Clinical trial NCT03593590: Non-interventional Study of Ocrelizumab in Participants With Relapsing or Primary Progressive Multiple Sclerosis
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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Multiple Sclerosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-07-20
Enrollment: 1710
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants with RMS or PPMS undergoing routine clinical care

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.


Eligibility criteria: 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

Primary outcomes:
measure: Changes in the overall SymptoMScreen score in participants with RMS
timeFrame: 4 years
measure: Changes in the overall SymptoMScreen score in participants with PPMS
timeFrame: 4 years
Secondary outcomes:
measure: Percentage of RMS Participants with Adverse Events
timeFrame: 4 years
measure: Percentage of PPMS participants with Adverse Events
timeFrame: 4 years
measure: Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS
timeFrame: 4 years
measure: Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS
timeFrame: 4 years
measure: Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants
timeFrame: 4 years
measure: Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants
timeFrame: 4 years
measure: Change in the score of ABILHAND - 56 scale in RMS participants
timeFrame: 4 years
measure: Change in the score of ABILHAND - 56 scale in PPMS participants
timeFrame: 4 years
measure: Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant
timeFrame: 4 years
measure: Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants
timeFrame: 4 years
measure: Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants
timeFrame: 4 years
measure: Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants
timeFrame: 4 years
measure: Change in the score of MSWS - 12 scale in RMS participants
timeFrame: 4 years
measure: Change in the score of MSWS - 12 scale in PPMS participants
timeFrame: 4 years
measure: 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
timeFrame: 4 years
measure: 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
timeFrame: 4 years
measure: Frequency of relapses over time in RMS patients
timeFrame: 4 years
measure: Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time
timeFrame: 4 years
measure: Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time
timeFrame: 4 years
Other outcomes:
Locations:
city: Amstetten
country: Austria
facility: Landesklinikum Amstetten
city: Innsbruck
country: Austria
facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
city: Linz
country: Austria
facility: Kepler Universitätsklinikum GmbH - Neuromed Campus
city: Linz
country: Austria
facility: Kepler Universitätskliniken GmbH - Med Campus III
city: Melk
country: Austria
facility: Multiple Sklerose Zentrum
city: Wien
country: Austria
facility: Klinik Floridsdorf
city: Bonheiden
country: Belgium
facility: Imeldaziekenhuis
city: Brasschaat
country: Belgium
facility: AZ KLINA
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Charleroi
country: Belgium
facility: CHU de Charleroi
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Fraiture
country: Belgium
facility: CNRF - Centre Neurologique et Réadaptation Fonctionnelle
city: Hasselt
country: Belgium
facility: Jessa Zkh (Campus Virga Jesse)
city: Kortrijk
country: Belgium
facility: AZ Groeninge
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Liege
country: Belgium
facility: CHC MontLégia
city: Melsbroek
country: Belgium
facility: Nationaal MS Centrum
city: Mont-godinne
country: Belgium
facility: CHU UCL Mont-Godinne
city: Oostende
country: Belgium
facility: AZ Oostende
city: Overpelt
country: Belgium
facility: Revalidatie en MS Centrum
city: Roeselare
country: Belgium
facility: AZ Delta (Campus Rumbeke)
city: Salvador
country: Brazil
facility: Clinica Amo - Assistencia Medica Em Oncologia
state: Bahia
city: Brasilia
country: Brazil
facility: Hospital de Base do Distrito Federal
state: Distrito Federal
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: Paraná
city: Sao Paulo
country: Brazil
facility: CPQuali Pesquisa Clinica Ltda
state: São Paulo
city: Rio de Janeiro
country: Brazil
facility: Hospital Universitario Gaffree e Guinle
city: Pleven
country: Bulgaria
facility: UMHAT 'Dr. Georgi Stranski', EAD
city: Plovdiv
country: Bulgaria
facility: UMHAT Sveti Georgi Clinic of neurology
city: Sofia
country: Bulgaria
facility: Shat Np Sveti Naum
city: Sofia
country: Bulgaria
facility: First MHAT
city: Sofia
country: Bulgaria
facility: Multiprofile Hosp. for Active Treatment
city: Sofia
country: Bulgaria
facility: "City Clinic UMHAC" EOOD
city: Sofia
country: Bulgaria
facility: Acibadem City Clinic Tokuda Hospital Ead
city: Sofia
country: Bulgaria
facility: UMHAT "Sv. Ivan Rilski", EAD
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska, EAD
city: Sofia
country: Bulgaria
facility: UMHAT Tsaritsa Yoanna - ISUL EAD
city: Varna
country: Bulgaria
facility: MBAL St. Marina
city: Santiago
country: Chile
facility: Clinica Las Condes
city: Bogota, DC
country: Colombia
facility: Fundacion ABOOD Shaio
city: Bogota
country: Colombia
facility: Centro Javeriano de Oncología
city: Bogota
country: Colombia
facility: Organizacion Sanitas Internacional
city: Cali
country: Colombia
facility: Fundacion Clinica Valle del Lili
city: Santo Domingo
country: Dominican Republic
facility: Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)
city: Cairo
country: Egypt
facility: Faculty of Medicine-Ain Shams University
city: Cairo
country: Egypt
facility: Al Qahira Al Fatmiya Hospital
city: Cairo
country: Egypt
facility: Clinical Research Center-Alex university
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore
state: Abruzzo
city: Napoli
country: Italy
facility: Università degli Studi della Campania Luigi Vanvitelli
state: Campania
city: Napoli
country: Italy
facility: AOU Seconda Università degli Studi
state: Campania
city: Cona
country: Italy
facility: Arcispedale Sant'Anna
state: Emilia-Romagna
city: Parma
country: Italy
facility: A.O.U. di Parma
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
state: Lazio
city: Genova
country: Italy
facility: Irccs A.O.U.San Martino Ist
state: Liguria
city: Sestri Ponente (GE)
country: Italy
facility: Presidio Ospedaliero S.O.P.A. Micone
state: Liguria
city: Gallarate
country: Italy
facility: Ospedale S.Antonio Abate
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Fond. Istituto Neurologico C.Besta
state: Lombardia
city: Pavia
country: Italy
facility: IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
state: Lombardia
city: San Donato Milanese
country: Italy
facility: Policlinico San Donato
state: Lombardia
city: Torrette - Ancona
country: Italy
facility: Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
state: Marche
city: Pozzilli
country: Italy
facility: IRCCS Istituto Neurologico Neuromed
state: Molise
city: Mondovì (CN)
country: Italy
facility: Ospedale Regina Montis Regalis
state: Piemonte
city: Bari
country: Italy
facility: Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
state: Puglia
city: Casarano
country: Italy
facility: Ospedale F. Ferrari
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Binaghi
state: Sardegna
city: Catania
country: Italy
facility: AOU Policlinico V. Emanuele - P.O G. Rodolico
state: Sicilia
city: Palermo
country: Italy
facility: AOU Policlinico Giaccone
state: Sicilia
city: Siena
country: Italy
facility: AOU Senese - Presidio Ospedaliero Le Scotte
state: Toscana
city: Kuwait
country: Kuwait
facility: Ibn Sina Hospital
city: Podgorica
country: Montenegro
facility: Clinical Center of Montenegro
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: NL -rotterdam
country: Netherlands
facility: Maasstadziekenhuis
city: Venlo
country: Netherlands
facility: Ziekenhuis VieCuri Medisch Centrum
city: Zwolle
country: Netherlands
facility: Isala
city: Asunción
country: Paraguay
facility: Hospital Central del Instituto de Previsión Social
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
city: Glogow Malopolski
country: Poland
facility: Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa
city: Katowice
country: Poland
facility: Gornoslaskie Centrum Medyczne
city: Katowice
country: Poland
facility: UCK im. prof. K. Gibinskiego SUM
city: Lodz
country: Poland
facility: SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM
city: Rybnik
country: Poland
facility: SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii
city: Warszawa
country: Poland
facility: Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
city: Zabrze
country: Poland
facility: SPSK nr 1
city: Lisboa
country: Portugal
facility: Hospital Santo Antonio dos Capuchos
city: Porto
country: Portugal
facility: Centro Hospitalar do Porto
city: Doha
country: Qatar
facility: Hamad General Hospital
city: Bucharest
country: Romania
facility: Fundeni Clinical Institute
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Cluj-Napoca
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Cluj-Napoca
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Sibiu
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Mures
city: Sankt-peterburg
country: Russian Federation
facility: National Center of Social Significant Disease
state: Leningrad
city: Moscow
country: Russian Federation
facility: Jusupovskaya Hospital
state: Moskovskaja Oblast
city: Krasnodar
country: Russian Federation
facility: Regional clinical hospital named after prof. S.V. Ochapovsky
city: Novosibirsk
country: Russian Federation
facility: State Novosibirsk Regional Clinical Hospital
city: Riyadh
country: Saudi Arabia
facility: King Abdul Aziz Medical City, King Fahd National Guard
city: Belgrade
country: Serbia
facility: Clinical Center of Serbia
city: Kragujevac
country: Serbia
facility: Clinical Center Kragujevac
city: NIS
country: Serbia
facility: Clinical Center Nis
city: Bratislava
country: Slovakia
facility: Univerzitna Nemocnica - Nemocnica svateho Michala
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava - Nemocnica Ruzinov
city: Bratislava
country: Slovakia
facility: Nemocnica akademika Ladislava Derera
city: Martin
country: Slovakia
facility: Univerzitna nemocnica Martin
city: Ruzomberok
country: Slovakia
facility: Ustredna vojenska nemocnica SNP Ruzomberok
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Vitoria-gasteiz
country: Spain
facility: Hospital Universitario de Araba
state: Alava
city: Elche
country: Spain
facility: Hospital General Universitario de Elche
state: Alicante
city: Sabadell
country: Spain
facility: Corporació Sanitaria Parc Taulí
state: Barcelona
city: Figueres
country: Spain
facility: Hospital de Figueres
state: Girona
city: San Sebastian
country: Spain
facility: Hospital de Donostia
state: Guipuzcoa
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
state: LA Coruna
city: Santiago de Compostela
country: Spain
facility: Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
state: LA Coruna
city: Cartagena (Murcia)
country: Spain
facility: Hospital General Universitario Santa Lucia
state: Murcia
city: Vigo
country: Spain
facility: Hospital Alvaro Cunqueiro
state: Pontevedra
city: San Cristóbal de La Laguna
country: Spain
facility: Hospital Universitario de Canarias
state: Tenerife
city: Santa Cruz de Tenerife
country: Spain
facility: Hospital Nuestra Señora de Candelaria
state: Tenerife
city: Avila
country: Spain
facility: Hospital Nuestra Señora de Sonsoles
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Barcelona
country: Spain
facility: Hospital Germans Trias i Pujol
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Cordoba
country: Spain
facility: Hospital Universitario Reina Sofia
city: Malaga
country: Spain
facility: Hospital Regional Universitario de Malaga ? Hospital General
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Sevilla
country: Spain
facility: Hospital Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Univ. Nuestra Señora de Valme
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitari i Politecnic La Fe
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul School of Medicine
city: Istanbul
country: Turkey
facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical Uni. Med. Fac.
city: Dubai-UAE
country: United Arab Emirates
facility: Mediclinic Parkview Hospital
city: Belfast
country: United Kingdom
facility: Royal Victoria Hospital
city: Coventry
country: United Kingdom
facility: University Hospital Coventry
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Leeds
country: United Kingdom
facility: Leeds General Infirmary
city: Lincoln
country: United Kingdom
facility: Lincoln County Hospital
city: London
country: United Kingdom
facility: St George?s Hospital
city: Luton
country: United Kingdom
facility: Luton General Hospital
city: Middlesbrough
country: United Kingdom
facility: James Cook Hospital
city: Oxford
country: United Kingdom
facility: John Radcliffe Hospital
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospital
city: Stoke on Trent
country: United Kingdom
facility: Royal Stoke University Hospital
city: Sunderland
country: United Kingdom
facility: Sunderland Royal Hospital
city: Swansea
country: United Kingdom
facility: Morriston Hospital
city: Westbury-on-Trym, Bristol
country: United Kingdom
facility: Southmead Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: