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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03593590
Other study ID # MN39889
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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