Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis
- Registration Number
- NCT03593590
- Lead Sponsor
- Hoffmann-La Roche
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1710
- 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
- 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
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Ocrelizumab Ocrelizumab Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.
- Primary Outcome Measures
Name Time Method Changes in the overall SymptoMScreen score in participants with RMS 4 years 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)Changes in the overall SymptoMScreen score in participants with PPMS 4 years 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)
- Secondary Outcome Measures
Name Time Method 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 Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS 4 years 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 Change in the score of ABILHAND - 56 scale in PPMS participants 4 years Change in the score of MSWS - 12 scale in RMS 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 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 Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time 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 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
Trial Locations
- Locations (160)
Landesklinikum Amstetten
🇦🇹Amstetten, Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
🇦🇹Innsbruck, Austria
Kepler Universitätsklinikum GmbH - Neuromed Campus
🇦🇹Linz, Austria
Kepler Universitätskliniken GmbH - Med Campus III
🇦🇹Linz, Austria
Klinik Floridsdorf
🇦🇹Wien, Austria
Hospital de Base do Distrito Federal
🇧🇷Brasilia, Distrito Federal, Brazil
Shat Np Sveti Naum
🇧🇬Sofia, Bulgaria
First MHAT
🇧🇬Sofia, Bulgaria
Multiprofile Hosp. for Active Treatment
🇧🇬Sofia, Bulgaria
Acibadem City Clinic Tokuda Hospital Ead
🇧🇬Sofia, Bulgaria
UMHAT Alexandrovska, EAD
🇧🇬Sofia, Bulgaria
UMHAT Tsaritsa Yoanna - ISUL EAD
🇧🇬Sofia, Bulgaria
MBAL St. Marina
🇧🇬Varna, Bulgaria
Fundacion Clinica Valle del Lili
🇨🇴Cali, Colombia
Faculty of Medicine-Ain Shams University
🇪🇬Cairo, Egypt
Clinical Research Center-Alex university
🇪🇬Cairo, Egypt
Ospedale San Salvatore
🇮🇹L'Aquila, Abruzzo, Italy
Università degli Studi della Campania Luigi Vanvitelli
🇮🇹Napoli, Campania, Italy
AOU Seconda Università degli Studi
🇮🇹Napoli, Campania, Italy
Arcispedale Sant'Anna
🇮🇹Cona, Emilia-Romagna, Italy
A.O.U. di Parma
🇮🇹Parma, Emilia-Romagna, Italy
Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Lazio, Italy
Irccs A.O.U.San Martino Ist
🇮🇹Genova, Liguria, Italy
Presidio Ospedaliero S.O.P.A. Micone
🇮🇹Sestri Ponente (GE), Liguria, Italy
Ospedale S.Antonio Abate
🇮🇹Gallarate, Lombardia, Italy
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Fond. Istituto Neurologico C.Besta
🇮🇹Milano, Lombardia, Italy
Policlinico San Donato
🇮🇹San Donato Milanese, Lombardia, Italy
IRCCS Istituto Neurologico Neuromed
🇮🇹Pozzilli, Molise, Italy
Ospedale Regina Montis Regalis
🇮🇹Mondovì (CN), Piemonte, Italy
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
🇮🇹Bari, Puglia, Italy
Ospedale F. Ferrari
🇮🇹Casarano, Puglia, Italy
Ospedale Binaghi
🇮🇹Cagliari, Sardegna, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
🇮🇹Catania, Sicilia, Italy
AOU Policlinico Giaccone
🇮🇹Palermo, Sicilia, Italy
AOU Senese - Presidio Ospedaliero Le Scotte
🇮🇹Siena, Toscana, Italy
Ibn Sina Hospital
🇰🇼Kuwait, Kuwait
Clinical Center of Montenegro
🇲🇪Podgorica, Montenegro
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
🇵🇱Gdansk, Poland
UCK im. prof. K. Gibinskiego SUM
🇵🇱Katowice, Poland
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM
🇵🇱Lodz, Poland
SPSK nr 1
🇵🇱Zabrze, Poland
Hospital Santo Antonio dos Capuchos
🇵🇹Lisboa, Portugal
Centro Hospitalar do Porto
🇵🇹Porto, Portugal
Hamad General Hospital
🇶🇦Doha, Qatar
Fundeni Clinical Institute
🇷🇴Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Cluj-Napoca
🇷🇴Cluj-Napoca, Romania
Spitalul Clinic Judetean de Urgenta Sibiu
🇷🇴Sibiu, Romania
King Abdul Aziz Medical City, King Fahd National Guard
🇸🇦Riyadh, Saudi Arabia
Univerzitna Nemocnica - Nemocnica svateho Michala
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica Bratislava - Nemocnica Ruzinov
🇸🇰Bratislava, Slovakia
Nemocnica akademika Ladislava Derera
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica Martin
🇸🇰Martin, Slovakia
Ustredna vojenska nemocnica SNP Ruzomberok
🇸🇰Ruzomberok, Slovakia
Hospital Universitario de Araba
🇪🇸Vitoria-gasteiz, Alava, Spain
Hospital General Universitario de Elche
🇪🇸Elche, Alicante, Spain
Corporació Sanitaria Parc Taulí
🇪🇸Sabadell, Barcelona, Spain
Hospital de Figueres
🇪🇸Figueres, Girona, Spain
Hospital de Donostia
🇪🇸San Sebastian, Guipuzcoa, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
🇪🇸Coruña, LA Coruna, Spain
Hospital General Universitario Santa Lucia
🇪🇸Cartagena (Murcia), Murcia, Spain
Hospital Alvaro Cunqueiro
🇪🇸Vigo, Pontevedra, Spain
Hospital Universitario de Canarias
🇪🇸San Cristóbal de La Laguna, Tenerife, Spain
Hospital Nuestra Señora de Candelaria
🇪🇸Santa Cruz de Tenerife, Tenerife, Spain
Hospital Nuestra Señora de Sonsoles
🇪🇸Avila, Spain
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Puerta del Mar
🇪🇸Cadiz, Spain
Hospital Universitario Reina Sofia
🇪🇸Cordoba, Spain
Hospital Regional Universitario de Malaga ? Hospital General
🇪🇸Malaga, Spain
Hospital Universitario Virgen de Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Virgen del Rocío
🇪🇸Sevilla, Spain
Hospital Univ. Nuestra Señora de Valme
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital General Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitari i Politecnic La Fe
🇪🇸Valencia, Spain
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Istanbul University Istanbul School of Medicine
🇹🇷Istanbul, Turkey
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
Kocaeli University Hospital
🇹🇷Kocaeli, Turkey
Mersin University Medical Faculty
🇹🇷Mersin, Turkey
Ondokuz Mayis Univ. Med. Fac.
🇹🇷Samsun, Turkey
Karadeniz Tecnical Uni. Med. Fac.
🇹🇷Trabzon, Turkey
Raigmore Hospital
🇬🇧Inverness, United Kingdom
Luton General Hospital
🇬🇧Luton, United Kingdom
Royal Hallamshire Hospital
🇬🇧Sheffield, United Kingdom
Morriston Hospital
🇬🇧Swansea, United Kingdom
Multiple Sklerose Zentrum
🇦🇹Melk, Austria
Imeldaziekenhuis
🇧🇪Bonheiden, Belgium
AZ KLINA
🇧🇪Brasschaat, Belgium
UZ Brussel
🇧🇪Brussel, Belgium
Hospital Erasme
🇧🇪Bruxelles, Belgium
Cliniques Universitaires St-Luc
🇧🇪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, Belgium
Clinica Amo - Assistencia Medica Em Oncologia
🇧🇷Salvador, Bahia, Brazil
Instituto de Neurologia de Curitiba
🇧🇷Curitiba, Paraná, Brazil
CPQuali Pesquisa Clinica Ltda
🇧🇷Sao Paulo, São Paulo, Brazil
Hospital Universitario Gaffree e Guinle
🇧🇷Rio de Janeiro, Brazil
UMHAT 'Dr. Georgi Stranski', EAD
🇧🇬Pleven, Bulgaria
UMHAT Sveti Georgi Clinic of neurology
🇧🇬Plovdiv, Bulgaria
"City Clinic UMHAC" EOOD
🇧🇬Sofia, Bulgaria
UMHAT "Sv. Ivan Rilski", EAD
🇧🇬Sofia, Bulgaria
Clinica Las Condes
🇨🇱Santiago, Chile
Fundacion ABOOD Shaio
🇨🇴Bogota, DC, Colombia
Centro Javeriano de Oncología
🇨🇴Bogota, Colombia
Organizacion Sanitas Internacional
🇨🇴Bogota, Colombia
Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)
🇩🇴Santo Domingo, Dominican Republic
Al Qahira Al Fatmiya Hospital
🇪🇬Cairo, Egypt
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
🇮🇹Roma, Lazio, Italy
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
🇮🇹Pavia, Lombardia, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
🇮🇹Torrette - Ancona, Marche, Italy
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
St. Antonius Ziekenhuis Nieuwegein
🇳🇱Nieuwegein, Netherlands
Maasstadziekenhuis
🇳🇱NL -rotterdam, Netherlands
Ziekenhuis VieCuri Medisch Centrum
🇳🇱Venlo, Netherlands
Isala
🇳🇱Zwolle, Netherlands
Hospital Central del Instituto de Previsión Social
🇵🇾Asunción, Paraguay
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa
🇵🇱Glogow Malopolski, Poland
Gornoslaskie Centrum Medyczne
🇵🇱Katowice, Poland
SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
🇵🇱Rybnik, Poland
Instytut Psychiatrii i Neurologii
🇵🇱Warszawa, Poland
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
🇵🇱Warszawa, Poland
Spitalul Universitar de Urgenta Bucuresti
🇷🇴Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Mures
🇷🇴Targu-Mures, Romania
National Center of Social Significant Disease
🇷🇺Sankt-peterburg, Leningrad, Russian Federation
Jusupovskaya Hospital
🇷🇺Moscow, Moskovskaja Oblast, Russian Federation
Regional clinical hospital named after prof. S.V. Ochapovsky
🇷🇺Krasnodar, Russian Federation
State Novosibirsk Regional Clinical Hospital
🇷🇺Novosibirsk, Russian Federation
Clinical Center of Serbia
🇷🇸Belgrade, Serbia
Clinical Center Kragujevac
🇷🇸Kragujevac, Serbia
Clinical Center Nis
🇷🇸NIS, Serbia
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
🇪🇸Santiago de Compostela, LA Coruna, Spain
Hospital Germans Trias i Pujol
🇪🇸Barcelona, Spain
Ege University Medical Faculty
🇹🇷Izmir, Turkey
Mediclinic Parkview Hospital
🇦🇪Dubai-UAE, United Arab Emirates
Royal Victoria Hospital
🇬🇧Belfast, United Kingdom
University Hospital Coventry
🇬🇧Coventry, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, United Kingdom
Lincoln County Hospital
🇬🇧Lincoln, United Kingdom
St George?s Hospital
🇬🇧London, United Kingdom
James Cook Hospital
🇬🇧Middlesbrough, United Kingdom
John Radcliffe Hospital
🇬🇧Oxford, United Kingdom
Derriford Hospital
🇬🇧Plymouth, United Kingdom
Royal Stoke University Hospital
🇬🇧Stoke on Trent, United Kingdom
Sunderland Royal Hospital
🇬🇧Sunderland, United Kingdom
Southmead Hospital
🇬🇧Westbury-on-Trym, Bristol, United Kingdom