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

Sponsor
Hoffmann-La Roche (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03593590
Collaborator
(none)
1,700
165
80.4
10.3
0.1

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

Study Design

Study Type:
Observational
Anticipated Enrollment :
1700 participants
Observational Model:
Cohort
Time Perspective:
Prospective
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
Actual Study Start Date :
Nov 12, 2018
Anticipated Primary Completion Date :
Jul 26, 2025
Anticipated Study Completion Date :
Jul 26, 2025

Arms and Interventions

Arm Intervention/Treatment
Ocrelizumab

Participants with relapsing or primary progressive MS receiving ocrelizumab under routine clinical care.

Drug: Ocrelizumab
Ocrelizumab is administered as an intravenous infusion in accordance with the approved labelling.
Other Names:
  • Ocrevus
  • Outcome Measures

    Primary Outcome Measures

    1. 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)

    2. 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

    1. Percentage of RMS Participants with Adverse Events [4 years]

    2. Percentage of PPMS participants with Adverse Events [4 years]

    3. Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS [4 years]

    4. Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS [4 years]

    5. Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants [4 years]

    6. Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants [4 years]

    7. Change in the score of ABILHAND - 56 scale in RMS participants [4 years]

    8. Change in the score of ABILHAND - 56 scale in PPMS participants [4 years]

    9. Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant [4 years]

    10. Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants [4 years]

    11. Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants [4 years]

    12. Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants [4 years]

    13. Change in the score of MSWS - 12 scale in RMS participants [4 years]

    14. Change in the score of MSWS - 12 scale in PPMS participants [4 years]

    15. 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]

    16. 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]

    17. Frequency of relapses over time in RMS patients [4 years]

    18. Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time [4 years]

    19. Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time [4 years]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Landesklinikum Amstetten; Abteilung für Kinder- und Jugendheilkunde Amstetten Austria 3300
    2 Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie Innsbruck Austria 6020
    3 Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie Linz Austria 4020
    4 Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie Linz Austria 4021
    5 Multiple Sklerose Zentrum Melk Austria 3390
    6 Otto Wagner Spital; Neurologisches Zentrum Wien Austria 1140
    7 Imeldaziekenhuis Bonheiden Belgium 2820
    8 AZ KLINA Brasschaat Belgium 2930
    9 UZ Brussel Brussel Belgium 1090
    10 Hospital Erasme Bruxelles Belgium 1070
    11 Cliniques Universitaires St-Luc Bruxelles Belgium 1200
    12 CHU de Charleroi Charleroi Belgium 6042
    13 UZ Antwerpen Edegem Belgium 2650
    14 CNRF - Centre Neurologique et Réadaptation Fonctionnelle Fraiture Belgium 4557
    15 Jessa Zkh (Campus Virga Jesse) Hasselt Belgium 3500
    16 AZ Groeninge Kortrijk Belgium 8500
    17 CHU Tivoli La Louvière Belgium 7100
    18 CHC MontLégia Liege Belgium 4000
    19 Nationaal MS Centrum Melsbroek Belgium 1820
    20 CHU UCL Mont-Godinne Mont-godinne Belgium 5530
    21 AZ Damiaan Oostende Belgium 8400
    22 Revalidatie en MS Centrum Overpelt Belgium 3900
    23 AZ Delta (Campus Rumbeke) Roeselare Belgium 8800
    24 Clinica Amo - Assistencia Medica Em Oncologia Salvador BA Brazil 41950640
    25 Hospital de Base do Distrito Federal; Núcleo de Citopatologia e Anatomia Patológica Brasilia DF Brazil 70330-150
    26 Instituto de Neurologia de Curitiba Curitiba PR Brazil 81210-310
    27 Hospital Universitario Gaffree e Guinle Rio de Janeiro RJ Brazil 20270-004
    28 CPQuali Pesquisa Clinica Ltda Sao Paulo SP Brazil 01228-000
    29 Centro de Pesquisas Clinicas; CPCLIN Sao Paulo SP Brazil 01228-200
    30 UMHAT 'Dr. Georgi Stranski', EAD Pleven Bulgaria 5800
    31 UMHAT Sveti Georgi Clinic of neurology Plovdiv Bulgaria 4000
    32 Shat Np Sveti Naum; 3Rd Clinic of Neurology Sofia Bulgaria 1113
    33 First MHAT; Clinic of Neurology Sofia Bulgaria 1142
    34 Multiprofile Hosp. for Active Treatment;National Cardiology Hosp. Sofia Bulgaria 1309
    35 "City Clinic UMHAC" EOOD Sofia Bulgaria 1407
    36 ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine Sofia Bulgaria 1407
    37 UMHAT "Sv. Ivan Rilski", EAD Sofia Bulgaria 1431
    38 UMHAT Alexandrovska, EAD; Neurology Sofia Bulgaria 1431
    39 UMHAT Tsaritsa Yoanna - ISUL EAD; Clinic of Neurology Sofia Bulgaria 1527
    40 MBAL St. Marina; First Neurology Department Varna Bulgaria 9010
    41 Clinica Las Condes Santiago Chile 7591046
    42 Organizacion Sanitas Internacional Bogota, D.C. Colombia 111321
    43 Fundacion ABOOD Shaio Bogota, DC Colombia
    44 Centro Javeriano de Oncología Bogota Colombia
    45 Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas Cali Colombia
    46 Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART) Santo Domingo Dominican Republic
    47 Faculty of Medicine-Ain Shams University; Neurology Department Cairo Egypt 1156 6111
    48 Clinical Research Center-Alex university; Neurology Department Cairo Egypt 21561
    49 Al Azhar University Hospital Cairo Egypt
    50 Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla L'Aquila Abruzzo Italy 67100
    51 Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur Napoli Campania Italy 80131
    52 AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica Napoli Campania Italy 80138
    53 Arcispedale Sant'Anna; Neurochirurgia - Dipartimento Neuroscienze e Riabilitazione Cona Emilia-Romagna Italy 44124
    54 A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti) Parma Emilia-Romagna Italy 43126
    55 Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla Roma Lazio Italy 00133
    56 Azienda Ospedaliera Sant'Andrea; UOC Neurologia Roma Lazio Italy 00189
    57 Irccs A.O.U.San Martino Ist; Dinogmi Genova Liguria Italy 16132
    58 Presidio Ospedaliero S.O.P.A. Micone; S.C. Neurologia, Centro Sclerosi Multipla Sestri Ponente (GE) Liguria Italy 16153
    59 Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico Gallarate Lombardia Italy 21013
    60 Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia Milano Lombardia Italy 20122
    61 IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla Milano Lombardia Italy 20132
    62 Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari Milano Lombardia Italy 20133
    63 IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla Pavia Lombardia Italy 27100
    64 Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona Torrette - Ancona Marche Italy 60100
    65 IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla Pozzilli Molise Italy 86077
    66 Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla Mondovì (CN) Piemonte Italy 12084
    67 Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso Bari Puglia Italy 70124
    68 Ospedale F. Ferrari; UO Neurologia, Centro Sclerosi Multipla Casarano Puglia Italy 73042
    69 Ospedale Binaghi; Centro Sclerosi Multipla Cagliari Sardegna Italy 09126
    70 AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla Catania Sicilia Italy 95123
    71 AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla Palermo Sicilia Italy 90129
    72 AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale Siena Toscana Italy 53100
    73 Ibn Sina Hospital; Neurology Department Kuwait Kuwait 10002
    74 Clinical Center of Montenegro; Clinic for neurology Podgorica Montenegro 20000
    75 Amphia Ziekenhuis Breda Netherlands 4819 EV
    76 St. Antonius Ziekenhuis Nieuwegein Nieuwegein Netherlands 3435 CM
    77 Maasstadziekenhuis Rotterdam Netherlands 3079 DZ
    78 Ziekenhuis VieCuri Medisch Centrum Venlo Netherlands 5912 BL
    79 Isala Zwolle Netherlands 8025 AB
    80 Consultorio Médico Paitilla Ciudad Panama Panama
    81 Hospital Central del Instituto de Previsión Social Asunción Paraguay
    82 Uniwersytecki Szpital Kliniczny w Bialymstoku Białystok Poland 15-276
    83 COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny Gdansk Poland 80-803
    84 Szpital Specjalistyczny im. Swiętej Rodziny w Rudnej Małej k. Rzeszowa Glogow Malopolski Poland 36-060
    85 Gornoslaskie Centrum Medyczne Katowice Poland 40-635
    86 UCK im. prof. K. Gibinskiego SUM; Klinika Neurologii Katowice Poland 40-752
    87 SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii Lodz Poland 90-153
    88 SPZOZ Wojewodzki Szpital Specjalistyczny nr 3 Rybnik Poland 44-200
    89 Instytut Psychiatrii i Neurologii Warszawa Poland 02-957
    90 Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON Warszawa Poland 04-141
    91 SPSK nr 1; Klinika Neurologii Zabrze Poland 41-800
    92 Hospital Santo Antonio dos Capuchos; Servico de Neurologia Lisboa Portugal 1169-050
    93 Centro Hospitalar do Porto; CICAP - Unidade Clínica de Paramiloidose Porto Portugal 4000-436
    94 Hamad General Hospital; Neurology Department Doha Qatar 3050
    95 Fundeni Clinical Institute Bucharest Romania 022328
    96 Spitalul Universitar de Urgenta Bucuresti Bucharest Romania 11172
    97 Spitalul Clinic Judetean de Urgenta Cluj-Napoca; Neurologie Cluj-Napoca Romania 400012
    98 Spitalul Clinic Judetean de Urgenta Sibiu; Neurologie Sibiu Romania 550166
    99 Spitalul Clinic Judetean de Urgenta Mures Targu-Mures Romania 540136
    100 National Center of Social Significant Disease Sankt-peterburg Leningrad Russian Federation 197110
    101 Jusupovskaya Hospital Moscow Moskovskaja Oblast Russian Federation 117186
    102 Regional clinical hospital named after prof. S.V. Ochapovsky Krasnodar Russian Federation 350086
    103 State Novosibirsk Regional Clinical Hospital Novosibirsk Russian Federation 630087
    104 King Abdul Aziz Medical City, King Fahd National Guard; Oncology Riyadh Saudi Arabia 22490
    105 Clinical Center of Serbia Belgrade Serbia 11000
    106 Clinical Center Kragujevac Kragujevac Serbia 34000
    107 Clinical Center Nis NIS Serbia 18000
    108 Clinical Centre of Vojvodina Nova Sad Serbia 21000
    109 Univerzitna Nemocnica - Nemocnica svateho Michala; Neurologicke oddelenie Bratislava Slovakia 811 08
    110 UN Bratislava Nemocnica Ruzinov; Neurologicka klinika Bratislava Slovakia 826 06
    111 Nemocnica akademika Ladislava Derera; Neurologicka klinika Bratislava Slovakia 833 05
    112 Univerzitna nemocnica Martin; Neurologicka klinika Martin Slovakia 036 59
    113 Ustredna vojenska nemocnica SNP Ruzomberok; Klinika neurologie Ruzomberok Slovakia
    114 Fakultna nemocnica Trnava Trnava Slovakia 917 75
    115 Hospital Universitario de Araba; Servicio de Neurologia Vitoria-gasteiz Alava Spain 1009
    116 Hospital General Universitario de Elche; Servicio de Neurología Elche Alicante Spain 03203
    117 Corporació Sanitaria Parc Taulí; Servicio de Neurología Sabadell Barcelona Spain 08208
    118 Hospital de Figueres; Servicio de Neurología Figueres Girona Spain 17600
    119 Hospital de Donostia; Servicio de Neurologia San Sebastian Guipuzcoa Spain 20014
    120 Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia Coruña LA Coruña Spain 15006
    121 Complejo Hospitalario Universitario de Santiago (CHUS) ; Servicio de Neurologia Santiago de Compostela LA Coruña Spain 15706
    122 Hospital General Universitario Santa Lucia; Servicio de Neurología Cartagena (Murcia) Murcia Spain 30202
    123 Hospital Universitario Virgen de Arrixaca; Servicio de Neurología EL Palmar (EL Palmar) Murcia Spain 30120
    124 Hospital Alvaro Cunqueiro; Servicio de Neurologia Vigo Pontevedra Spain
    125 Hospital Universitario de Canarias; Servicio de Neurologia San Cristóbal de La Laguna Tenerife Spain
    126 Hospital Nuestra Señora de Candelaria; Unidad de Esclerosis Multiple Santa Cruz de Tenerife Tenerife Spain
    127 Hospital Nuestra Señora de Sonsoles; Servicio de Neurología Avila Spain 05071
    128 Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia Barcelona Spain 08041
    129 Hospital Germans Trias i Pujol Barcelona Spain 08916
    130 Hospital Puerta del Mar; Sevicio de Neurologia Cadiz Spain 11009
    131 Hospital Universitario Reina Sofia; Servicio de Neurologia Cordoba Spain 14004
    132 Hospital Regional Universitario de Malaga - Hospital General; Servicio de Neurologia Malaga Spain 29010
    133 Hospital Universitario Virgen de la Victoria; Servicio de Neurología Malaga Spain 29010
    134 Hospital Universitario Virgen Macarena; Servicio de Neurologia Sevilla Spain 41009
    135 Hospital Virgen del Rocío; Servicio de Neurología Sevilla Spain 41013
    136 Hospital Univ. Nuestra Señora de Valme; Servicio de Neurología Sevilla Spain 41014
    137 Hospital Clinico Universitario de Valencia; Servicio de Neurologia Valencia Spain 46010
    138 Hospital General Universitario de Valencia; Servicio de Neurología Valencia Spain 46014
    139 Hospital Universitario Dr. Peset; Servicio de Neurologia Valencia Spain 46017
    140 Hospital Universitari i Politecnic La Fe; Servicio de Neurología Valencia Spain 46026
    141 Hacettepe University Medical Faculty; Neurology Ankara Turkey 06100
    142 Istanbul University Istanbul School of Medicine; Neurology Istanbul Turkey 34093
    143 Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali Istanbul Turkey 34098
    144 Ege University Medical Faculty Izmir Turkey 35100
    145 Kocaeli University Hospital; Department of Neurology Kocaeli Turkey 41380
    146 Mersin University Medical Faculty; Neurology Mersin Turkey 33079
    147 Ondokuz Mayis Univ. Med. Fac.; Neurology Samsun Turkey 55139
    148 Karadeniz Tecnical Uni. Med. Fac.; Neurology Trabzon Turkey 61080
    149 Sheikh Shakhbout Medical City Abu Dhabi United Arab Emirates 11001
    150 Mediclinic Parkview Hospital Dubai-UAE United Arab Emirates
    151 Royal Victoria Hospital Belfast United Kingdom BT12 6BA
    152 University Hospital Coventry Coventry United Kingdom CV2 2DX
    153 Raigmore Hospital; Highland Clin Rsrch Facility, Ctr For Health Sci Inverness United Kingdom IV2 3JH
    154 Leeds General Infirmary Leeds United Kingdom LS1 3EX
    155 Lincoln County Hospital Lincoln United Kingdom LN2 5QY
    156 St George's Hospital London United Kingdom SW17 ORE
    157 Luton General Hospital; Luton & Dunstable University Hospital, Neurology department Luton United Kingdom LU4 0DZ
    158 James Cook Hospital Middlesbrough United Kingdom TS4 3BW
    159 John Radcliffe Hospital Oxford United Kingdom OX3 9DU
    160 Derriford Hospital Plymouth United Kingdom PL6 8DH
    161 Royal Hallamshire Hospital; Neurology Sheffield United Kingdom S10 2JF
    162 Royal Stoke University Hospital Stoke-on-Trent United Kingdom ST4 6QG
    163 Sunderland Royal Hospital Sunderland United Kingdom SR4 7TP
    164 Morriston Hospital; Cardiac Center Swansea United Kingdom SA6 6NL
    165 Southmead Hospital Westbury-on-Trym, Bristol United Kingdom BS10 5NB

    Sponsors and Collaborators

    • Hoffmann-La Roche

    Investigators

    • Study Director: Clinical Trials, Hoffmann-La Roche

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Hoffmann-La Roche
    ClinicalTrials.gov Identifier:
    NCT03593590
    Other Study ID Numbers:
    • MN39889
    First Posted:
    Jul 20, 2018
    Last Update Posted:
    Aug 23, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 23, 2022