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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Ocrelizumab

• Study Type: Observational
• Enrollment (Actual): 1710

Contacts and Locations

Study Locations

• Austria
  • Amstetten, Austria, 3300
    • Landesklinikum Amstetten; Abteilung für Neurologie
  • Innsbruck, Austria, 6020
    • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
  • Linz, Austria, 4020
    • Kepler Universitätsklinikum GmbH - Neuromed Campus; Neurologie
  • Linz, Austria, 4021
    • Kepler Universitätskliniken GmbH - Med Campus III; Neurologie & Psychiatrie
  • Melk, Austria, 3390
    • Multiple Sklerose Zentrum
  • Wien, Austria, 1210
    • Klinik Floridsdorf; Abteilung für Neurologie
• Belgium
  • Bonheiden, Belgium, 2820
    • Imeldaziekenhuis
  • Brasschaat, Belgium, 2930
    • AZ Klina
  • Brussel, Belgium, 1090
    • UZ Brussel
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires St-Luc
  • Bruxelles, Belgium, 1070
    • Hospital Erasme
  • Charleroi, Belgium, 6042
    • CHU de Charleroi
  • Edegem, Belgium, 2650
    • UZ Antwerpen
  • Fraiture, Belgium, 4557
    • CNRF - Centre Neurologique et Réadaptation Fonctionnelle
  • Hasselt, Belgium, 3500
    • Jessa Zkh (Campus Virga Jesse)
  • Kortrijk, Belgium, 8500
    • Az Groeninge
  • La Louvière, Belgium, 7100
    • CHU Tivoli
  • Liege, Belgium, 4000
    • Chc Montlegia
  • Melsbroek, Belgium, 1820
    • Nationaal MS Centrum
  • Mont-godinne, Belgium, 5530
    • CHU UCL Mont-Godinne
  • Oostende, Belgium, 8400
    • AZ Damiaan
  • Overpelt, Belgium, 3900
    • Revalidatie en MS Centrum
  • Roeselare, Belgium, 8800
    • AZ Delta (Campus Rumbeke)
• Brazil
  • BA
    • Salvador, BA, Brazil, 41950640
      • Clinica Amo - Assistencia Medica Em Oncologia
  • DF
    • Brasilia, DF, Brazil, 70330-150
      • Hospital de Base do Distrito Federal; Núcleo de Citopatologia e Anatomia Patológica
  • PR
    • Curitiba, PR, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba
  • RJ
    • Rio de Janeiro, RJ, Brazil, 20270-004
      • Hospital Universitario Gaffree e Guinle
  • SP
    • Sao Paulo, SP, Brazil, 01228-000
      • CPQuali Pesquisa Clínica Ltda
    • Sao Paulo, SP, Brazil, 01228-200
      • Centro de Pesquisas Clinicas; CPCLIN
• Bulgaria
  • Pleven, Bulgaria, 5800
    • UMHAT 'Dr. Georgi Stranski', EAD
  • Plovdiv, Bulgaria, 4000
    • UMHAT Sveti Georgi Clinic of neurology
  • Sofia, Bulgaria, 1407
    • "City Clinic UMHAC" EOOD
  • Sofia, Bulgaria, 1431
    • UMHAT "Sv. Ivan Rilski", EAD
  • Sofia, Bulgaria, 1113
    • Shat Np Sveti Naum; 3Rd Clinic of Neurology
  • Sofia, Bulgaria, 1431
    • UMHAT Alexandrovska, EAD; Neurology
  • Sofia, Bulgaria, 1309
    • Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
  • Sofia, Bulgaria, 1407
    • ACIBADEM CITY CLINIC TOKUDA HOSPITAL EAD; Clinic of Neurology and Sleep Medicine
  • Sofia, Bulgaria, 1527
    • UMHAT Tsaritsa Yoanna - ISUL EAD; Clinic of Neurology
  • Sofia, Bulgaria, 1000
    • First MHAT; Clinic of Neurology
  • Varna, Bulgaria, 9010
    • MBAL St. Marina; First Neurology Department
• Chile
  • Santiago, Chile, 7591046
    • Clinica Las Condes
• Colombia
  • Bogota, Colombia
    • Centro Javeriano de Oncología
  • Bogota, D.C., Colombia, 111321
    • Organizacion Sanitas Internacional
  • Bogota, DC, Colombia
    • Fundacion ABOOD Shaio
  • Cali, Colombia
    • Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
• Dominican Republic
  • Santo Domingo, Dominican Republic
    • Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)
• Egypt
  • Alexandria, Egypt, 21561
    • Clinical Research Center-Alex university; Neurology Department
  • Cairo, Egypt, 1156 6111
    • Faculty of Medicine-Ain Shams University; Neurology Department
  • Cairo, Egypt
    • Al Qahira Al Fatmiya Hospital
• Italy
  • Abruzzo
    • L'Aquila, Abruzzo, Italy, 67100
      • Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
  • Campania
    • Napoli, Campania, Italy, 80138
      • AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
    • Napoli, Campania, Italy, 80131
      • Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
  • Emilia-Romagna
    • Cona, Emilia-Romagna, Italy, 44124
      • Arcispedale Sant'Anna; Neurochirurgia - Dipartimento Neuroscienze e Riabilitazione
    • Parma, Emilia-Romagna, Italy, 43126
      • A.O.U. di Parma; SC Neurologia, Amb. Sclerosi Multipla (malattie demielinizzanti)
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
    • Roma, Lazio, Italy, 00189
      • Azienda Ospedaliera Sant'Andrea; UOC Neurologia
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Irccs A.O.U.San Martino Ist; Dinogmi
    • Sestri Ponente (GE), Liguria, Italy, 16153
      • Presidio Ospedaliero S.O.P.A. Micone; S.C. Neurologia, Centro Sclerosi Multipla
  • Lombardia
    • Gallarate, Lombardia, Italy, 21013
      • Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico
    • Milano, Lombardia, Italy, 20133
      • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
    • Milano, Lombardia, Italy, 20122
      • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico; Unità Operativa Complessa di Neurologia
    • Milano, Lombardia, Italy, 20132
      • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
    • Pavia, Lombardia, Italy, 27100
      • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
  • Marche
    • Torrette - Ancona, Marche, Italy, 60100
      • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • Piemonte
    • Mondovì (CN), Piemonte, Italy, 12084
      • Ospedale Regina Montis Regalis; SC Neurologia, Centro Sclerosi Multipla
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari; Neuroscienze e Organi di Senso
    • Casarano, Puglia, Italy, 73042
      • Ospedale F. Ferrari; UO Neurologia, Centro Sclerosi Multipla
  • Sardegna
    • Cagliari, Sardegna, Italy, 09126
      • Ospedale Binaghi; Centro Sclerosi Multipla
  • Sicilia
    • Catania, Sicilia, Italy, 95123
      • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
    • Palermo, Sicilia, Italy, 90129
      • AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
  • Toscana
    • Siena, Toscana, Italy, 53100
      • AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
• Kuwait
  • Kuwait, Kuwait, 10002
    • Ibn Sina Hospital; Neurology Department
• Montenegro
  • Podgorica, Montenegro, 20000
    • Clinical Center of Montenegro; Clinic for neurology
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Nieuwegein, Netherlands, 3435 CM
    • St. Antonius Ziekenhuis Nieuwegein
  • Rotterdam, Netherlands, 3079 DZ
    • Maasstadziekenhuis
  • Venlo, Netherlands, 5912 BL
    • Ziekenhuis VieCuri Medisch Centrum
  • Zwolle, Netherlands, 8025 AB
    • Isala
• Panama
  • Ciudad Panama, Panama
    • Consultorio Médico Paitilla
• Paraguay
  • Asunción, Paraguay
    • Hospital Central del Instituto de Previsión Social
• Poland
  • Bia?ystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Gdansk, Poland, 80-803
    • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
  • Glogow Malopolski, Poland, 36-060
    • Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa
  • Katowice, Poland, 40-635
    • Gornoslaskie Centrum Medyczne
  • Katowice, Poland, 40-752
    • UCK im. prof. K. Gibinskiego SUM; Klinika Neurologii
  • Lodz, Poland, 90-153
    • SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
  • Rybnik, Poland, 44-200
    • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
  • Warszawa, Poland, 02-957
    • Instytut Psychiatrii i Neurologii
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
  • Zabrze, Poland, 41-800
    • SPSK nr 1; Klinika Neurologii
• Portugal
  • Lisboa, Portugal, 1169-050
    • Hospital Santo Antonio dos Capuchos; Servico de Neurologia
  • Porto, Portugal, 4000-436
    • Centro Hospitalar do Porto; CICAP - Unidade Clínica de Paramiloidose
• Qatar
  • Doha, Qatar, 3050
    • Hamad General Hospital; Neurology Department
• Romania
  • Bucharest, Romania, 11172
    • Spitalul Universitar de Urgență București
  • Cluj-Napoca, Romania, 400012
    • Spitalul Clinic Judetean de Urgenta Cluj-Napoca; Neurologie
  • Sibiu, Romania, 550166
    • Spitalul Clinic Judetean de Urgenta Sibiu; Neurologie
  • Targu-Mures, Romania, 540136
    • Spitalul Clinic Judetean de Urgenta Mures
• Russian Federation
  • Krasnodar, Russian Federation, 350086
    • Regional clinical hospital named after prof. S.V. Ochapovsky
  • Novosibirsk, Russian Federation, 630087
    • State Novosibirsk Regional Clinical Hospital
  • Leningrad
    • Sankt-peterburg, Leningrad, Russian Federation, 197110
      • National Center of Social Significant Disease
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 117186
      • Jusupovskaya Hospital
• Saudi Arabia
  • Riyadh, Saudi Arabia, 22490
    • King Abdul Aziz Medical City, King Fahd National Guard; Oncology
• Serbia
  • Belgrade, Serbia, 11000
    • Clinical Center of Serbia
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • NIS, Serbia, 18000
    • Clinical Center Nis
  • Nova Sad, Serbia, 21000
    • Clinical Centre of Vojvodina
• Slovakia
  • Bratislava, Slovakia, 811 08
    • Univerzitna Nemocnica - Nemocnica svateho Michala; Neurologicke oddelenie
  • Bratislava, Slovakia, 833 05
    • Nemocnica akademika Ladislava Derera; Neurologicka klinika
  • Bratislava, Slovakia, 826 06
    • Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB
  • Martin, Slovakia, 036 59
    • Univerzitna nemocnica Martin; Neurologicka klinika
  • Ruzomberok, Slovakia
    • Ustredna vojenska nemocnica SNP Ruzomberok; Klinika neurologie
  • Trnava, Slovakia, 917 75
    • Fakultna nemocnica Trnava
• Spain
  • Avila, Spain, 05071
    • Hospital Nuestra Señora de Sonsoles; Servicio de Neurología
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau; Servicio de Neurologia
  • Barcelona, Spain, 08916
    • Hospital Germans Trias i Pujol
  • Cadiz, Spain, 11009
    • Hospital Puerta del Mar; Sevicio de Neurologia
  • Cordoba, Spain, 14004
    • Hospital Universitario Reina Sofia; Servicio de Neurologia
  • Malaga, Spain, 29010
    • Hospital Universitario Virgen de la Victoria; Servicio de Neurología
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
  • Sevilla, Spain, 41009
    • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Sevilla, Spain, 41013
    • Hospital Virgen del Rocío; Servicio de Neurología
  • Sevilla, Spain, 41014
    • Hospital Univ. Nuestra Señora de Valme; Servicio de Neurología
  • Valencia, Spain, 46017
    • Hospital Universitario Dr. Peset; Servicio de Neurologia
  • Valencia, Spain, 46026
    • Hospital Universitari i Politecnic La Fe; Servicio de Neurología
  • Valencia, Spain, 46010
    • Hospital Clinico Universitario de Valencia; Servicio de Neurologia
  • Valencia, Spain, 46014
    • Hospital General Universitario de Valencia; Servicio de Neurología
  • Alava
    • Vitoria-gasteiz, Alava, Spain, 1009
      • Hospital Universitario de Araba; Servicio de Neurologia
  • Alicante
    • Elche, Alicante, Spain, 03203
      • Hospital General Universitario de Elche; Servicio de Neurología
  • Barcelona
    • Sabadell, Barcelona, Spain, 08208
      • Corporació Sanitaria Parc Taulí; Servicio de Neurología
  • Girona
    • Figueres, Girona, Spain, 17600
      • Hospital de Figueres; Servicio de Neurología
  • Guipuzcoa
    • San Sebastian, Guipuzcoa, Spain, 20014
      • Hospital de Donostia; Servicio de Neurologia
  • LA Coruña
    • Coruña, LA Coruña, Spain, 15006
      • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
  • Murcia
    • Cartagena (Murcia), Murcia, Spain, 30202
      • Hospital General Universitario Santa Lucia; Servicio de Neurología
    • EL Palmar (EL Palmar), Murcia, Spain, 30120
      • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Pontevedra
    • Vigo, Pontevedra, Spain
      • Hospital Alvaro Cunqueiro; Servicio de Neurologia
  • Tenerife
    • San Cristóbal de La Laguna, Tenerife, Spain
      • Hospital Universitario de Canarias; Servicio de Neurologia
    • Santa Cruz de Tenerife, Tenerife, Spain, 38010
      • Hospital Nuestra Señora de Candelaria; Unidad de Esclerosis Multiple
• Turkey
  • Ankara, Turkey, 06100
    • Hacettepe University Medical Faculty; Neurology
  • Istanbul, Turkey, 34093
    • Istanbul University Istanbul School of Medicine; Neurology
  • Istanbul, Turkey, 34098
    • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Izmir, Turkey, 35100
    • Ege University Medical Faculty
  • Kocaeli, Turkey, 41380
    • Kocaeli University Hospital; Department of Neurology
  • Mersin, Turkey, 33079
    • Mersin University Medical Faculty; Neurology
  • Samsun, Turkey, 55139
    • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Trabzon, Turkey, 61080
    • Karadeniz Tecnical Uni. Med. Fac.; Neurology
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 11001
    • Sheikh Shakhbout Medical City
  • Dubai-UAE, United Arab Emirates
    • Mediclinic Parkview Hospital
• United Kingdom
  • Belfast, United Kingdom, BT12 6BA
    • Royal Victoria Hospital
  • Coventry, United Kingdom, CV2 2DX
    • University Hospital Coventry
  • Inverness, United Kingdom, IV2 3JH
    • Raigmore Hospital; Highland Clin Rsrch Facility, Ctr For Health Sci
  • Leeds, United Kingdom, LS1 3EX
    • Leeds General Infirmary
  • Lincoln, United Kingdom, LN2 5QY
    • Lincoln County Hospital
  • London, United Kingdom, SW17 ORE
    • St George?s Hospital
  • Luton, United Kingdom, LU4 0DZ
    • Luton General Hospital; Luton & Dunstable University Hospital, Neurology department
  • Middlesbrough, United Kingdom, TS4 3BW
    • James Cook Hospital
  • Oxford, United Kingdom, OX3 9DU
    • John Radcliffe Hospital
  • Plymouth, United Kingdom, PL6 8BT
    • Derriford Hospital
  • Sheffield, United Kingdom, S10 2JF
    • Royal Hallamshire Hospital; Neurology
  • Stoke-on-Trent, United Kingdom, ST4 6QG
    • Royal Stoke University Hospital
  • Sunderland, United Kingdom, SR4 7TP
    • Sunderland Royal Hospital
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital; Cardiac Center
  • Westbury-on-Trym, Bristol, United Kingdom, BS10 5NB
    • Southmead Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Participants with RMS or PPMS undergoing routine clinical care

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Time Frame
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
Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS	4 years
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
Change in the score of ABILHAND - 56 scale in PPMS 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 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
Change in the score of MSWS - 12 scale in RMS participants	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
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
Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time	4 years

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): November 12, 2018
• Primary Completion (Estimated): July 26, 2025
• Study Completion (Estimated): July 26, 2025

Study Registration Dates

• First Submitted: July 11, 2018
• First Submitted That Met QC Criteria: July 11, 2018
• First Posted (Actual): July 20, 2018

Study Record Updates

• Last Update Posted (Actual): February 20, 2024
• Last Update Submitted That Met QC Criteria: February 16, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Disease Attributes; Chronic Disease; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis; Physiological Effects of Drugs; Immunologic Factors; Ocrelizumab
• Other Study ID Numbers: MN39889

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No