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
1 other identifier
observational
1,710
25 countries
158
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2018
Longer than P75 for all trials
158 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 11, 2018
CompletedFirst Posted
Study publicly available on registry
July 20, 2018
CompletedStudy Start
First participant enrolled
November 12, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 19, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
January 19, 2026
CompletedFebruary 17, 2026
February 1, 2026
7.2 years
July 11, 2018
February 12, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
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 Outcomes (19)
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
- +14 more secondary outcomes
Study Arms (1)
Ocrelizumab
Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
Interventions
Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.
Eligibility Criteria
Participants with RMS or PPMS undergoing routine clinical care
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (158)
Landesklinikum Amstetten
Amstetten, 3300, Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
Innsbruck, 6020, Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus
Linz, 4020, Austria
Kepler Universitätskliniken GmbH - Med Campus III
Linz, 4021, Austria
Multiple Sklerose Zentrum
Melk, 3390, Austria
Klinik Floridsdorf
Vienna, 1210, Austria
Imeldaziekenhuis
Bonheiden, 2820, Belgium
AZ KLINA
Brasschaat, 2930, Belgium
Hospital Erasme
Brussels, 1070, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
CHU de Charleroi
Charleroi, 6042, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
CNRF - Centre Neurologique et Réadaptation Fonctionnelle
Fraiture, 4557, Belgium
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500, Belgium
AZ Groeninge
Kortrijk, 8500, Belgium
CHU Tivoli
La Louvière, 7100, Belgium
CHC MontLégia
Liège, 4000, Belgium
Nationaal MS Centrum
Melsbroek, 1820, Belgium
CHU UCL Mont-Godinne
Mont-godinne, 5530, Belgium
AZ Oostende
Ostend, 8400, Belgium
Revalidatie en MS Centrum
Overpelt, 3900, Belgium
AZ Delta (Campus Rumbeke)
Roeselare, 8800, Belgium
Clinica Amo Assistencia Medica Em Oncologia
Salvador, Estado de Bahia, 41950-610, Brazil
Hospital de Base do Distrito Federal
Brasília, Federal District, 70330-150, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310, Brazil
CPQuali Pesquisa Clinica Ltda
São Paulo, São Paulo, 01228-000, Brazil
Hospital Universitario Gaffree e Guinle
Rio de Janeiro, 20270-004, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
Pleven, 5800, Bulgaria
UMHAT Sveti Georgi Clinic of neurology
Plovdiv, 4000, Bulgaria
Shat Np Sveti Naum
Sofia, 1113, Bulgaria
First MHAT
Sofia, 1142, Bulgaria
Multiprofile Hosp. for Active Treatment
Sofia, 1309, Bulgaria
"City Clinic UMHAC" EOOD
Sofia, 1407, Bulgaria
Acibadem City Clinic Tokuda Hospital Ead
Sofia, 1407, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
Sofia, 1431, Bulgaria
UMHAT Alexandrovska, EAD
Sofia, 1431, Bulgaria
UMHAT Tsaritsa Yoanna - ISUL EAD
Sofia, 1527, Bulgaria
MBAL St. Marina
Varna, 9010, Bulgaria
Clinica Las Condes
Santiago, 7591046, Chile
Fundacion ABOOD Shaio
Bogota, DC, DUMMY_VALUE, Colombia
Centro Javeriano de Oncología
Bogotá, DUMMY_VALUE, Colombia
Organizacion Sanitas Internacional
Bogotá, DUMMY_VALUE, Colombia
Fundacion Clinica Valle del Lili
Cali, DUMMY_VALUE, Colombia
Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)
Santo Domingo, DUMMY_VALUE, Dominican Republic
Faculty of Medicine-Ain Shams University
Cairo, 11566, Egypt
Al Qahira Al Fatmiya Hospital
Cairo, DUMMY_VALUE, Egypt
Clinical Research Center-Alex university
Cairo, DUMMY_VALUE, Egypt
Ospedale San Salvatore
L’Aquila, Abruzzo, 67100, Italy
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
Bari, Apulia, 70124, Italy
Ospedale F. Ferrari
Casarano, Apulia, 73042, Italy
Università degli Studi della Campania Luigi Vanvitelli
Naples, Campania, 80131, Italy
AOU Seconda Università degli Studi
Naples, Campania, 80138, Italy
Arcispedale Sant'Anna
Cona, Emilia-Romagna, 44124, Italy
A.O.U. di Parma
Parma, Emilia-Romagna, 43126, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, 00133, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, 00189, Italy
Irccs A.O.U.San Martino Ist
Genoa, Liguria, 16132, Italy
Presidio Ospedaliero S.O.P.A. Micone
Sestri Ponente (GE), Liguria, 16153, Italy
Ospedale S.Antonio Abate
Gallarate, Lombardy, 21013, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
Milan, Lombardy, 20122, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, 20132, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, 20133, Italy
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Pavia, Lombardy, 27100, Italy
Policlinico San Donato
San Donato Milanese, Lombardy, 20097, Italy
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, 86077, Italy
Ospedale Regina Montis Regalis
Mondovì (CN), Piedmont, 12084, Italy
Ospedale Binaghi
Cagliari, Sardinia, 09126, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
Catania, Sicily, 95123, Italy
AOU Policlinico Giaccone
Palermo, Sicily, 90129, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
Torrette - Ancona, The Marches, 60100, Italy
AOU Senese - Presidio Ospedaliero Le Scotte
Siena, Tuscany, 53100, Italy
Ibn Sina Hospital
Kuwait City, 10002, Kuwait
Clinical Center of Montenegro
Podgorica, 20000, Montenegro
Amphia Ziekenhuis
Breda, 4819 EV, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3430 EM, Netherlands
Maasstadziekenhuis
NL -rotterdam, 3079 DZ, Netherlands
Ziekenhuis VieCuri Medisch Centrum
Venlo, 5912 BL, Netherlands
Isala
Zwolle, 8025 AB, Netherlands
Hospital Central del Instituto de Previsión Social
Asunción, DUMMY_VALUE, Paraguay
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, 15-276, Poland
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
Gdansk, 80-803, Poland
Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa
Głogów Małopolski, 36-060, Poland
Gornoslaskie Centrum Medyczne
Katowice, 40-635, Poland
UCK im. prof. K. Gibinskiego SUM
Katowice, 40-752, Poland
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM
Lodz, 90-153, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
Rybnik, 44-200, Poland
Instytut Psychiatrii i Neurologii
Warsaw, 02-957, Poland
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
Warsaw, 04-141, Poland
SPSK nr 1
Zabrze, 41-800, Poland
Hospital Santo Antonio dos Capuchos
Lisbon, 1169-050, Portugal
Centro Hospitalar do Porto
Porto, 4000-436, Portugal
Hamad General Hospital
Doha, 3050, Qatar
Fundeni Clinical Institute
Bucharest, 022328, Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 11172, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
Cluj-Napoca, 400012, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
Sibiu, 550166, Romania
Spitalul Clinic Judetean de Urgenta Mures
Târgu Mureş, 540136, Romania
Jusupovskaya Hospital
Moscow, Moscow Oblast, 117186, Russia
National Center of Social Significant Disease
Saint Petersburg, Sankt-Peterburg, 197110, Russia
Regional clinical hospital named after prof. S.V. Ochapovsky
Krasnodar, 350086, Russia
State Novosibirsk Regional Clinical Hospital
Novosibirsk, 630087, Russia
King Abdul Aziz Medical City, King Fahd National Guard
Riyadh, 22490, Saudi Arabia
Clinical Center Kragujevac
Kragujevac, 34000, Serbia
Univerzitna Nemocnica - Nemocnica svateho Michala
Bratislava, 811 08, Slovakia
Univerzitna nemocnica Bratislava - Nemocnica Ruzinov
Bratislava, 826 06, Slovakia
Nemocnica akademika Ladislava Derera
Bratislava, 833 05, Slovakia
Univerzitna nemocnica Martin
Martin, 036 59, Slovakia
Ustredna vojenska nemocnica SNP Ruzomberok
Ružomberok, DUMMY_VALUE, Slovakia
Fakultna nemocnica Trnava
Trnava, 917 75, Slovakia
Hospital Universitario de Araba
Vitoria-Gasteiz, Alava, 1009, Spain
Hospital General Universitario de Elche
Elche, Alicante, 03203, Spain
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, 08208, Spain
Hospital de Figueres
Figueres, Girona, 17600, Spain
Hospital de Donostia
Donostia / San Sebastian, Guipuzcoa, 20014, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
A Coruña, LA Coruna, 15006, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
Santiago de Compostela, LA Coruna, 15706, Spain
Hospital General Universitario Santa Lucia
Cartagena (Murcia), Murcia, 30202, Spain
Hospital Alvaro Cunqueiro
Vigo, Pontevedra, DUMMY_VALUE, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, DUMMY_VALUE, Spain
Hospital Nuestra Señora de Candelaria
Santa Cruz de Tenerife, Tenerife, DUMMY_VALUE, Spain
Hospital Nuestra Señora de Sonsoles
Ávila, 05071, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, 08025, Spain
Hospital Germans Trias i Pujol
Barcelona, 08916, Spain
Hospital Puerta del Mar
Cadiz, 11009, Spain
Hospital Universitario Reina Sofia
Córdoba, 14011, Spain
Hospital Regional Universitario de Malaga ? Hospital General
Málaga, 29010, Spain
Hospital Universitario Virgen de Arrixaca
Murcia, DUMMY_VALUE, Spain
Hospital Universitario Virgen Macarena
Seville, 41009, Spain
Hospital Virgen del Rocío
Seville, 41013, Spain
Hospital Univ. Nuestra Señora de Valme
Seville, 41014, Spain
Hospital Clinico Universitario de Valencia
Valencia, 46010, Spain
Hospital General Universitario de Valencia
Valencia, 46014, Spain
Hospital Universitari i Politecnic La Fe
Valencia, 46026, Spain
Hacettepe University Medical Faculty
Ankara, 06100, Turkey (Türkiye)
Istanbul University Istanbul School of Medicine
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
Istanbul, 34098, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Kocaeli University Hospital
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty
Mersin, 33079, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.
Samsun, 55139, Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.
Trabzon, 61080, Turkey (Türkiye)
Mediclinic Parkview Hospital
Dubai-UAE, DUMMY_VALUE, United Arab Emirates
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
University Hospital Coventry
Coventry, CV2 2DX, United Kingdom
Raigmore Hospital
Inverness, IV2 3JH, United Kingdom
Leeds General Infirmary
Leeds, LS1 3EX, United Kingdom
Lincoln County Hospital
Lincoln, LN2 5QY, United Kingdom
St George?s Hospital
London, SW17 ORE, United Kingdom
Luton General Hospital
Luton, LU4 0DZ, United Kingdom
James Cook Hospital
Middlesbrough, TS4 3BW, United Kingdom
John Radcliffe Hospital
Oxford, OX3 9DU, United Kingdom
Derriford Hospital
Plymouth, PL6 8DH, United Kingdom
Royal Hallamshire Hospital
Sheffield, S10 2JF, United Kingdom
Royal Stoke University Hospital
Stoke-on-Trent, ST4 6QG, United Kingdom
Sunderland Royal Hospital
Sunderland, SR4 7TP, United Kingdom
Morriston Hospital
Swansea, SA6 6NL, United Kingdom
Southmead Hospital
Westbury-on-Trym, Bristol, BS10 5NB, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 11, 2018
First Posted
July 20, 2018
Study Start
November 12, 2018
Primary Completion
January 19, 2026
Study Completion
January 19, 2026
Last Updated
February 17, 2026
Record last verified: 2026-02
Data Sharing
- IPD Sharing
- Will share
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