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Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Completed
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 Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

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

Inclusion Criteria:

  • Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
  • Have a length of disease duration, from first documented clinical attack consistent with MS disease of less than or equal to (</=) 3 years
  • Within the last 12 months one or more clinically reported relapse(s) or one or more signs of MRI activity
  • EDSS of 0.0 to 3.5 inclusive, at screening
  • An agreement to use an acceptable birth control method for women of childbearing potential, during the treatment period and for at least 6 months or longer after the last dose of study drug

Exclusion Criteria:

  • Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
  • Inability to complete an MRI
  • Known presence of other neurological disorders

Exclusions Related to General Health:

  • Pregnancy or lactation
  • Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug
  • Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
  • History or currently active primary or secondary immunodeficiency
  • Lack of peripheral venous access
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study
  • Congestive heart failure (New York Heart Association III or IV functional severity)
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
  • History of malignancy, major opportunistic infections, alcohol or drug abuse, recurrent or chronic infection, and/or coagulation disorders

Exclusions Related to Medications:

  • Received any prior approved disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
  • Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
  • Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
  • Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone marrow transplantation)
  • Treatment with investigational DMT
  • Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to screening

Exclusion related to Shorter Infusion Substudy:

- Any previous serious IRRs experienced with ocrelizumab treatment

Sites / Locations

  • University of California Irvine
  • Palo Alto Medical Foundation Research Center
  • University of Colorado Denver
  • Advanced Neurology of Colorado, LLC
  • KI Health Partners, LLC; New England Institute for Clinical Research
  • Georgetown University Medical Center
  • University of South Florida - Bradenton
  • Shepherd Center Inc.
  • College Park Family Care Ctr
  • The NeuroMedical Center
  • Maine Medical Center
  • University of Maryland Medical Center; Department of Neurology
  • Neurology Center of New England
  • Dragonfly Research, LLC
  • Minneapolis Clinic of Neurology
  • Cleveland Clinic Lou Ruvo; Center for Brain Research
  • Columbia University Medical Center
  • Island Neurological Associates, P.C.
  • Neurology Associates PA
  • Wake Forest University Health Sciences
  • Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
  • Neurology Specialists, Inc
  • Vanderbilt University Medical Center
  • Kane Hall Barry Neurology
  • MultiCare Health System Institute for Research and Innovation
  • Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR
  • Hospital Churruca Visca
  • Fundacion Rosarina de Neurorehabilitacion
  • Brain and Mind Centre
  • Liverpool Hospital
  • John Hunter Hospital
  • Royal North Shore Hospital; Department of Neurology
  • Princess Alexandra Hospital
  • Box Hill Hospital; Department of Neurology
  • Austin Hospital; Department of Neurology
  • Royal Melbourne Hospital; Department of Neurology
  • Perron Institute for Neurological and Translational Science
  • Medizinische Universität Graz; Universitätsklinik für Neurologie
  • Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
  • Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
  • Medizinische Universität Wien; Univ.Klinik fuer Neurologie
  • AZ Sint Jan
  • UZ Brussel
  • Cliniques Universitaires St-Luc
  • UZ Antwerpen
  • CHU Tivoli
  • CHU Sart-Tilman
  • Revalidatie en MS Centrum
  • Hospital das Clinicas - UFMG
  • Instituto de Neurologia de Curitiba
  • Hospital Sao Lucas - PUCRS
  • Hospital das Clinicas - FMUSP
  • Shat Np Sveti Naum; 3Rd Clinic of Neurology
  • Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
  • UMHAT Alexandrovska, EAD; Neurology
  • UBC Hospital; Div of Neurology, Dept of Medicine
  • London Health Sciences Centre Uni Campus
  • Ottawa Hospital Research Institute
  • Sunnybrook Health Science Centre
  • Clinique NeuroOutaouais
  • Recherche Sepmus Inc.
  • Montreal Neurological Institute and Hospital
  • Clinical Hospital Centre Zagreb
  • Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
  • Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
  • Rigshospitalet; Neurologisk Klinik Glostrup
  • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
  • Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
  • Hopital Pierre Wertheimer; Neurologie D
  • CHU de Caen Hopital Cote de Nacre
  • CHU Hopital Gabriel Montpied; Service de Neurologie
  • CH de Gonesse; Neurologie
  • CHU de Grenoble; Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • Hopital Central - CHU de Nancy; Service de Neurologie
  • Hôpital Guillaume et René Laënnec; Service Neurologie
  • Hôpital Pasteur; Service de Neurologie
  • CHU de Nîmes Hopital Caremeau; Service de Neurologie
  • Hôpital de Poissy; Service neurologie
  • Centre Hospitalier Universitaire de Rennes
  • CHU de Rouen Hopital; Service de Neurologie
  • CHU de Strasbourg
  • Hopital Foch; Neurologie
  • HIA de Toulon hôpital militaire; Neurologie
  • CHU toulouse - Hôpital Purpan; Departement de Neurologie
  • CHRU - Hôpital Bretonneau; Neurologie
  • Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie
  • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
  • St. Josef-Hospital, Klinik für Neurologie
  • Studienzentrum für Neurologie und Psychiatrie
  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Universitätsklinikum Düsseldorf; Klinik für Neurologie
  • NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
  • Universitätsklinikum Essen (AöR); Klinik für Neurologie
  • MultipEL Studies - Institut für klinische Studien
  • Universitaetsklinikum Heidelberg
  • Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
  • Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
  • Universitaetsklinikum Marburg; Klinik fuer Neurologie
  • Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
  • Praxis Dr. med. Bergmann
  • Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie
  • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • Semmelweis Egyetem AOK; Neurologiai Klinika
  • Budapesti Uzsoki Utcai Kórház
  • Jahn Ferenc Dél-Pesti Kórház
  • VALEOMED Diagnosztikai Központ
  • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
  • A.O.U. Mater Domin; U.O. NEUROLOGIA
  • 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
  • Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica
  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • 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
  • Ospedale Civile di Montichiari; Centro Sclerosi Multipla
  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
  • AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
  • AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
  • Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia
  • Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche
  • Ibn Sina Hospital; Neurology Department
  • American University of Beirut - Medical Center
  • Neurociencias Estudios Clinicos S.C.
  • Hospital General de Mexico
  • Unidad de investigacion en salud (UIS); Neurociencias
  • Jeroen Bosch Ziekenhuis
  • VU Medisch Centrum; Afdeling Neurologie
  • Groene Hart Ziekenhuis
  • Zuyderland Medisch Centrum - Sittard Geleen
  • Akershus universitetssykehus HF; Nevroklinikken S203
  • Stavanger Universitetssykehus, Helse Stavanger HF
  • Neurocentrum Bydgoszcz sp. z o.o
  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
  • Care Clinic
  • Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
  • Centrum Neurologii Krzysztof Selmaj
  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
  • Hospital Garcia de Orta; Servico de Neurologia
  • Hospital de Braga; Servico de Neurologia
  • HUC; Servico de Neurologia
  • Hospital Beatriz Angelo; Servico de Neurologia
  • Hospital Geral de Santo Antonio; Servico de Neurologia
  • Spitalul Universitar de Urgenta Bucuresti
  • Spitalul Clinic Judetean Sibiu
  • Spitalul Clinic Judetean de Urgenta Mures
  • Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB
  • Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB
  • GB NeuroPRAKTIK, s.r.o
  • Fakultna nemocnica Trnava
  • University Medical Centre; Neurology
  • University Medical Centre Maribor
  • Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
  • Hospital de Cruces; Servicio de Neurologia
  • Hospital General Universitario de Alicante; Servicio de Neurología
  • Hospital del Mar; Servicio de Neurologia
  • Hospital Vall d'Hebron; Servicio de Neurología
  • Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
  • Hospital General Universitario Morales Meseguer; Servicio de Neurología
  • Sahlgrenska Sjukhuset; Neurology
  • Centralsjukhuset; Neurologi och rehabiliteringskliniken
  • Centrum för Neurologi
  • Universitätsspital Basel; Neurologie
  • Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
  • Ospedale Regionale di Lugano - Civico; Neurologia
  • Luzerner Kantonsspital Luzern Medizin Neurologie
  • Kantonsspital; Neurologische Klinik
  • Hacettepe University Medical Faculty; Neurology
  • Gazi University Medical Faculty; Departmant of Norology
  • Mustafa Kemal Ataturk UTF; Department of norology
  • Istanbul University Istanbul Medical Faculty; Neurology
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Istanbul Bilim Universty Medical Fac.
  • Selcuk University Medical Faculty; Norology department
  • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Karadeniz Tecnical Uni. Med. Fac.; Neurology
  • Cambridge University Hospitals NHS Foundation Trust
  • Queen Elizabeth University Hospital
  • Royal Free Hospital
  • King'S College Hospital
  • Charing Cross Hospital
  • National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
  • Royal Victoria Infirmary
  • Derriford Hospital
  • Salford Royal NHS Foundation Trust
  • Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Ocrelizumab

Substudy Group 1

Substudy Group 2

Arm Description

Ocrelizumab will be administered intravenously (IV) as two 300-milligram (mg) infusions (infusion length=2.5 hours) on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period.

At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 3.5 hours every 24 weeks for the remainder of the study duration

At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 2 hours followed by sodium chloride given as a slow infusion over the remaining 1.5 hours to mimic the standard-length infusion (3.5 hour) every 24 weeks for the remainder of the study duration

Outcomes

Primary Outcome Measures

Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 and 48 Weeks, As Measured Using Expanded Disability Status Scale (EDSS)
Percentage of Participants With Confirmed Disability Improvement (CDI) at Year 1, As Measured Using EDSS
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 1, As Measured Using EDSS
Percentage of Participants With CDI at Year 2, As Measured Using EDSS
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 2, As Measured Using EDSS
Percentage of Participants With CDI at Year 4, As Measured Using EDSS
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 4, As Measured Using EDSS
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 3, As Measured Using EDSS
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 4, As Measured Using EDSS
Mean Change From Baseline in EDSS Score at Week 24
Mean Change From Baseline in EDSS Score at Week 48
Mean Change From Baseline in EDSS Score at Week 72
Mean Change From Baseline in EDSS Score at Week 96
Mean Change From Baseline in EDSS Score at Week 120
Mean Change From Baseline in EDSS Score at Week 144
Mean Change From Baseline in EDSS Score at Week 168
Mean Change From Baseline in EDSS Score at Week 192
Time to First Protocol-Defined Event of Disease Activity
Protocol-defined event of disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8 (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan.
Time to First Relapse
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Annualized Relapse Rate
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Proportion of Participants with Infusion Related Reactions (IRRs) Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy

Secondary Outcome Measures

Percentage of Participants Who Are Relapse Free
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Percentage of Participants With No Evidence of Protocol Defined Disease Activity
Protocol-defined disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8. (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan.
Percentage 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 (CDP; 20 percent [%] increase from baseline in timed 25 Foot Walk Test [T25FWT]; 20% increase from baseline in timed 9 hole peg test [9HPT]). CDP will be assessed using EDSS.
Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD)
NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion. CDP will be assessed using EDSS. Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Change from Baseline in Multiple Sclerosis Functional Composite (MSFC) Total Score
Change from Baseline in MSFC Composite Timed 25 Foot Walk Test (T25FW) Score
Change from Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score
Change from Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score
Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI
Change from baseline in total T1 hypointense lesion volume as Detected by Brain MRI
Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI
Change From Baseline in Brain Volume as Detected by Brain MRI
Time to Treatment Discontinuation
Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score
SymptoMScreen Composite Score
Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Short term safety related to the infusion (infusion-related reactions [IRRs], during infusion and up to 24h after) the overall safety is measured continuously at clinical visits and including every 8 week telephone visits up to 48 weeks post study.
Proportion of Participants with IRR (overall) in the Shorter Infusion Substudy
Proportion of Participants with IRR By Dose at Randomization in the Shorter Infusion Substudy
Proportion of Participants with IRRs Leading to Treatment Discontinuation in the Shorter Infusion Substudy

Full Information

First Posted
March 16, 2017
Last Updated
October 23, 2023
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT03085810
Brief Title
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Official Title
An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Completed
Study Start Date
March 24, 2017 (Actual)
Primary Completion Date
April 27, 2023 (Actual)
Study Completion Date
April 27, 2023 (Actual)

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 is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks. The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
1239 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
Ocrelizumab will be administered intravenously (IV) as two 300-milligram (mg) infusions (infusion length=2.5 hours) on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period.
Arm Title
Substudy Group 1
Arm Type
Active Comparator
Arm Description
At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 3.5 hours every 24 weeks for the remainder of the study duration
Arm Title
Substudy Group 2
Arm Type
Experimental
Arm Description
At week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 2 hours followed by sodium chloride given as a slow infusion over the remaining 1.5 hours to mimic the standard-length infusion (3.5 hour) every 24 weeks for the remainder of the study duration
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Primary Outcome Measure Information:
Title
Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 and 48 Weeks, As Measured Using Expanded Disability Status Scale (EDSS)
Time Frame
Baseline up to 4 years
Title
Percentage of Participants With Confirmed Disability Improvement (CDI) at Year 1, As Measured Using EDSS
Time Frame
Year 1
Title
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 1, As Measured Using EDSS
Time Frame
Year 1
Title
Percentage of Participants With CDI at Year 2, As Measured Using EDSS
Time Frame
Year 2
Title
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 2, As Measured Using EDSS
Time Frame
Year 2
Title
Percentage of Participants With CDI at Year 4, As Measured Using EDSS
Time Frame
Year 4
Title
Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 4, As Measured Using EDSS
Time Frame
Year 4
Title
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS
Time Frame
Year 1
Title
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS
Time Frame
Year 2
Title
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 3, As Measured Using EDSS
Time Frame
Year 3
Title
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 4, As Measured Using EDSS
Time Frame
Year 4
Title
Mean Change From Baseline in EDSS Score at Week 24
Time Frame
Baseline, Week 24
Title
Mean Change From Baseline in EDSS Score at Week 48
Time Frame
Baseline, Week 48
Title
Mean Change From Baseline in EDSS Score at Week 72
Time Frame
Baseline, Week 72
Title
Mean Change From Baseline in EDSS Score at Week 96
Time Frame
Baseline, Week 96
Title
Mean Change From Baseline in EDSS Score at Week 120
Time Frame
Baseline, Week 120
Title
Mean Change From Baseline in EDSS Score at Week 144
Time Frame
Baseline, Week 144
Title
Mean Change From Baseline in EDSS Score at Week 168
Time Frame
Baseline, Week 168
Title
Mean Change From Baseline in EDSS Score at Week 192
Time Frame
Baseline, Week 192
Title
Time to First Protocol-Defined Event of Disease Activity
Description
Protocol-defined event of disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8 (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan.
Time Frame
Baseline up to 4 years
Title
Time to First Relapse
Description
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Time Frame
Baseline up to 4 years
Title
Annualized Relapse Rate
Description
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Time Frame
Baseline up to 4 years
Title
Proportion of Participants with Infusion Related Reactions (IRRs) Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy
Time Frame
From Week 24 through Week 192
Secondary Outcome Measure Information:
Title
Percentage of Participants Who Are Relapse Free
Description
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Time Frame
Weeks 48, 96, 144, 192
Title
Percentage of Participants With No Evidence of Protocol Defined Disease Activity
Description
Protocol-defined disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis [MS], as determined using EDSS/Functional Systems Score [FSS] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8. (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan.
Time Frame
Weeks 96, 144, 192
Title
Percentage 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 (CDP; 20 percent [%] increase from baseline in timed 25 Foot Walk Test [T25FWT]; 20% increase from baseline in timed 9 hole peg test [9HPT]). CDP will be assessed using EDSS.
Time Frame
Weeks 96, 192
Title
Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD)
Description
NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion. CDP will be assessed using EDSS. Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Time Frame
Weeks 96, 192
Title
Change from Baseline in Multiple Sclerosis Functional Composite (MSFC) Total Score
Time Frame
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Title
Change from Baseline in MSFC Composite Timed 25 Foot Walk Test (T25FW) Score
Time Frame
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Title
Change from Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score
Time Frame
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Title
Change from Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score
Time Frame
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Title
Change from baseline in cognitive performance as measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS)
Time Frame
Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
Title
Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
Time Frame
Baseline, Weeks 8, 24, 48, 96, 144, 192
Title
Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI
Time Frame
Baseline, Weeks 8, 24, 48, 96, 144, 192
Title
Change from baseline in total T1 hypointense lesion volume as Detected by Brain MRI
Time Frame
Baseline, Weeks 8, 24, 48, 96, 144, 192
Title
Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI
Time Frame
Baseline, Weeks 8, 24, 48, 96, 144, 192
Title
Change From Baseline in Brain Volume as Detected by Brain MRI
Time Frame
Baseline, Weeks 8, 24, 48, 96, 144, 192
Title
Time to Treatment Discontinuation
Time Frame
Baseline up to 4 years
Title
Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score
Time Frame
Baseline, Weeks 24, 48, 96, 120, 144, 192
Title
SymptoMScreen Composite Score
Time Frame
Baseline, Weeks 24, 48, 96, 120, 144, 192
Title
Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score
Time Frame
Baseline, Weeks 24, 48, 96, 120, 144, 192
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Description
Short term safety related to the infusion (infusion-related reactions [IRRs], during infusion and up to 24h after) the overall safety is measured continuously at clinical visits and including every 8 week telephone visits up to 48 weeks post study.
Time Frame
Baseline up to 4 years
Title
Proportion of Participants with IRR (overall) in the Shorter Infusion Substudy
Time Frame
From Week 24 through Week 192
Title
Proportion of Participants with IRR By Dose at Randomization in the Shorter Infusion Substudy
Time Frame
From Week 24 through Week 192
Title
Proportion of Participants with IRRs Leading to Treatment Discontinuation in the Shorter Infusion Substudy
Time Frame
From Week 24 through Week 192

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: Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria Have a length of disease duration, from first documented clinical attack consistent with MS disease of less than or equal to (</=) 3 years Within the last 12 months one or more clinically reported relapse(s) or one or more signs of MRI activity EDSS of 0.0 to 3.5 inclusive, at screening An agreement to use an acceptable birth control method for women of childbearing potential, during the treatment period and for at least 6 months or longer after the last dose of study drug Exclusion Criteria: Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS Inability to complete an MRI Known presence of other neurological disorders Exclusions Related to General Health: Pregnancy or lactation Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study History or currently active primary or secondary immunodeficiency Lack of peripheral venous access History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study Congestive heart failure (New York Heart Association III or IV functional severity) Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening History of malignancy, major opportunistic infections, alcohol or drug abuse, recurrent or chronic infection, and/or coagulation disorders Exclusions Related to Medications: Received any prior approved disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab) Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone marrow transplantation) Treatment with investigational DMT Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to screening Exclusion related to Shorter Infusion Substudy: - Any previous serious IRRs experienced with ocrelizumab treatment
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
University of California Irvine
City
Irvine
State/Province
California
ZIP/Postal Code
92697
Country
United States
Facility Name
Palo Alto Medical Foundation Research Center
City
Sunnyvale
State/Province
California
ZIP/Postal Code
94086
Country
United States
Facility Name
University of Colorado Denver
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
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
KI Health Partners, LLC; New England Institute for Clinical Research
City
Stamford
State/Province
Connecticut
ZIP/Postal Code
06905
Country
United States
Facility Name
Georgetown University Medical Center
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20007
Country
United States
Facility Name
University of South Florida - Bradenton
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Facility Name
Shepherd Center Inc.
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30309
Country
United States
Facility Name
College Park Family Care Ctr
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66212
Country
United States
Facility Name
The NeuroMedical Center
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70810
Country
United States
Facility Name
Maine Medical Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Facility Name
University of Maryland Medical Center; Department of Neurology
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Neurology Center of New England
City
Foxboro
State/Province
Massachusetts
ZIP/Postal Code
02035
Country
United States
Facility Name
Dragonfly Research, LLC
City
Wellesley
State/Province
Massachusetts
ZIP/Postal Code
02481
Country
United States
Facility Name
Minneapolis Clinic of Neurology
City
Golden Valley
State/Province
Minnesota
ZIP/Postal Code
55422
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
Columbia University Medical Center
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Island Neurological Associates, P.C.
City
Plainview
State/Province
New York
ZIP/Postal Code
11803
Country
United States
Facility Name
Neurology Associates PA
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Wake Forest University Health Sciences
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27157
Country
United States
Facility Name
Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Neurology Specialists, Inc
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45417
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37212
Country
United States
Facility Name
Kane Hall Barry Neurology
City
Bedford
State/Province
Texas
ZIP/Postal Code
76021
Country
United States
Facility Name
MultiCare Health System Institute for Research and Innovation
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Facility Name
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
City
Buenos Aires
ZIP/Postal Code
C1424
Country
Argentina
Facility Name
Hospital Churruca Visca
City
Buenos Aires
ZIP/Postal Code
C1437JCP
Country
Argentina
Facility Name
Fundacion Rosarina de Neurorehabilitacion
City
Rosario
ZIP/Postal Code
S2000BZL
Country
Argentina
Facility Name
Brain and Mind Centre
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Liverpool Hospital
City
Liverpool
State/Province
New South Wales
ZIP/Postal Code
2170
Country
Australia
Facility Name
John Hunter Hospital
City
New Lambton
State/Province
New South Wales
ZIP/Postal Code
2305
Country
Australia
Facility Name
Royal North Shore Hospital; Department of Neurology
City
St Leonards
State/Province
New South Wales
ZIP/Postal Code
2065
Country
Australia
Facility Name
Princess Alexandra Hospital
City
Woolloongabba
State/Province
Queensland
ZIP/Postal Code
4102
Country
Australia
Facility Name
Box Hill Hospital; Department of Neurology
City
Box Hill
State/Province
Victoria
ZIP/Postal Code
3128
Country
Australia
Facility Name
Austin Hospital; Department of Neurology
City
Heidelberg
State/Province
Victoria
ZIP/Postal Code
3084
Country
Australia
Facility Name
Royal Melbourne Hospital; Department of Neurology
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3050
Country
Australia
Facility Name
Perron Institute for Neurological and Translational Science
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Medizinische Universität Graz; Universitätsklinik für Neurologie
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
City
Innsbruck
ZIP/Postal Code
6020
Country
Austria
Facility Name
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
AZ Sint Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Facility Name
UZ Brussel
City
Brussel
ZIP/Postal Code
1090
Country
Belgium
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
CHU Sart-Tilman
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
Revalidatie en MS Centrum
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Hospital das Clinicas - UFMG
City
Belo Horizonte
State/Province
MG
ZIP/Postal Code
31270-901
Country
Brazil
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 Clinicas - FMUSP
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-010
Country
Brazil
Facility Name
Shat Np Sveti Naum; 3Rd Clinic of Neurology
City
Sofia
ZIP/Postal Code
1113
Country
Bulgaria
Facility Name
Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
City
Sofia
ZIP/Postal Code
1309
Country
Bulgaria
Facility Name
UMHAT Alexandrovska, EAD; Neurology
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
UBC Hospital; Div of Neurology, Dept of Medicine
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6T 1Z3
Country
Canada
Facility Name
London Health Sciences Centre Uni Campus
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Ottawa Hospital Research Institute
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1Y 4E9
Country
Canada
Facility Name
Sunnybrook Health Science Centre
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4N 3M5
Country
Canada
Facility Name
Clinique NeuroOutaouais
City
Gatineau
State/Province
Quebec
ZIP/Postal Code
J8Y 1W2
Country
Canada
Facility Name
Recherche Sepmus Inc.
City
Greenfield Park
State/Province
Quebec
ZIP/Postal Code
J4V 2J2
Country
Canada
Facility Name
Montreal Neurological Institute and Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3A 2B4
Country
Canada
Facility Name
Clinical Hospital Centre Zagreb
City
Zagreb
ZIP/Postal Code
10000
Country
Croatia
Facility Name
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
City
Aalborg
ZIP/Postal Code
9000
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
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Pierre Wertheimer; Neurologie D
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
CHU de Caen Hopital Cote de Nacre
City
Caen
ZIP/Postal Code
14033
Country
France
Facility Name
CHU Hopital Gabriel Montpied; Service de Neurologie
City
Clermont Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
CH de Gonesse; Neurologie
City
Gonesse
ZIP/Postal Code
95503
Country
France
Facility Name
CHU de Grenoble; Neurologie
City
La Tronche
ZIP/Postal Code
38700
Country
France
Facility Name
Hopital Gui de Chauliac; Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
Hopital Central - CHU de Nancy; Service de Neurologie
City
Nancy
ZIP/Postal Code
54035
Country
France
Facility Name
Hôpital Guillaume et René Laënnec; Service Neurologie
City
Nantes
ZIP/Postal Code
44805
Country
France
Facility Name
Hôpital Pasteur; Service de Neurologie
City
Nice
ZIP/Postal Code
06002
Country
France
Facility Name
CHU de Nîmes Hopital Caremeau; Service de Neurologie
City
Nimes
ZIP/Postal Code
30900
Country
France
Facility Name
Hôpital de Poissy; Service neurologie
City
Poissy
ZIP/Postal Code
78300
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes
City
Rennes
ZIP/Postal Code
35033
Country
France
Facility Name
CHU de Rouen Hopital; Service de Neurologie
City
Rouen
ZIP/Postal Code
76031
Country
France
Facility Name
CHU de Strasbourg
City
Strasbourg
ZIP/Postal Code
67098
Country
France
Facility Name
Hopital Foch; Neurologie
City
Suresnes
ZIP/Postal Code
92151
Country
France
Facility Name
HIA de Toulon hôpital militaire; Neurologie
City
Toulon
ZIP/Postal Code
83041
Country
France
Facility Name
CHU toulouse - Hôpital Purpan; Departement de Neurologie
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
CHRU - Hôpital Bretonneau; Neurologie
City
Tours
ZIP/Postal Code
37000
Country
France
Facility Name
Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie
City
Barsinghausen
ZIP/Postal Code
30890
Country
Germany
Facility Name
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
City
Berlin
ZIP/Postal Code
13347
Country
Germany
Facility Name
St. Josef-Hospital, Klinik für Neurologie
City
Bochum
ZIP/Postal Code
44791
Country
Germany
Facility Name
Studienzentrum für Neurologie und Psychiatrie
City
Böblingen
ZIP/Postal Code
71034
Country
Germany
Facility Name
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
City
Dresden
ZIP/Postal Code
01307
Country
Germany
Facility Name
Universitätsklinikum Düsseldorf; Klinik für Neurologie
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
City
Erbach/Odenwald
ZIP/Postal Code
64711
Country
Germany
Facility Name
Universitätsklinikum Essen (AöR); Klinik für Neurologie
City
Essen
ZIP/Postal Code
45147
Country
Germany
Facility Name
MultipEL Studies - Institut für klinische Studien
City
Hamburg
ZIP/Postal Code
22179
Country
Germany
Facility Name
Universitaetsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
City
Kassel
ZIP/Postal Code
34121
Country
Germany
Facility Name
Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Universitaetsklinikum Marburg; Klinik fuer Neurologie
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
City
München
ZIP/Postal Code
81675
Country
Germany
Facility Name
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
City
Münster
ZIP/Postal Code
48149
Country
Germany
Facility Name
Praxis Dr. med. Bergmann
City
Neuburg
ZIP/Postal Code
86633
Country
Germany
Facility Name
Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie
City
Seesen
ZIP/Postal Code
38723
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Zentrum für Neurologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
Semmelweis Egyetem AOK; Neurologiai Klinika
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Facility Name
Budapesti Uzsoki Utcai Kórház
City
Budapest
ZIP/Postal Code
1145
Country
Hungary
Facility Name
Jahn Ferenc Dél-Pesti Kórház
City
Budapest
ZIP/Postal Code
1204
Country
Hungary
Facility Name
VALEOMED Diagnosztikai Központ
City
Esztergom
ZIP/Postal Code
2500
Country
Hungary
Facility Name
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
City
Szeged
ZIP/Postal Code
6725
Country
Hungary
Facility Name
A.O.U. Mater Domin; U.O. NEUROLOGIA
City
Catanzaro
State/Province
Calabria
ZIP/Postal Code
88100
Country
Italy
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
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
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
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
City
Montichiari
State/Province
Lombardia
ZIP/Postal Code
25018
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
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
AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90146
Country
Italy
Facility Name
AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia
City
Grosseto
State/Province
Toscana
ZIP/Postal Code
58100
Country
Italy
Facility Name
Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
Ibn Sina Hospital; Neurology Department
City
Kuwait
ZIP/Postal Code
10002
Country
Kuwait
Facility Name
American University of Beirut - Medical Center
City
Beirut
ZIP/Postal Code
1107 2020
Country
Lebanon
Facility Name
Neurociencias Estudios Clinicos S.C.
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80020
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
Jeroen Bosch Ziekenhuis
City
'S Hertogenbosch
ZIP/Postal Code
5223 GZ
Country
Netherlands
Facility Name
VU Medisch Centrum; Afdeling Neurologie
City
Amsterdam
ZIP/Postal Code
1081 HV
Country
Netherlands
Facility Name
Groene Hart Ziekenhuis
City
Gouda
ZIP/Postal Code
2803 HH
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Akershus universitetssykehus HF; Nevroklinikken S203
City
Lørenskog
ZIP/Postal Code
1478
Country
Norway
Facility Name
Stavanger Universitetssykehus, Helse Stavanger HF
City
Stavanger
ZIP/Postal Code
4011
Country
Norway
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
Care Clinic
City
Katowice
ZIP/Postal Code
40-568
Country
Poland
Facility Name
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
City
Krakow
ZIP/Postal Code
31-637
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
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
Hospital Garcia de Orta; Servico de Neurologia
City
Almada
ZIP/Postal Code
2801-951
Country
Portugal
Facility Name
Hospital de Braga; Servico de Neurologia
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Facility Name
HUC; Servico de Neurologia
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
Hospital Beatriz Angelo; Servico de Neurologia
City
Loures
ZIP/Postal Code
2674-514
Country
Portugal
Facility Name
Hospital Geral de Santo Antonio; Servico de Neurologia
City
Porto
ZIP/Postal Code
4099-001
Country
Portugal
Facility Name
Spitalul Universitar de Urgenta Bucuresti
City
Bucharest
ZIP/Postal Code
11172
Country
Romania
Facility Name
Spitalul Clinic Judetean Sibiu
City
Sibiu
ZIP/Postal Code
550245
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta Mures
City
Targu-Mures
ZIP/Postal Code
540136
Country
Romania
Facility Name
Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB
City
Bratislava
ZIP/Postal Code
813 69
Country
Slovakia
Facility Name
Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB
City
Bratislava
ZIP/Postal Code
826 06
Country
Slovakia
Facility Name
GB NeuroPRAKTIK, s.r.o
City
Nitra
ZIP/Postal Code
949 11
Country
Slovakia
Facility Name
Fakultna nemocnica Trnava
City
Trnava
ZIP/Postal Code
917 75
Country
Slovakia
Facility Name
University Medical Centre; Neurology
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Facility Name
University Medical Centre Maribor
City
Maribor
ZIP/Postal Code
2000
Country
Slovenia
Facility Name
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
City
Santa Cruz De Tenerife
State/Province
Tenerife
ZIP/Postal Code
38010
Country
Spain
Facility Name
Hospital de Cruces; Servicio de Neurologia
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Facility Name
Hospital General Universitario de Alicante; Servicio de Neurología
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Hospital del Mar; Servicio de Neurologia
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Facility Name
Hospital Vall d'Hebron; Servicio de Neurología
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
Hospital General Universitario Morales Meseguer; Servicio de Neurología
City
Murcia
ZIP/Postal Code
30008
Country
Spain
Facility Name
Sahlgrenska Sjukhuset; Neurology
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Centralsjukhuset; Neurologi och rehabiliteringskliniken
City
Karlstad
ZIP/Postal Code
651 85
Country
Sweden
Facility Name
Centrum för Neurologi
City
Stockholm
ZIP/Postal Code
113 41
Country
Sweden
Facility Name
Universitätsspital Basel; Neurologie
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
Luzerner Kantonsspital Luzern Medizin Neurologie
City
Luzern
ZIP/Postal Code
6004
Country
Switzerland
Facility Name
Kantonsspital; Neurologische Klinik
City
St. Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Gazi University Medical Faculty; Departmant of Norology
City
Ankara
ZIP/Postal Code
06500
Country
Turkey
Facility Name
Mustafa Kemal Ataturk UTF; Department of norology
City
Hatay
ZIP/Postal Code
31001
Country
Turkey
Facility Name
Istanbul University Istanbul Medical Faculty; Neurology
City
Istanbul
ZIP/Postal Code
34093
Country
Turkey
Facility Name
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
City
Istanbul
ZIP/Postal Code
34098
Country
Turkey
Facility Name
Istanbul Bilim Universty Medical Fac.
City
Istanbul
ZIP/Postal Code
34394
Country
Turkey
Facility Name
Selcuk University Medical Faculty; Norology department
City
Istanbul
ZIP/Postal Code
42131
Country
Turkey
Facility Name
Ondokuz Mayis Univ. Med. Fac.; Neurology
City
Samsun
ZIP/Postal Code
55139
Country
Turkey
Facility Name
Karadeniz Tecnical Uni. Med. Fac.; Neurology
City
Trabzon
ZIP/Postal Code
61080
Country
Turkey
Facility Name
Cambridge University Hospitals NHS Foundation Trust
City
Cambridge
ZIP/Postal Code
CB2 0QQ
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Royal Free Hospital
City
London
ZIP/Postal Code
NW3 2QS
Country
United Kingdom
Facility Name
King'S College Hospital
City
London
ZIP/Postal Code
SE5 9RS
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
City
London
ZIP/Postal Code
WC1 3BG
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Derriford Hospital
City
Plymouth
ZIP/Postal Code
PL6 8BT
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
City
Swansea
ZIP/Postal Code
SA6 6NL
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/members/ourmembers/). 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).
Citations:
PubMed Identifier
32503093
Citation
Hartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5):e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep.
Results Reference
derived

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Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

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