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

February 12, 2026 updated by: Hoffmann-La Roche

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1710

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Amstetten, Austria, 3300
        • Landesklinikum Amstetten
      • Innsbruck, Austria, 6020
        • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck
      • Linz, Austria, 4021
        • Kepler Universitätskliniken GmbH - Med Campus III
      • Linz, Austria, 4020
        • Kepler Universitätsklinikum GmbH - Neuromed Campus
      • Melk, Austria, 3390
        • Multiple Sklerose Zentrum
      • Vienna, Austria, 1210
        • Klinik Floridsdorf
  • Belgium
      • Bonheiden, Belgium, 2820
        • Imeldaziekenhuis
      • Brasschaat, Belgium, 2930
        • AZ Klina
      • Brussels, Belgium, 1090
        • UZ Brussel
      • Brussels, Belgium, 1070
        • Hospital Erasme
      • Brussels, Belgium, 1200
        • Cliniques Universitaires St-Luc
      • 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
      • Liège, Belgium, 4000
        • CHC MontLégia
      • Melsbroek, Belgium, 1820
        • Nationaal MS Centrum
      • Mont-godinne, Belgium, 5530
        • CHU UCL Mont-Godinne
      • Ostend, Belgium, 8400
        • AZ Oostende
      • Overpelt, Belgium, 3900
        • Revalidatie en MS Centrum
      • Roeselare, Belgium, 8800
        • AZ Delta (Campus Rumbeke)
  • Brazil
      • Rio de Janeiro, Brazil, 20270-004
        • Hospital Universitario Gaffree e Guinle
    • Estado de Bahia
      • Salvador, Estado de Bahia, Brazil, 41950-610
        • Clinica Amo Assistencia Medica Em Oncologia
    • Federal District
      • Brasília, Federal District, Brazil, 70330-150
        • Hospital de Base do Distrito Federal
    • Paraná
      • Curitiba, Paraná, Brazil, 81210-310
        • Instituto de Neurologia de Curitiba
    • São Paulo
      • São Paulo, São Paulo, Brazil, 01228-000
        • CPQuali Pesquisa Clinica Ltda
  • 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, 1431
        • UMHAT Alexandrovska, EAD
      • Sofia, Bulgaria, 1407
        • Acibadem City Clinic Tokuda Hospital Ead
      • Sofia, Bulgaria, 1527
        • UMHAT Tsaritsa Yoanna - ISUL EAD
      • Sofia, Bulgaria, 1113
        • Shat Np Sveti Naum
      • Sofia, Bulgaria, 1142
        • First MHAT
      • Sofia, Bulgaria, 1309
        • Multiprofile Hosp. for Active Treatment
      • Varna, Bulgaria, 9010
        • MBAL St. Marina
  • Chile
      • Santiago, Chile, 7591046
        • Clinica Las Condes
  • Colombia
      • Bogota, DC, Colombia, DUMMY_VALUE
        • Fundacion Abood Shaio
      • Bogotá, Colombia, DUMMY_VALUE
        • Centro Javeriano de Oncología
      • Bogotá, Colombia, DUMMY_VALUE
        • Organizacion Sanitas Internacional
      • Cali, Colombia, DUMMY_VALUE
        • Fundacion Clinica Valle del Lili
  • Dominican Republic
      • Santo Domingo, Dominican Republic, DUMMY_VALUE
        • Instituto Nacional del Cáncer Rosa Emilia Sánchez Pérez de Tavares (INCART)
  • Egypt
      • Cairo, Egypt, 11566
        • Faculty of Medicine-Ain Shams University
      • Cairo, Egypt, DUMMY_VALUE
        • Al Qahira Al Fatmiya Hospital
      • Cairo, Egypt, DUMMY_VALUE
        • Clinical Research Center-Alex university
  • Italy
    • Abruzzo
      • L’Aquila, Abruzzo, Italy, 67100
        • Ospedale San Salvatore
    • Apulia
      • Bari, Apulia, Italy, 70124
        • Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari
      • Casarano, Apulia, Italy, 73042
        • Ospedale F. Ferrari
    • Campania
      • Napoli, Campania, Italy, 80131
        • Università degli studi della Campania Luigi Vanvitelli
      • Napoli, Campania, Italy, 80138
        • AOU Seconda Università degli Studi
    • Emilia-Romagna
      • Cona, Emilia-Romagna, Italy, 44124
        • Arcispedale Sant'Anna
      • Parma, Emilia-Romagna, Italy, 43126
        • A.O.U. di Parma
    • Lazio
      • Rome, Lazio, Italy, 00189
        • Azienda Ospedaliera Sant'Andrea
      • Rome, Lazio, Italy, 00133
        • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
    • Liguria
      • Genoa, Liguria, Italy, 16132
        • Irccs A.O.U.San Martino Ist
      • Sestri Ponente (GE), Liguria, Italy, 16153
        • Presidio Ospedaliero S.O.P.A. Micone
    • Lombardy
      • Gallarate, Lombardy, Italy, 21013
        • Ospedale S.Antonio Abate
      • Milan, Lombardy, Italy, 20132
        • IRCCS Ospedale San Raffaele
      • Milan, Lombardy, Italy, 20133
        • Fond. Istituto Neurologico C.Besta
      • Milan, Lombardy, Italy, 20122
        • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
      • Pavia, Lombardy, Italy, 27100
        • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
      • San Donato Milanese, Lombardy, Italy, 20097
        • Policlinico San Donato
    • Molise
      • Pozzilli, Molise, Italy, 86077
        • IRCCS Istituto Neurologico Neuromed
    • Piedmont
      • Mondovì (CN), Piedmont, Italy, 12084
        • Ospedale Regina Montis Regalis
    • Sardinia
      • Cagliari, Sardinia, Italy, 09126
        • Ospedale Binaghi
    • Sicily
      • Catania, Sicily, Italy, 95123
        • AOU Policlinico V. Emanuele - P.O G. Rodolico
      • Palermo, Sicily, Italy, 90129
        • AOU Policlinico Giaccone
    • The Marches
      • Torrette - Ancona, The Marches, Italy, 60100
        • Azienda Ospedaliero Universitaria Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi Di Ancona
    • Tuscany
      • Siena, Tuscany, Italy, 53100
        • AOU Senese - Presidio Ospedaliero Le Scotte
  • Kuwait
      • Kuwait City, Kuwait, 10002
        • Ibn Sina Hospital
  • Montenegro
      • Podgorica, Montenegro, 20000
        • Clinical Center of Montenegro
  • Netherlands
      • Breda, Netherlands, 4819 EV
        • Amphia Ziekenhuis
      • NL -rotterdam, Netherlands, 3079 DZ
        • Maasstadziekenhuis
      • Nieuwegein, Netherlands, 3430 EM
        • St. Antonius Ziekenhuis Nieuwegein
      • Venlo, Netherlands, 5912 BL
        • Ziekenhuis VieCuri Medisch Centrum
      • Zwolle, Netherlands, 8025 AB
        • Isala
  • Paraguay
      • Asunción, Paraguay, DUMMY_VALUE
        • Hospital Central del Instituto de Previsión Social
  • Poland
      • Bialystok, Poland, 15-276
        • Uniwersytecki Szpital Kliniczny w Bialymstoku
      • Gdansk, Poland, 80-803
        • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
      • Głogów Małopolski, Poland, 36-060
        • Szpital Specjalistyczny im. Swi?tej Rodziny w Rudnej Ma?ej k. Rzeszowa
      • Katowice, Poland, 40-635
        • Górnośląskie Centrum Medyczne
      • Katowice, Poland, 40-752
        • UCK im. prof. K. Gibinskiego SUM
      • Lodz, Poland, 90-153
        • SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM
      • Rybnik, Poland, 44-200
        • SPZOZ Wojewodzki Szpital Specjalistyczny nr 3
      • Warsaw, Poland, 02-957
        • Instytut Psychiatrii i Neurologii
      • Warsaw, Poland, 04-141
        • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
      • Zabrze, Poland, 41-800
        • SPSK nr 1
  • Portugal
      • Lisbon, Portugal, 1169-050
        • Hospital Santo Antonio dos Capuchos
      • Porto, Portugal, 4000-436
        • Centro Hospitalar do Porto
  • Qatar
      • Doha, Qatar, 3050
        • Hamad General Hospital
  • Romania
      • Bucharest, Romania, 022328
        • Fundeni Clinical Institute
      • Bucharest, Romania, 11172
        • Spitalul Universitar de Urgență București
      • Cluj-Napoca, Romania, 400012
        • Spitalul Clinic Judetean de Urgenta Cluj-Napoca
      • Sibiu, Romania, 550166
        • Spitalul Clinic Judetean de Urgenta Sibiu
      • Târgu Mureş, Romania, 540136
        • Spitalul Clinic Judetean de Urgenta Mures
  • Russia
      • Krasnodar, Russia, 350086
        • Regional clinical hospital named after prof. S.V. Ochapovsky
      • Novosibirsk, Russia, 630087
        • State Novosibirsk regional clinical hospital
    • Moscow Oblast
      • Moscow, Moscow Oblast, Russia, 117186
        • Jusupovskaya Hospital
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russia, 197110
        • National Center of Social Significant Disease
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 22490
        • King Abdul Aziz Medical City, King Fahd National Guard
  • Serbia
      • Kragujevac, Serbia, 34000
        • Clinical Center Kragujevac
  • Slovakia
      • Bratislava, Slovakia, 811 08
        • Univerzitna Nemocnica - Nemocnica svateho Michala
      • Bratislava, Slovakia, 826 06
        • Univerzitná nemocnica Bratislava - Nemocnica Ružinov
      • Bratislava, Slovakia, 833 05
        • Nemocnica akademika Ladislava Derera
      • Martin, Slovakia, 036 59
        • Univerzitna Nemocnica Martin
      • Ružomberok, Slovakia, DUMMY_VALUE
        • Ustredna vojenska nemocnica SNP Ruzomberok
      • Trnava, Slovakia, 917 75
        • Fakultna nemocnica Trnava
  • Spain
      • Barcelona, Spain, 08025
        • Hospital de la Santa Creu i Sant Pau
      • Barcelona, Spain, 08916
        • Hospital Germans Trias i Pujol
      • Cadiz, Spain, 11009
        • Hospital Puerta del Mar
      • Córdoba, Spain, 14011
        • Hospital Universitario Reina Sofia
      • Murcia, Spain, DUMMY_VALUE
        • Hospital Universitario Virgen de Arrixaca
      • Málaga, Spain, 29010
        • Hospital Regional Universitario de Malaga ? Hospital General
      • Seville, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Seville, Spain, 41013
        • Hospital Virgen del Rocío
      • Seville, Spain, 41014
        • Hospital Univ. Nuestra Señora de Valme
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valencia, Spain, 46010
        • Hospital Clinico Universitario de Valencia
      • Valencia, Spain, 46014
        • Hospital General Universitario de Valencia
      • Ávila, Spain, 05071
        • Hospital Nuestra Señora de Sonsoles
    • Alava
      • Vitoria-Gasteiz, Alava, Spain, 1009
        • Hospital Universitario de Araba
    • Alicante
      • Elche, Alicante, Spain, 03203
        • Hospital General Universitario de Elche
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Corporacio Sanitaria Parc Tauli
    • Girona
      • Figueres, Girona, Spain, 17600
        • Hospital de Figueres
    • Guipuzcoa
      • Donostia / San Sebastian, Guipuzcoa, Spain, 20014
        • Hospital de Donostia
    • LA Coruna
      • A Coruña, LA Coruna, Spain, 15006
        • Complejo Hospitalario Universitario A Coruña (CHUAC)
      • Santiago de Compostela, LA Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
    • Murcia
      • Cartagena (Murcia), Murcia, Spain, 30202
        • Hospital General Universitario Santa Lucía
    • Pontevedra
      • Vigo, Pontevedra, Spain, DUMMY_VALUE
        • Hospital Alvaro Cunqueiro
    • Tenerife
      • San Cristóbal de La Laguna, Tenerife, Spain, DUMMY_VALUE
        • Hospital Universitario de Canarias
      • Santa Cruz de Tenerife, Tenerife, Spain, DUMMY_VALUE
        • Hospital Nuestra Señora de Candelaria
  • Turkey (Türkiye)
      • Ankara, Turkey (Türkiye), 06100
        • Hacettepe University Medical Faculty
      • Istanbul, Turkey (Türkiye), 34098
        • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
      • Istanbul, Turkey (Türkiye), 34093
        • Istanbul University Istanbul School of Medicine
      • Izmir, Turkey (Türkiye), 35100
        • Ege University Medical Faculty
      • Kocaeli, Turkey (Türkiye), 41380
        • Kocaeli University Hospital
      • Mersin, Turkey (Türkiye), 33079
        • Mersin University Medical Faculty
      • Samsun, Turkey (Türkiye), 55139
        • Ondokuz Mayis Univ. Med. Fac.
      • Trabzon, Turkey (Türkiye), 61080
        • Karadeniz Tecnical Uni. Med. Fac.
  • United Arab Emirates
      • Dubai-UAE, United Arab Emirates, DUMMY_VALUE
        • 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
      • 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
      • Middlesbrough, United Kingdom, TS4 3BW
        • James Cook Hospital
      • Oxford, United Kingdom, OX3 9DU
        • John Radcliffe Hospital
      • Plymouth, United Kingdom, PL6 8DH
        • Derriford Hospital
      • Sheffield, United Kingdom, S10 2JF
        • Royal Hallamshire Hospital
      • 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
      • Westbury-on-Trym, Bristol, United Kingdom, BS10 5NB
        • Southmead Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in the overall SymptoMScreen score in participants with RMS
Time Frame: 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)
4 years
Changes in the overall SymptoMScreen score in participants with PPMS
Time Frame: 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)
4 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Percentage of RMS Participants with Adverse Events
Time Frame: 4 years
4 years
Percentage of PPMS participants with Adverse Events
Time Frame: 4 years
4 years
Time to treatment discontinuation due to adverse events with ocrelizumab in participants with RMS
Time Frame: 4 years
4 years
Time to treatment discontinuation due to adverse events with ocrelizumab in participants with PPMS
Time Frame: 4 years
4 years
Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in RMS participants
Time Frame: 4 years
4 years
Change in the score of Multiple Sclerosis Impact Scale (MSIS-29) in PPMS participants
Time Frame: 4 years
4 years
Change in the score of ABILHAND - 56 scale in RMS participants
Time Frame: 4 years
4 years
Change in the score of ABILHAND - 56 scale in PPMS participants
Time Frame: 4 years
4 years
Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in RMS participant
Time Frame: 4 years
4 years
Change in the score of Fatigue Scale Motor and Cognitive functions (FSMC) in PPMS participants
Time Frame: 4 years
4 years
Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in RMS participants
Time Frame: 4 years
4 years
Change in the score of Treatment Satisfaction Questionnaire for Medication (TSQM) in PPMS participants
Time Frame: 4 years
4 years
Change in the score of MSWS - 12 scale in RMS participants
Time Frame: 4 years
4 years
Change in the score of MSWS - 12 scale in PPMS participants
Time Frame: 4 years
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
Time Frame: 4 years
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
Time Frame: 4 years
4 years
Frequency of relapses over time in RMS patients
Time Frame: 4 years
4 years
Disease progression in participants with RMS as measured by Expanded Disability Status Scale (EDSS) over time
Time Frame: 4 years
4 years
Disease progression in participants with PPMS as measured by Expanded Disability Status Scale (EDSS) over time
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Hoffmann-La Roche

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 12, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 19, 2026

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 19, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
July 11, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2018

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 12, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MN39889

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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Clinical Trials on Multiple Sclerosis

Clinical Trials on Ocrelizumab

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