Clinical trial NCT03085810: Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
Official title: An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2017-03-21
Enrollment: 1225
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

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

Exclusions Related to General Health:

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

Exclusions Related to Medications:

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

Exclusion related to Shorter Infusion Substudy:

- Any previous serious IRRs experienced with ocrelizumab treatment

Primary outcomes:
measure: Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks and 48 Weeks as Measured Using Expanded Disability Status Scale (EDSS)
timeFrame: Baseline up to 4 years
measure: Percentage of Participants With 24-Week and 48-Week Confirmed Disability Improvement (CDI) During the Year 1 Treatment Period, as Measured Using EDSS
timeFrame: At Weeks 24 and 48 during Year 1
measure: Percentage of Participants Event-Free for CDP Sustained for at Least 24 and 48 Weeks at Year 1, as Measured Using EDSS
timeFrame: Year 1 (Weeks 24 and 48)
measure: Percentage of Participants With 24-Week and 48-Week CDI During the Year 2 Treatment Period, as Measured Using EDSS
timeFrame: At Weeks 48, 72 and 96 during Year 2
measure: Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 2, as Measured Using EDSS
timeFrame: Year 2 (Weeks 72 and 96)
measure: Percentage of Participants With 24-Week and 48-Week CDI at Year 4, as Measured Using EDSS
timeFrame: At Weeks 144, 168 and 192 during Year 4
measure: Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 4, as Measured Using EDSS
timeFrame: Year 4 (Weeks 168 and 192)
measure: Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS
timeFrame: Year 1 (Week 48)
measure: Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS
timeFrame: Year 2 (Week 96)
measure: Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 3, As Measured Using EDSS
timeFrame: Year 3
measure: Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 4, As Measured Using EDSS
timeFrame: Year 4
measure: Mean Change From Baseline in EDSS Score at Week 24
timeFrame: From Baseline to Week 24
measure: Mean Change From Baseline in EDSS Score at Week 48
timeFrame: From Baseline to Week 48
measure: Mean Change From Baseline in EDSS Score at Week 72
timeFrame: From Baseline to Week 72
measure: Mean Change From Baseline in EDSS Score at Week 96
timeFrame: Baseline, Week 96
measure: Mean Change From Baseline in EDSS Score at Week 120
timeFrame: Baseline, Week 120
measure: Mean Change From Baseline in EDSS Score at Week 144
timeFrame: Baseline, Week 144
measure: Mean Change From Baseline in EDSS Score at Week 168
timeFrame: Baseline, Week 168
measure: Mean Change From Baseline in EDSS Score at Week 192
timeFrame: Baseline, Week 192
measure: Percentage of Participants Without Protocol-Defined Event of Disease Activity
timeFrame: Baseline up to 4 years
measure: Percentage of Participants Without Relapse
timeFrame: Baseline up to 4 years
measure: Annualized Relapse Rate
timeFrame: Baseline up to 4 years
measure: Sub Study: Number of Participants With IRRs Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy
timeFrame: Week 24 through Week 144
Secondary outcomes:
measure: Percentage of Participants Who Are Relapse Free
timeFrame: Week 192
measure: Percentage of Participants With No Evidence of Protocol Defined Disease Activity
timeFrame: Weeks 96, 144, 192
measure: Percentage of Participants Without Protocol-defined Event of Evidence of Progression (NEP)
timeFrame: Weeks 96, 192
measure: Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD)
timeFrame: Weeks 96, 192
measure: Secondary: Change From Baseline in Multiple Sclerosis Functional Composite Score (MSFC) Total
timeFrame: Weeks 24, 48, 72, 96, 120, 144, 168, 192
measure: Change From Baseline in MSFC Composite Timed 25 Foot Walk Test (T25FW) Score.
timeFrame: Baseline, Weeks 24, 48, 72, 96, 120, 144, 168, 192
measure: Change From Baseline in MSFC Composite 9 Hole Peg Test (9HPT) Score
timeFrame: Weeks 24, 48, 72, 96, 120, 144, 168, 192
measure: Change From Baseline in MSFC Composite (Paced Auditory Serial Addition Test [PASAT]) Score
timeFrame: Weeks 24, 48, 72, 96, 120, 144, 168, 192
measure: Change From Baseline in Cognitive Performance as Measured by Brief International Cognitive Assessment for Multiple Sclerosis (BICAMS) - Symbol Digits Modalities Test (SDMT)
timeFrame: Baseline, Weeks 48, 96, 144, 192
measure: Change From Baseline in Cognitive Performance as Measured by BICAMS -California Verbal Learning Test-II (CVLT-II)
timeFrame: Baseline, Weeks 48, 96, 144, 192
measure: Change From Baseline in Cognitive Performance as Measured by BICAMS - Brief Visuospatial Memory Test-Revised (BVMT-R)
timeFrame: Baseline, Weeks 48, 96, 144, 192
measure: Total Number of T1 Gd-Enhancing Lesions as Detected by Brain MRI
timeFrame: Weeks 24, 48, 96, 144, 192
measure: Total Number of New and/or Enlarging T2 Lesion as Detected by Brain MRI
timeFrame: Baseline, Weeks 24, 48, 96, 144, 192
measure: Change From Baseline in Total T1 Hypointense Lesion Volume as Detected by Brain MRI
timeFrame: Baseline, Weeks 48, 96, 144, 192
measure: Total Number of Fluid-Attenuated Inversion-Recovery (FLAIR) Lesion as Detected by Brain MRI
timeFrame: Baseline, Weeks 8, 24, 48, 96, 144, 192
measure: Change From Baseline in Brain Volume as Detected by Brain MRI
timeFrame: From Baseline to Weeks 24, 48, 96, 144, 192
measure: Percentage of Participants Without Treatment Discontinuation
timeFrame: Baseline up to 4 years
measure: Employment Status: Work Productivity and Activity Impairment Questionnaire (WAPI) Score
timeFrame: Baseline, Weeks 24, 48, 96, 120, 144, 192
measure: SymptoMScreen Composite Score
timeFrame: Baseline, Weeks 24, 48, 96, 144, 192
measure: Quality of Life: Multiple Sclerosis Impact Scale (MSIS)-29 Questionnaire Score
timeFrame: Baseline, Weeks 24, 48, 96, 144, 192
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to 4 years
measure: Substudy: Number of Participants With IRR Overall and by Dose at Randomization
timeFrame: From Week 24 to Week 144
measure: Substudy: Severity of IRRs
timeFrame: From Week 24 to Week 144
measure: Substudy: Number of IRR Symptoms
timeFrame: From Week 24 to Week 144
measure: Substudy: IRRs Leading to Treatment Discontinuation
timeFrame: From Week 24 to Week 144
Other outcomes:
Locations:
city: Irvine
country: United States
facility: University of California Irvine
state: California
city: Sunnyvale
country: United States
facility: Palo Alto Medical Foundation Research Center
state: California
city: Aurora
country: United States
facility: University of Colorado Denver
state: Colorado
city: Fort Collins
country: United States
facility: Advanced Neurology of Colorado, LLC
state: Colorado
city: Stamford
country: United States
facility: KI Health Partners, LLC; New England Institute for Clinical Research
state: Connecticut
city: Washington
country: United States
facility: Georgetown University Medical Center
state: District of Columbia
city: Tampa
country: United States
facility: University of South Florida - Bradenton
state: Florida
city: Atlanta
country: United States
facility: Shepherd Center Inc.
state: Georgia
city: Overland Park
country: United States
facility: College Park Family Care Ctr
state: Kansas
city: Baton Rouge
country: United States
facility: The NeuroMedical Center
state: Louisiana
city: Scarborough
country: United States
facility: Maine Medical Center
state: Maine
city: Baltimore
country: United States
facility: University of Maryland Medical Center; Department of Neurology
state: Maryland
city: Foxboro
country: United States
facility: Neurology Center of New England
state: Massachusetts
city: Wellesley
country: United States
facility: Dragonfly Research, LLC
state: Massachusetts
city: Golden Valley
country: United States
facility: Minneapolis Clinic of Neurology
state: Minnesota
city: Las Vegas
country: United States
facility: Cleveland Clinic Lou Ruvo; Center for Brain Research
state: Nevada
city: New York
country: United States
facility: Columbia University Medical Center
state: New York
city: Plainview
country: United States
facility: Island Neurological Associates, P.C.
state: New York
city: Hickory
country: United States
facility: Neurology Associates PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest University Health Sciences
state: North Carolina
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
state: Ohio
city: Dayton
country: United States
facility: Neurology Specialists, Inc
state: Ohio
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
city: Bedford
country: United States
facility: Kane Hall Barry Neurology
state: Texas
city: Tacoma
country: United States
facility: MultiCare Health System Institute for Research and Innovation
state: Washington
city: Milwaukee
country: United States
facility: Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
state: Wisconsin
city: Buenos Aires
country: Argentina
facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR
city: Buenos Aires
country: Argentina
facility: Hospital Churruca Visca
city: Rosario
country: Argentina
facility: Fundacion Rosarina de Neurorehabilitacion
city: Camperdown
country: Australia
facility: Brain and Mind Centre
state: New South Wales
city: Liverpool
country: Australia
facility: Liverpool Hospital
state: New South Wales
city: New Lambton
country: Australia
facility: John Hunter Hospital
state: New South Wales
city: St Leonards
country: Australia
facility: Royal North Shore Hospital; Department of Neurology
state: New South Wales
city: Woolloongabba
country: Australia
facility: Princess Alexandra Hospital
state: Queensland
city: Box Hill
country: Australia
facility: Box Hill Hospital; Department of Neurology
state: Victoria
city: Heidelberg
country: Australia
facility: Austin Hospital; Department of Neurology
state: Victoria
city: Parkville
country: Australia
facility: Royal Melbourne Hospital; Department of Neurology
state: Victoria
city: Nedlands
country: Australia
facility: Perron Institute for Neurological and Translational Science
state: Western Australia
city: Graz
country: Austria
facility: Medizinische Universität Graz; Universitätsklinik für Neurologie
city: Innsbruck
country: Austria
facility: Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
city: Salzburg
country: Austria
facility: Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
city: Wien
country: Austria
facility: Medizinische Universität Wien; Univ.Klinik fuer Neurologie
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Brussel
country: Belgium
facility: UZ Brussel
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Overpelt
country: Belgium
facility: Revalidatie en MS Centrum
city: Belo Horizonte
country: Brazil
facility: Hospital das Clinicas - UFMG
state: MG
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: PR
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: RS
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: SP
city: Sofia
country: Bulgaria
facility: Shat Np Sveti Naum; 3Rd Clinic of Neurology
city: Sofia
country: Bulgaria
facility: Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
city: Sofia
country: Bulgaria
facility: UMHAT Alexandrovska, EAD; Neurology
city: Vancouver
country: Canada
facility: UBC Hospital; Div of Neurology, Dept of Medicine
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre Uni Campus
state: Ontario
city: Ottawa
country: Canada
facility: Ottawa Hospital Research Institute
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Science Centre
state: Ontario
city: Gatineau
country: Canada
facility: Clinique NeuroOutaouais
state: Quebec
city: Greenfield Park
country: Canada
facility: Recherche Sepmus Inc.
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
city: Glostrup
country: Denmark
facility: Rigshospitalet; Neurologisk Klinik Glostrup
city: Besançon
country: France
facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
city: Bordeaux
country: France
facility: Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
city: Bron
country: France
facility: Hopital Pierre Wertheimer; Neurologie D
city: Caen
country: France
facility: CHU de Caen Hopital Cote de Nacre
city: Clermont Ferrand
country: France
facility: CHU Hopital Gabriel Montpied; Service de Neurologie
city: Gonesse
country: France
facility: CH de Gonesse; Neurologie
city: La Tronche
country: France
facility: CHU de Grenoble; Neurologie
city: Montpellier
country: France
facility: Hopital Gui de Chauliac; Neurologie
city: Nancy
country: France
facility: Hopital Central - CHU de Nancy; Service de Neurologie
city: Nantes
country: France
facility: Hôpital Guillaume et René Laënnec; Service Neurologie
city: Nice
country: France
facility: Hôpital Pasteur; Service de Neurologie
city: Nimes
country: France
facility: CHU de Nîmes Hopital Caremeau; Service de Neurologie
city: Poissy
country: France
facility: Hôpital de Poissy; Service neurologie
city: Rennes
country: France
facility: Centre Hospitalier Universitaire de Rennes
city: Rouen
country: France
facility: CHU de Rouen Hopital; Service de Neurologie
city: Strasbourg
country: France
facility: CHU de Strasbourg
city: Suresnes
country: France
facility: Hopital Foch; Neurologie
city: Toulon
country: France
facility: HIA de Toulon hôpital militaire; Neurologie
city: Toulouse
country: France
facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie
city: Tours
country: France
facility: CHRU - Hôpital Bretonneau; Neurologie
city: Barsinghausen
country: Germany
facility: Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
city: Bochum
country: Germany
facility: St. Josef-Hospital, Klinik für Neurologie
city: Böblingen
country: Germany
facility: Studienzentrum Dr. Bischof GmbH
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
city: Düsseldorf
country: Germany
facility: Universitätsklinikum Düsseldorf; Klinik für Neurologie
city: Erbach/Odenwald
country: Germany
facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
city: Essen
country: Germany
facility: Universitätsklinikum Essen (AöR); Klinik für Neurologie
city: Hamburg
country: Germany
facility: MultipEL Studies - Institut für klinische Studien
city: Heidelberg
country: Germany
facility: Universitaetsklinikum Heidelberg
city: Kassel
country: Germany
facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
city: Kiel
country: Germany
facility: Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
city: Marburg
country: Germany
facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie
city: München
country: Germany
facility: Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
city: Münster
country: Germany
facility: Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
city: Neuburg
country: Germany
facility: Praxis Dr. med. Bergmann
city: Seesen
country: Germany
facility: Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Zentrum für Neurologie
city: Budapest
country: Hungary
facility: Semmelweis Egyetem AOK; Neurologiai Klinika
city: Budapest
country: Hungary
facility: Budapesti Uzsoki Utcai Kórház
city: Budapest
country: Hungary
facility: Jahn Ferenc Dél-Pesti Kórház
city: Esztergom
country: Hungary
facility: VALEOMED Diagnosztikai Központ
city: Szeged
country: Hungary
facility: Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
city: Catanzaro
country: Italy
facility: A.O.U. Mater Domin; U.O. NEUROLOGIA
state: Calabria
city: Napoli
country: Italy
facility: A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
state: Campania
city: Napoli
country: Italy
facility: Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
state: Campania
city: Trieste
country: Italy
facility: Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica
state: Friuli-Venezia Giulia
city: Roma
country: Italy
facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea; UOC Neurologia
state: Lazio
city: Genova
country: Italy
facility: Irccs A.O.U.San Martino Ist; Dinogmi
state: Liguria
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
state: Lombardia
city: Milano
country: Italy
facility: Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
state: Lombardia
city: Montichiari
country: Italy
facility: Ospedale Civile di Montichiari; Centro Sclerosi Multipla
state: Lombardia
city: Pozzilli
country: Italy
facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
state: Molise
city: Catania
country: Italy
facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
state: Sicilia
city: Palermo
country: Italy
facility: AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
state: Sicilia
city: Firenze
country: Italy
facility: AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
state: Toscana
city: Grosseto
country: Italy
facility: Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia
state: Toscana
city: Siena
country: Italy
facility: Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche
state: Toscana
city: Kuwait
country: Kuwait
facility: Ibn Sina Hospital; Neurology Department
city: Beirut
country: Lebanon
facility: American University of Beirut - Medical Center
city: Culiacán
country: Mexico
facility: Neurociencias Estudios Clinicos S.C.
state: Sinaloa
city: Mexico
country: Mexico
facility: Hospital General de Mexico
state: Tlaxcala
city: Ciudad de México
country: Mexico
facility: Unidad de investigacion en salud (UIS); Neurociencias
city: 'S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amsterdam
country: Netherlands
facility: VU Medisch Centrum; Afdeling Neurologie
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard Geleen
city: Lørenskog
country: Norway
facility: Akershus universitetssykehus HF; Nevroklinikken S203
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus, Helse Stavanger HF
city: Bydgoszcz
country: Poland
facility: Neurocentrum Bydgoszcz sp. z o.o
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
city: Katowice
country: Poland
facility: Care Clinic
city: Krakow
country: Poland
facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
city: Lodz
country: Poland
facility: Centrum Neurologii Krzysztof Selmaj
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
city: Warszawa
country: Poland
facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
city: Almada
country: Portugal
facility: Hospital Garcia de Orta; Servico de Neurologia
city: Braga
country: Portugal
facility: Hospital de Braga; Servico de Neurologia
city: Coimbra
country: Portugal
facility: HUC; Servico de Neurologia
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo; Servico de Neurologia
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio; Servico de Neurologia
city: Bucharest
country: Romania
facility: Spitalul Universitar de Urgenta Bucuresti
city: Sibiu
country: Romania
facility: Spitalul Clinic Judetean Sibiu
city: Targu-Mures
country: Romania
facility: Spitalul Clinic Judetean de Urgenta Mures
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB
city: Nitra
country: Slovakia
facility: GB NeuroPRAKTIK, s.r.o
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Ljubljana
country: Slovenia
facility: University Medical Centre; Neurology
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
city: Santa Cruz De Tenerife
country: Spain
facility: Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
state: Tenerife
city: Barakaldo
country: Spain
facility: Hospital de Cruces; Servicio de Neurologia
state: Vizcaya
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante; Servicio de Neurología
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Neurologia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
city: Murcia
country: Spain
facility: Hospital General Universitario Morales Meseguer; Servicio de Neurología
city: Göteborg
country: Sweden
facility: Sahlgrenska Sjukhuset; Neurology
city: Karlstad
country: Sweden
facility: Centralsjukhuset; Neurologi och rehabiliteringskliniken
city: Stockholm
country: Sweden
facility: Centrum för Neurologi
city: Basel
country: Switzerland
facility: Universitätsspital Basel; Neurologie
city: Bern
country: Switzerland
facility: Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
city: Lugano
country: Switzerland
facility: Ospedale Regionale di Lugano - Civico; Neurologia
city: Luzern
country: Switzerland
facility: Luzerner Kantonsspital Luzern Medizin Neurologie
city: St. Gallen
country: Switzerland
facility: Kantonsspital; Neurologische Klinik
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Neurology
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty; Departmant of Norology
city: Hatay
country: Turkey
facility: Mustafa Kemal Ataturk UTF; Department of norology
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul Medical Faculty; Neurology
city: Istanbul
country: Turkey
facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
city: Istanbul
country: Turkey
facility: Istanbul Bilim Universty Medical Fac.
city: Istanbul
country: Turkey
facility: Selcuk University Medical Faculty; Norology department
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.; Neurology
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: King'S College Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Plymouth
country: United Kingdom
facility: Derriford Hospital
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Swansea
country: United Kingdom
facility: Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Hartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5):e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep.