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

Multiple Sclerosis Clinical Trial

— MuSicalE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03593590
• Other study ID #: MN39889
• Status: Active, not recruiting
• Start date: November 12, 2018
• Est. completion date: July 26, 2025

Study information

• Verified date: May 2024
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 1710
• Est. completion date: July 26, 2025
• Est. primary completion date: July 26, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Chronic Progressive
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Austria	Landesklinikum Amstetten; Abteilung für Neurologie	Amstetten
Austria	Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie	Innsbruck
Austria	Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie	Linz
Austria	Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie	Linz
Austria	Multiple Sklerose Zentrum	Melk
Austria	Klinik Floridsdorf; Abteilung für Neurologie	Wien
Belgium	Imeldaziekenhuis	Bonheiden
Belgium	AZ KLINA	Brasschaat
Belgium	UZ Brussel	Brussel
Belgium	Cliniques Universitaires St-Luc	Bruxelles
Belgium	Hospital Erasme	Bruxelles
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	Liege
Belgium	Nationaal MS Centrum	Melsbroek
Belgium	CHU UCL Mont-Godinne	Mont-godinne
Belgium	AZ Damiaan	Oostende
Belgium	Revalidatie en MS Centrum	Overpelt
Belgium	AZ Delta (Campus Rumbeke)	Roeselare
Brazil	Hospital de Base do Distrito Federal; Núcleo de Citopatologia e Anatomia Patológica	Brasilia	DF
Brazil	Instituto de Neurologia de Curitiba	Curitiba	PR
Brazil	Hospital Universitario Gaffree e Guinle	Rio de Janeiro	RJ
Brazil	Clinica Amo - Assistencia Medica Em Oncologia	Salvador	BA
Brazil	Centro de Pesquisas Clinicas; CPCLIN	Sao Paulo	SP
Brazil	CPQuali Pesquisa Clinica Ltda	Sao Paulo	SP
Bulgaria	UMHAT 'Dr. Georgi Stranski', EAD	Pleven
Bulgaria	UMHAT Sveti Georgi Clinic of neurology	Plovdiv
Bulgaria	"City Clinic UMHAC" EOOD	Sofia
Bulgaria	ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine	Sofia
Bulgaria	First MHAT; Clinic of Neurology	Sofia
Bulgaria	Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.	Sofia
Bulgaria	Shat Np Sveti Naum; 3Rd Clinic of Neurology	Sofia
Bulgaria	UMHAT "Sv. Ivan Rilski", EAD	Sofia
Bulgaria	UMHAT Alexandrovska, EAD; Neurology	Sofia
Bulgaria	UMHAT Tsaritsa Yoanna - ISUL EAD; Clinic of Neurology	Sofia
Bulgaria	MBAL St. Marina; First Neurology Department	Varna
Chile	Clinica Las Condes	Santiago
Colombia	Centro Javeriano de Oncología	Bogota
Colombia	Organizacion Sanitas Internacional	Bogota, D.C.
Colombia	Fundacion ABOOD Shaio	Bogota, DC
Colombia	Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas	Cali
Dominican Republic	Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)	Santo Domingo
Egypt	Clinical Research Center-Alex university; Neurology Department	Alexandria
Egypt	Al Qahira Al Fatmiya Hospital	Cairo
Egypt	Faculty of Medicine-Ain Shams University; Neurology Department	Cairo
Italy	Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso	Bari	Puglia
Italy	Ospedale Binaghi; Centro Sclerosi Multipla	Cagliari	Sardegna
Italy	Ospedale F. Ferrari; UO Neurologia, Centro Sclerosi Multipla	Casarano	Puglia
Italy	AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla	Catania	Sicilia
Italy	Arcispedale Sant'Anna; Neurochirurgia - Dipartimento Neuroscienze e Riabilitazione	Cona	Emilia-Romagna
Italy	Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico	Gallarate	Lombardia
Italy	Irccs A.O.U.San Martino Ist; Dinogmi	Genova	Liguria
Italy	Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla	L'Aquila	Abruzzo
Italy	Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari	Milano	Lombardia
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia	Milano	Lombardia
Italy	IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla	Milano	Lombardia
Italy	Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla	Mondovì (CN)	Piemonte
Italy	AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica	Napoli	Campania
Italy	Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur	Napoli	Campania
Italy	AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla	Palermo	Sicilia
Italy	A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)	Parma	Emilia-Romagna
Italy	IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla	Pavia	Lombardia
Italy	IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla	Pozzilli	Molise
Italy	Azienda Ospedaliera Sant'Andrea; UOC Neurologia	Roma	Lazio
Italy	Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla	Roma	Lazio
Italy	Presidio Ospedaliero S.O.P.A. Micone; S.C. Neurologia, Centro Sclerosi Multipla	Sestri Ponente (GE)	Liguria
Italy	AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale	Siena	Toscana
Italy	Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona	Torrette - Ancona	Marche
Kuwait	Ibn Sina Hospital; Neurology Department	Kuwait
Montenegro	Clinical Center of Montenegro; Clinic for neurology	Podgorica
Netherlands	Amphia Ziekenhuis	Breda
Netherlands	St. Antonius Ziekenhuis Nieuwegein	Nieuwegein
Netherlands	Maasstadziekenhuis	Rotterdam
Netherlands	Ziekenhuis VieCuri Medisch Centrum	Venlo
Netherlands	Isala	Zwolle
Panama	Consultorio Médico Paitilla	Ciudad Panama
Paraguay	Hospital Central del Instituto de Previsión Social	Asunción
Poland	Uniwersytecki Szpital Kliniczny w Bialymstoku	Bia?ystok
Poland	COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny	Gdansk
Poland	Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa	Glogow Malopolski
Poland	Gornoslaskie Centrum Medyczne	Katowice
Poland	UCK im. prof. K. Gibinskiego SUM; Klinika Neurologii	Katowice
Poland	SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii	Lodz
Poland	SPZOZ Wojewodzki Szpital Specjalistyczny nr 3	Rybnik
Poland	Instytut Psychiatrii i Neurologii	Warszawa
Poland	Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy	Warszawa
Poland	SPSK nr 1; Klinika Neurologii	Zabrze
Portugal	Hospital Santo Antonio dos Capuchos; Servico de Neurologia	Lisboa
Portugal	Centro Hospitalar do Porto; CICAP - Unidade Clínica de Paramiloidose	Porto
Qatar	Hamad General Hospital; Neurology Department	Doha
Romania	Spitalul Universitar de Urgenta Bucuresti	Bucharest
Romania	Spitalul Clinic Judetean de Urgenta Cluj-Napoca; Neurologie	Cluj-Napoca
Romania	Spitalul Clinic Judetean de Urgenta Sibiu; Neurologie	Sibiu
Romania	Spitalul Clinic Judetean de Urgenta Mures	Targu-Mures
Russian Federation	Regional clinical hospital named after prof. S.V. Ochapovsky	Krasnodar
Russian Federation	Jusupovskaya Hospital	Moscow	Moskovskaja Oblast
Russian Federation	State Novosibirsk Regional Clinical Hospital	Novosibirsk
Russian Federation	National Center of Social Significant Disease	Sankt-peterburg	Leningrad
Saudi Arabia	King Abdul Aziz Medical City, King Fahd National Guard; Oncology	Riyadh
Serbia	Clinical Center of Serbia	Belgrade
Serbia	Clinical Center Kragujevac	Kragujevac
Serbia	Clinical Center Nis	NIS
Serbia	Clinical Centre of Vojvodina	Nova Sad
Slovakia	Nemocnica akademika Ladislava Derera; Neurologicka klinika	Bratislava
Slovakia	Univerzitna Nemocnica - Nemocnica svateho Michala; Neurologicke oddelenie	Bratislava
Slovakia	Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB	Bratislava
Slovakia	Univerzitna nemocnica Martin; Neurologicka klinika	Martin
Slovakia	Ustredna vojenska nemocnica SNP Ruzomberok; Klinika neurologie	Ruzomberok
Slovakia	Fakultna nemocnica Trnava	Trnava
Spain	Hospital Nuestra Señora de Sonsoles; Servicio de Neurología	Avila
Spain	Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia	Barcelona
Spain	Hospital Germans Trias i Pujol	Barcelona
Spain	Hospital Puerta del Mar; Sevicio de Neurologia	Cadiz
Spain	Hospital General Universitario Santa Lucia; Servicio de Neurología	Cartagena (Murcia)	Murcia
Spain	Hospital Universitario Reina Sofia; Servicio de Neurologia	Cordoba
Spain	Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia	Coruña	LA Coruña
Spain	Hospital Universitario Virgen de Arrixaca; Servicio de Neurología	EL Palmar (EL Palmar)	Murcia
Spain	Hospital General Universitario de Elche; Servicio de Neurología	Elche	Alicante
Spain	Hospital de Figueres; Servicio de Neurología	Figueres	Girona
Spain	Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia	Malaga
Spain	Hospital Universitario Virgen de la Victoria; Servicio de Neurología	Malaga
Spain	Corporació Sanitaria Parc Taulí; Servicio de Neurología	Sabadell	Barcelona
Spain	Hospital Universitario de Canarias; Servicio de Neurologia	San Cristóbal de La Laguna	Tenerife
Spain	Hospital de Donostia; Servicio de Neurologia	San Sebastian	Guipuzcoa
Spain	Hospital Nuestra Señora de Candelaria; Unidad de Esclerosis Multiple	Santa Cruz de Tenerife	Tenerife
Spain	Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia	Santiago de Compostela	LA Coruña
Spain	Hospital Univ. Nuestra Señora de Valme; Servicio de Neurología	Sevilla
Spain	Hospital Universitario Virgen Macarena; Servicio de Neurologia	Sevilla
Spain	Hospital Virgen del Rocío; Servicio de Neurología	Sevilla
Spain	Hospital Clinico Universitario de Valencia; Servicio de Neurologia	Valencia
Spain	Hospital General Universitario de Valencia; Servicio de Neurología	Valencia
Spain	Hospital Universitari i Politecnic La Fe; Servicio de Neurología	Valencia
Spain	Hospital Universitario Dr. Peset; Servicio de Neurologia	Valencia
Spain	Hospital Alvaro Cunqueiro; Servicio de Neurologia	Vigo	Pontevedra
Spain	Hospital Universitario de Araba; Servicio de Neurologia	Vitoria-gasteiz	Alava
Turkey	Hacettepe University Medical Faculty; Neurology	Ankara
Turkey	Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali	Istanbul
Turkey	Istanbul University Istanbul School of Medicine; Neurology	Istanbul
Turkey	Ege University Medical Faculty	Izmir
Turkey	Kocaeli University Hospital; Department of Neurology	Kocaeli
Turkey	Mersin University Medical Faculty; Neurology	Mersin
Turkey	Ondokuz Mayis Univ. Med. Fac.; Neurology	Samsun
Turkey	Karadeniz Tecnical Uni. Med. Fac.; Neurology	Trabzon
United Arab Emirates	Sheikh Shakhbout Medical City	Abu Dhabi
United Arab Emirates	Mediclinic Parkview Hospital	Dubai-UAE
United Kingdom	Royal Victoria Hospital	Belfast
United Kingdom	University Hospital Coventry	Coventry
United Kingdom	Raigmore Hospital; Highland Clin Rsrch Facility, Ctr For Health Sci	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 & Dunstable University Hospital, Neurology department	Luton
United Kingdom	James Cook Hospital	Middlesbrough
United Kingdom	John Radcliffe Hospital	Oxford
United Kingdom	Derriford Hospital	Plymouth
United Kingdom	Royal Hallamshire Hospital; Neurology	Sheffield
United Kingdom	Royal Stoke University Hospital	Stoke-on-Trent
United Kingdom	Sunderland Royal Hospital	Sunderland
United Kingdom	Morriston Hospital; Cardiac Center	Swansea
United Kingdom	Southmead Hospital	Westbury-on-Trym, Bristol

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Austria,  Belgium,  Brazil,  Bulgaria,  Chile,  Colombia,  Dominican Republic,  Egypt,  Italy,  Kuwait,  Montenegro,  Netherlands,  Panama,  Paraguay,  Poland,  Portugal,  Qatar,  Romania,  Russian Federation,  Saudi Arabia,  Serbia,  Slovakia,  Spain,  Turkey,  United Arab Emirates,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Percentage of RMS Participants with Adverse Events		4 years
Secondary	Percentage of PPMS participants with Adverse Events		4 years
Secondary	Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS		4 years
Secondary	Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS		4 years
Secondary	Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants		4 years
Secondary	Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants		4 years
Secondary	Change in the score of ABILHAND - 56 scale in RMS participants		4 years
Secondary	Change in the score of ABILHAND - 56 scale in PPMS participants		4 years
Secondary	Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant		4 years
Secondary	Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants		4 years
Secondary	Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants		4 years
Secondary	Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants		4 years
Secondary	Change in the score of MSWS - 12 scale in RMS participants		4 years
Secondary	Change in the score of MSWS - 12 scale in PPMS participants		4 years
Secondary	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
Secondary	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
Secondary	Frequency of relapses over time in RMS patients		4 years
Secondary	Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time		4 years
Secondary	Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time		4 years