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A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

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, confirmed as per the revised McDonald 2010 criteria
  • Have a length of disease duration, from first symptom, of less than (<) 10 years
  • Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy
  • Suboptimal disease control while on a DMT
  • Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening
  • For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

  • Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS)
  • Inability to complete an Magnetic Resonance Imaging (MRI) procedure
  • Known presence of other neurological disorders
  • 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
  • History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
  • History of opportunistic infections
  • History or known presence of recurrent or chronic infection
  • History of malignancy
  • Congestive heart failure
  • Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds

Sites / Locations

  • St George Hospital
  • Hospital Erasme
  • Cliniques Universitaires St-Luc
  • UZ Antwerpen
  • UZ Gent
  • CHU Tivoli
  • UZ Leuven Gasthuisberg
  • Nationaal MS Centrum
  • Revalidatie en MS Centrum
  • Fakultni nemocnice u sv. Anny; Neurologicka klinika
  • Nemocnice Jihlava; NEU-Neurologicke oddeleni
  • VFN Praha Poliklinika Rs Centrum - Budova A
  • Fakultni nemocnice Motol; Neurologicka klinika
  • Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
  • Rigshospitalet Glostrup; Neurologisk Klinik
  • Odense Universitetshospital, Neurologisk Afdeling N
  • Sydjysk Skleroseklinik - Sønderborg
  • East Tallinn Central Hospital; Neurology Department
  • West Tallinn Central Hospital
  • Tartu University Hospital
  • Terveystalo Tampere
  • Mehiläinen Neo Turku
  • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
  • Groupe Hospitalier Pellegrin; Service de neurochirurgie B
  • Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
  • Hopital Roger Salengro; Service de Neurologie
  • CHU de la Timone - Hopital d Adultes; Service de Neurologie
  • Hopital Gui de Chauliac; Neurologie
  • Hôpital Guillaume et René Laënnec; Service Neurologie
  • Hôpital Pasteur; Service de Neurologie
  • Fondation Rothschild; Service de Neurologie
  • Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
  • Hôpital Maison Blanche; Service de Neurologie
  • Hôpitaux Universitaires de strasbourg - hôpital civil
  • CHU toulouse - Hôpital Purpan; Departement de Neurologie
  • CHRU - Hôpital Bretonneau; Neurologie
  • Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie
  • Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
  • Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
  • Praxis Dr. Said Masri
  • Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz
  • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
  • St. Josef-Hospital, Klinik für Neurologie
  • Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc
  • PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge
  • Studienzentrum für Neurologie und Psychiatrie
  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
  • Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito
  • NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
  • Universitaetsklinikum Frankfurt; Klinik für Neurologie
  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
  • Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik
  • Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt
  • MultipEL Studies - Institut für klinische Studien
  • Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie
  • Neurologische Klinik, Universitätsklinikum Heidelberg
  • Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
  • Neurozentrum am Klosterforst in Itzehoe
  • Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
  • PANAKEIA - Arzneimittelforschung Leipzig GmbH
  • Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie
  • Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
  • Universitaetsklinikum Marburg; Klinik fuer Neurologie
  • Max-Planck-Institut für Psychiatrie
  • Klinikum Grosshadern der LMU; Neuroimmunologie II
  • Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
  • Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie
  • AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie
  • St. Josefs-Krankenhaus, Klinik für Neurologie
  • NeuroConcept AG C/O mind mvz GmbH
  • Universitätsklinikum Tübingen, Zentrum für Neurologie
  • NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH
  • Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
  • Cork University Hospital; Clinical Research Facility
  • St Vincents University Hospital
  • Beaumont Hospital
  • Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
  • Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
  • 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 Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA
  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
  • Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
  • Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
  • Azienda Ospedaliera Sant'Andrea; UOC Neurologia
  • Irccs A.O.U.San Martino Ist; Dinogmi
  • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
  • Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico
  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
  • 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 C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
  • AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla
  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
  • Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia
  • IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia
  • Ospedale Binaghi; Centro Sclerosi Multipla
  • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
  • Fondazione Istituto S. Raffaele - Giglio; UO Neurologia
  • AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb 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)
  • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
  • AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
  • AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
  • Azienda Ospedaliera di Padova; Clinica Neurologica
  • Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla
  • Amphia Ziekenhuis
  • St. Antonius Ziekenhuis Nieuwegein
  • Maasstadziekenhuis
  • Zuyderland Medisch Centrum - Sittard Geleen
  • Sint Elizabeth Ziekenhuis
  • Haukeland Universitetssykehus
  • Sykehuset Buskerud HF; Nevrologisk avdeling
  • Hospital Universitario Central de Asturias; Servicio de Neurología
  • Hospital Universitari de Bellvitge; Servicio de Neurologia
  • Hospital General de Castellon; Servicio de Neurología
  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
  • Hospital Quiron de Madrid; Servicio de Neurologia
  • Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
  • Hospital del Mar; Servicio de Neurologia
  • Hospital Vall d'Hebron; Servicio de Neurología
  • Hospital Puerta del Mar; Sevicio de Neurologia
  • Universitario de La Princesa; Servicio de Neurología
  • Hospital Universitario Clínico San Carlos; Servicio de Neurología
  • Hospital Universitario 12 de Octubre; Servicio de Neurologia
  • Hospital Universitario La Paz; Servicio de Neurologia
  • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
  • Hospital Universitario Virgen Macarena; Servicio de Neurologia
  • Hospital Clinico Universitario de Valencia; Servicio de Neurologia
  • Hospital Universitario la Fe; Servicio de Neurologia
  • Sahlgrenska Sjukhuset; Neurology
  • Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen
  • Centrum för Neurologi
  • Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
  • CHUV Lausanne Méd.Neurologie
  • Hacettepe University Medical Faculty; Neurology
  • Istanbul Uni Istanbul Medical Faculty
  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
  • Ege University Medical Faculty
  • Kocaeli University Hospital; Department of Neurology
  • Mersin University Medical Faculty; Neurology
  • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Karadeniz Tecnical Uni. Med. Fac.; Neurology
  • New Queen Elizabeth Hospital Birmingham
  • Western General Hospital
  • Royal Devon and Exeter Hospital (Wonford)
  • Queen Elizabeth University Hospital
  • Raigmore Hospital
  • Leeds Teaching Hospitals NHS Trust
  • The Royal London Hospital
  • Kings College Hospital
  • Charing Cross Hospital
  • Royal Victoria Infirmary
  • Salford Royal NHS Foundation Trust
  • Royal Hallamshire Hospita
  • Morriston Hospital
  • Royal Cornwall Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ocrelizumab

Arm Description

Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.

Outcomes

Primary Outcome Measures

Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse (PDR) 24-week CDP based on increase in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan

Secondary Outcome Measures

Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse (PDR) 24-week CDP based on increase in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse (PDR) 24-week CDP based on increase in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Time to First Protocol-Defined Event of Disease Activity
The definition of a protocol-defined event of disease activity is the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse defined as: Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors; Symptoms should be preceded by neurological stability for at least 30 days; Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment 24 weeks confirmed disability progression based on increases in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan.
Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Absolute Change From Baseline in EDSS Category at Week 96
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Annualized Protocol-defined Relapse Rate at Week 96
Time to Onset of 24-week Confirmed Disability Progression
Time to Onset of First Protocol-Defined Relapse
A protocol-defined multiple sclerosis (MS) relapse is an occurrence of new or worsening neurological symptoms attributable to MS that meets the following criteria: Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) Symptoms should be preceded by neurological stability for at least 30 days Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment, consistent with an increase of at least: ≥ 0.5 points on EDSS scale or ≥ 2 points on one of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual or ≥ 1 point on two or more of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual
Time to Onset of First New and/or Enlarging T2 Lesion
Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96
Mean number of T1 Gd-enhancing lesions per MRI scan: Total number of T1 Gd-enhanced lesions divided by the total number of interpretable MRI scans
Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From
Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI
Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96
The number of new and/or enlarging T2 lesions at week 24, 48 and 96 is calculated as the sum of the individual number of new and/or enlarging lesions at each visit. Data from other unscheduled assessments is included in this summary or analysis.
Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan
Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan: Total number of new and/or enlarging T2 hyperintense lesions divided by the total number of interpretable MRI scans
Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Adjusted Mean Percentage Change From Baseline in Brain Volume
Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume
Adjusted Mean Percentage Change From Baseline in White Matter Volume
Mean Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span. The higher the results, the better processing speed/working memory.
Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.
Percentage Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span.
Percentage Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

Full Information

First Posted
August 5, 2016
Last Updated
January 25, 2022
Sponsor
Hoffmann-La Roche
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1. Study Identification

Unique Protocol Identification Number
NCT02861014
Brief Title
A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)
Official Title
An Open-Label Study To Evaluate the Efficacy and Safety of Ocrelizumab in Patients With Relapsing Multiple Sclerosis Who Have A Suboptimal Response to an Adequate Course of Disease-Modifying Treatment
Study Type
Interventional

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
September 9, 2016 (Actual)
Primary Completion Date
October 25, 2019 (Actual)
Study Completion Date
December 15, 2020 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this prospective, multicenter, open-label, efficacy, and safety study is to assess the efficacy and safety of ocrelizumab in participants with Relapsing Remitting Multiple Sclerosis (RRMS) who have had a suboptimal response to an adequate course of a Disease-Modifying Treatment (DMT). The study will consist of a Screening period (up to 4 weeks), an Open-label treatment period (96 weeks; with last dose administered at Week 72), and a Follow-up period of at least 2 years.

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
681 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Intervention Type
Biological
Intervention Name(s)
Ocrelizumab
Other Intervention Name(s)
RO4964913
Intervention Description
Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Primary Outcome Measure Information:
Title
Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
Description
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse (PDR) 24-week CDP based on increase in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Time Frame
Week 96
Secondary Outcome Measure Information:
Title
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period
Description
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse (PDR) 24-week CDP based on increase in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Time Frame
Baseline up to 24 weeks
Title
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period
Description
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse (PDR) 24-week CDP based on increase in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Time Frame
Baseline up to 48 weeks
Title
Time to First Protocol-Defined Event of Disease Activity
Description
The definition of a protocol-defined event of disease activity is the occurrence of at least one of the following while on treatment with ocrelizumab: A protocol-defined relapse defined as: Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors; Symptoms should be preceded by neurological stability for at least 30 days; Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment 24 weeks confirmed disability progression based on increases in EDSS while on treatment with ocrelizumab A T1 Gd-enhanced lesion after Week 8 A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan.
Time Frame
Baseline up to 96 Weeks
Title
Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)
Description
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Time Frame
Baseline, Weeks: 24, 48, 72, 96
Title
Absolute Change From Baseline in EDSS Category at Week 96
Description
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Time Frame
Up to Week 96
Title
Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96
Description
The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.
Time Frame
Week 96
Title
Annualized Protocol-defined Relapse Rate at Week 96
Time Frame
Week 96
Title
Time to Onset of 24-week Confirmed Disability Progression
Time Frame
Baseline up to 96 Weeks
Title
Time to Onset of First Protocol-Defined Relapse
Description
A protocol-defined multiple sclerosis (MS) relapse is an occurrence of new or worsening neurological symptoms attributable to MS that meets the following criteria: Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications) Symptoms should be preceded by neurological stability for at least 30 days Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment, consistent with an increase of at least: ≥ 0.5 points on EDSS scale or ≥ 2 points on one of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual or ≥ 1 point on two or more of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual
Time Frame
Baseline up to 96 Weeks
Title
Time to Onset of First New and/or Enlarging T2 Lesion
Time Frame
Baseline up to 96 Weeks
Title
Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96
Description
Mean number of T1 Gd-enhancing lesions per MRI scan: Total number of T1 Gd-enhanced lesions divided by the total number of interpretable MRI scans
Time Frame
Weeks: 24, 48, 96
Title
Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From
Time Frame
Baseline, Week 96
Title
Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI
Time Frame
Baseline, Week 96
Title
Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96
Description
The number of new and/or enlarging T2 lesions at week 24, 48 and 96 is calculated as the sum of the individual number of new and/or enlarging lesions at each visit. Data from other unscheduled assessments is included in this summary or analysis.
Time Frame
Weeks 24, 48, 96
Title
Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan
Description
Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan: Total number of new and/or enlarging T2 hyperintense lesions divided by the total number of interpretable MRI scans
Time Frame
Weeks 24, 48, 96
Title
Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Time Frame
Weeks 48, 96
Title
Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Time Frame
Weeks 48, 96
Title
Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
Time Frame
Weeks 48, 96
Title
Adjusted Mean Percentage Change From Baseline in Brain Volume
Time Frame
Weeks 24, 48, 96
Title
Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume
Time Frame
Weeks 48, 96
Title
Adjusted Mean Percentage Change From Baseline in White Matter Volume
Time Frame
Weeks 48, 96
Title
Mean Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
Description
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span. The higher the results, the better processing speed/working memory.
Time Frame
Baseline, Weeks: 48, 96
Title
Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
Description
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.
Time Frame
Baseline, Weeks 48, 96
Title
Percentage Change From Baseline in Cognitive Performance (Processing Speed/Working Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Symbol Digit Modalities Test (SDMT) Score
Description
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span.
Time Frame
Baseline, Weeks 48, 96
Title
Percentage Change From Baseline in Cognitive Performance (Visuospatial Memory) at Week 48 and Week 96 as Measured by the Brief International Cognitive Assessment for MS - Brief Visuospatial Memory Test-Revised (BVMT-R) Score
Description
Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.
Time Frame
Baseline, Weeks: 48, 96
Title
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time Frame
Baseline up to to 96 weeks after the end of the Treatment Period

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, confirmed as per the revised McDonald 2010 criteria Have a length of disease duration, from first symptom, of less than (<) 10 years Have received no more than two prior DMTs, and the discontinuation of the most recent DMT was due to lack of efficacy Suboptimal disease control while on a DMT Expanded Disability Status Scale (EDSS) of 0.0 to 4.0, inclusive, at Screening For women of childbearing potential: agreement to use an acceptable birth control method during the treatment period and for at least 6 months after the last dose of study drug Exclusion Criteria: Secondary progressive multiple sclerosis (SPMS) or history of primary progressive or progressive relapsing multiple sclerosis (MS) Inability to complete an Magnetic Resonance Imaging (MRI) procedure Known presence of other neurological disorders 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 History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies History of opportunistic infections History or known presence of recurrent or chronic infection History of malignancy Congestive heart failure Known active bacterial, viral, fungal, mycobacterial infection or other infection, excluding fungal infection of nail beds
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
St George Hospital
City
Kogarah, New South Wales
State/Province
New South Wales
ZIP/Postal Code
2217
Country
Australia
Facility Name
Hospital Erasme
City
Bruxelles
ZIP/Postal Code
1070
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
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
CHU Tivoli
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
UZ Leuven Gasthuisberg
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Nationaal MS Centrum
City
Melsbroek
ZIP/Postal Code
1820
Country
Belgium
Facility Name
Revalidatie en MS Centrum
City
Overpelt
ZIP/Postal Code
3900
Country
Belgium
Facility Name
Fakultni nemocnice u sv. Anny; Neurologicka klinika
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Nemocnice Jihlava; NEU-Neurologicke oddeleni
City
Jihlava
ZIP/Postal Code
58633
Country
Czechia
Facility Name
VFN Praha Poliklinika Rs Centrum - Budova A
City
Prague
ZIP/Postal Code
12808
Country
Czechia
Facility Name
Fakultni nemocnice Motol; Neurologicka klinika
City
Praha
ZIP/Postal Code
150 06
Country
Czechia
Facility Name
Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
City
Aarhus N
ZIP/Postal Code
8200
Country
Denmark
Facility Name
Rigshospitalet Glostrup; Neurologisk Klinik
City
Glostrup
ZIP/Postal Code
2600
Country
Denmark
Facility Name
Odense Universitetshospital, Neurologisk Afdeling N
City
Odense C
ZIP/Postal Code
5000
Country
Denmark
Facility Name
Sydjysk Skleroseklinik - Sønderborg
City
Sønderborg
ZIP/Postal Code
6400
Country
Denmark
Facility Name
East Tallinn Central Hospital; Neurology Department
City
Tallinn
ZIP/Postal Code
10138
Country
Estonia
Facility Name
West Tallinn Central Hospital
City
Tallinn
ZIP/Postal Code
10617
Country
Estonia
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Facility Name
Terveystalo Tampere
City
Tampere
ZIP/Postal Code
33100
Country
Finland
Facility Name
Mehiläinen Neo Turku
City
Turku
ZIP/Postal Code
20520
Country
Finland
Facility Name
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
City
Besançon
ZIP/Postal Code
25030
Country
France
Facility Name
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
City
Bron
ZIP/Postal Code
69677
Country
France
Facility Name
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Facility Name
Hopital Roger Salengro; Service de Neurologie
City
Lille
Country
France
Facility Name
CHU de la Timone - Hopital d Adultes; Service de Neurologie
City
Marseille
ZIP/Postal Code
13005
Country
France
Facility Name
Hopital Gui de Chauliac; Neurologie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Facility Name
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
Fondation Rothschild; Service de Neurologie
City
Paris
ZIP/Postal Code
75019
Country
France
Facility Name
Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
City
Paris
ZIP/Postal Code
75651
Country
France
Facility Name
Hôpital Maison Blanche; Service de Neurologie
City
Reims
ZIP/Postal Code
51092
Country
France
Facility Name
Hôpitaux Universitaires de strasbourg - hôpital civil
City
Strasbourg
ZIP/Postal Code
67091
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
Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie
City
Augsburg
ZIP/Postal Code
86156
Country
Germany
Facility Name
Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
City
Berg
ZIP/Postal Code
82335
Country
Germany
Facility Name
Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Praxis Dr. Said Masri
City
Berlin
ZIP/Postal Code
12099
Country
Germany
Facility Name
Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz
City
Berlin
ZIP/Postal Code
12163
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
Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc
City
Bonn
ZIP/Postal Code
53111
Country
Germany
Facility Name
PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge
City
Buchholz
ZIP/Postal Code
21244
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
Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito
City
Düsseldorf
ZIP/Postal Code
40211
Country
Germany
Facility Name
NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
City
Erbach/Odenwald
ZIP/Postal Code
64711
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt; Klinik für Neurologie
City
Frankfurt
ZIP/Postal Code
60528
Country
Germany
Facility Name
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
City
Freiburg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt
City
Hamburg
ZIP/Postal Code
22083
Country
Germany
Facility Name
MultipEL Studies - Institut für klinische Studien
City
Hamburg
ZIP/Postal Code
22179
Country
Germany
Facility Name
Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie
City
Hannover
ZIP/Postal Code
30171
Country
Germany
Facility Name
Neurologische Klinik, Universitätsklinikum Heidelberg
City
Heidelberg
ZIP/Postal Code
69120
Country
Germany
Facility Name
Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
City
Hennigsdorf
ZIP/Postal Code
16761
Country
Germany
Facility Name
Neurozentrum am Klosterforst in Itzehoe
City
Itzehoe
ZIP/Postal Code
25524
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
PANAKEIA - Arzneimittelforschung Leipzig GmbH
City
Leipzig
ZIP/Postal Code
04275
Country
Germany
Facility Name
Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
City
Mainz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Universitaetsklinikum Marburg; Klinik fuer Neurologie
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Facility Name
Max-Planck-Institut für Psychiatrie
City
München
ZIP/Postal Code
80804
Country
Germany
Facility Name
Klinikum Grosshadern der LMU; Neuroimmunologie II
City
München
ZIP/Postal Code
81377
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
Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie
City
Neuruppin
ZIP/Postal Code
16816
Country
Germany
Facility Name
AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie
City
Oldenburg in Holstein
ZIP/Postal Code
23758
Country
Germany
Facility Name
St. Josefs-Krankenhaus, Klinik für Neurologie
City
Potsdam
ZIP/Postal Code
14471
Country
Germany
Facility Name
NeuroConcept AG C/O mind mvz GmbH
City
Stuttgart
ZIP/Postal Code
70182
Country
Germany
Facility Name
Universitätsklinikum Tübingen, Zentrum für Neurologie
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
Facility Name
NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH
City
Ulm
ZIP/Postal Code
89073
Country
Germany
Facility Name
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
City
Westerstede
ZIP/Postal Code
26655
Country
Germany
Facility Name
Cork University Hospital; Clinical Research Facility
City
Cork
Country
Ireland
Facility Name
St Vincents University Hospital
City
Dublin 4
Country
Ireland
Facility Name
Beaumont Hospital
City
Dublin
ZIP/Postal Code
9
Country
Ireland
Facility Name
Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66013
Country
Italy
Facility Name
Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
City
L'Aquila
State/Province
Abruzzo
ZIP/Postal Code
67100
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 Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40139
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
Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
City
Roma
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
City
Roma
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
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
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
City
Bergamo
State/Province
Lombardia
ZIP/Postal Code
24127
Country
Italy
Facility Name
Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico
City
Gallarate
State/Province
Lombardia
ZIP/Postal Code
21013
Country
Italy
Facility Name
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20122
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 C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
City
Pavia
State/Province
Lombardia
ZIP/Postal Code
27100
Country
Italy
Facility Name
AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla
City
Ancona
State/Province
Marche
ZIP/Postal Code
60100
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
Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia
City
Barletta
State/Province
Puglia
ZIP/Postal Code
70051
Country
Italy
Facility Name
IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia
City
San Giovanni Rotondo
State/Province
Puglia
ZIP/Postal Code
71013
Country
Italy
Facility Name
Ospedale Binaghi; Centro Sclerosi Multipla
City
Cagliari
State/Province
Sardegna
ZIP/Postal Code
09126
Country
Italy
Facility Name
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Facility Name
Fondazione Istituto S. Raffaele - Giglio; UO Neurologia
City
Cefalù
State/Province
Sicilia
ZIP/Postal Code
90015
Country
Italy
Facility Name
AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
City
Palermo
State/Province
Sicilia
ZIP/Postal Code
90129
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
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
City
Firenze
State/Province
Toscana
ZIP/Postal Code
50134
Country
Italy
Facility Name
AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
City
Siena
State/Province
Toscana
ZIP/Postal Code
53100
Country
Italy
Facility Name
AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
City
Perugia
State/Province
Umbria
ZIP/Postal Code
06156
Country
Italy
Facility Name
Azienda Ospedaliera di Padova; Clinica Neurologica
City
Padova
State/Province
Veneto
ZIP/Postal Code
35128
Country
Italy
Facility Name
Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla
City
Verona
State/Province
Veneto
ZIP/Postal Code
37134
Country
Italy
Facility Name
Amphia Ziekenhuis
City
Breda
ZIP/Postal Code
4819 EV
Country
Netherlands
Facility Name
St. Antonius Ziekenhuis Nieuwegein
City
Nieuwegein
ZIP/Postal Code
3435 CM
Country
Netherlands
Facility Name
Maasstadziekenhuis
City
Rotterdam
ZIP/Postal Code
3079 DZ
Country
Netherlands
Facility Name
Zuyderland Medisch Centrum - Sittard Geleen
City
Sittard-Geleen
ZIP/Postal Code
6162 BG
Country
Netherlands
Facility Name
Sint Elizabeth Ziekenhuis
City
Tilburg
ZIP/Postal Code
5042 AD
Country
Netherlands
Facility Name
Haukeland Universitetssykehus
City
Bergen
ZIP/Postal Code
5021
Country
Norway
Facility Name
Sykehuset Buskerud HF; Nevrologisk avdeling
City
Drammen
ZIP/Postal Code
3004
Country
Norway
Facility Name
Hospital Universitario Central de Asturias; Servicio de Neurología
City
Oviedo
State/Province
Asturias
Country
Spain
Facility Name
Hospital Universitari de Bellvitge; Servicio de Neurologia
City
L'Hospitalet de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Hospital General de Castellon; Servicio de Neurología
City
Castelló de la Plana
State/Province
Castellon
ZIP/Postal Code
12004
Country
Spain
Facility Name
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
City
Salt
State/Province
Girona
ZIP/Postal Code
17190
Country
Spain
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 Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
City
Lleida
State/Province
Lerida
ZIP/Postal Code
25198
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
Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
City
Vigo
State/Province
Pontevedra
ZIP/Postal Code
36312
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 Puerta del Mar; Sevicio de Neurologia
City
Cadiz
ZIP/Postal Code
11009
Country
Spain
Facility Name
Universitario de La Princesa; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Clínico San Carlos; Servicio de Neurología
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
Hospital Universitario 12 de Octubre; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
City
Murcia
Country
Spain
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Facility Name
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hospital Universitario la Fe; Servicio de Neurologia
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Facility Name
Sahlgrenska Sjukhuset; Neurology
City
Göteborg
ZIP/Postal Code
413 45
Country
Sweden
Facility Name
Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen
City
Jönköping
ZIP/Postal Code
55185
Country
Sweden
Facility Name
Centrum för Neurologi
City
Stockholm
ZIP/Postal Code
113 41
Country
Sweden
Facility Name
Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
CHUV Lausanne Méd.Neurologie
City
Lausanne
ZIP/Postal Code
1011
Country
Switzerland
Facility Name
Hacettepe University Medical Faculty; Neurology
City
Ankara
ZIP/Postal Code
06100
Country
Turkey
Facility Name
Istanbul Uni Istanbul Medical Faculty
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
Ege University Medical Faculty
City
Izmir
ZIP/Postal Code
35100
Country
Turkey
Facility Name
Kocaeli University Hospital; Department of Neurology
City
Kocaeli
ZIP/Postal Code
41380
Country
Turkey
Facility Name
Mersin University Medical Faculty; Neurology
City
Mersin
ZIP/Postal Code
33079
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
New Queen Elizabeth Hospital Birmingham
City
Birmingham
ZIP/Postal Code
B15 2WB
Country
United Kingdom
Facility Name
Western General Hospital
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital (Wonford)
City
Exeter
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Queen Elizabeth University Hospital
City
Glasgow
ZIP/Postal Code
G51 4TF
Country
United Kingdom
Facility Name
Raigmore Hospital
City
Inverness
ZIP/Postal Code
IV2 3UV
Country
United Kingdom
Facility Name
Leeds Teaching Hospitals NHS Trust
City
Leeds
ZIP/Postal Code
LS9 7AU
Country
United Kingdom
Facility Name
The Royal London Hospital
City
London
ZIP/Postal Code
E1 1FR
Country
United Kingdom
Facility Name
Kings College Hospital
City
London
ZIP/Postal Code
SW9 8RR
Country
United Kingdom
Facility Name
Charing Cross Hospital
City
London
ZIP/Postal Code
W6 8RF
Country
United Kingdom
Facility Name
Royal Victoria Infirmary
City
Newcastle upon Tyne
ZIP/Postal Code
NE1 4LP
Country
United Kingdom
Facility Name
Salford Royal NHS Foundation Trust
City
Salford
ZIP/Postal Code
M6 8HD
Country
United Kingdom
Facility Name
Royal Hallamshire Hospita
City
Sheffield
ZIP/Postal Code
S10 2JF
Country
United Kingdom
Facility Name
Morriston Hospital
City
Swansea
ZIP/Postal Code
SA6 6NL
Country
United Kingdom
Facility Name
Royal Cornwall Hospital
City
Truro
ZIP/Postal Code
TR1 3LQ
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
34748672
Citation
Vermersch P, Oreja-Guevara C, Siva A, Van Wijmeersch B, Wiendl H, Wuerfel J, Buffels R, Kadner K, Kuenzel T, Comi G; CASTING Investigators. Efficacy and safety of ocrelizumab in patients with relapsing-remitting multiple sclerosis with suboptimal response to prior disease-modifying therapies: A primary analysis from the phase 3b CASTING single-arm, open-label trial. Eur J Neurol. 2022 Mar;29(3):790-801. doi: 10.1111/ene.15171. Epub 2021 Nov 25.
Results Reference
derived

Learn more about this trial

A Study of Ocrelizumab in Participants With Relapsing Remitting Multiple Sclerosis (RRMS) Who Have Had a Suboptimal Response to an Adequate Course of Disease-Modifying Treatment (DMT)

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