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A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

Primary Purpose

Multiple Sclerosis

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

About this trial

This is an interventional treatment trial for Multiple Sclerosis

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Diagnosis of relapsing multiple sclerosis (RMS) (i.e., RRMS or aSPMS where participants still experience relapses) in accordance with the revised McDonald Criteria 2017
  • At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening. No relapse 30 days prior to screening and at baseline.
  • Participants must be neurologically stable for at least 30 days prior to randomization and baseline.
  • Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive.
  • Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds
  • Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds
  • Documented MRI of brain with abnormalities consistent with MS at screening.
  • Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization.
  • For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods.
  • For female participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for her menopause or if surgically sterile

Exclusion Criteria:

  • History of primary progressive MS at screening.
  • Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening.
  • History of confirmed or suspected progressive multifocal leukoencephalopathy.
  • History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening.
  • Immunocompromised state.
  • Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization.
  • Inability to complete an MRI or contraindication to gadolinium administration.
  • Contraindications to mandatory pre-medications for IRRs.
  • Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study.
  • Significant, uncontrolled disease that may preclude participant from participating in the study.
  • History of or currently active primary or secondary, non-drug-related, immunodeficiency.
  • Pregnant or breastfeeding or intending to become pregnant
  • Lack of peripheral venous access.
  • History of alcohol or other drug abuse within 12 months prior to screening.
  • Treatment with any investigational agent within 24 weeks prior to screening or treatment with any experimental procedure for MS.
  • Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy.
  • Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline
  • Previous treatment with natalizumab within 4.5 months of baseline
  • Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline
  • Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab
  • Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication.
  • Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation.
  • Any previous history of transplantation or anti-rejection therapy.
  • Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization.
  • Systemic corticosteroid therapy within 4 weeks prior to screening.
  • Positive screening tests for active, latent, or inadequately treated hepatitis B.
  • Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab.
  • Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.

Sites / Locations

  • North Central Neurology Associates
  • Alabama Neurology Associates
  • 21st Century Neurology
  • Profound Research, LLC
  • Stanford University Medical Center; Stanford Neuroscience Health Center
  • Collaborative Neuroscience Network Inc.
  • Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
  • Advanced Neurology of Colorado, LLC
  • Neurology Associates, PA; Research Department
  • University of South Florida
  • American Health Network Institute, LLC
  • University of Kansas Medical Center
  • The NeuroMedical Clinic of Central Louisiana
  • Maine Medical Center
  • Dragonfly Research, LLC
  • Henry Ford Health System
  • Washington University School of Medicine
  • Cleveland Clinic Lou Ruvo; Center for Brain Research
  • Dent Neurological Institute
  • UC Health Neurology
  • Oklahoma Medical Research Foundation; MS Center of Excellence
  • Abington Neurological Associates
  • Tri-State Mountain Neurology
  • Hope Neurology
  • Bhupesh Dihenia M.D. P.A.
  • Neurology Center of San Antonio
  • Evergreen MS Center
  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • CEMIC
  • Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
  • Austin Hospital; Department of Neurology
  • Hospital Erasme
  • Revalidatie en MS Centrum
  • Instituto de Neurologia de Curitiba
  • IMV Pesquisa Neurológica
  • Clinica Neurologica; Neurocirurgica de Joinville
  • CPQuali Pesquisa Clinica Ltda
  • Recherche Sepmus Inc.
  • Hotel-Dieu de Levis
  • Rigshospitalet Glostrup; Neurologisk Klinik
  • Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
  • CHU Hopital Gabriel Montpied; Service de Neurologie
  • CH St Vincent de Paul
  • Hôpital Charles Nicolle; Service de Neurologie
  • Charite - Universitätsmedizin Berlin
  • St. Josef-Hospital, Klinik für Neurologie
  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie
  • Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
  • PANAKEIA - Arzneimittelforschung Leipzig GmbH
  • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Universitätsklinikum Ulm; Klinik für Neurologie
  • Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
  • 401 Military Hospital of Athens; Neurology Department
  • AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
  • S-Medicon Egeszsegugyi Szolgaltato Kft.
  • UNO Medical Trials Kft.
  • Somogy Vármegyei Kaposi Mór Oktató Kórház
  • Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
  • AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica
  • AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • NCL Institute Neuroscience
  • Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale
  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
  • Clinica Internacional; Unidad De Investigacion
  • Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
  • Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru
  • Hospital Maria Auxiliadora
  • Clinica Sanchez Ferrer
  • Neurocentrum Bydgoszcz sp. z o.o
  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
  • MA-LEK Clinical Sp. Z o.o.
  • SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
  • Centrum Neurologii Krzysztof Selmaj
  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
  • EMC Instytut Medyczny SA
  • Nzoz Palomed
  • Osrodek Badan Klinicznych Euromedis
  • Centrum Medyczne NeuroProtect
  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
  • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
  • Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
  • Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia
  • Hospital de Santa Maria; Servico de Neurologia
  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
  • National Center of Social Significant Disease
  • Neiro Clinica LLC
  • Research Center of Neurology of RAMS
  • Federal center of brain research and neurotechnologies
  • City Clinical Hospital #24; Multipal Sclerosis department
  • N.P. Bechtereva Institute of the Human Brain
  • City Hospital #40 of Kurortniy Administrative District
  • SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
  • Vertebronevrologiya LLC
  • KSMU Interregional Clinical Diagnostic Centre
  • Ulyanovsk Regional Clinical Hospital
  • Saratov State Medical University of RosZdrav; Neurology
  • Nebbiolo Center for Clinical Trials
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Hospital Alvaro Cunqueiro; Servicio de Neurologia
  • Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
  • Hospital Puerta del Mar; Sevicio de Neurologia
  • Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
  • Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
  • Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
  • Ospedale Regionale di Lugano - Civico; Neurologia
  • Kocaeli University Hospital; Department of Neurology
  • Medical Center Dopomoga Plus
  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
  • Zaporizhia City Multispecialty Clinical Hospital #9
  • Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
  • 5th Cherkasy City Center of Primary Health Care
  • SI USSRI of Medical and Social Problems of Disabilities of MOHU
  • Medical Center of Private Execution First Private Clinic
  • Lvivska oblasna tsentralna likarnia
  • Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?; Neurology Department
  • Bukovinsky SMU RMI Chernivtsi RCH
  • Regional Clinical Hospital; Neurology Department
  • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis
  • Derriford Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Ocrelizumab Higher Dose

Ocrelizumab Approved Dose

Arm Description

Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.

Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.

Outcomes

Primary Outcome Measures

Reduction in cCDP sustained for at least 12 weeks, measured by time to onset of cCDP sustained for at least 12 weeks.
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.

Secondary Outcome Measures

Time to Onset of 24-week cCDP (cCDP24)
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Time to Onset of 12-week CDP (CDP12)
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time to Onset of 24-week CDP (CDP24)
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time to >/= 20% Increase in 12-week Confirmed by Timed 25-Foot Walk Test (T25FWT)
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Time to >/= 20% Increase in 24-week Confirmed T25FWT
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Change from baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical scale at Week 120
The MSIS-29 is a 29-item participant-reported measure of the physical and psychological impacts of MS. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale, from "Not at all" (1) to "Extremely" (4).
Annual rate of percent change from baseline in total brain volume
Time to 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT)
The SDMT is a performance measure that has demonstrated sensitivity in detecting not only the presence of cognitive impairment but also changes in cognitive functioning over time and in response to treatment. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected orally. A four-point change from baseline is typically considered clinically meaningful.
Serum Concentration of Ocrelizumab at Specified Time points
Change in B-cell Levels in Blood
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood in Participants with the High versus Low Affinity Fcgamma Receptor 3A (FcgR3A) Genotype per Arm
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
Levels of Neurofilament Light Chain (NfL) in Blood
Levels of Interleukin-6 (IL-6) in Blood
Levels of Blood B-cells
Levels of blood B-cells is based on a highly sensitive assay that can accurately measure below 5 B-cells per microliter in blood
Levels of Lymphocytes in Blood
Proportion of Participants with Different DNA Genotypes

Full Information

First Posted
September 4, 2020
Last Updated
October 5, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT04544436
Brief Title
A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)
Official Title
A Phase IIIb Multicenter, Randomized, Double-Blind, Controlled Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 26, 2020 (Actual)
Primary Completion Date
March 3, 2025 (Anticipated)
Study Completion Date
August 31, 2028 (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
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This is a randomized, double blind, controlled, parallel group, multicenter study to evaluate efficacy, safety and pharmacokinetics of a higher dose of ocrelizumab per intravenous (IV) infusion every 24 weeks in participants with RMS, in comparison to the approved 600 mg dose of ocrelizumab.
Detailed Description
Participants will be treated for a minimum of 120 weeks in the double-blind phase. Upon positive primary results after the double-blind phase, an optional higher dose extension treatment (OLE phase) is planned for eligible participants. The OLE will be carried out for approximately 96 weeks. Participants will be followed for safety for 48 weeks thereafter. Participants whose B-cell levels still did not replete to their baseline level or the low level of normal (LLN), whichever is lower, will move into the B-cell monitoring (BCM) phase following the safety follow-up phase. The study will end when all participants who were not treated with an alternative B-cell depleting therapy have repleted their B-cells to the baseline value or the lower limit of normal.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
865 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab Higher Dose
Arm Type
Experimental
Arm Description
Participants will be randomized to receive a minimum of 5 higher treatment doses (1200 mg or 1800 mg) of ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the double blind treatment (DBT) phase. During the optional open-label extension (OLE) phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Arm Title
Ocrelizumab Approved Dose
Arm Type
Active Comparator
Arm Description
Participants will be randomized to receive a minimum of 5 treatment doses of 600 mg ocrelizumab administered by intravenous (IV) infusion every 24 weeks in the DBT phase. During the optional OLE phase, participants will be offered a higher dose of ocrelizumab (either 1200 or 1800 mg), based on their body weight at OLE baseline, for approximately 96 weeks (4 doses in total). Mandatory methylprednisolone (or equivalent) and antihistaminic drug (e.g., diphenhydramine or equivalent) will be administered approximately 30-60 minutes prior to the start of each ocrelizumab infusion.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
Ocrevus
Intervention Description
The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (participants's body weight <75 kg) or 1800 mg (participant's body weight >/=75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion every 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
Ocrevus
Intervention Description
Ocrelizumab will be administered at a dose of 600 milligram (mg) every 24 weeks. The first dose of ocrelizumab will be administered as two 300 mg intravenous (IV) infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion every 24 weeks.
Intervention Type
Drug
Intervention Name(s)
Antihistamine
Other Intervention Name(s)
Non-Investigational Medicinal Product
Intervention Description
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Non-Investigation Medicinal Product
Intervention Description
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
Primary Outcome Measure Information:
Title
Reduction in cCDP sustained for at least 12 weeks, measured by time to onset of cCDP sustained for at least 12 weeks.
Description
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Time Frame
Baseline up to approximately 4.3 years
Secondary Outcome Measure Information:
Title
Time to Onset of 24-week cCDP (cCDP24)
Description
Time to onset of cCDP is defined as the first occurrence of a predefined confirmed progression event measured by EDSS, T25FWT or 9-HPT.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to Onset of 12-week CDP (CDP12)
Description
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to Onset of 24-week CDP (CDP24)
Description
CDP, defined as a sustained increase from baseline in EDSS score of >/=1.0 point in participants with a baseline EDSS score of </=5.5 or a sustained increase of >/=0.5 points in participants with a baseline EDSS score of >5.5.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to >/= 20% Increase in 12-week Confirmed by Timed 25-Foot Walk Test (T25FWT)
Description
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Time Frame
Baseline up to approximately 4.3 years
Title
Time to >/= 20% Increase in 24-week Confirmed T25FWT
Description
The T25FWT is a performance measure used to assess walking speed based on a timed 25-foot walk. The participant is directed to start at one end of a clearly marked 25-foot course and is instructed to walk 25 feet as quickly and safely as possible.
Time Frame
Baseline up to approximately 4.3 years
Title
Change from baseline in the Multiple Sclerosis Impact Scale-29 (MSIS-29) physical scale at Week 120
Description
The MSIS-29 is a 29-item participant-reported measure of the physical and psychological impacts of MS. Participants are asked to rate how much their functioning and well-being has been impacted over the past 14 days on a 4-point scale, from "Not at all" (1) to "Extremely" (4).
Time Frame
Baseline, Week 120
Title
Annual rate of percent change from baseline in total brain volume
Time Frame
Baseline up to approximately 4.3 years
Title
Time to 12-week Confirmed 4-point Worsening in Symbol Digit Modality Test (SDMT)
Description
The SDMT is a performance measure that has demonstrated sensitivity in detecting not only the presence of cognitive impairment but also changes in cognitive functioning over time and in response to treatment. Using a reference key, the examinee has 90 seconds to pair specific numbers with given geometric figures. Responses will be collected orally. A four-point change from baseline is typically considered clinically meaningful.
Time Frame
Baseline up to approximately 4.3 years
Title
Serum Concentration of Ocrelizumab at Specified Time points
Time Frame
Week 0, 2, 12, 24, 36, 48, 60, 72, 84, 96, 120
Title
Change in B-cell Levels in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Proportion of Participants Achieving 5 or Less B-cells per Microliter of Blood in Participants with the High versus Low Affinity Fcgamma Receptor 3A (FcgR3A) Genotype per Arm
Time Frame
Week 0, 2, 12, 24, 36, 48, 60, 72, 84, 96, 120
Title
Change from Baseline in the Anti-Drug Antibody (ADA) Levels
Time Frame
Week 0, 24, 48, 72, 96, 120
Title
Levels of Neurofilament Light Chain (NfL) in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Levels of Interleukin-6 (IL-6) in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Levels of Blood B-cells
Description
Levels of blood B-cells is based on a highly sensitive assay that can accurately measure below 5 B-cells per microliter in blood
Time Frame
Baseline up to approximately 4.3 years
Title
Levels of Lymphocytes in Blood
Time Frame
Baseline up to approximately 4.3 years
Title
Proportion of Participants with Different DNA Genotypes
Time Frame
Week 0, 2, 12, 24, 48, 72, 96, 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of relapsing multiple sclerosis (RMS) (i.e., RRMS or aSPMS where participants still experience relapses) in accordance with the revised McDonald Criteria 2017 At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening. No relapse 30 days prior to screening and at baseline. Participants must be neurologically stable for at least 30 days prior to randomization and baseline. Expanded disability status scale (EDSS) score, at screening and baseline, from 0 to 5.5 inclusive. Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds Documented MRI of brain with abnormalities consistent with MS at screening. Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization. For females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods. For female participants, without reproductive potential may be enrolled if post-menopausal, unless receiving a hormonal therapy for her menopause or if surgically sterile Exclusion Criteria: History of primary progressive MS at screening. Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening. History of confirmed or suspected progressive multifocal leukoencephalopathy. History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening. Immunocompromised state. Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization. Inability to complete an MRI or contraindication to gadolinium administration. Contraindications to mandatory pre-medications for IRRs. Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study. Significant, uncontrolled disease that may preclude participant from participating in the study. History of or currently active primary or secondary, non-drug-related, immunodeficiency. Pregnant or breastfeeding or intending to become pregnant Lack of peripheral venous access. History of alcohol or other drug abuse within 12 months prior to screening. Treatment with any investigational agent within 24 weeks prior to screening or treatment with any experimental procedure for MS. Previous use of anti-CD20s (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy. Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline Previous treatment with natalizumab within 4.5 months of baseline Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication. Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation. Any previous history of transplantation or anti-rejection therapy. Treatment with intravenous (IV) immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization. Systemic corticosteroid therapy within 4 weeks prior to screening. Positive screening tests for active, latent, or inadequately treated hepatitis B. Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab. Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above.
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
North Central Neurology Associates
City
Cullman
State/Province
Alabama
ZIP/Postal Code
35058
Country
United States
Facility Name
Alabama Neurology Associates
City
Homewood
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
21st Century Neurology
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85004
Country
United States
Facility Name
Profound Research, LLC
City
Carlsbad
State/Province
California
ZIP/Postal Code
92011
Country
United States
Facility Name
Stanford University Medical Center; Stanford Neuroscience Health Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
Collaborative Neuroscience Network Inc.
City
Torrance
State/Province
California
ZIP/Postal Code
90502
Country
United States
Facility Name
Mountain Neurological Research Center; Roaring Fork Neurologt, P.C.
City
Basalt
State/Province
Colorado
ZIP/Postal Code
81621
Country
United States
Facility Name
Advanced Neurology of Colorado, LLC
City
Fort Collins
State/Province
Colorado
ZIP/Postal Code
80528
Country
United States
Facility Name
Neurology Associates, PA; Research Department
City
Maitland
State/Province
Florida
ZIP/Postal Code
32751
Country
United States
Facility Name
University of South Florida
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
American Health Network Institute, LLC
City
Avon
State/Province
Indiana
ZIP/Postal Code
46123
Country
United States
Facility Name
University of Kansas Medical Center
City
Kansas City
State/Province
Kansas
ZIP/Postal Code
66160
Country
United States
Facility Name
The NeuroMedical Clinic of Central Louisiana
City
Alexandria
State/Province
Louisiana
ZIP/Postal Code
71301
Country
United States
Facility Name
Maine Medical Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
Dragonfly Research, LLC
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Henry Ford Health System
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48202
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
Cleveland Clinic Lou Ruvo; Center for Brain Research
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Dent Neurological Institute
City
Amherst
State/Province
New York
ZIP/Postal Code
14226
Country
United States
Facility Name
UC Health Neurology
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Oklahoma Medical Research Foundation; MS Center of Excellence
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Abington Neurological Associates
City
Abington
State/Province
Pennsylvania
ZIP/Postal Code
19001
Country
United States
Facility Name
Tri-State Mountain Neurology
City
Johnson City
State/Province
Tennessee
ZIP/Postal Code
37604
Country
United States
Facility Name
Hope Neurology
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37922
Country
United States
Facility Name
Bhupesh Dihenia M.D. P.A.
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79410
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
Evergreen MS Center
City
Kirkland
State/Province
Washington
ZIP/Postal Code
98034
Country
United States
Facility Name
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
City
Buenos Aires
ZIP/Postal Code
C1424
Country
Argentina
Facility Name
CEMIC
City
Buenos Aires
ZIP/Postal Code
C1431FWO
Country
Argentina
Facility Name
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Facility Name
Austin Hospital; Department of Neurology
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Hospital Erasme
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Revalidatie en MS Centrum
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Facility Name
IMV Pesquisa Neurológica
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90110-000
Country
Brazil
Facility Name
Clinica Neurologica; Neurocirurgica de Joinville
City
Joinville
State/Province
SC
ZIP/Postal Code
89202-190
Country
Brazil
Facility Name
CPQuali Pesquisa Clinica Ltda
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-000
Country
Brazil
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Hotel-Dieu de Levis
City
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Rigshospitalet Glostrup; Neurologisk Klinik
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
CHU Hopital Gabriel Montpied; Service de Neurologie
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CH St Vincent de Paul
City
Lille
ZIP/Postal Code
59000
Country
France
Facility Name
Hôpital Charles Nicolle; Service de Neurologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
Charite - Universitätsmedizin Berlin
City
Berlin
ZIP/Postal Code
12203
Country
Germany
Facility Name
St. Josef-Hospital, Klinik für Neurologie
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Schleswig-Holstein; Klinik für Neurologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universität Leipzig; Innere Medizin, Neurologie, Dermatologie
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
PANAKEIA - Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Zentrum für Neurologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Universitätsklinikum Ulm; Klinik für Neurologie
City
Ulm
ZIP/Postal Code
89081
Country
Germany
Facility Name
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
City
Wiesbaden
ZIP/Postal Code
65191
Country
Germany
Facility Name
401 Military Hospital of Athens; Neurology Department
City
Athens
ZIP/Postal Code
115 25
Country
Greece
Facility Name
AHEPA Univ. General Hospital of Thessaloniki; B' Neurology Dept.
City
Thessaloniki
ZIP/Postal Code
546 36
Country
Greece
Facility Name
S-Medicon Egeszsegugyi Szolgaltato Kft.
City
Budapest
ZIP/Postal Code
1138
Country
Hungary
Facility Name
UNO Medical Trials Kft.
City
Budapest
ZIP/Postal Code
1152
Country
Hungary
Facility Name
Somogy Vármegyei Kaposi Mór Oktató Kórház
City
Kaposvar
ZIP/Postal Code
7400
Country
Hungary
Facility Name
Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Facility Name
AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Facility Name
AOU Seconda Università degli Studi; Dip.Assistenziale Integrato Medicina Int-I Clinica Neurologica
City
Napoli
State/Province
Campania
ZIP/Postal Code
80138
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
NCL Institute Neuroscience
City
Roma
State/Province
Lazio
ZIP/Postal Code
00178
Country
Italy
Facility Name
Policlinico Umberto I; Centro Sclerosi Multipla DAI Neuroscienze e Salute Mentale
City
Roma
State/Province
Lazio
ZIP/Postal Code
00185
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 Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
City
Pozzilli
State/Province
Molise
ZIP/Postal Code
86077
Country
Italy
Facility Name
Hospital IV Alberto Sabogal Sologuren; Unidad de Investigacion
City
Bellavista
ZIP/Postal Code
Callao 2
Country
Peru
Facility Name
Clinica Internacional; Unidad De Investigacion
City
Lima
ZIP/Postal Code
15001
Country
Peru
Facility Name
Hospital Nacional Dos de Mayo; Unidad de Investigacion de Neurologia
City
Lima
ZIP/Postal Code
15003
Country
Peru
Facility Name
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo; Peru
City
Lima
ZIP/Postal Code
Lima 01
Country
Peru
Facility Name
Hospital Maria Auxiliadora
City
Lima
ZIP/Postal Code
Lima 29
Country
Peru
Facility Name
Clinica Sanchez Ferrer
City
Trujillo
ZIP/Postal Code
13009
Country
Peru
Facility Name
Neurocentrum Bydgoszcz sp. z o.o
City
Bydgoszcz
ZIP/Postal Code
85-796
Country
Poland
Facility Name
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Facility Name
MA-LEK Clinical Sp. Z o.o.
City
Katowice
ZIP/Postal Code
40-595
Country
Poland
Facility Name
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM;Oddzial Kliniczny Neurologii
City
Lodz
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Centrum Neurologii Krzysztof Selmaj
City
Lodz
ZIP/Postal Code
90-324
Country
Poland
Facility Name
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
City
Lublin
ZIP/Postal Code
20-410
Country
Poland
Facility Name
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych
City
Plewiska
ZIP/Postal Code
62-064
Country
Poland
Facility Name
EMC Instytut Medyczny SA
City
Pozna?
ZIP/Postal Code
60-309
Country
Poland
Facility Name
Nzoz Palomed
City
Rzeszów
ZIP/Postal Code
35-232
Country
Poland
Facility Name
Osrodek Badan Klinicznych Euromedis
City
Szczecin
ZIP/Postal Code
70-111
Country
Poland
Facility Name
Centrum Medyczne NeuroProtect
City
Warszawa
ZIP/Postal Code
01-684
Country
Poland
Facility Name
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
City
Warszawa
ZIP/Postal Code
02-097
Country
Poland
Facility Name
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Facility Name
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
City
Warszawa
ZIP/Postal Code
04-141
Country
Poland
Facility Name
Hospital de Braga; Centro Clínico Académico (Piso 1, Ala E)
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz; Neurologia
City
Lisboa
ZIP/Postal Code
1349-019
Country
Portugal
Facility Name
Hospital de Santa Maria; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Facility Name
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
City
Krasnoyarsk
State/Province
Krasnojarsk
ZIP/Postal Code
660037
Country
Russian Federation
Facility Name
National Center of Social Significant Disease
City
Sankt-peterburg
State/Province
Leningrad
ZIP/Postal Code
197110
Country
Russian Federation
Facility Name
Neiro Clinica LLC
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117186
Country
Russian Federation
Facility Name
Research Center of Neurology of RAMS
City
Moscow
State/Province
Moskovskaja Oblast
ZIP/Postal Code
125367
Country
Russian Federation
Facility Name
Federal center of brain research and neurotechnologies
City
Moskva
State/Province
Moskovskaja Oblast
ZIP/Postal Code
117997
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
N.P. Bechtereva Institute of the Human Brain
City
Sankt-petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197376
Country
Russian Federation
Facility Name
City Hospital #40 of Kurortniy Administrative District
City
St. Petersburg
State/Province
Sankt Petersburg
ZIP/Postal Code
197706
Country
Russian Federation
Facility Name
SHI Sverdlovsk Regional Clinical Hospital #1;Neurology
City
Yekaterinburg
State/Province
Sverdlovsk
ZIP/Postal Code
620102
Country
Russian Federation
Facility Name
Vertebronevrologiya LLC
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420047
Country
Russian Federation
Facility Name
KSMU Interregional Clinical Diagnostic Centre
City
Kazan
State/Province
Tatarstan
ZIP/Postal Code
420101
Country
Russian Federation
Facility Name
Ulyanovsk Regional Clinical Hospital
City
Ulyanovsk
State/Province
Uljanovsk
ZIP/Postal Code
432063
Country
Russian Federation
Facility Name
Saratov State Medical University of RosZdrav; Neurology
City
Saratov
ZIP/Postal Code
410012
Country
Russian Federation
Facility Name
Nebbiolo Center for Clinical Trials
City
Tomsk
ZIP/Postal Code
634009
Country
Russian Federation
Facility Name
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
City
Coruña
State/Province
LA Coruña
ZIP/Postal Code
15006
Country
Spain
Facility Name
Hospital Quiron de Madrid; Servicio de Neurologia
City
Pozuelo de Alarcon
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital Alvaro Cunqueiro; Servicio de Neurologia
City
Vigo
State/Province
Pontevedra
Country
Spain
Facility Name
Hospital Universitari Vall d'Hebron; Servicio de Neumo-Inmunologia
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Puerta del Mar; Sevicio de Neurologia
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Hospital Regional Universitario de Malaga ? Hospital General; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Facility Name
Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
City
Bern
ZIP/Postal Code
3010
Country
Switzerland
Facility Name
Ospedale Regionale di Lugano - Civico; Neurologia
City
Lugano
ZIP/Postal Code
6903
Country
Switzerland
Facility Name
Kocaeli University Hospital; Department of Neurology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Medical Center Dopomoga Plus
City
Kyiv
State/Province
Chernihiv Governorate
ZIP/Postal Code
02123
Country
Ukraine
Facility Name
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
City
Zaporizhzhia
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69600
Country
Ukraine
Facility Name
Zaporizhia City Multispecialty Clinical Hospital #9
City
Zaporizhzhye
State/Province
Katerynoslav Governorate
ZIP/Postal Code
69063
Country
Ukraine
Facility Name
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61058
Country
Ukraine
Facility Name
5th Cherkasy City Center of Primary Health Care
City
Cherkasy
State/Province
KIEV Governorate
ZIP/Postal Code
18029
Country
Ukraine
Facility Name
SI USSRI of Medical and Social Problems of Disabilities of MOHU
City
Dnipro
State/Province
KIEV Governorate
ZIP/Postal Code
49027
Country
Ukraine
Facility Name
Medical Center of Private Execution First Private Clinic
City
Kyiv
State/Province
KIEV Governorate
ZIP/Postal Code
03037
Country
Ukraine
Facility Name
Lvivska oblasna tsentralna likarnia
City
Lviv
State/Province
KIEV Governorate
ZIP/Postal Code
79010
Country
Ukraine
Facility Name
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?; Neurology Department
City
Chernihiv
ZIP/Postal Code
14029
Country
Ukraine
Facility Name
Bukovinsky SMU RMI Chernivtsi RCH
City
Chernivtsi
ZIP/Postal Code
58013
Country
Ukraine
Facility Name
Regional Clinical Hospital; Neurology Department
City
Ivano-Frankivsk
ZIP/Postal Code
76008
Country
Ukraine
Facility Name
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU; Dept. of Neuroinfection and Multiply Sclerosis
City
Kharkov
ZIP/Postal Code
61068
Country
Ukraine
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom

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.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/ourmember/roche/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

Learn more about this trial

A Study to Evaluate the Efficacy, Safety and Pharmacokinetics of a Higher Dose of Ocrelizumab in Adults With Relapsing Multiple Sclerosis (RMS)

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