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

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: NCT03085810
Recruitment Status : Active, not recruiting
First Posted : March 21, 2017
Last Update Posted : January 10, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: Ocrelizumab Phase 3

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1233 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : April 4, 2017
Actual Primary Completion Date : September 26, 2019
Estimated Study Completion Date : August 27, 2024

Resource links provided by the National Library of Medicine

Drug Information available for: Ocrelizumab

Arm Intervention/treatment
Experimental: Ocrelizumab
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 for a maximum of 8 doses throughout the 192 weeks treatment period.
Drug: Ocrelizumab
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.




Primary Outcome Measures :
  1. 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 ]
  2. Percentage of Participants With Confirmed Disability Improvement (CDI) at Year 1, As Measured Using EDSS [ Time Frame: Year 1 ]
  3. Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 1, As Measured Using EDSS [ Time Frame: Year 1 ]
  4. Percentage of Participants With CDI at Year 2, As Measured Using EDSS [ Time Frame: Year 2 ]
  5. Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 2, As Measured Using EDSS [ Time Frame: Year 2 ]
  6. Percentage of Participants With CDI at Year 4, As Measured Using EDSS [ Time Frame: Year 4 ]
  7. Percentage of Participants With CDP Sustained for At Least 24 and 48 Weeks at Year 4, As Measured Using EDSS [ Time Frame: Year 4 ]
  8. Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS [ Time Frame: Year 1 ]
  9. Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS [ Time Frame: Year 2 ]
  10. Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 3, As Measured Using EDSS [ Time Frame: Year 3 ]
  11. Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 4, As Measured Using EDSS [ Time Frame: Year 4 ]
  12. Mean Change From Baseline in EDSS Score at Week 24 [ Time Frame: Baseline, Week 24 ]
  13. Mean Change From Baseline in EDSS Score at Week 48 [ Time Frame: Baseline, Week 48 ]
  14. Mean Change From Baseline in EDSS Score at Week 72 [ Time Frame: Baseline, Week 72 ]
  15. Mean Change From Baseline in EDSS Score at Week 96 [ Time Frame: Baseline, Week 96 ]
  16. Mean Change From Baseline in EDSS Score at Week 120 [ Time Frame: Baseline, Week 120 ]
  17. Mean Change From Baseline in EDSS Score at Week 144 [ Time Frame: Baseline, Week 144 ]
  18. Mean Change From Baseline in EDSS Score at Week 168 [ Time Frame: Baseline, Week 168 ]
  19. Mean Change From Baseline in EDSS Score at Week 192 [ Time Frame: Baseline, Week 192 ]
  20. Time to First Protocol-Defined Event of Disease Activity [ Time Frame: Baseline up to 4 years ]
    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.

  21. Time to First Relapse [ Time Frame: Baseline up to 4 years ]
    Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.

  22. Annualized Relapse Rate [ Time Frame: Baseline up to 4 years ]
    Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.


Secondary Outcome Measures :
  1. Percentage of Participants Who Are Relapse Free [ Time Frame: Weeks 48, 96, 144, 192 ]
    Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.

  2. Percentage of Participants With No Evidence of Protocol Defined Disease Activity [ Time Frame: Weeks 96, 144, 192 ]
    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.

  3. Percentage of Participants With no Evidence of Progression (NEP) [ Time Frame: Weeks 96, 192 ]
    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.

  4. Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD) [ Time Frame: Weeks 96, 192 ]
    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.

  5. Change from Baseline in Multiple Sclerosis Functional Composite (MSFC) Total Score [ Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 ]
  6. 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 ]
  7. Change from Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score [ Time Frame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192 ]
  8. 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 ]
  9. 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 ]
  10. Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  11. Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  12. Change from baseline in total T1 hypointense lesion volume as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  13. Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  14. Change From Baseline in Brain Volume as Detected by Brain MRI [ Time Frame: Baseline, Weeks 8, 24, 48, 96, 144, 192 ]
  15. Time to Treatment Discontinuation [ Time Frame: Baseline up to 4 years ]
  16. Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score [ Time Frame: Baseline, Weeks 24, 48, 96, 120, 144, 192 ]
  17. SymptoMScreen Composite Score [ Time Frame: Baseline, Weeks 24, 48, 96, 120, 144, 192 ]
  18. Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score [ Time Frame: Baseline, Weeks 24, 48, 96, 120, 144, 192 ]
  19. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to 4 years ]
    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.



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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 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
  • 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

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): NCT03085810


Locations
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United States, California
University of California Irvine
Irvine, California, United States, 92697
Palo Alto Medical Foundation Research Center
Sunnyvale, California, United States, 94086
United States, Colorado
University of Colorado Denver
Aurora, Colorado, United States, 80045
Advanced Neurology of Colorado, LLC
Fort Collins, Colorado, United States, 80528
United States, Connecticut
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford, Connecticut, United States, 06905
United States, District of Columbia
Georgetown University Medical Center
Washington, District of Columbia, United States, 20007
United States, Florida
Neurology Associates PA
Maitland, Florida, United States, 32751
University of South Florida - Bradenton
Tampa, Florida, United States, 33612
United States, Georgia
Shepherd Center Inc.
Atlanta, Georgia, United States, 30309
United States, Kansas
College Park Family Care Ctr
Overland Park, Kansas, United States, 66212
United States, Louisiana
The NeuroMedical Center
Baton Rouge, Louisiana, United States, 70810
United States, Maine
Maine Medical Center
Scarborough, Maine, United States, 04074
United States, Maryland
University of Maryland Medical Center; Department of Neurology
Baltimore, Maryland, United States, 21201
United States, Massachusetts
Neurology Center of New England
Foxboro, Massachusetts, United States, 02035
Dragonfly Research, LLC
Wellesley, Massachusetts, United States, 02481
United States, Minnesota
Minneapolis Clinic of Neurology
Golden Valley, Minnesota, United States, 55422
United States, Nevada
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas, Nevada, United States, 89106
United States, New York
Columbia University Medical Center
New York, New York, United States, 10032
Island Neurological Associates, P.C.
Plainview, New York, United States, 11803
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States, 27157
United States, Ohio
Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
Cleveland, Ohio, United States, 44195
Neurology Specialists, Inc
Dayton, Ohio, United States, 45417
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
United States, Texas
Kane Hall Barry Neurology
Bedford, Texas, United States, 76021
United States, Washington
MultiCare Health System Institute for Research and Innovation
Tacoma, Washington, United States, 98405
United States, Wisconsin
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
Milwaukee, Wisconsin, United States, 53215
Argentina
Hospital Churruca Visca
Buenos Aires, Argentina, C1437JCP
Instituto DIABAID
Ciudad Autónoma de Buenos Aires, Argentina, C1061ABD
Fundacion Rosarina de Neurorehabilitacion
Rosario, Argentina, 2000
Australia, New South Wales
Brain and Mind Centre
Camperdown, New South Wales, Australia, 2050
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
John Hunter Hospital
New Lambton, New South Wales, Australia, 2305
Royal North Shore Hospital; Department of Neurology
St Leonards, New South Wales, Australia, 2065
Australia, Queensland
Princess Alexandra Hospital
Woolloongabba, Queensland, Australia, 4102
Australia, Victoria
Box Hill Hospital; Department of Neurology
Box Hill, Victoria, Australia, 3128
Austin Hospital; Department of Neurology
Heidelberg, Victoria, Australia, 3084
Royal Melbourne Hospital; Department of Neurology
Parkville, Victoria, Australia, 3050
Australia, Western Australia
Perron Institute for Neurological and Translational Science
Nedlands, Western Australia, Australia, 6009
Austria
Medizinische Universität Graz; Universitätsklinik für Neurologie
Graz, Austria, 8036
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
Innsbruck, Austria, 6020
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
Salzburg, Austria, 5020
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Wien, Austria, 1090
Belgium
AZ Sint Jan
Brugge, Belgium, 8000
UZ Brussel
Brussel, Belgium, 1090
Cliniques Universitaires St-Luc
Bruxelles, Belgium, 1200
UZ Antwerpen
Edegem, Belgium, 2650
CHU Tivoli
La Louvière, Belgium, 7100
CHU Sart-Tilman
Liège, Belgium, 4000
Revalidatie en MS Centrum
Overpelt, Belgium, 3900
Brazil
Hospital das Clinicas - UFMG; Centro de Pesquisa Clínica
Belo Horizonte, MG, Brazil, 30130-100
Instituto de Neurologia de Curitiba
Curitiba, PR, Brazil, 81210-310
Hospital Sao Lucas - PUCRS
Porto Alegre, RS, Brazil, 90610-000
Hosp Clinicas da FMUSP
Sao Paulo, SP, Brazil, 05403-000
Bulgaria
Shat Np Sveti Naum; 3Rd Clinic of Neurology
Sofia, Bulgaria, 1113
Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
Sofia, Bulgaria, 1309
UMHAT Alexandrovska, EAD; Neurology
Sofia, Bulgaria, 1431
Canada, British Columbia
UBC Hospital; Div of Neurology, Dept of Medicine
Vancouver, British Columbia, Canada, V6T 1Z3
Canada, Ontario
London Health Sciences Centre Uni Campus
London, Ontario, Canada, N6A 5A5
Ottawa Hospital Research Institute
Ottawa, Ontario, Canada, K1Y 4E9
Sunnybrook Health Science Centre
Toronto, Ontario, Canada, M4N 3M5
Canada, Quebec
Clinique NeuroOutaouais
Gatineau, Quebec, Canada, J8Y 1W2
Recherche Sepmus, Inc.
Greenfield Park, Quebec, Canada, J4V 2J2
McGill University; Montreal Neurological Institute; Neurological and Psychiatric
Montreal, Quebec, Canada, H3A 2B4
Croatia
Clinical Hospital Centre Zagreb
Zagreb, Croatia, 10000
Denmark
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
Aalborg, Denmark, 9000
Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
Aarhus N, Denmark, 8200
Rigshospitalet; Neurologisk Klinik Glostrup
Glostrup, Denmark, 2600
France
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
Besançon, France, 25030
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux, France, 33076
Hopital Pierre Wertheimer; Neurologie D
Bron, France, 69677
CHU de Caen - Hopital Cote de Nacre
Caen, France, 14033
CHU Hopital Gabriel Montpied; Service de Neurologie
Clermont Ferrand, France, 63003
CH de Gonesse; Neurologie
Gonesse, France, 95503
CHU de Grenoble; Neurologie
La Tronche, France, 38700
Hopital Gui de Chauliac; Neurologie
Montpellier, France, 34295
Hopital Central - CHU de Nancy; Service de Neurologie
Nancy, France, 54035
Hôpital Guillaume et René Laënnec; Service Neurologie
Nantes, France, 44805
Hôpital Pasteur; Service de Neurologie
Nice, France, 06002
CHU de Nîmes Hopital Caremeau; Service de Neurologie
Nimes, France, 30900
Hôpital de Poissy; Service neurologie
Poissy, France, 78300
Centre Hospitalier Universitaire de Rennes
Rennes, France, 35033
CHU de Rouen Hopital; Service de Neurologie
Rouen, France, 76031
CHU de Strasbourg
Strasbourg, France, 67098
Hopital Foch; Neurologie
Suresnes, France, 92151
HIA de Toulon hôpital militaire; Neurologie
Toulon, France, 83041
CHU toulouse - Hôpital Purpan; Departement de Neurologie
Toulouse, France, 31059
CHRU - Hôpital Bretonneau; Neurologie
Tours, France, 37000
Germany
Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie
Barsinghausen, Germany, 30890
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin, Germany, 13347
St. Josef-Hospital, Klinik für Neurologie
Bochum, Germany, 44791
Studienzentrum für Neurologie und Psychiatrie
Böblingen, Germany, 71034
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, Germany, 01307
Universitätsklinikum Düsseldorf; Neurologische Klinik
Düsseldorf, Germany, 40225
NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
Erbach/Odenwald, Germany, 64711
Universitätsklinikum Essen (AöR); Klinik für Neurologie
Essen, Germany, 45147
MultipEL Studies - Institut für klinische Studien
Hamburg, Germany, 22179
Universitätsklinikum Heidelberg
Heidelberg, Germany, 69120
Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
Kassel, Germany, 34121
Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
Kiel, Germany, 24105
Universitaetsklinikum Marburg; Klinik fuer Neurologie
Marburg, Germany, 35043
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München, Germany, 81675
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster, Germany, 48149
Praxis Dr. med. Bergmann
Neuburg, Germany, 86633
Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie
Seesen, Germany, 38723
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, Germany, 72076
Hungary
Semmelweis Egyetem AOK; Neurologiai Klinika
Budapest, Hungary, 1083
Uzsoki Utcai Korhaz
Budapest, Hungary, 1145
Jahn Ferenc Dél-Pesti Kórház
Budapest, Hungary, 1204
VALEOMED Diagnosztikai Központ; VALEOMED Diagnosztikai Központ
Esztergom, Hungary, 2500
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
Szeged, Hungary, H-6725
Italy
A.O.U. Mater Domin; U.O. NEUROLOGIA
Catanzaro, Calabria, Italy, 88100
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Napoli, Campania, Italy, 80131
AOU Seconda Università degli Studi; Dip. Assistenziale Integrato Medicina Int-II Clinica Neurologica
Napoli, Campania, Italy, 80131
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
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
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari, Lombardia, Italy, 25018
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Pozzilli, Molise, Italy, 86077
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Catania, Sicilia, Italy, 95123
AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
Palermo, Sicilia, Italy, 90146
AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
Firenze, Toscana, Italy, 50134
Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia
Grosseto, Toscana, Italy, 58100
AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
Siena, Toscana, Italy, 53100
Kuwait
Ibn Sina Hospital; Neurology Department
Kuwait, Kuwait, 10002
Lebanon
American University of Beirut - Medical Center
Beirut, Lebanon, 1107 2020
Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán, Sinaloa, Mexico, 80020
Hospital General de Mexico
Mexico, Tlaxcala, Mexico, 06726
Unidad de investigacion en salud (UIS); Neurociencias
Ciudad de México, Mexico, 14050
Netherlands
Jeroen Bosch Ziekenhuis
'S Hertogenbosch, Netherlands, 5223 GZ
VU Medisch Centrum; Afdeling Neurologie
Amsterdam, Netherlands, 1081 HV
Groene Hart Ziekenhuis
Gouda, Netherlands, 2803 HH
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, Netherlands, 6162 BG
Norway
Akershus universitetssykehus HF; Nevroklinikken S203
Lørenskog, Norway, 1478
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger, Norway, 4011
Poland
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz, Poland, 85-796
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddział Neurologiczny
Gdansk, Poland, 80-803
Care Clinic
Katowice, Poland, 40-568
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
Krakow, Poland, 31-637
Centrum Neurologii Krzysztof Selmaj
Lodz, Poland, 90-324
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, Poland, 20-016
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Warszawa, Poland, 02-097
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warszawa, Poland, 02-957
Portugal
Hospital Garcia de Orta; Servico de Neurologia
Almada, Portugal, 2801-951
Hospital de Braga; Servico de Neurologia
Braga, Portugal, 4710-243
HUC; Servico de Neurologia
Coimbra, Portugal, 3000-075
Hospital Beatriz Angelo; Servico de Neurologia
Loures, Portugal, 2674-514
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, Portugal, 4099-001
Romania
Spitalul Universitar de Urgenta Bucuresti
Bucharest, Romania, 11172
Spitalul Clinic Judetean de Urgenta Sibiu; Neurologie
Sibiu, Romania, 550166
Spitalul Clinic Judetean de Urgenta Mures
Targu-Mures, Romania, 540136
Slovakia
Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika LF UK a UNB
Bratislava, Slovakia, 813 69
UN Bratislava Nemocnica Ruzinov; Neurologicka klinika
Bratislava, Slovakia, 826 06
GB NeuroPRAKTIK, s.r.o
Nitra, Slovakia, 949 11
Fakultna nemocnica Trnava
Trnava, Slovakia, 917 75
Slovenia
University Medical Centre; Neurology
Ljubljana, Slovenia, 1000
University Medical Centre Maribor
Maribor, Slovenia, 2000
Spain
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
Santa Cruz De Tenerife, Tenerife, Spain, 38010
Hospital de Cruces; Servicio de Neurologia
Barakaldo, Vizcaya, Spain, 48903
Hospital General Universitario de Alicante; Servicio de Neurología
Alicante, Spain, 03010
Hospital del Mar; Servicio de Neurologia
Barcelona, Spain, 08003
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona, Spain, 08035
Hospital Universitario Puerta de Hierro; Servicio de Neurologia
Madrid, Spain, 28222
Hospital General Universitario Morales Meseguer; Servicio de Neurología
Murcia, Spain, 30008
Sweden
Sahlgrenska Sjukhuset; Neurology
Göteborg, Sweden, 413 45
Centralsjukhuset; Neurologi och rehabiliteringskliniken
Karlstad, Sweden, 65185
Centrum för Neurologi
Stockholm, Sweden, 113 41
Switzerland
Universitätsspital Basel; Neurologie
Basel, Switzerland, 4031
Inselspital-Universitaetsspital Bern; Neurologische Poliklinik
Bern, Switzerland, 3010
Ospedale Regionale di Lugano - Civico; Neurologia
Lugano, Switzerland, 6903
Luzerner Kantonsspital; Zentrum für Neurologie und Neurorehabilitation (ZNN)
Luzern, Switzerland, 6004
Kantonsspital; Neurologische Klinik
St. Gallen, Switzerland, 9007
Turkey
Hacettepe University Medical Faculty; Neurology
Ankara, Turkey, 06100
Gazi University Medical Faculty; Departmant of Neurology.
Ankara, Turkey, 06500
Mustafa Kemal UTF; Department of norology
Hatay, Turkey, 31001
Istanbul University Istanbul Medical Faculty; Neurology
Istanbul, Turkey, 34093
Istanbul University Cerrahpasa Medical Faculty; Noroloji Anabilim Dali
Istanbul, Turkey, 34098
Istanbul Bilim Universty Medical Fac.
Istanbul, Turkey, 34394
Selcuk University Medical Faculty; Norology department
Istanbul, Turkey, 42131
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, Turkey, 55139
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon, Turkey, 61080
United Kingdom
Cambridge University Hospitals NHS Foundation Trust
Cambridge, United Kingdom, CB2 0QQ
Queen Elizabeth University Hospital
Glasgow, United Kingdom, G51 4TF
Royal Free Hospital
London, United Kingdom, NW3 2QS
King'S College Hospital
London, United Kingdom, SE5 9RS
Charing Cross Hospital
London, United Kingdom, W6 8RF
National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
London, United Kingdom, WC1 3BG
Royal Victoria Infirmary
Newcastle upon Tyne, United Kingdom, NE1 4LP
Derriford Hospital
Plymouth, United Kingdom, PL6 8DH
Salford Royal NHS Foundation Trust
Salford, United Kingdom, M6 8HD
Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
Swansea, United Kingdom, SA6 6NL
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: NCT03085810    
Other Study ID Numbers: MA30143
2016-002937-31 ( EudraCT Number )
First Posted: March 21, 2017    Key Record Dates
Last Update Posted: January 10, 2020
Last Verified: January 2020

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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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Ocrelizumab
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Immunologic Factors
Physiological Effects of Drugs