A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis (CONSONANCE)

An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Study Overview

• Status: Active, not recruiting
• Conditions: Progressive Multiple Sclerosis (PMS)
• Intervention / Treatment: Drug: Ocrelizumab

• Study Type: Interventional
• Enrollment (Actual): 927
• Phase: Phase 3

Contacts and Locations

Study Locations

• Bosnia and Herzegovina
  • Banja Luka, Bosnia and Herzegovina, 78000
    • University Clinical Center of the Republic of Srpska; Neurology Clinic
  • Mostar, Bosnia and Herzegovina, 88000
    • University Hospital Mostar; Neurology Clinic
  • Sarajevo, Bosnia and Herzegovina, 71000
    • Clinical Center University of Sarajevo; Neurology clinic
  • Tuzla, Bosnia and Herzegovina, 75000
    • University Clinical Center Tuzla; Neurology
• Brazil
  • PR
    • Curitiba, PR, Brazil, 81210-310
      • Instituto de Neurologia de Curitiba
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas - PUCRS
  • SP
    • Ribeirao Preto, SP, Brazil, 14051-140
      • Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
    • Sao Paulo, SP, Brazil, 05403-000
      • Hospital das Clinicas - FMUSP_X; Neurologia
• Canada
  • British Columbia
    • Burnaby, British Columbia, Canada, V5G 2X6
      • Fraser Health Authority - Fraser Health Multiple Sclerosis
    • Vancouver, British Columbia, Canada, V6T 2B5
      • University of British Columbia Hospital; Division of Neurology
  • Ontario
    • London, Ontario, Canada, N6A 5A5
      • London Health Sciences Centre Uni Campus
    • Toronto, Ontario, Canada, M5B 1W8
      • St. Michael's Hospital
  • Quebec
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Recherche Sepmus Inc.
    • Montreal, Quebec, Canada, H2L 4M1
      • Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
  • Saskatchewan
    • Saskatoon, Saskatchewan, Canada, S7K 0M7
      • Saskatoon City Hospital; Neurology
• Colombia
  • Bogota, D.C., Colombia, 111321
    • Organizacion Sanitas Internacional
  • Cali, Colombia
    • Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
• Costa Rica
  • San José, Costa Rica, 10101
    • Hospital Clínica Biblica
• Czechia
  • Jihlava, Czechia, 58633
    • Nemocnice Jihlava; NEU-Neurologicke oddeleni
  • Olomouc, Czechia, 779 00
    • Fakultní Nemocnice Olomouc; Neurologicka Klinika
  • Ostrava-Poruba, Czechia, 708 52
    • Fakultni nemocnice Ostrava; MS centrum
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
• Denmark
  • Aabenraa, Denmark, 6200
    • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
  • Aarhus N, Denmark, 8200
    • Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
  • Glostrup, Denmark, 2600
    • Rigshospitalet; Neurologisk Klinik Glostrup
  • Glostrup, Denmark, 2600
    • Rigshospitalet; Skleroseklinikken - Glostrup
• Egypt
  • Alexandria, Egypt, 21561
    • Clinical Research Center-Alex university; Neurology Department
  • Cairo, Egypt, 11566
    • Ain Shams University Hospital; Clinical Research Center (MASRI-CRC)
• France
  • Amiens Cedex1, France, 80054
    • CHU Amiens Hopital Sud; Neurologie
  • Bayonne Cedex, France, 64109
    • CHIC Cote Basque Bayonne; Neurologie
  • Bordeaux, France, 33076
    • Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
  • Bron, France, 69677
    • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
  • Caen, France, 14033
    • CHU De Caen; Service De Neurologie Dejerine
  • Clermont-Ferrand, France, 63003
    • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
  • Lille, France, 59037
    • Hopital B Roger Salengro; Neurologie C
  • Marseille, France, 13005
    • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Montpellier, France, 34295
    • Hopital Gui de Chauliac; Neurologie
  • Nancy, France, 54035
    • CHRU Nancy; Service de neurologie
  • Nantes, France, 44093
    • Hôpital Nord Laennec
  • Nice, France, 06002
    • Hôpital Pasteur; Service de Neurologie
  • Nimes, France, 30029
    • Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
  • Rennes, France, 35033
    • Centre hospitalier universitaire de Rennes
  • Strasbourg, France, 67091
    • Hopital Civil de Strasbourg; Service de Neurologie
• Germany
  • Dresden, Germany, 01307
    • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Greifswald, Germany, 17475
    • Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie
  • Stuttgart, Germany, 70182
    • NeuroConcept AG C/O mind mvz GmbH
  • Ulm, Germany, 89073
    • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
  • Westerstede, Germany, 26655
    • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
  • Wiesbaden, Germany, 65191
    • Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
• Guatemala
  • Ciudad Guatemala, Guatemala, 01015
    • Nucare
• Hungary
  • Budapest, Hungary, 1083
    • Semmelweis Egyetem AOK; Neurologiai Klinika
  • Esztergom, Hungary, 2500
    • VALEOMED Diagnosztikai Központ
  • Nyíregyháza, Hungary, 4400
    • Jósa András Oktatókórház
  • Pécs, Hungary, 7623
    • Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika; Klinikai Központ Neurológiai Klinika
• Ireland
  • Cork, Ireland
    • Cork University Hospital
  • Dublin, Ireland, 9
    • Beaumont Hospital; Clinical Research and Education Centre, Smurfit Building
  • Dublin, Ireland, Dublin 4
    • St Vincents University Hospital; Carew House-Neurology Department
• Italy
  • Campania
    • Napoli, Campania, Italy, 80131
      • A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
    • Napoli, Campania, Italy, 80131
      • Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
    • Napoli, Campania, Italy, 80138
      • Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
  • Friuli-Venezia Giulia
    • Trieste, Friuli-Venezia Giulia, Italy, 34149
      • Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica
  • 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
    • Roma, Lazio, Italy, 00168
      • Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
    • Roma, Lazio, Italy, 00189
      • A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Irccs A.O.U.San Martino Ist; Dinogmi
  • Lombardia
    • Milano, Lombardia, Italy, 20133
      • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
    • 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
  • Molise
    • Pozzilli, Molise, Italy, 86077
      • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • Piemonte
    • Orbassano, Piemonte, Italy, 10043
      • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
    • Torino, Piemonte, Italy, 10126
      • AOU Città della Salute e della Scienza; Neurologia 1
  • Puglia
    • Bari, Puglia, Italy, 70124
      • Azienda Ospedaliero Universitaria Consorziale Policlinico di; Scienze Neurologiche
  • 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
  • Toscana
    • Firenze, Toscana, Italy, 50134
      • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
  • Veneto
    • Verona, Veneto, Italy, 37134
      • Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla
• Lebanon
  • Beirut, Lebanon, 1107 2020
    • American University of Beirut - Medical Center
  • Beirut, Lebanon, 1132 8811
    • Lebanese American University Medical Center- Rizk Hospial
• Mexico
  • Ciudad de México, Mexico, 14050
    • Unidad de investigacion en salud (UIS); Neurociencias
  • Mexico CITY (federal District)
    • Mexico City, Mexico CITY (federal District), Mexico, 06700
      • Clinstile S.A de C.V.
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Grupo Medico de Investigacion Clinica Multidisciplinaria
  • Tlaxcala
    • Mexico, Tlaxcala, Mexico, 06726
      • Hospital General de Mexico
• Morocco
  • FES, Morocco, 30000
    • Centre Hospitalier Universitaire Hassan II
  • Rabat, Morocco, 10000
    • Hopital Cheikh Zaid
  • Rabat, Morocco, 10100
    • Hopital Militaire d'Instruction Mohamed V
• Netherlands
  • Breda, Netherlands, 4818 CK
    • Amphia Ziekenhuis
  • Eindhoven, Netherlands, 5623 EJ
    • Catharina Ziekenhuis
  • Rotterdam, Netherlands, 3079 DZ
    • Maasstadziekenhuis
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard Geleen
• Panama
  • Panama City, Panama, 0816 03075
    • Consultorios Médicos PaItilla
• Poland
  • Bia?ystok, Poland, 15-276
    • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Kraków, Poland, 31-503
    • Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii
  • Lodz, Poland, 90-324
    • Centrum Neurologii Krzysztof Selmaj
  • Pozna?, Poland, 60-355
    • SP Swiecickiego UM Marcinkowskiego; Od. Klin. Neurologii z podod. Udarowym
  • Rzeszow, Poland, 35-055
    • Centrum Medyczne "Medyk"
  • Warszawa, Poland, 04-141
    • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
  • Zabrze, Poland, 41-800
    • SPSK nr 1; Klinika Neurologii
• Russian Federation
  • Leningrad
    • Sankt-peterburg, Leningrad, Russian Federation, 197110
      • National Center of Social Significant Disease
  • Moskovskaja Oblast
    • Moscow, Moskovskaja Oblast, Russian Federation, 117186
      • Jusupovskaya Hospital
    • Moscow, Moskovskaja Oblast, Russian Federation, 125367
      • Scientific Neurology Center; Neurological department #6?
    • Moscow, Moskovskaja Oblast, Russian Federation, 129110
      • Vladimirskiy Regional Scientific Research Inst.
    • Moskva, Moskovskaja Oblast, Russian Federation, 127015
      • City Clinical Hospital #24; Multipal Sclerosis department
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron; Servicio de Neurología
  • Valencia, Spain, 46026
    • Hospital Universitario la Fe; Servicio de Neurologia
  • Murcia
    • EL Palmar (EL Palmar), Murcia, Spain, 30120
      • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
• United Arab Emirates
  • Abu Dhabi, United Arab Emirates, 112412
    • Cleveland Clinic Abu Dhabi
  • Dubai, United Arab Emirates, 4545
    • Rashid hospital
• United States
  • California
    • Laguna Hills, California, United States, 92653
      • MS Center of California
    • Pasadena, California, United States, 91105
      • SC3 Research Group, Inc
    • San Francisco, California, United States, 94117
      • University of California San Francisco
  • Connecticut
    • New Haven, Connecticut, United States, 06473
      • Yale University Multiple Sclerosis Center
  • Florida
    • Tampa, Florida, United States, 33612
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60637-1470
      • University of Chicago; Neurology/MC 2030
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital; Neurological Clinical Research Institute (NCRI)
    • Wellesley, Massachusetts, United States, 02481
      • The Elliot Lewis Center
  • Michigan
    • Detroit, Michigan, United States, 48210
      • Wayne State University School of Medicine
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University School of Medicine
  • New York
    • Latham, New York, United States, 12110
      • The MS Center of Northeastern New York
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University of Cincinnati; Department of Neurology
    • Cleveland, Ohio, United States, 44195
      • Cleveland Clinic Mellen Center; U10
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19104
      • University of Pennsylvania
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic PC
  • Texas
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio
  • Washington
    • Seattle, Washington, United States, 98122
      • Swedish Multiple Sclerosis Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
• EDSS (Expanded Disability Status Scale) </ =6.5 at screening
• Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment
• Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
• Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
• For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug

Exclusion Criteria:

• Relapsing-remitting multiple sclerosis (RRMS) at screening
• Inability to complete an MRI
• Gadolinium (Gd) intolerance
• Known presence of other neurological disorders

Exclusions Related to General Health:

• Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening
• Lactation
• Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study
• History or currently active primary or secondary immunodeficiency
• Lack of peripheral venous access
• Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study.
• Active infections must be treated and resolved prior to the first infusion of ocrelizumab
• Participants in a severely immunocompromised state until the condition resolves
• Participants with known active malignancies or being actively monitored for recurrence of malignancy
• Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML)

Exclusions Related to Laboratory Findings:

• Positive screening tests for hepatitis B
• CD4 count <250/μL
• ANC <1.0 × 103/μL
• AST/SGOT or ALT/SGPT ≥3.0 × ULN in combination with either an elevated total bilirubin (>2 X ULN) or clinical jaundice

Exclusions Related to Medications:

• Hypersensitivity to ocrelizumab or to any of its excipients
• Previous treatment with ocrelizumab
• Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or immunogenicity AND if Bcell levels are above the lower limit of normal (LLN) prior to screening.
• Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation
• Previous treatment with natalizumab where PML has not been excluded according to specific algorithm
• Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
• Systemic corticosteroid therapy within 4 weeks prior to screening
• All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab, unless the local regulations allow for a shorter interval. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted
• Previous treatment with daclizumab, ozanimod or figolimod in the last 8 weeks
• Previous treatment with siponimod in the last 2 weeks
• Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening
• Previous treatment with natalizumab in the last 12 weeks.
• Previous treatment with teriflunomide in the last 12 weeks. This washout period can be shortened if an accelerated elimination procedure is implemented before screening visit. One of the following elimination procedures can be used:
• Cholestyramine 8 g administered 3 times daily for a period of at least 7 days (cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated)
• Alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of at least 7 days.
• Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
• Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
• Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks
• Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ocrelizumab; Ocrelizumab will be administered via intravenous (IV) infusion.	Drug: Ocrelizumab; Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Participants with No Evidence of Progression (NEP)	NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (confirmed disability progression [CDP]; ≥20% increase in timed 25-foot walk test [T25FWT]; ≥20% increase in nine-hole peg test [9HPT])	From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192
Proportion of Participants with no evidence of progression and no active disease (NEPAD)	NEPAD is defined as no progression sustained for at least 24 weeks on all of the three components of NEP (CDP, T25FWT, 9HPT), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium (Gd+)-enhancing lesion	From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)		Baseline to end of study (Week 192)
Change from Baseline in Cognitive Function, as Measured by Brief Visuospatial Memory Test - Revised (BVMT-R)		Baseline to end of study (Week 192)
Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study		Baseline to end of study (Week 192)
Time to Onset of First Confirmed Disability Progression (CDP) Sustained for at least 24 and 48 Weeks		Baseline to onset of first CDP (as measured by EDSS) sustained for at least 24 and 48 weeks
Time to Onset of First >=20% Increase in Timed 25-foot Walk Test (T25FWT) Sustained for at least 24 Weeks		Baseline to onset of first >=20% increase in T25FWT sustained for at least 24 weeks
Time to Onset of First >=20% Increase in 9 Hole Peg Test (9HPT) Sustained For At Least 24 Weeks		Baseline to onset of first >=20% increase in 9HPT sustained for at least 24 weeks
Proportion of Participants with NEP		Week 24 to Week 96, Week 24 to Week 192, and Week 48 to Week 192
Proportion of Participants with NEPAD		Week 24 to Week 96, Week 24 to Week 192, Week 48 to Week 192
Change from Baseline in Patient-Reported Outcomes (PROs)	PROs collected in this study will be the Multiple Sclerosis Impact Scale (MSIS-29), the Multiple Sclerosis Walking scale (MSWS-12), the ABILHAND-56 Questionnaire, Fatigue Scale for Motor and Cognitive function (FSMC), SymptoMScreen, 88-item Multiple Sclerosis Spasticity Scale (MSSS-88), Numerical Pain Rating Scale (NPRS), and the Patient Global Impression of Severity (PGIS) for upper limb, lower limb and cognitive function	Baseline to end of study (Week 192)
Change from Baseline in the number of falls and near-falls		Baseline to end of study (Week 192)
Change in Whole Brain Volume (Whole, Cerebral White Matter, Cortical Grey Matter, Deep grey matter)		Baseline to end of study (Week 192)
Change in thalamic volumes		Baseline to end of study (Week 192)
Change in whole and regional cerebellar volume (cervical cord grey and white matter area)		Baseline to end of study (Week 192)
Change in cervical cord cross-sectional area (total, white matter and grey matter)		Baseline to end of study (Week 192)
Change in number of new/enlarging T2 lesions and total T2 Lesion Volume		Baseline to end of study (Week 192)
Change in number of T1 Gadolinium (Gd)+ Lesions and total volume		'Baseline to end of study (Week 192)
Change in number of T1 lesions		Baseline to end of study (Week 192)
Number in total volume of T1 lesions		Baseline to end of study (Week 192)
Change in Slowly Evolving Lesions (SEL)		Baseline to end of study (Week 192)
Change in normalised T1 intensity/T1 Gd+ enhancement in New Focal T2 Lesions, SELs, Persistent Areas of Non-SEL T2 Lesions, and Normal-Appearing Brain Tissue		Baseline to end of study (Week 192)
Change in Gd-enhancing late-Fluid-Attenuated Inversion-Recovery (FLAIR) Meningeal Lesions		Baseline to end of study (Week 192)
Change in the number/ spatial distribution of lesions in the cervical spinal cord		Baseline to end of study (Week 192)
Spectroscopic MR: Measure of the Relative Signal Amplitude of N-Acetyl Aspartate (NAA), and Choline to Creatine	Only in centers with 1.5-Tesla MRI capable to perform it	Baseline to end of study (Week 192)
Measure of phase rim lesions using a Susceptibility-Weighted Imaging [SWI]/T2 sequence	Only in centers with 3-Tesla MRI capable to perform it, where this sequence would replace the spectroscopic MR in the acquisition flow	Baseline to end of study (Week 192)
Percentage of Participants with Adverse Events (AEs)		Baseline to end of study (Week 192)
Rates of study treatment discontinuation due to adverse events		Baseline to Week 192

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): May 28, 2018
• Primary Completion (Estimated): January 15, 2026
• Study Completion (Estimated): December 4, 2026

Study Registration Dates

• First Submitted: April 16, 2018
• First Submitted That Met QC Criteria: May 10, 2018
• First Posted (Actual): May 14, 2018

Study Record Updates

• Last Update Posted (Actual): March 13, 2024
• Last Update Submitted That Met QC Criteria: March 12, 2024
• Last Verified: March 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: MN39159

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.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). 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: Yes
• Studies a U.S. FDA-regulated device product: No