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

Primary Purpose

Progressive Multiple Sclerosis (PMS)

Status
Active
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ocrelizumab
Sponsored by
Hoffmann-La Roche
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Progressive Multiple Sclerosis (PMS)

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • MS Center of California
  • SC3 Research Group, Inc
  • University of California San Francisco
  • Yale University Multiple Sclerosis Center
  • University of South Florida
  • University of Chicago; Neurology/MC 2030
  • Massachusetts General Hospital; Neurological Clinical Research Institute (NCRI)
  • The Elliot Lewis Center
  • Wayne State University School of Medicine
  • Washington University School of Medicine
  • The MS Center of Northeastern New York
  • University of Cincinnati; Department of Neurology
  • Cleveland Clinic Mellen Center; U10
  • University of Pennsylvania
  • Neurology Clinic PC
  • Central Texas Neurology Consultants
  • Neurology Center of San Antonio
  • Swedish Multiple Sclerosis Center
  • University Clinical Center of the Republic of Srpska; Neurology Clinic
  • University Hospital Mostar; Neurology Clinic
  • Clinical Center University of Sarajevo; Neurology clinic
  • University Clinical Center Tuzla; Neurology
  • Instituto de Neurologia de Curitiba
  • Hospital Sao Lucas - PUCRS
  • Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
  • Hospital das Clinicas - FMUSP_X; Neurologia
  • Fraser Health Authority - Fraser Health Multiple Sclerosis
  • University of British Columbia Hospital; Division of Neurology
  • London Health Sciences Centre Uni Campus
  • St. Michael'S Hospital
  • Recherche Sepmus Inc.
  • Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
  • Saskatoon City Hospital; Neurology
  • Organizacion Sanitas Internacional
  • Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
  • Hospital Clínica Biblica
  • Nemocnice Jihlava; NEU-Neurologicke oddeleni
  • Fakultní Nemocnice Olomouc; Neurologicka Klinika
  • Fakultni nemocnice Ostrava; MS centrum
  • Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
  • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
  • Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
  • Rigshospitalet; Neurologisk Klinik Glostrup
  • Rigshospitalet; Skleroseklinikken - Glostrup
  • Clinical Research Center-Alex university; Neurology Department
  • Ain Shams University Hospital; Clinical Research Center (MASRI-CRC)
  • CHU Amiens Hopital Sud; Neurologie
  • CHIC Cote Basque Bayonne; Neurologie
  • Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
  • Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
  • CHU De Caen; Service De Neurologie Dejerine
  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
  • Hopital B Roger Salengro; Neurologie C
  • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • CHRU Nancy; Service de neurologie
  • Hopital Nord Laennec
  • Hôpital Pasteur; Service de Neurologie
  • Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
  • Centre Hospitalier Universitaire de Rennes
  • Hopital Civil de Strasbourg; Service de Neurologie
  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie
  • NeuroConcept AG C/O mind mvz GmbH
  • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
  • Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
  • Nucare
  • Semmelweis Egyetem AOK; Neurologiai Klinika
  • VALEOMED Diagnosztikai Központ
  • Jósa András Oktatókórház
  • Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika; Klinikai Központ Neurológiai Klinika
  • Cork University Hospital
  • Beaumont Hospital; Clinical Research and Education Centre, Smurfit Building
  • St Vincents University Hospital; Carew House-Neurology Department
  • A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
  • Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
  • Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
  • Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica
  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
  • A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
  • Azienda Ospedaliera Sant'Andrea; UOC Neurologia
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
  • AOU Città della Salute e della Scienza; Neurologia 1
  • Azienda Ospedaliero Universitaria Consorziale Policlinico di; Scienze Neurologiche
  • Ospedale Binaghi; Centro Sclerosi Multipla
  • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
  • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
  • Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla
  • American University of Beirut - Medical Center
  • Lebanese American University Medical Center- Rizk Hospial
  • Grupo Medico de Investigacion Clinica Multidisciplinaria
  • Clinstile S.A de C.V.
  • Hospital General de Mexico
  • Unidad de investigacion en salud (UIS); Neurociencias
  • Centre Hospitalier Universitaire Hassan II
  • Hopital Cheikh Zaid
  • Hopital Militaire d'Instruction Mohamed V
  • Amphia Ziekenhuis
  • Catharina ziekenhuis
  • Maasstadziekenhuis
  • Zuyderland Medisch Centrum - Sittard Geleen
  • Consultorios Médicos PaItilla
  • Uniwersytecki Szpital Kliniczny w Bialymstoku
  • Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii
  • Centrum Neurologii Krzysztof Selmaj
  • SP Swiecickiego UM Marcinkowskiego; Od. Klin. Neurologii z podod. Udarowym
  • Centrum Medyczne "MEDYK"
  • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
  • SPSK nr 1; Klinika Neurologii
  • National Center of Social Significant Disease
  • Jusupovskaya Hospital
  • Scientific Neurology Center; Neurological department #6?
  • Vladimirskiy Regional Scientific Research Inst.
  • City Clinical Hospital #24; Multipal Sclerosis department
  • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Hospital Vall d'Hebron; Servicio de Neurología
  • Hospital Universitario la Fe; Servicio de Neurologia
  • Cleveland Clinic Abu Dhabi
  • Rashid hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ocrelizumab

Arm Description

Ocrelizumab will be administered via intravenous (IV) infusion.

Outcomes

Primary Outcome Measures

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])
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

Secondary Outcome Measures

Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)
Change from Baseline in Cognitive Function, as Measured by Brief Visuospatial Memory Test - Revised (BVMT-R)
Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study
Time to Onset of First Confirmed Disability Progression (CDP) 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
Time to Onset of First >=20% Increase in 9 Hole Peg Test (9HPT) Sustained For At Least 24 Weeks
Proportion of Participants with NEP
Proportion of Participants with NEPAD
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
Change from Baseline in the number of falls and near-falls
Change in Whole Brain Volume (Whole, Cerebral White Matter, Cortical Grey Matter, Deep grey matter)
Change in thalamic volumes
Change in whole and regional cerebellar volume (cervical cord grey and white matter area)
Change in cervical cord cross-sectional area (total, white matter and grey matter)
Change in number of new/enlarging T2 lesions and total T2 Lesion Volume
Change in number of T1 Gadolinium (Gd)+ Lesions and total volume
Change in number of T1 lesions
Number in total volume of T1 lesions
Change in Slowly Evolving Lesions (SEL)
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
Change in Gd-enhancing late-Fluid-Attenuated Inversion-Recovery (FLAIR) Meningeal Lesions
Change in the number/ spatial distribution of lesions in the cervical spinal cord
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
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
Percentage of Participants with Adverse Events (AEs)
Rates of study treatment discontinuation due to adverse events

Full Information

First Posted
April 16, 2018
Last Updated
August 30, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03523858
Brief Title
A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis
Acronym
CONSONANCE
Official Title
An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 28, 2018 (Actual)
Primary Completion Date
January 15, 2026 (Anticipated)
Study Completion Date
December 4, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Progressive Multiple Sclerosis (PMS)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
927 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
Ocrelizumab will be administered via intravenous (IV) infusion.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
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)
Primary Outcome Measure Information:
Title
Proportion of Participants with No Evidence of Progression (NEP)
Description
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])
Time Frame
From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192
Title
Proportion of Participants with no evidence of progression and no active disease (NEPAD)
Description
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
Time Frame
From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192
Secondary Outcome Measure Information:
Title
Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)
Time Frame
Baseline to end of study (Week 192)
Title
Change from Baseline in Cognitive Function, as Measured by Brief Visuospatial Memory Test - Revised (BVMT-R)
Time Frame
Baseline to end of study (Week 192)
Title
Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study
Time Frame
Baseline to end of study (Week 192)
Title
Time to Onset of First Confirmed Disability Progression (CDP) Sustained for at least 24 and 48 Weeks
Time Frame
Baseline to onset of first CDP (as measured by EDSS) sustained for at least 24 and 48 weeks
Title
Time to Onset of First >=20% Increase in Timed 25-foot Walk Test (T25FWT) Sustained for at least 24 Weeks
Time Frame
Baseline to onset of first >=20% increase in T25FWT sustained for at least 24 weeks
Title
Time to Onset of First >=20% Increase in 9 Hole Peg Test (9HPT) Sustained For At Least 24 Weeks
Time Frame
Baseline to onset of first >=20% increase in 9HPT sustained for at least 24 weeks
Title
Proportion of Participants with NEP
Time Frame
Week 24 to Week 96, Week 24 to Week 192, and Week 48 to Week 192
Title
Proportion of Participants with NEPAD
Time Frame
Week 24 to Week 96, Week 24 to Week 192, Week 48 to Week 192
Title
Change from Baseline in Patient-Reported Outcomes (PROs)
Description
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
Time Frame
Baseline to end of study (Week 192)
Title
Change from Baseline in the number of falls and near-falls
Time Frame
Baseline to end of study (Week 192)
Title
Change in Whole Brain Volume (Whole, Cerebral White Matter, Cortical Grey Matter, Deep grey matter)
Time Frame
Baseline to end of study (Week 192)
Title
Change in thalamic volumes
Time Frame
Baseline to end of study (Week 192)
Title
Change in whole and regional cerebellar volume (cervical cord grey and white matter area)
Time Frame
Baseline to end of study (Week 192)
Title
Change in cervical cord cross-sectional area (total, white matter and grey matter)
Time Frame
Baseline to end of study (Week 192)
Title
Change in number of new/enlarging T2 lesions and total T2 Lesion Volume
Time Frame
Baseline to end of study (Week 192)
Title
Change in number of T1 Gadolinium (Gd)+ Lesions and total volume
Time Frame
'Baseline to end of study (Week 192)
Title
Change in number of T1 lesions
Time Frame
Baseline to end of study (Week 192)
Title
Number in total volume of T1 lesions
Time Frame
Baseline to end of study (Week 192)
Title
Change in Slowly Evolving Lesions (SEL)
Time Frame
Baseline to end of study (Week 192)
Title
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
Time Frame
Baseline to end of study (Week 192)
Title
Change in Gd-enhancing late-Fluid-Attenuated Inversion-Recovery (FLAIR) Meningeal Lesions
Time Frame
Baseline to end of study (Week 192)
Title
Change in the number/ spatial distribution of lesions in the cervical spinal cord
Time Frame
Baseline to end of study (Week 192)
Title
Spectroscopic MR: Measure of the Relative Signal Amplitude of N-Acetyl Aspartate (NAA), and Choline to Creatine
Description
Only in centers with 1.5-Tesla MRI capable to perform it
Time Frame
Baseline to end of study (Week 192)
Title
Measure of phase rim lesions using a Susceptibility-Weighted Imaging [SWI]/T2 sequence
Description
Only in centers with 3-Tesla MRI capable to perform it, where this sequence would replace the spectroscopic MR in the acquisition flow
Time Frame
Baseline to end of study (Week 192)
Title
Percentage of Participants with Adverse Events (AEs)
Time Frame
Baseline to end of study (Week 192)
Title
Rates of study treatment discontinuation due to adverse events
Time Frame
Baseline to Week 192

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
MS Center of California
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
SC3 Research Group, Inc
City
Pasadena
State/Province
California
ZIP/Postal Code
91105
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Facility Name
Yale University Multiple Sclerosis Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06473
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
University of Chicago; Neurology/MC 2030
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1470
Country
United States
Facility Name
Massachusetts General Hospital; Neurological Clinical Research Institute (NCRI)
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
The Elliot Lewis Center
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Wayne State University School of Medicine
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48210
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
The MS Center of Northeastern New York
City
Latham
State/Province
New York
ZIP/Postal Code
12110
Country
United States
Facility Name
University of Cincinnati; Department of Neurology
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Cleveland Clinic Mellen Center; U10
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Neurology Clinic PC
City
Cordova
State/Province
Tennessee
ZIP/Postal Code
38018
Country
United States
Facility Name
Central Texas Neurology Consultants
City
Round Rock
State/Province
Texas
ZIP/Postal Code
78681
Country
United States
Facility Name
Neurology Center of San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
Country
United States
Facility Name
Swedish Multiple Sclerosis Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98122
Country
United States
Facility Name
University Clinical Center of the Republic of Srpska; Neurology Clinic
City
Banja Luka
ZIP/Postal Code
78000
Country
Bosnia and Herzegovina
Facility Name
University Hospital Mostar; Neurology Clinic
City
Mostar
ZIP/Postal Code
88000
Country
Bosnia and Herzegovina
Facility Name
Clinical Center University of Sarajevo; Neurology clinic
City
Sarajevo
ZIP/Postal Code
71000
Country
Bosnia and Herzegovina
Facility Name
University Clinical Center Tuzla; Neurology
City
Tuzla
ZIP/Postal Code
75000
Country
Bosnia and Herzegovina
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Facility Name
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
City
Ribeirao Preto
State/Province
SP
ZIP/Postal Code
14051-140
Country
Brazil
Facility Name
Hospital das Clinicas - FMUSP_X; Neurologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-000
Country
Brazil
Facility Name
Fraser Health Authority - Fraser Health Multiple Sclerosis
City
Burnaby
State/Province
British Columbia
ZIP/Postal Code
V5G 2X6
Country
Canada
Facility Name
University of British Columbia Hospital; Division of Neurology
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 2B5
Country
Canada
Facility Name
London Health Sciences Centre Uni Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
St. Michael'S Hospital
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5B 1W8
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
Saskatoon City Hospital; Neurology
City
Saskatoon
State/Province
Saskatchewan
ZIP/Postal Code
S7K 0M7
Country
Canada
Facility Name
Organizacion Sanitas Internacional
City
Bogota, D.C.
ZIP/Postal Code
111321
Country
Colombia
Facility Name
Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
City
Cali
Country
Colombia
Facility Name
Hospital Clínica Biblica
City
San José
ZIP/Postal Code
10101
Country
Costa Rica
Facility Name
Nemocnice Jihlava; NEU-Neurologicke oddeleni
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
Fakultní Nemocnice Olomouc; Neurologicka Klinika
City
Olomouc
ZIP/Postal Code
779 00
Country
Czechia
Facility Name
Fakultni nemocnice Ostrava; MS centrum
City
Ostrava-Poruba
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
City
Praha 2
ZIP/Postal Code
128 08
Country
Czechia
Facility Name
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
City
Aabenraa
ZIP/Postal Code
6200
Country
Denmark
Facility Name
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet; Neurologisk Klinik Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Rigshospitalet; Skleroseklinikken - Glostrup
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Clinical Research Center-Alex university; Neurology Department
City
Alexandria
ZIP/Postal Code
21561
Country
Egypt
Facility Name
Ain Shams University Hospital; Clinical Research Center (MASRI-CRC)
City
Cairo
ZIP/Postal Code
11566
Country
Egypt
Facility Name
CHU Amiens Hopital Sud; Neurologie
City
Amiens Cedex1
ZIP/Postal Code
80054
Country
France
Facility Name
CHIC Cote Basque Bayonne; Neurologie
City
Bayonne Cedex
ZIP/Postal Code
64109
Country
France
Facility Name
Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU De Caen; Service De Neurologie Dejerine
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital B Roger Salengro; Neurologie C
City
Lille
ZIP/Postal Code
59037
Country
France
Facility Name
CHU de la Timone - Hopital d Adultes; Service de Neurologie
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Gui de Chauliac; Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
CHRU Nancy; Service de neurologie
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hopital Nord Laennec
City
Nantes
ZIP/Postal Code
44093
Country
France
Facility Name
Hôpital Pasteur; Service de Neurologie
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
City
Nimes
ZIP/Postal Code
30029
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
Hopital Civil de Strasbourg; Service de Neurologie
City
Strasbourg
ZIP/Postal Code
67091
Country
France
Facility Name
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie
City
Greifswald
ZIP/Postal Code
17475
Country
Germany
Facility Name
NeuroConcept AG C/O mind mvz GmbH
City
Stuttgart
ZIP/Postal Code
70182
Country
Germany
Facility Name
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
Nucare
City
Ciudad Guatemala
ZIP/Postal Code
01015
Country
Guatemala
Facility Name
Semmelweis Egyetem AOK; Neurologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
VALEOMED Diagnosztikai Központ
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Jósa András Oktatókórház
City
Nyíregyháza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika; Klinikai Központ Neurológiai Klinika
City
Pécs
ZIP/Postal Code
7623
Country
Hungary
Facility Name
Cork University Hospital
City
Cork
Country
Ireland
Facility Name
Beaumont Hospital; Clinical Research and Education Centre, Smurfit Building
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
St Vincents University Hospital; Carew House-Neurology Department
City
Dublin
ZIP/Postal Code
Dublin 4
Country
Ireland
Facility Name
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
Country
Italy
Facility Name
Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica
City
Trieste
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
34149
Country
Italy
Facility Name
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00133
Country
Italy
Facility Name
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Facility Name
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20133
Country
Italy
Facility Name
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
City
Orbassano
State/Province
Piemonte
ZIP/Postal Code
10043
Country
Italy
Facility Name
AOU Città della Salute e della Scienza; Neurologia 1
City
Torino
State/Province
Piemonte
ZIP/Postal Code
10126
Country
Italy
Facility Name
Azienda Ospedaliero Universitaria Consorziale Policlinico di; Scienze Neurologiche
City
Bari
State/Province
Puglia
ZIP/Postal Code
70124
Country
Italy
Facility Name
Ospedale Binaghi; Centro Sclerosi Multipla
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09126
Country
Italy
Facility Name
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Facility Name
American University of Beirut - Medical Center
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Facility Name
Lebanese American University Medical Center- Rizk Hospial
City
Beirut
ZIP/Postal Code
1132 8811
Country
Lebanon
Facility Name
Grupo Medico de Investigacion Clinica Multidisciplinaria
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03100
Country
Mexico
Facility Name
Clinstile S.A de C.V.
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Facility Name
Hospital General de Mexico
City
Mexico
State/Province
Tlaxcala
ZIP/Postal Code
06726
Country
Mexico
Facility Name
Unidad de investigacion en salud (UIS); Neurociencias
City
Ciudad de México
ZIP/Postal Code
14050
Country
Mexico
Facility Name
Centre Hospitalier Universitaire Hassan II
City
FES
ZIP/Postal Code
30000
Country
Morocco
Facility Name
Hopital Cheikh Zaid
City
Rabat
ZIP/Postal Code
10000
Country
Morocco
Facility Name
Hopital Militaire d'Instruction Mohamed V
City
Rabat
ZIP/Postal Code
10100
Country
Morocco
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
Catharina ziekenhuis
City
Eindhoven
ZIP/Postal Code
5623 EJ
Country
Netherlands
Facility Name
Maasstadziekenhuis
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Consultorios Médicos PaItilla
City
Panama City
ZIP/Postal Code
0816 03075
Country
Panama
Facility Name
Uniwersytecki Szpital Kliniczny w Bialymstoku
City
Bia?ystok
ZIP/Postal Code
15-276
Country
Poland
Facility Name
Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii
City
Kraków
ZIP/Postal Code
31-503
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
SP Swiecickiego UM Marcinkowskiego; Od. Klin. Neurologii z podod. Udarowym
City
Pozna?
ZIP/Postal Code
60-355
Country
Poland
Facility Name
Centrum Medyczne "MEDYK"
City
Rzeszow
ZIP/Postal Code
35-055
Country
Poland
Facility Name
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
SPSK nr 1; Klinika Neurologii
City
Zabrze
ZIP/Postal Code
41-800
Country
Poland
Facility Name
National Center of Social Significant Disease
City
Sankt-peterburg
State/Province
Leningrad
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Jusupovskaya Hospital
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117186
Country
Russian Federation
Facility Name
Scientific Neurology Center; Neurological department #6?
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Vladimirskiy Regional Scientific Research Inst.
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
129110
Country
Russian Federation
Facility Name
City Clinical Hospital #24; Multipal Sclerosis department
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
127015
Country
Russian Federation
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
City
EL Palmar (EL Palmar)
State/Province
Murcia
ZIP/Postal Code
30120
Country
Spain
Facility Name
Hospital Vall d'Hebron; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Cleveland Clinic Abu Dhabi
City
Abu Dhabi
ZIP/Postal Code
112412
Country
United Arab Emirates
Facility Name
Rashid hospital
City
Dubai
ZIP/Postal Code
4545
Country
United Arab Emirates

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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).

Learn more about this trial

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

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