Clinical trial NCT02861014: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2016-08-10
Enrollment: 681
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: 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.


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

Primary outcomes:
measure: Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
timeFrame: Week 96
Secondary outcomes:
measure: Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period
timeFrame: Baseline up to 24 weeks
measure: Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period
timeFrame: Baseline up to 48 weeks
measure: Time to First Protocol-Defined Event of Disease Activity
timeFrame: Baseline up to 96 Weeks
measure: Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)
timeFrame: Baseline, Weeks: 24, 48, 72, 96
measure: Absolute Change From Baseline in EDSS Category at Week 96
timeFrame: Up to Week 96
measure: Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96
timeFrame: Week 96
measure: Annualized Protocol-defined Relapse Rate at Week 96
timeFrame: Week 96
measure: Time to Onset of 24-week Confirmed Disability Progression
timeFrame: Baseline up to 96 Weeks
measure: Time to Onset of First Protocol-Defined Relapse
timeFrame: Baseline up to 96 Weeks
measure: Time to Onset of First New and/or Enlarging T2 Lesion
timeFrame: Baseline up to 96 Weeks
measure: Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96
timeFrame: Weeks: 24, 48, 96
measure: Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From
timeFrame: Baseline, Week 96
measure: Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI
timeFrame: Baseline, Week 96
measure: Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96
timeFrame: Weeks 24, 48, 96
measure: Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan
timeFrame: Weeks 24, 48, 96
measure: Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
timeFrame: Weeks 48, 96
measure: Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
timeFrame: Weeks 48, 96
measure: Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume
timeFrame: Weeks 48, 96
measure: Adjusted Mean Percentage Change From Baseline in Brain Volume
timeFrame: Weeks 24, 48, 96
measure: Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume
timeFrame: Weeks 48, 96
measure: Adjusted Mean Percentage Change From Baseline in White Matter Volume
timeFrame: Weeks 48, 96
measure: 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
timeFrame: Baseline, Weeks: 48, 96
measure: 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
timeFrame: Baseline, Weeks 48, 96
measure: 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
timeFrame: Baseline, Weeks 48, 96
measure: 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
timeFrame: Baseline, Weeks: 48, 96
measure: Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline up to to 96 weeks after the end of the Treatment Period
Other outcomes:
Locations:
city: Kogarah, New South Wales
country: Australia
facility: St George Hospital
state: New South Wales
city: Bruxelles
country: Belgium
facility: Hospital Erasme
city: Bruxelles
country: Belgium
facility: Cliniques Universitaires St-Luc
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: Gent
country: Belgium
facility: UZ Gent
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Leuven
country: Belgium
facility: UZ Leuven Gasthuisberg
city: Melsbroek
country: Belgium
facility: Nationaal MS Centrum
city: Overpelt
country: Belgium
facility: Revalidatie en MS Centrum
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny; Neurologicka klinika
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava; NEU-Neurologicke oddeleni
city: Prague
country: Czechia
facility: VFN Praha Poliklinika Rs Centrum - Budova A
city: Praha
country: Czechia
facility: Fakultni nemocnice Motol; Neurologicka klinika
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup; Neurologisk Klinik
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Neurologisk Afdeling N
city: Sønderborg
country: Denmark
facility: Sydjysk Skleroseklinik - Sønderborg
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital; Neurology Department
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Tampere
country: Finland
facility: Terveystalo Tampere
city: Turku
country: Finland
facility: Mehiläinen Neo Turku
city: Besançon
country: France
facility: CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin; Service de neurochirurgie B
city: Bron
country: France
facility: Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
city: Lille
country: France
facility: Hopital Roger Salengro; Service de Neurologie
city: Marseille
country: France
facility: CHU de la Timone - Hopital d Adultes; Service de Neurologie
city: Montpellier
country: France
facility: Hopital Gui de Chauliac; Neurologie
city: Nantes
country: France
facility: Hôpital Guillaume et René Laënnec; Service Neurologie
city: Nice
country: France
facility: Hôpital Pasteur; Service de Neurologie
city: Paris
country: France
facility: Fondation Rothschild; Service de Neurologie
city: Paris
country: France
facility: Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
city: Reims
country: France
facility: Hôpital Maison Blanche; Service de Neurologie
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de strasbourg - hôpital civil
city: Toulouse
country: France
facility: CHU toulouse - Hôpital Purpan; Departement de Neurologie
city: Tours
country: France
facility: CHRU - Hôpital Bretonneau; Neurologie
city: Augsburg
country: Germany
facility: Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie
city: Berg
country: Germany
facility: Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
city: Berlin
country: Germany
facility: Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
city: Berlin
country: Germany
facility: Praxis Dr. Said Masri
city: Berlin
country: Germany
facility: Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz
city: Berlin
country: Germany
facility: Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
city: Bochum
country: Germany
facility: St. Josef-Hospital, Klinik für Neurologie
city: Bonn
country: Germany
facility: Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc
city: Buchholz
country: Germany
facility: PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge
city: Böblingen
country: Germany
facility: Studienzentrum für Neurologie und Psychiatrie
city: Dresden
country: Germany
facility: Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
city: Düsseldorf
country: Germany
facility: Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito
city: Erbach/Odenwald
country: Germany
facility: NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt; Klinik für Neurologie
city: Freiburg
country: Germany
facility: Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
city: Hamburg
country: Germany
facility: Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik
city: Hamburg
country: Germany
facility: Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt
city: Hamburg
country: Germany
facility: MultipEL Studies - Institut für klinische Studien
city: Hannover
country: Germany
facility: Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie
city: Heidelberg
country: Germany
facility: Neurologische Klinik, Universitätsklinikum Heidelberg
city: Hennigsdorf
country: Germany
facility: Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
city: Itzehoe
country: Germany
facility: Neurozentrum am Klosterforst in Itzehoe
city: Kassel
country: Germany
facility: Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
city: Leipzig
country: Germany
facility: PANAKEIA - Arzneimittelforschung Leipzig GmbH
city: Magdeburg
country: Germany
facility: Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie
city: Mainz
country: Germany
facility: Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
city: Marburg
country: Germany
facility: Universitaetsklinikum Marburg; Klinik fuer Neurologie
city: München
country: Germany
facility: Max-Planck-Institut für Psychiatrie
city: München
country: Germany
facility: Klinikum Grosshadern der LMU; Neuroimmunologie II
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: Neuruppin
country: Germany
facility: Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie
city: Oldenburg in Holstein
country: Germany
facility: AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie
city: Potsdam
country: Germany
facility: St. Josefs-Krankenhaus, Klinik für Neurologie
city: Stuttgart
country: Germany
facility: NeuroConcept AG C/O mind mvz GmbH
city: Tübingen
country: Germany
facility: Universitätsklinikum Tübingen, Zentrum für Neurologie
city: Ulm
country: Germany
facility: NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH
city: Westerstede
country: Germany
facility: Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
city: Cork
country: Ireland
facility: Cork University Hospital; Clinical Research Facility
city: Dublin 4
country: Ireland
facility: St Vincents University Hospital
city: Dublin
country: Ireland
facility: Beaumont Hospital
city: Chieti
country: Italy
facility: Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
state: Abruzzo
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
state: Abruzzo
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: Bologna
country: Italy
facility: Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
state: Lazio
city: Roma
country: Italy
facility: Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
state: Lazio
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli; UOC Neurologia - Centro 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: Bergamo
country: Italy
facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
state: Lombardia
city: Gallarate
country: Italy
facility: Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
state: Lombardia
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: Pavia
country: Italy
facility: IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
state: Lombardia
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla
state: Marche
city: Pozzilli
country: Italy
facility: IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
state: Molise
city: Barletta
country: Italy
facility: Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia
state: Puglia
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Binaghi; Centro Sclerosi Multipla
state: Sardegna
city: Catania
country: Italy
facility: AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
state: Sicilia
city: Cefalù
country: Italy
facility: Fondazione Istituto S. Raffaele - Giglio; UO Neurologia
state: Sicilia
city: Palermo
country: Italy
facility: AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb 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: Firenze
country: Italy
facility: AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
state: Toscana
city: Siena
country: Italy
facility: AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
state: Toscana
city: Perugia
country: Italy
facility: AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
state: Umbria
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova; Clinica Neurologica
state: Veneto
city: Verona
country: Italy
facility: Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla
state: Veneto
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Nieuwegein
country: Netherlands
facility: St. Antonius Ziekenhuis Nieuwegein
city: Rotterdam
country: Netherlands
facility: Maasstadziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard Geleen
city: Tilburg
country: Netherlands
facility: Sint Elizabeth Ziekenhuis
city: Bergen
country: Norway
facility: Haukeland Universitetssykehus
city: Drammen
country: Norway
facility: Sykehuset Buskerud HF; Nevrologisk avdeling
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias; Servicio de Neurología
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge; Servicio de Neurologia
state: Barcelona
city: Castelló de la Plana
country: Spain
facility: Hospital General de Castellon; Servicio de Neurología
state: Castellon
city: Salt
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
state: Girona
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
state: LA Coruña
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
state: Lerida
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid; Servicio de Neurologia
state: Madrid
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital del Mar; Servicio de Neurologia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron; Servicio de Neurología
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar; Sevicio de Neurologia
city: Madrid
country: Spain
facility: Universitario de La Princesa; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos; Servicio de Neurología
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre; Servicio de Neurologia
city: Madrid
country: Spain
facility: Hospital Universitario La Paz; Servicio de Neurologia
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia; Servicio de Neurologia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe; Servicio de Neurologia
city: Göteborg
country: Sweden
facility: Sahlgrenska Sjukhuset; Neurology
city: Jönköping
country: Sweden
facility: Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen
city: Stockholm
country: Sweden
facility: Centrum för Neurologi
city: Basel
country: Switzerland
facility: Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
city: Lausanne
country: Switzerland
facility: CHUV Lausanne Méd.Neurologie
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty; Neurology
city: Istanbul
country: Turkey
facility: Istanbul Uni Istanbul Medical Faculty
city: Istanbul
country: Turkey
facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
city: Izmir
country: Turkey
facility: Ege University Medical Faculty
city: Kocaeli
country: Turkey
facility: Kocaeli University Hospital; Department of Neurology
city: Mersin
country: Turkey
facility: Mersin University Medical Faculty; Neurology
city: Samsun
country: Turkey
facility: Ondokuz Mayis Univ. Med. Fac.; Neurology
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical Uni. Med. Fac.; Neurology
city: Birmingham
country: United Kingdom
facility: New Queen Elizabeth Hospital Birmingham
city: Edinburgh
country: United Kingdom
facility: Western General Hospital
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospita
city: Swansea
country: United Kingdom
facility: Morriston Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References:
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.