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

A Multicentre Non-interventional Study to Assess the Real-world Effectiveness of Ocrelizumab in Patients With Relapsing or Primary Progressive Multiple Sclerosis - The MuSicalE STUDY

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.

Study Overview

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

• Study Type: Observational
• Enrollment (Actual): 1710

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • Landesklinikum Amstetten
  • Innsbruck, Austria, 6020
    • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
  • Linz, Austria, 4021
    • Kepler Universitätskliniken GmbH - Med Campus III
  • Linz, Austria, 4020
    • Kepler Universitätsklinikum GmbH - Neuromed Campus
  • Melk, Austria, 3390
    • Multiple Sklerose Zentrum
  • Vienna, Austria, 1210
    • Klinik Floridsdorf
• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Brussels, Belgium, 1090
    • UZ Brussel
  • Brussels, Belgium, 1070
    • Hospital Erasme
  • Brussels, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Charleroi, Belgium, 6042
    • CHU de Charleroi
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Fraiture, Belgium, 4557
    • CNRF - Centre Neurologique et Réadaptation Fonctionnelle
  • Hasselt, Belgium, 3500
    • Jessa Zkh (Campus Virga Jesse)
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • La Louvière, Belgium, 7100
    • Chu Tivoli
  • Liège, Belgium, 4000
    • CHC MontLegia
  • Melsbroek, Belgium, 1820
    • Nationaal MS Centrum
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
  • Ostend, Belgium, 8400
    • AZ Oostende
  • Overpelt, Belgium, 3900
    • Revalidatie en MS Centrum
  • Roeselare, Belgium, 8800
    • AZ Delta (Campus Rumbeke)
• Brazil
  • Rio de Janeiro, Brazil, 20270-004
    • Hospital Universitario Gaffree e Guinle
  • Estado de Bahia
    • Salvador, Estado de Bahia, Brazil, 41950-610
      • Clinica Amo Assistencia Medica Em Oncologia
  • Federal District
    • Brasília, Federal District, Brazil, 70330-150
      • Hospital de Base do Distrito Federal
  • Paraná
    • Curitiba, Paraná, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba
  • São Paulo
    • São Paulo, São Paulo, Brazil, 01228-000
      • CPQuali Pesquisa Clinica Ltda
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4000
    • UMHAT Sveti Georgi Clinic of neurology
  • Sofia, Bulgaria, 1407
    • "City Clinic UMHAC" EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska, EAD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital Ead
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Yoanna - ISUL EAD
  • Sofia, Bulgaria, 1113
    • Shat Np Sveti Naum
  • Sofia, Bulgaria, 1142
    • First MHAT
  • Sofia, Bulgaria, 1309
    • Multiprofile Hosp. for Active Treatment
  • Varna, Bulgaria, 9010
    • MBAL St. Marina
• Chile
  • Santiago, Chile, 7591046
    • Clinica Las Condes
• Colombia
  • Bogota, DC, Colombia, DUMMY_VALUE
    • Fundación Abood Shaio
  • Bogotá, Colombia, DUMMY_VALUE
    • Centro Javeriano de Oncología
  • Bogotá, Colombia, DUMMY_VALUE
    • Organizacion Sanitas Internacional
  • Cali, Colombia, DUMMY_VALUE
    • Fundacion Clinica Valle del Lili
• Dominican Republic
  • Santo Domingo, Dominican Republic, DUMMY_VALUE
    • Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)
• Egypt
  • Cairo, Egypt, 11566
    • Faculty of Medicine-Ain Shams University
  • Cairo, Egypt, DUMMY_VALUE
    • Al Qahira Al Fatmiya Hospital
  • Cairo, Egypt, DUMMY_VALUE
    • Clinical Research Center-Alex university
• Italy
  • Abruzzo
    • L’Aquila, Abruzzo, Italy, 67100
      • Ospedale San Salvatore
  • Apulia
    • Bari, Apulia, Italy, 70124
      • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
    • Casarano, Apulia, Italy, 73042
      • Ospedale F. Ferrari
  • Campania
    • Napoli, Campania, Italy, 80131
      • Università degli studi della Campania Luigi Vanvitelli
    • Napoli, Campania, Italy, 80138
      • AOU Seconda Università degli Studi
  • Emilia-Romagna
    • Cona, Emilia-Romagna, Italy, 44124
      • Arcispedale Sant'Anna
    • Parma, Emilia-Romagna, Italy, 43126
      • A.O.U. di Parma
  • Lazio
    • Rome, Lazio, Italy, 00189
      • Azienda Ospedaliera Sant'Andrea
    • 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
    • Sestri Ponente (GE), Liguria, Italy, 16153
      • Presidio Ospedaliero S.O.P.A. Micone
  • Lombardy
    • 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
    • Pavia, Lombardy, Italy, 27100
      • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
    • San Donato Milanese, Lombardy, Italy, 20097
      • Policlinico San Donato
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • IRCCS Istituto Neurologico Neuromed
  • Piedmont
    • Mondovì (CN), Piedmont, Italy, 12084
      • Ospedale Regina Montis Regalis
  • Sardinia
    • Cagliari, Sardinia, Italy, 09126
      • Ospedale Binaghi
  • Sicily
    • Catania, Sicily, Italy, 95123
      • AOU Policlinico V. Emanuele - P.O G. Rodolico
    • Palermo, Sicily, Italy, 90129
      • AOU Policlinico Giaccone
  • The Marches
    • Torrette - Ancona, The Marches, Italy, 60100
      • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
  • Tuscany
    • Siena, Tuscany, Italy, 53100
      • AOU Senese - Presidio Ospedaliero Le Scotte
• Kuwait
  • Kuwait City, Kuwait, 10002
    • Ibn Sina Hospital
• Montenegro
  • Podgorica, Montenegro, 20000
    • Clinical Center of Montenegro
• Netherlands
  • Breda, Netherlands, 4819 EV
    • Amphia Ziekenhuis
  • NL -rotterdam, Netherlands, 3079 DZ
    • Maasstadziekenhuis
  • Nieuwegein, Netherlands, 3430 EM
    • St. Antonius Ziekenhuis Nieuwegein
  • Venlo, Netherlands, 5912 BL
    • Ziekenhuis VieCuri Medisch Centrum
  • Zwolle, Netherlands, 8025 AB
    • Isala
• Paraguay
  • Asunción, Paraguay, DUMMY_VALUE
    • Hospital Central del Instituto de Previsión Social
• Poland
  • Bialystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Gdansk, Poland, 80-803
    • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
  • Głogów Małopolski, Poland, 36-060
    • Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa
  • Katowice, Poland, 40-635
    • Górnośląskie Centrum Medyczne
  • Katowice, Poland, 40-752
    • UCK im. prof. K. Gibinskiego SUM
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM
  • Rybnik, Poland, 44-200
    • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
  • Warsaw, Poland, 02-957
    • Instytut Psychiatrii i Neurologii
  • Warsaw, Poland, 04-141
    • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
  • Zabrze, Poland, 41-800
    • SPSK nr 1
• Portugal
  • Lisbon, Portugal, 1169-050
    • Hospital Santo Antonio dos Capuchos
  • Porto, Portugal, 4000-436
    • Centro Hospitalar do Porto
• Qatar
  • Doha, Qatar, 3050
    • Hamad General Hospital
• Romania
  • Bucharest, Romania, 022328
    • Fundeni Clinical Institute
  • Bucharest, Romania, 11172
    • Spitalul Universitar de Urgenta Bucuresti
  • Cluj-Napoca, Romania, 400012
    • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
  • Sibiu, Romania, 550166
    • Spitalul Clinic Judetean de Urgenta Sibiu
  • Târgu Mureş, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Mures
• Russia
  • Krasnodar, Russia, 350086
    • Regional clinical hospital named after prof. S.V. Ochapovsky
  • Novosibirsk, Russia, 630087
    • State Novosibirsk regional clinical hospital
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russia, 117186
      • Jusupovskaya Hospital
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 197110
      • National Center of Social Significant Disease
• Saudi Arabia
  • Riyadh, Saudi Arabia, 22490
    • King Abdul Aziz Medical City, King Fahd National Guard
• Serbia
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
• Slovakia
  • Bratislava, Slovakia, 811 08
    • Univerzitna Nemocnica - Nemocnica svateho Michala
  • Bratislava, Slovakia, 826 06
    • Univerzitná nemocnica Bratislava - Nemocnica Ružinov
  • Bratislava, Slovakia, 833 05
    • Nemocnica akademika Ladislava Derera
  • Martin, Slovakia, 036 59
    • Univerzitná nemocnica Martin
  • Ružomberok, Slovakia, DUMMY_VALUE
    • Ustredna vojenska nemocnica SNP Ruzomberok
  • Trnava, Slovakia, 917 75
    • Fakultna nemocnica Trnava
• Spain
  • Barcelona, Spain, 08025
    • Hospital de la Santa Creu i Sant Pau
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar
  • Córdoba, Spain, 14011
    • Hospital Universitario Reina Sofia
  • Murcia, Spain, DUMMY_VALUE
    • Hospital Universitario Virgen de Arrixaca
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga ? Hospital General
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Seville, Spain, 41013
    • Hospital Virgen del Rocío
  • Seville, Spain, 41014
    • Hospital Univ. Nuestra Señora de Valme
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe
  • Valencia, Spain, 46010
    • Hospital Clínico Universitario de Valencia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia
  • Ávila, Spain, 05071
    • Hospital Nuestra Señora de Sonsoles
  • Alava
    • Vitoria-Gasteiz, Alava, Spain, 1009
      • Hospital Universitario de Araba
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporacio Sanitaria Parc Tauli
  • Girona
    • Figueres, Girona, Spain, 17600
      • Hospital de Figueres
  • Guipuzcoa
    • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
      • Hospital de Donostia
  • LA Coruna
    • A Coruña, LA Coruna, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC)
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
  • Murcia
    • Cartagena (Murcia), Murcia, Spain, 30202
      • Hospital General Universitario Santa Lucía
  • Pontevedra
    • Vigo, Pontevedra, Spain, DUMMY_VALUE
      • Hospital Alvaro Cunqueiro
  • Tenerife
    • San Cristóbal de La Laguna, Tenerife, Spain, DUMMY_VALUE
      • Hospital Universitario de Canarias
    • Santa Cruz de Tenerife, Tenerife, Spain, DUMMY_VALUE
      • Hospital Nuestra Señora de Candelaria
• Turkey (Türkiye)
  • Ankara, Turkey (Türkiye), 06100
    • Hacettepe University Medical Faculty
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
  • Istanbul, Turkey (Türkiye), 34093
    • Istanbul University Istanbul School of Medicine
  • Izmir, Turkey (Türkiye), 35100
    • Ege University Medical Faculty
  • Kocaeli, Turkey (Türkiye), 41380
    • Kocaeli University Hospital
  • Mersin, Turkey (Türkiye), 33079
    • Mersin University Medical Faculty
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayis Univ. Med. Fac.
  • Trabzon, Turkey (Türkiye), 61080
    • Karadeniz Tecnical Uni. Med. Fac.
• United Arab Emirates
  • Dubai-UAE, United Arab Emirates, DUMMY_VALUE
    • Mediclinic Parkview Hospital
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry
  • Inverness, United Kingdom, IV2 3JH
    • Raigmore Hospital
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • Lincoln, United Kingdom, LN2 5QY
    • Lincoln County Hospital
  • London, United Kingdom, SW17 ORE
    • St George?s Hospital
  • Luton, United Kingdom, LU4 0DZ
    • Luton General Hospital
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Plymouth, United Kingdom, PL6 8DH
    • Derriford Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Royal Stoke University Hospital
  • Sunderland, United Kingdom, SR4 7TP
    • Sunderland Royal Hospital
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital
  • Westbury-on-Trym, Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with RMS or PPMS undergoing routine clinical care

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Ocrelizumab; Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.	Drug: Ocrelizumab; Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.; Other Names: Ocrevus

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in the overall SymptoMScreen score in participants with RMS	SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)	4 years
Changes in the overall SymptoMScreen score in participants with PPMS	SymptoMScreen is a battery of 7-point Likert scales for 12 distinct domains: mobility, dexterity, body pain, sensation, bladder function, fatigue, vision, dizziness, cognition, depression, and anxiety. Composite scores (range min: 0, max: 72) Subscores for each functional domain (range: 0-not affected at all; 6: total limitation/I'm unable to do most daily activities)	4 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Percentage of RMS Participants with Adverse Events	4 years
Percentage of PPMS participants with Adverse Events	4 years
Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS	4 years
Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS	4 years
Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants	4 years
Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants	4 years
Change in the score of ABILHAND - 56 scale in RMS participants	4 years
Change in the score of ABILHAND - 56 scale in PPMS participants	4 years
Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant	4 years
Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants	4 years
Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants	4 years
Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants	4 years
Change in the score of MSWS - 12 scale in RMS participants	4 years
Change in the score of MSWS - 12 scale in PPMS participants	4 years
Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in RMS Participants	4 years
Changes in proportion of patients employed/non-employed, number of inpatient days, hospital admissions, medication use and associated costs over the course of the study, captured by the MS-COI in PPMS Participants	4 years
Frequency of relapses over time in RMS patients	4 years
Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time	4 years
Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time	4 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): November 12, 2018
• Primary Completion (Actual): January 19, 2026
• Study Completion (Actual): January 19, 2026

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 17, 2026
• Last Update Submitted That Met QC Criteria: February 12, 2026
• Last Verified: February 1, 2026

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: MN39889

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