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Multiple SclerosisMuSicalENCT03593590

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

An observational study of Multiple Sclerosis, run by Hoffmann-La Roche at 158 sites in 25 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Multiple Sclerosis
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
How many people
1,710 participants
Where
158 sitesin 25 countries
Study dates
12 Nov 2018to 19 Jan 2026
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants with RMS or PPMS undergoing routine clinical care

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

158 sites in 25 countries.

158 sites in 25 countries

Italy24 sites

  • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari

    Bari, Apulia, 70124

  • Ospedale Binaghi

    Cagliari, Sardinia, 09126

  • Ospedale F. Ferrari

    Casarano, Apulia, 73042

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

    Catania, Sicily, 95123

  • Arcispedale Sant'Anna

    Cona, Emilia-Romagna, 44124

  • Ospedale S.Antonio Abate

    Gallarate, Lombardy, 21013

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132

  • Ospedale San Salvatore

    L’Aquila, Abruzzo, 67100

  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

    Milan, Lombardy, 20122

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133

  • Ospedale Regina Montis Regalis

    Mondovì (CN), Piedmont, 12084

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80131

  • AOU Seconda Università degli Studi

    Naples, Campania, 80138

  • AOU Policlinico Giaccone

    Palermo, Sicily, 90129

  • A.O.U. di Parma

    Parma, Emilia-Romagna, 43126

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

    Pavia, Lombardy, 27100

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077

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

    Rome, Lazio, 00133

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189

  • Policlinico San Donato

    San Donato Milanese, Lombardy, 20097

  • Presidio Ospedaliero S.O.P.A. Micone

    Sestri Ponente (GE), Liguria, 16153

  • AOU Senese - Presidio Ospedaliero Le Scotte

    Siena, Tuscany, 53100

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

    Torrette - Ancona, The Marches, 60100

Other trials in Italy

Spain24 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05071

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 08025

  • Hospital Germans Trias i Pujol

    Barcelona, 08916

  • Hospital Puerta del Mar

    Cadiz, 11009

  • Hospital General Universitario Santa Lucia

    Cartagena (Murcia), Murcia, 30202

  • Hospital Universitario Reina Sofia

    Córdoba, 14011

  • Hospital de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20014

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Hospital de Figueres

    Figueres, Girona, 17600

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010

  • Hospital Universitario Virgen de Arrixaca

    Murcia, DUMMY_VALUE

  • Corporació Sanitaria Parc Taulí

    Sabadell, Barcelona, 08208

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Tenerife, DUMMY_VALUE

  • Hospital Nuestra Señora de Candelaria

    Santa Cruz de Tenerife, Tenerife, DUMMY_VALUE

  • Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Virgen del Rocío

    Seville, 41013

  • Hospital Univ. Nuestra Señora de Valme

    Seville, 41014

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, DUMMY_VALUE

  • Hospital Universitario de Araba

    Vitoria-Gasteiz, Alava, 1009

Other trials in Spain

Belgium17 sites

  • Imeldaziekenhuis

    Bonheiden, 2820

  • AZ KLINA

    Brasschaat, 2930

  • Hospital Erasme

    Brussels, 1070

  • UZ Brussel

    Brussels, 1090

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • CHU de Charleroi

    Charleroi, 6042

  • UZ Antwerpen

    Edegem, 2650

  • CNRF - Centre Neurologique et Réadaptation Fonctionnelle

    Fraiture, 4557

  • Jessa Zkh (Campus Virga Jesse)

    Hasselt, 3500

  • AZ Groeninge

    Kortrijk, 8500

  • CHU Tivoli

    La Louvière, 7100

  • CHC MontLégia

    Liège, 4000

  • Nationaal MS Centrum

    Melsbroek, 1820

  • CHU UCL Mont-Godinne

    Mont-godinne, 5530

  • AZ Oostende

    Ostend, 8400

  • Revalidatie en MS Centrum

    Overpelt, 3900

  • AZ Delta (Campus Rumbeke)

    Roeselare, 8800

Other trials in Belgium

United Kingdom15 sites

  • Royal Victoria Hospital

    Belfast, BT12 6BA

  • University Hospital Coventry

    Coventry, CV2 2DX

  • Raigmore Hospital

    Inverness, IV2 3JH

  • Leeds General Infirmary

    Leeds, LS1 3EX

  • Lincoln County Hospital

    Lincoln, LN2 5QY

  • St George?s Hospital

    London, SW17 ORE

  • Luton General Hospital

    Luton, LU4 0DZ

  • James Cook Hospital

    Middlesbrough, TS4 3BW

  • John Radcliffe Hospital

    Oxford, OX3 9DU

  • Derriford Hospital

    Plymouth, PL6 8DH

  • Royal Hallamshire Hospital

    Sheffield, S10 2JF

  • Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • Sunderland Royal Hospital

    Sunderland, SR4 7TP

  • Morriston Hospital

    Swansea, SA6 6NL

  • Southmead Hospital

    Westbury-on-Trym, Bristol, BS10 5NB

Other trials in United Kingdom

Bulgaria11 sites

  • UMHAT 'Dr. Georgi Stranski', EAD

    Pleven, 5800

  • UMHAT Sveti Georgi Clinic of neurology

    Plovdiv, 4000

  • Shat Np Sveti Naum

    Sofia, 1113

  • First MHAT

    Sofia, 1142

  • Multiprofile Hosp. for Active Treatment

    Sofia, 1309

  • "City Clinic UMHAC" EOOD

    Sofia, 1407

  • Acibadem City Clinic Tokuda Hospital Ead

    Sofia, 1407

  • UMHAT "Sv. Ivan Rilski", EAD

    Sofia, 1431

  • UMHAT Alexandrovska, EAD

    Sofia, 1431

  • UMHAT Tsaritsa Yoanna - ISUL EAD

    Sofia, 1527

  • MBAL St. Marina

    Varna, 9010

Other trials in Bulgaria

Poland10 sites

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276

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

    Gdansk, 80-803

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

    Głogów Małopolski, 36-060

  • Gornoslaskie Centrum Medyczne

    Katowice, 40-635

  • UCK im. prof. K. Gibinskiego SUM

    Katowice, 40-752

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

    Lodz, 90-153

  • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3

    Rybnik, 44-200

  • Instytut Psychiatrii i Neurologii

    Warsaw, 02-957

  • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

    Warsaw, 04-141

  • SPSK nr 1

    Zabrze, 41-800

Other trials in Poland

Turkey (Türkiye)8 sites

  • Hacettepe University Medical Faculty

    Ankara, 06100

  • Istanbul University Istanbul School of Medicine

    Istanbul, 34093

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi

    Istanbul, 34098

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli University Hospital

    Kocaeli, 41380

  • Mersin University Medical Faculty

    Mersin, 33079

  • Ondokuz Mayis Univ. Med. Fac.

    Samsun, 55139

  • Karadeniz Tecnical Uni. Med. Fac.

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Austria6 sites

  • Landesklinikum Amstetten

    Amstetten, 3300

  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck

    Innsbruck, 6020

  • Kepler Universitätsklinikum GmbH - Neuromed Campus

    Linz, 4020

  • Kepler Universitätskliniken GmbH - Med Campus III

    Linz, 4021

  • Multiple Sklerose Zentrum

    Melk, 3390

  • Klinik Floridsdorf

    Vienna, 1210

Other trials in Austria

Slovakia6 sites

  • Univerzitna Nemocnica - Nemocnica svateho Michala

    Bratislava, 811 08

  • Univerzitna nemocnica Bratislava - Nemocnica Ruzinov

    Bratislava, 826 06

  • Nemocnica akademika Ladislava Derera

    Bratislava, 833 05

  • Univerzitna nemocnica Martin

    Martin, 036 59

  • Ustredna vojenska nemocnica SNP Ruzomberok

    Ružomberok, DUMMY_VALUE

  • Fakultna nemocnica Trnava

    Trnava, 917 75

Other trials in Slovakia

Brazil5 sites

  • Hospital de Base do Distrito Federal

    Brasília, Federal District, 70330-150

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310

  • Hospital Universitario Gaffree e Guinle

    Rio de Janeiro, 20270-004

  • Clinica Amo Assistencia Medica Em Oncologia

    Salvador, Estado de Bahia, 41950-610

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, São Paulo, 01228-000

Other trials in Brazil

Netherlands5 sites

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3430 EM

  • Maasstadziekenhuis

    NL -rotterdam, 3079 DZ

  • Ziekenhuis VieCuri Medisch Centrum

    Venlo, 5912 BL

  • Isala

    Zwolle, 8025 AB

Other trials in Netherlands

Romania5 sites

  • Fundeni Clinical Institute

    Bucharest, 022328

  • Spitalul Universitar de Urgenta Bucuresti

    Bucharest, 11172

  • Spitalul Clinic Judetean de Urgenta Cluj-Napoca

    Cluj-Napoca, 400012

  • Spitalul Clinic Judetean de Urgenta Sibiu

    Sibiu, 550166

  • Spitalul Clinic Judetean de Urgenta Mures

    Târgu Mureş, 540136

Other trials in Romania

Colombia4 sites

  • Centro Javeriano de Oncología

    Bogotá, DUMMY_VALUE

  • Organizacion Sanitas Internacional

    Bogotá, DUMMY_VALUE

  • Fundacion ABOOD Shaio

    Bogota, DC, DUMMY_VALUE

  • Fundacion Clinica Valle del Lili

    Cali, DUMMY_VALUE

Other trials in Colombia

Russia4 sites

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

    Krasnodar, 350086

  • Jusupovskaya Hospital

    Moscow, Moscow Oblast, 117186

  • State Novosibirsk Regional Clinical Hospital

    Novosibirsk, 630087

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110

Other trials in Russia

Egypt3 sites

  • Faculty of Medicine-Ain Shams University

    Cairo, 11566

  • Al Qahira Al Fatmiya Hospital

    Cairo, DUMMY_VALUE

  • Clinical Research Center-Alex university

    Cairo, DUMMY_VALUE

Other trials in Egypt

Portugal2 sites

  • Hospital Santo Antonio dos Capuchos

    Lisbon, 1169-050

  • Centro Hospitalar do Porto

    Porto, 4000-436

Other trials in Portugal

Chile1 site

  • Clinica Las Condes

    Santiago, 7591046

Other trials in Chile

Dominican Republic1 site

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

    Santo Domingo, DUMMY_VALUE

Other trials in Dominican Republic

Kuwait1 site

  • Ibn Sina Hospital

    Kuwait City, 10002

Other trials in Kuwait

Montenegro1 site

  • Clinical Center of Montenegro

    Podgorica, 20000

Other trials in Montenegro

Paraguay1 site

  • Hospital Central del Instituto de Previsión Social

    Asunción, DUMMY_VALUE

Other trials in Paraguay

Qatar1 site

  • Hamad General Hospital

    Doha, 3050

Other trials in Qatar

Saudi Arabia1 site

  • King Abdul Aziz Medical City, King Fahd National Guard

    Riyadh, 22490

Other trials in Saudi Arabia

Serbia1 site

  • Clinical Center Kragujevac

    Kragujevac, 34000

Other trials in Serbia

United Arab Emirates1 site

  • Mediclinic Parkview Hospital

    Dubai-UAE, DUMMY_VALUE

Other trials in United Arab Emirates

About this study

Official title: 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.

Being tested
Ocrelizumab
Medical subject headings
Multiple Sclerosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabDrug

    Also called Ocrevus

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

Study groups in NCT03593590
Study groupRoleWhat they receive
OcrelizumabParticipants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
Receives: Drug: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: 4 years

  2. 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)

    Measured: 4 years

Secondary outcomes (19)

  1. Percentage of RMS Participants with Adverse Events

    Measured: 4 years

  2. Percentage of PPMS participants with Adverse Events

    Measured: 4 years

  3. Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS

    Measured: 4 years

  4. Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS

    Measured: 4 years

  5. Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants

    Measured: 4 years

  6. Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants

    Measured: 4 years

  7. Change in the score of ABILHAND - 56 scale in RMS participants

    Measured: 4 years

  8. Change in the score of ABILHAND - 56 scale in PPMS participants

    Measured: 4 years

  9. Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant

    Measured: 4 years

  10. Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants

    Measured: 4 years

  11. Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants

    Measured: 4 years

  12. Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants

    Measured: 4 years

  13. Change in the score of MSWS - 12 scale in RMS participants

    Measured: 4 years

  14. Change in the score of MSWS - 12 scale in PPMS participants

    Measured: 4 years

  15. 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

    Measured: 4 years

  16. 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

    Measured: 4 years

  17. Frequency of relapses over time in RMS patients

    Measured: 4 years

  18. Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time

    Measured: 4 years

  19. Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time

    Measured: 4 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2018
  2. Study start12 Nov 2018
  3. Primary completion19 Jan 2026
  4. Study completion19 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,710 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03593590
Sponsor's protocol ID
MN39889
Acronym
MuSicalE
Status last verified
Feb 2026
First submitted
11 Jul 2018
Last updated
17 Feb 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: 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

Questions about this trial

What is this clinical trial studying?

An observational study of Multiple Sclerosis, run by Hoffmann-La Roche at 158 sites in 25 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 158 sites in Italy, Spain, Belgium, United Kingdom, Bulgaria and 20 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Changes in the overall SymptoMScreen score in participants with RMS (time frame: 4 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03593590.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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