estado de Bahia, Brazil

Hospital de Base do Distrito Federal

Brasília, Federal District, Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

CPQuali Pesquisa Clinica Ltda

São Paulo, São Paulo, Brazil

Hospital Universitario Gaffree e Guinle

Rio de Janeiro, , Brazil

UMHAT 'Dr. Georgi Stranski', EAD

Pleven, , Bulgaria

UMHAT Sveti Georgi Clinic of neurology

Plovdiv, , Bulgaria

Shat Np Sveti Naum

Sofia, , Bulgaria

First MHAT

Sofia, , Bulgaria

Multiprofile Hosp. for Active Treatment

Sofia, , Bulgaria

"City Clinic UMHAC" EOOD

Sofia, , Bulgaria

Acibadem City Clinic Tokuda Hospital Ead

Sofia, , Bulgaria

UMHAT "Sv. Ivan Rilski", EAD

Sofia, , Bulgaria

UMHAT Alexandrovska, EAD

Sofia, , Bulgaria

UMHAT Tsaritsa Yoanna - ISUL EAD

Sofia, , Bulgaria

MBAL St. Marina

Varna, , Bulgaria

Clinica Las Condes

Santiago, , Chile

Fundacion ABOOD Shaio

Bogota, DC, , Colombia

Centro Javeriano de Oncología

Bogotá, , Colombia

Organizacion Sanitas Internacional

Bogotá, , Colombia

Fundacion Clinica Valle del Lili

Cali, , Colombia

Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)

Santo Domingo, , Dominican Republic

Faculty of Medicine-Ain Shams University

Cairo, , Egypt

Al Qahira Al Fatmiya Hospital

Cairo, , Egypt

Clinical Research Center-Alex university

Cairo, , Egypt

Ospedale San Salvatore

L’Aquila, Abruzzo, Italy

Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari

Bari, Apulia, Italy

Ospedale F. Ferrari

Casarano, Apulia, Italy

Università degli Studi della Campania Luigi Vanvitelli

Napoli, Campania, Italy

AOU Seconda Università degli Studi

Napoli, Campania, Italy

Arcispedale Sant'Anna

Cona, Emilia-Romagna, Italy

A.O.U. di Parma

Parma, Emilia-Romagna, Italy

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

Rome, Lazio, Italy

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, Italy

Irccs A.O.U.San Martino Ist

Genoa, Liguria, Italy

Presidio Ospedaliero S.O.P.A. Micone

Sestri Ponente (GE), Liguria, 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

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

Pavia, Lombardy, Italy

Policlinico San Donato

San Donato Milanese, Lombardy, Italy

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, Italy

Ospedale Regina Montis Regalis

Mondovì (CN), Piedmont, Italy

Ospedale Binaghi

Cagliari, Sardinia, Italy

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

Catania, Sicily, Italy

AOU Policlinico Giaccone

Palermo, Sicily, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona

Torrette - Ancona, The Marches, Italy

AOU Senese - Presidio Ospedaliero Le Scotte

Siena, Tuscany, Italy

Ibn Sina Hospital

Kuwait City, , Kuwait

Clinical Center of Montenegro

Podgorica, , Montenegro

Amphia Ziekenhuis

Breda, , Netherlands

St. Antonius Ziekenhuis Nieuwegein

Nieuwegein, , Netherlands

Maasstadziekenhuis

NL -rotterdam, , Netherlands

Ziekenhuis VieCuri Medisch Centrum

Venlo, , Netherlands

Isala

Zwolle, , Netherlands

Hospital Central del Instituto de Previsión Social

Asunción, , Paraguay

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, , Poland

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

Gdansk, , Poland

Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa

Głogów Małopolski, , Poland

Gornoslaskie Centrum Medyczne

Katowice, , Poland

UCK im. prof. K. Gibinskiego SUM

Katowice, , Poland

SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM

Lodz, , Poland

SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

Rybnik, , Poland

Instytut Psychiatrii i Neurologii

Warsaw, , Poland

Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

Warsaw, , Poland

SPSK nr 1

Zabrze, , Poland

Hospital Santo Antonio dos Capuchos

Lisbon, , Portugal

Centro Hospitalar do Porto

Porto, , Portugal

Hamad General Hospital

Doha, , Qatar

Fundeni Clinical Institute

Bucharest, , Romania

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , Romania

Spitalul Clinic Judetean de Urgenta Cluj-Napoca

Cluj-Napoca, , Romania

Spitalul Clinic Judetean de Urgenta Sibiu

Sibiu, , Romania

Spitalul Clinic Judetean de Urgenta Mures

Târgu Mureş, , Romania

Jusupovskaya Hospital

Moscow, Moscow Oblast, Russia

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, Russia

Regional clinical hospital named after prof. S.V. Ochapovsky

Krasnodar, , Russia

State Novosibirsk Regional Clinical Hospital

Novosibirsk, , Russia

King Abdul Aziz Medical City, King Fahd National Guard

Riyadh, , Saudi Arabia

Clinical Center of Serbia

Belgrade, , Serbia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Nis

Niš, , Serbia

Univerzitna Nemocnica - Nemocnica svateho Michala

Bratislava, , Slovakia

Univerzitna nemocnica Bratislava - Nemocnica Ruzinov

Bratislava, , Slovakia

Nemocnica akademika Ladislava Derera

Bratislava, , Slovakia

Univerzitna nemocnica Martin

Martin, , Slovakia

Ustredna vojenska nemocnica SNP Ruzomberok

Ružomberok, , Slovakia

Fakultna nemocnica Trnava

Trnava, , Slovakia

Hospital Universitario de Araba

Vitoria-Gasteiz, Alava, Spain

Hospital General Universitario de Elche

Elche, Alicante, Spain

Corporació Sanitaria Parc Taulí

Sabadell, Barcelona, Spain

Hospital de Figueres

Figueres, Girona, Spain

Hospital de Donostia

Donostia / San Sebastian, Guipuzcoa, Spain

Complejo Hospitalario Universitario A Coruña (CHUAC)

A Coruña, LA Coruna, Spain

Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia

Santiago de Compostela, LA Coruna, Spain

Hospital General Universitario Santa Lucia

Cartagena (Murcia), Murcia, Spain

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, Spain

Hospital Nuestra Señora de Candelaria

Santa Cruz de Tenerife, Tenerife, Spain

Hospital Nuestra Señora de Sonsoles

Ávila, , Spain

Hospital de la Santa Creu i Sant Pau

Barcelona, , Spain

Hospital Germans Trias i Pujol

Barcelona, , Spain

Hospital Puerta del Mar

Cadiz, , Spain

Hospital Universitario Reina Sofia

Córdoba, , Spain

Hospital Regional Universitario de Malaga ? Hospital General

Málaga, , Spain

Hospital Universitario Virgen de Arrixaca

Murcia, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Hospital Virgen del Rocío

Seville, , Spain

Hospital Univ. Nuestra Señora de Valme

Seville, , Spain

Hospital Clinico Universitario de Valencia

Valencia, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Hospital Universitari i Politecnic La Fe

Valencia, , Spain

Hacettepe University Medical Faculty

Ankara, , Turkey (Türkiye)

Istanbul University Istanbul School of Medicine

Istanbul, , Turkey (Türkiye)

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

Istanbul, , Turkey (Türkiye)

Ege University Medical Faculty

Izmir, , Turkey (Türkiye)

Kocaeli University Hospital

Kocaeli, , Turkey (Türkiye)

Mersin University Medical Faculty

Mersin, , Turkey (Türkiye)

Ondokuz Mayis Univ. Med. Fac.

Samsun, , Turkey (Türkiye)

Karadeniz Tecnical Uni. Med. Fac.

Trabzon, , Turkey (Türkiye)

Mediclinic Parkview Hospital

Dubai-UAE, , United Arab Emirates

Royal Victoria Hospital

Belfast, , United Kingdom

University Hospital Coventry

Coventry, , United Kingdom

Raigmore Hospital

Inverness, , United Kingdom

Leeds General Infirmary

Leeds, , United Kingdom

Lincoln County Hospital

Lincoln, , United Kingdom

St George?s Hospital

London, , United Kingdom

Luton General Hospital

Luton, , United Kingdom

James Cook Hospital

Middlesbrough, , United Kingdom

John Radcliffe Hospital

Oxford, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Royal Hallamshire Hospital

Sheffield, , United Kingdom

Royal Stoke University Hospital

Stoke-on-Trent, , United Kingdom

Sunderland Royal Hospital

Sunderland, , United Kingdom

Morriston Hospital

Swansea, , United Kingdom

Southmead Hospital

Westbury-on-Trym, Bristol, , United Kingdom

Countries

Austria; Belgium; Brazil; Bulgaria; Chile; Colombia; Dominican Republic; Egypt; Italy; Kuwait; Montenegro; Netherlands; Paraguay; Poland; Portugal; Qatar; Romania; Russia; Saudi Arabia; Serbia; Slovakia; Spain; Turkey (Türkiye); United Arab Emirates; United Kingdom

Other Identifiers

MN39889

Identifier Type: -

Identifier Source: org_study_id