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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03523858
Recruitment Status : Active, not recruiting
First Posted : May 14, 2018
Last Update Posted : August 19, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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

Condition or disease Intervention/treatment Phase
Progressive Multiple Sclerosis (PMS) Drug: Ocrelizumab Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 633 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis
Actual Study Start Date : May 28, 2018
Estimated Primary Completion Date : March 27, 2024
Estimated Study Completion Date : September 25, 2025

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

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




Primary Outcome Measures :
  1. Proportion of Participants with No Evidence of Progression (NEP) [ Time Frame: From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192 ]
    NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (confirmed disability progression [CDP]; ≥20% increase in timed 25-foot walk test [T25FWT]; ≥20% increase in nine-hole peg test [9HPT])

  2. Proportion of Participants with no evidence of progression and no active disease (NEPAD) [ Time Frame: From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192 ]
    NEPAD is defined as no progression sustained for at least 24 weeks on all of the three components of NEP (CDP, T25FWT, 9HPT), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium (Gd+)-enhancing lesion


Secondary Outcome Measures :
  1. Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT) [ Time Frame: Baseline to end of study (Week 192) ]
  2. Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study [ Time Frame: Baseline to end of study (Week 192) ]
  3. Time to Onset of First Confirmed Disability Progression (CDP) Sustained for at least 24 and 48 Weeks [ Time Frame: Baseline to onset of first CDP (as measured by EDSS) sustained for at least 24 and 48 weeks ]
  4. Time to Onset of First >=20% Increase in Timed 25-foot Walk Test (T25FWT) Sustained for at least 24 Weeks [ Time Frame: Baseline to onset of first >=20% increase in T25FWT sustained for at least 24 weeks ]
  5. Time to Onset of First >=20% Increase in 9 Hole Peg Test (9HPT) Sustained For At Least 24 Weeks [ Time Frame: Baseline to onset of first >=20% increase in 9HPT sustained for at least 24 weeks ]
  6. Proportion of Participants with NEP [ Time Frame: Week 24 to Week 96, Week 24 to Week 192, and Week 48 to Week 192 ]
  7. Proportion of Participants with NEPAD [ Time Frame: Week 24 to Week 96, Week 24 to Week 192, Week 48 to Week 192 ]
  8. Change from Baseline in Patient-Reported Outcomes (PROs) [ Time Frame: Baseline to end of study (Week 192) ]
    PROs collected in this study will be the Multiple Sclerosis Impact Scale (MSIS-29), the Multiple Sclerosis Walking scale (MSWS-12), the ABILHAND-56 Questionnaire, Fatigue Scale for Motor and Cognitive function (FSMC), SymptoMScreen, 88-item Multiple Sclerosis Spasticity Scale (MSSS-88), Numerical Pain Rating Scale (NPRS), and the Patient Global Impression of Severity (PGIS) for upper limb, lower limb and cognitive function

  9. Change from Baseline in the number of falls and near-falls [ Time Frame: Baseline to end of study (Week 192) ]
  10. Change in Whole Brain Volume (Whole, Cerebral White Matter, Cortical Grey Matter) [ Time Frame: Baseline to end of study (Week 192) ]
  11. Change in thalamic and hippocampal volumes [ Time Frame: Baseline to end of study (Week 192) ]
  12. Change in cerebellar volume (whole, grey matter, white matter) [ Time Frame: Baseline to end of study (Week 192) ]
  13. Change in cervical cord cross-sectional area (total, white matter and grey matter) [ Time Frame: Baseline to end of study (Week 192) ]
  14. Change in number of new/enlarging T2 lesionsand total T2 Lesion Volume [ Time Frame: Baseline to end of study (Week 192) ]
  15. Change in number of T1 Gadolinium (Gd)+ Lesions and total volume [ Time Frame: 'Baseline to end of study (Week 192) ]
  16. Change in Slowly Evolving Lesions (SEL) [ Time Frame: Baseline to end of study (Week 192) ]
  17. Measurement of T1 Gd+ enhancement in New Focal T2 Lesions, SELs, Persistent Areas of Non-SEL T2 Lesions, and Normal-Appearing Brain Tissue [ Time Frame: Baseline to end of study (Week 192) ]
  18. Change in Gd-enhancing late-Fluid-Attenuated Inversion-Recovery (FLAIR) Meningeal Lesions [ Time Frame: Baseline to end of study (Week 192) ]
  19. Change in the number of cortical lesions (subpial, intracortical, and leucocortical) [ Time Frame: Baseline to end of study (Week 192) ]
  20. Change in the number/ spatial distribution of lesions in the cervical spinal cord [ Time Frame: Baseline to end of study (Week 192) ]
  21. Spectroscopic MR: Measure of the Relative Signal Amplitude of N-Acetyl Aspartate (NAA), and Choline to Creatine [ Time Frame: Baseline to end of study (Week 192) ]
    Only in centers with 1.5-Tesla MRI capable to perform it

  22. Measure of Phase Rim Lesions by T2* sequence [ Time Frame: Baseline to end of study (Week 192) ]
    Only in centers with 3-Tesla MRI capable to perform it, where this sequence would replace the spectroscopic MR in the acquisition flow

  23. Change in number of white mater lesions with central veins, using T2* sequences [ Time Frame: Baseline to end of study (Week 192) ]
  24. Measure of cortical and periventricular magnetization transfer ratio (MTR) gradients [ Time Frame: Baseline to end of study (Week 192) ]
  25. Measure of mean lesional magnetization transfer ratio (MTR) and mean MTR in normal-appearing white matter (NAWM) and grey matter (NAGM) [ Time Frame: Baseline to end of study (Week 192) ]
  26. Precentage of Participants with Adverse Events (AEs) [ Time Frame: Baseline to end of study (Week 192) ]
  27. Time to Study Treatment Discontinuation due to Adverse Events [ Time Frame: Baseline to Week 192 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
  • EDSS (Expanded Disability Status Scale) </ =6.5 at screening
  • Have a length of disease duration since Progressive Multiple Sclerosis (PMS) disease symptom onsent </= 10 years if baseline Expanded Disability Status Scale (EDSS) </=5.0 and </=15 years if baseline EDSS >5.0
  • Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment
  • Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
  • Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
  • For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug

Exclusion Criteria:

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

Exclusions Related to General Health:

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

Exclusions Related to Medications:

  • Hypersensitivity to ocrelizumab or to any of its excipients
  • Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, tabalumab, belimumab, ofatumumab, or obinutizumab)
  • Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation
  • Previous treatment with natalizumab where PML has not been excluded according to specific algorithm
  • Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
  • Systemic corticosteroid therapy within 4 weeks prior to screening
  • All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted
  • Previous treatment with daclizumab or figolimod in the last 8 weeks
  • Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening
  • Previous treatment with natalizumab in the last 12 weeks
  • Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
  • Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
  • Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks
  • Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit

Exclusions for Participants in the Optical Coherence Tomography (OCT) Assessments:

- Participants with clinically relevant ocular pathologies, potentially interfering with clinical and instrumental evaluations

Exclusions for Participants Participating in the Measurement of Motor Evoked Potentials:

  • History of seizures
  • Prior craniotomy or skull fracture
  • Movable metallic implant in the head
  • Implanted stimulators (e.g. cochlear implant or cardiac pacemaker, deep brain stimulator)
  • Known history of high intracranial pressure

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03523858


Locations
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United States, California
MS Center of California
Newport Beach, California, United States, 92663
SC3 Research Group, Inc
Pasadena, California, United States, 91105
University of California San Francisco
San Francisco, California, United States, 94117
United States, Connecticut
Yale University Multiple Sclerosis Center
New Haven, Connecticut, United States, 06473
United States, Florida
University of South Florida
Tampa, Florida, United States, 33612
United States, Illinois
University of Chicago; Neurology/MC 2030
Chicago, Illinois, United States, 60637-1470
United States, Massachusetts
Massachusetts General Hospital; Neurological Clinical Research Institute (NCRI)
Boston, Massachusetts, United States, 02114
The Elliot Lewis Center
Wellesley, Massachusetts, United States, 02481
United States, Michigan
Wayne State University School of Medicine
Detroit, Michigan, United States, 48210
United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
United States, New York
The MS Center of Northeastern New York
Latham, New York, United States, 12110
United States, Ohio
University of Cincinnati; Department of Neurology
Cincinnati, Ohio, United States, 45267
Cleveland Clinic Mellen Center; U10
Cleveland, Ohio, United States, 44195
United States, Pennsylvania
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
United States, Tennessee
Neurology Clinic PC
Cordova, Tennessee, United States, 38018
United States, Texas
Central Texas Neurology Consultants
Round Rock, Texas, United States, 78681
Neurology Center of San Antonio
San Antonio, Texas, United States, 78212
United States, Washington
Swedish Multiple Sclerosis Center
Seattle, Washington, United States, 98122
Bosnia and Herzegovina
University Clinical Center of the Republic of Srpska; Neurology Clinic
Banja Luka, Bosnia and Herzegovina, 78000
University Hospital Mostar; Neurology Clinic
Mostar, Bosnia and Herzegovina, 88000
Clinical Center University of Sarajevo; Neurology clinic
Sarajevo, Bosnia and Herzegovina, 71000
University Clinical Center Tuzla; Neurology
Tuzla, Bosnia and Herzegovina, 75000
Brazil
Instituto de Neurologia de Curitiba
Curitiba, PR, Brazil, 81210-310
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
Ribeirao Preto, SP, Brazil, 14051-140
Hospital das Clinicas - FMUSP_X; Neurologia
Sao Paulo, SP, Brazil, 05403-000
Canada, British Columbia
Fraser Health Authority - Fraser Health Multiple Sclerosis
Burnaby, British Columbia, Canada, V5G 2X6
University of British Columbia Hospital; Division of Neurology
Vancouver, British Columbia, Canada, V6T 2B5
Canada, Ontario
London Health Sciences Centre Uni Campus
London, Ontario, Canada, N6A 5A5
St. Michael'S Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada, J4V 2J2
Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2L 4M1
Canada, Saskatchewan
Saskatoon City Hospital; Neurology
Saskatoon, Saskatchewan, Canada, S7K 0M7
Colombia
Organizacion Sanitas Internacional
Bogota, Colombia
Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
Cali, Colombia
Costa Rica
Hospital Clínica Biblica
San José, Costa Rica, 10101
Czechia
Nemocnice Jihlava; NEU-Neurologicke oddeleni
Jihlava, Czechia, 58633
Fakultní Nemocnice Olomouc; Neurologicka Klinika
Olomouc, Czechia, 77521
Fakultni nemocnice Ostrava; MS centrum
Ostrava-Poruba, Czechia, 708 52
Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
Praha 2, Czechia, 128 08
Denmark
Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
Aarhus N, Denmark, 8200
Rigshospitalet; Neurologisk Klinik Glostrup
Glostrup, Denmark, 2600
Sydjysk Skleroseklinik - Sønderborg
Sønderborg, Denmark, 6400
Egypt
Faculty of Medicine-Ain Shams University; Neurology Department
Cairo, Egypt, 11566
Clinical Research Center-Alex university; Neurology Department
Cairo, Egypt, 21561
France
CHU Amiens Hopital Sud; Neurologie
Amiens Cedex1, France, 80054
CHIC Cote Basque Bayonne; Neurologie
Bayonne Cedex, France, 64109
Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
Bordeaux, France, 33076
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron, France, 69677
CHU De Caen; Service De Neurologie Dejerine
Caen, France, 14033
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, France, 63003
Hopital B Roger Salengro; Neurologie C
Lille, France, 59037
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, France, 13005
Hopital Gui de Chauliac; Neurologie
Montpellier, France, 34295
CHRU Nancy; Service de neurologie
Nancy, France, 54035
Hopital Nord Laennec
Nantes, France, 44093
Hôpital Pasteur; Service de Neurologie
Nice, France, 06002
Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
Nimes, France, 30029
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35033
Hopital Civil de Strasbourg; Service de Neurologie
Strasbourg, France, 67091
Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, Germany, 01307
Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie
Greifswald, Germany, 17475
Krankenhaus Martha-Maria Hallo-Dölau, Klinik für Neurologie
Halle (Saale), Germany, 06120
NeuroConcept AG C/O mind mvz GmbH
Stuttgart, Germany, 70182
NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH
Ulm, Germany, 89073
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
Westerstede, Germany, 26655
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
Wiesbaden, Germany, 65191
Guatemala
Nucare
Ciudad Guatemala, Guatemala, 01015
Hungary
Semmelweis Egyetem AOK; Neurologiai Klinika
Budapest, Hungary, 1083
VALEOMED Diagnosztikai Központ; VALEOMED Diagnosztikai Központ
Esztergom, Hungary, 2500
Jósa András Oktatókórház
Nyíregyháza, Hungary, 4400
Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika; Klinikai Központ Neurológiai Klinika
Pécs, Hungary, 7623
Ireland
Cork University Hospital
Cork, Ireland
Beaumont Hospital; Clinical Research and Education Centre, Smurfit Building
Dublin, Ireland, 9
St Vincents University Hospital; Carew House-Neurology Department
Dublin, Ireland, Dublin 4
Italy
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Napoli, Campania, Italy, 80131
Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
Napoli, Campania, Italy, 80131
Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
Napoli, Campania, Italy, 80138
Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica
Trieste, Friuli-Venezia Giulia, Italy, 34149
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Roma, Lazio, Italy, 00133
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
Roma, Lazio, Italy, 00168
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
Roma, Lazio, Italy, 00189
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
Roma, Lazio, Italy, 00189
Irccs A.O.U.San Martino Ist; Dinogmi
Genova, Liguria, Italy, 16132
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano, Lombardia, Italy, 20132
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Milano, Lombardia, Italy, 20133
IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Pavia, Lombardia, Italy, 27100
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Pozzilli, Molise, Italy, 86077
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
Orbassano, Piemonte, Italy, 10043
AOU Città della Salute e della Scienza; Neurologia 1
Torino, Piemonte, Italy, 10126
Azienda Ospedaliero Universitaria Consorziale Policlinico di; Scienze Neurologiche
Bari, Puglia, Italy, 70124
Ospedale Binaghi; Centro Sclerosi Multipla
Cagliari, Sardegna, Italy, 09126
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Catania, Sicilia, Italy, 95123
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
Firenze, Toscana, Italy, 50134
Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla
Verona, Veneto, Italy, 37134
Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon, 1107 2020
Lebanese American University Medical Center- Rizk Hospial
Beirut, Lebanon, 1132 8811
Mexico
Grupo Medico de Investigacion Clinica Multidisciplinaria
Mexico City, Mexico CITY (federal District), Mexico, 03100
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico, 06700
Hospital General de Mexico
Mexico, Tlaxcala, Mexico, 06726
Unidad de investigacion en salud (UIS); Neurociencias
Ciudad de México, Mexico, 14050
Morocco
Centre Hospitalier Universitaire Hassan II
FES, Morocco, 30000
Hopital Cheikh Zaid
Rabat, Morocco, 10000
Hopital Militaire d'Instruction Mohamed V
Rabat, Morocco, 10100
Netherlands
Amphia Ziekenhuis
Breda, Netherlands, 4819 EV
Catharina ziekenhuis
Eindhoven, Netherlands, 5623 EJ
Maasstadziekenhuis
Rotterdam, Netherlands, 3079 DZ
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, Netherlands, 6162 BG
Panama
Consultorios Médicos PaItilla
Panama City, Panama, 0816 03075
Poland
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland, 15-276
Szpital Uniwersytecki w Krakowie; Oddział kliniczny Neurologii
Kraków, Poland, 31-503
Centrum Neurologii Krzysztof Selmaj
Lodz, Poland, 90-324
SP Swiecickiego UM Marcinkowskiego; Od. Klin. Neurologii z podod. Udarowym
Poznań, Poland, 60-355
Centrum Medyczne "MEDYK"
Rzeszow, Poland, 35-055
Wojskowy Instytut Medyczny Centralny Szpital Kliniczny MON
Warszawa, Poland, 04-141
SPSK nr 1; Klinika Neurologii
Zabrze, Poland, 41-800
Russian Federation
National Center of Social Significant Disease
Sankt-peterburg, Leningrad, Russian Federation, 197110
Jusupovskaya Hospital
Moscow, Moskovskaja Oblast, Russian Federation, 117186
Scientific Neurology Center; Neurological department #6
Moscow, Moskovskaja Oblast, Russian Federation, 125367
City Clinical Hospital #24; Multipal Sclerosis department
Moskva, Moskovskaja Oblast, Russian Federation, 127015
Vladimirskiy Regional Scientific Research Inst.
Moscow, Russian Federation, 129110
Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona, Spain, 08035
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
Murcia, Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, Spain, 46026
United Arab Emirates
Cleveland Clinic Abu Dhabi
Abu Dhabi, United Arab Emirates, 112412
Rashid hospital
Dubai, United Arab Emirates, 4545
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT03523858    
Other Study ID Numbers: MN39159
First Posted: May 14, 2018    Key Record Dates
Last Update Posted: August 19, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm).

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Multiple Sclerosis
Multiple Sclerosis, Chronic Progressive
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Ocrelizumab
Immunologic Factors
Physiological Effects of Drugs