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)
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
2 other identifiers
interventional
681
16 countries
144
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2016
Typical duration for phase_3
144 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 5, 2016
CompletedFirst Posted
Study publicly available on registry
August 10, 2016
CompletedStudy Start
First participant enrolled
September 9, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 25, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 15, 2020
CompletedResults Posted
Study results publicly available
February 3, 2021
CompletedJanuary 27, 2022
January 1, 2022
3.1 years
August 5, 2016
October 13, 2020
January 25, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period
A protocol-defined event of disease activity was defined by the occurrence of at least one of the following while on treatment with ocrelizumab: * A protocol-defined relapse (PDR) * 24-week CDP based on increase in EDSS while on treatment with ocrelizumab * A T1 Gd-enhanced lesion after Week 8 * A new and/or enlarging T2 hyperintense lesion on MRI after Week 8 compared to the Week 8 MRI scan
Week 96
Secondary Outcomes (26)
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks Period
Baseline up to 24 weeks
Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks Period
Baseline up to 48 weeks
Time to First Protocol-Defined Event of Disease Activity
Baseline up to 96 Weeks
Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)
Baseline, Weeks: 24, 48, 72, 96
Absolute Change From Baseline in EDSS Category at Week 96
Up to Week 96
- +21 more secondary outcomes
Study Arms (1)
Ocrelizumab
EXPERIMENTALOcrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Interventions
Ocrelizumab will be administered as two 300 mg IV infusions on Days 1 and 15 followed by one 600 mg IV infusions administered at Weeks 24, 48, and 72.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (163)
St George Hospital
Kogarah, New South Wales, New South Wales, 2217, Australia
Hospital Erasme
Brussels, 1070, Belgium
Cliniques Universitaires St-Luc
Brussels, 1200, Belgium
UZ Antwerpen
Edegem, 2650, Belgium
UZ Gent
Ghent, 9000, Belgium
CHU Tivoli
La Louvière, 7100, Belgium
UZ Leuven Gasthuisberg
Leuven, 3000, Belgium
Nationaal MS Centrum
Melsbroek, 1820, Belgium
Revalidatie en MS Centrum
Overpelt, 3900, Belgium
Fakultni nemocnice u sv. Anny; Neurologicka klinika
Brno, 656 91, Czechia
Nemocnice Jihlava; NEU-Neurologicke oddeleni
Jihlava, 58633, Czechia
VFN Praha Poliklinika Rs Centrum - Budova A
Prague, 12808, Czechia
Fakultni nemocnice Motol; Neurologicka klinika
Prague, 150 06, Czechia
Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken
Aarhus N, 8200, Denmark
Rigshospitalet Glostrup; Neurologisk Klinik
Glostrup Municipality, 2600, Denmark
Odense Universitetshospital, Neurologisk Afdeling N
Odense C, 5000, Denmark
Sydjysk Skleroseklinik - Sønderborg
Sønderborg, 6400, Denmark
East Tallinn Central Hospital; Neurology Department
Tallinn, 10138, Estonia
West Tallinn Central Hospital
Tallinn, 10617, Estonia
Tartu University Hospital
Tartu, 51014, Estonia
Terveystalo Tampere
Tampere, 33100, Finland
Mehiläinen Neo Turku
Turku, 20520, Finland
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
Besançon, 25030, France
Groupe Hospitalier Pellegrin; Service de neurochirurgie B
Bordeaux, 33076, France
Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A
Bron, 69677, France
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand, 63003, France
Hopital Roger Salengro; Service de Neurologie
Lille, France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille, 13005, France
Hopital Gui de Chauliac; Neurologie
Montpellier, 34295, France
Hôpital Guillaume et René Laënnec; Service Neurologie
Nantes, 44805, France
Hôpital Pasteur; Service de Neurologie
Nice, 06002, France
Fondation Rothschild; Service de Neurologie
Paris, 75019, France
Groupe Hospitalier Pitié- Salpétrière; Service Neurologie
Paris, 75651, France
Hôpital Maison Blanche; Service de Neurologie
Reims, 51092, France
Hôpitaux Universitaires de strasbourg - hôpital civil
Strasbourg, 67091, France
CHU toulouse - Hôpital Purpan; Departement de Neurologie
Toulouse, 31059, France
CHRU - Hôpital Bretonneau; Neurologie
Tours, 37000, France
Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie
Augsburg, 86156, Germany
Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH
Berg, 82335, Germany
Charite - Universitatsmedizin Berlin; Klinik fur Neurologie
Berlin, 10117, Germany
Praxis Dr. Said Masri
Berlin, 12099, Germany
Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz
Berlin, 12163, Germany
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin, 13347, Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum, 44791, Germany
Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc
Bonn, 53111, Germany
Studienzentrum für Neurologie und Psychiatrie
Böblingen, 71034, Germany
PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge
Buchholz, 21244, Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, 01307, Germany
Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito
Düsseldorf, 40211, Germany
NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
Erbach/Odenwald, 64711, Germany
Universitaetsklinikum Frankfurt; Klinik für Neurologie
Frankfurt, 60528, Germany
Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie
Freiburg im Breisgau, 79106, Germany
Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik
Hamburg, 20246, Germany
Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt
Hamburg, 22083, Germany
MultipEL Studies - Institut für klinische Studien
Hamburg, 22179, Germany
Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie
Hanover, 30171, Germany
Neurologische Klinik, Universitätsklinikum Heidelberg
Heidelberg, 69120, Germany
Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie
Hennigsdorf, 16761, Germany
Neurozentrum am Klosterforst in Itzehoe
Itzehoe, 25524, Germany
Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
Kassel, 34121, Germany
PANAKEIA - Arzneimittelforschung Leipzig GmbH
Leipzig, 04275, Germany
Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie
Magdeburg, 39120, Germany
Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie
Mainz, 55131, Germany
Universitaetsklinikum Marburg; Klinik fuer Neurologie
Marburg, 35043, Germany
Max-Planck-Institut für Psychiatrie
München, 80804, Germany
Klinikum Grosshadern der LMU; Neuroimmunologie II
München, 81377, Germany
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München, 81675, Germany
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster, 48149, Germany
Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie
Neuruppin, 16816, Germany
AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie
Oldenburg in Holstein, 23758, Germany
St. Josefs-Krankenhaus, Klinik für Neurologie
Potsdam, 14471, Germany
NeuroConcept AG C/O mind mvz GmbH
Stuttgart, 70182, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen, 72076, Germany
NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH
Ulm, 89073, Germany
Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz
Westerstede, 26655, Germany
Cork University Hospital; Clinical Research Facility
Cork, Ireland
Beaumont Hospital
Dublin, 9, Ireland
St Vincents University Hospital
Dublin, Ireland
Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
Chieti, Abruzzo, 66013, Italy
Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla
L’Aquila, Abruzzo, 67100, Italy
Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia
Barletta, Apulia, 70051, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia
San Giovanni Rotondo, Apulia, 71013, Italy
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Napoli, Campania, 80131, Italy
Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
Napoli, Campania, 80131, Italy
Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA
Bologna, Emilia-Romagna, 40139, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, 00133, Italy
Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico
Rome, Lazio, 00152, Italy
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
Rome, Lazio, 00168, Italy
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
Rome, Lazio, 00189, Italy
Irccs A.O.U.San Martino Ist; Dinogmi
Genoa, Liguria, 16132, Italy
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
Bergamo, Lombardy, 24127, Italy
Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico
Gallarate, Lombardy, 21013, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative
Milan, Lombardy, 20122, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milan, Lombardy, 20132, Italy
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Milan, Lombardy, 20133, Italy
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari, Lombardy, 25018, Italy
IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Pavia, Lombardy, 27100, Italy
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Pozzilli, Molise, 86077, Italy
Ospedale Binaghi; Centro Sclerosi Multipla
Cagliari, Sardinia, 09126, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Catania, Sicily, 95123, Italy
Fondazione Istituto S. Raffaele - Giglio; UO Neurologia
Cefalù, Sicily, 90015, Italy
AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla
Palermo, Sicily, 90129, Italy
AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
Palermo, Sicily, 90146, Italy
AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla
Ancona, The Marches, 60100, Italy
AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
Florence, Tuscany, 50134, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
Florence, Tuscany, 50134, Italy
AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale
Siena, Tuscany, 53100, Italy
AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica
Perugia, Umbria, 06156, Italy
Azienda Ospedaliera di Padova; Clinica Neurologica
Padua, Veneto, 35128, Italy
Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla
Verona, Veneto, 37134, Italy
Amphia Ziekenhuis
Breda, 4819 EV, Netherlands
St. Antonius Ziekenhuis Nieuwegein
Nieuwegein, 3435 CM, Netherlands
Maasstadziekenhuis
Rotterdam, 3079 DZ, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, 6162 BG, Netherlands
Sint Elizabeth Ziekenhuis
Tilburg, 5042 AD, Netherlands
Haukeland Universitetssykehus
Bergen, 5021, Norway
Sykehuset Buskerud HF; Nevrologisk avdeling
Drammen, 3004, Norway
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital General de Castellon; Servicio de Neurología
Castellon, Castellon, 12004, Spain
Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia
Salt, Girona, 17190, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia
A Coruña, LA Coruña, 15006, Spain
Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología
Lleida, Lerida, 25198, Spain
Hospital Quiron de Madrid; Servicio de Neurologia
Pozuelo de Alarcón, Madrid, 28223, Spain
Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia
Vigo, Pontevedra, 36312, Spain
Hospital Universitario Central de Asturias; Servicio de Neurología
Oviedo, Principality of Asturias, Spain
Hospital del Mar; Servicio de Neurologia
Barcelona, 08003, Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona, 08035, Spain
Hospital Puerta del Mar; Sevicio de Neurologia
Cadiz, 11009, Spain
Universitario de La Princesa; Servicio de Neurología
Madrid, 28006, Spain
Hospital Universitario Clínico San Carlos; Servicio de Neurología
Madrid, 28040, Spain
Hospital Universitario 12 de Octubre; Servicio de Neurologia
Madrid, 28041, Spain
Hospital Universitario La Paz; Servicio de Neurologia
Madrid, 28046, Spain
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
Murcia, Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Seville, 41009, Spain
Hospital Clinico Universitario de Valencia; Servicio de Neurologia
Valencia, 46010, Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia, 46026, Spain
Sahlgrenska Sjukhuset; Neurology
Gothenburg, 413 45, Sweden
Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen
Jönköping, 55185, Sweden
Centrum för Neurologi
Stockholm, 113 41, Sweden
Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik
Basel, 4031, Switzerland
CHUV Lausanne Méd.Neurologie
Lausanne, 1011, Switzerland
Hacettepe University Medical Faculty; Neurology
Ankara, 06100, Turkey (Türkiye)
Istanbul Uni Istanbul Medical Faculty
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
Istanbul, 34098, Turkey (Türkiye)
Ege University Medical Faculty
Izmir, 35100, Turkey (Türkiye)
Kocaeli University Hospital; Department of Neurology
Kocaeli, 41380, Turkey (Türkiye)
Mersin University Medical Faculty; Neurology
Mersin, 33079, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, 55139, Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon, 61080, Turkey (Türkiye)
New Queen Elizabeth Hospital Birmingham
Birmingham, B15 2WB, United Kingdom
Western General Hospital
Edinburgh, EH4 2XU, United Kingdom
Royal Devon and Exeter Hospital (Wonford)
Exeter, EX2 5DW, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Raigmore Hospital
Inverness, IV2 3UV, United Kingdom
Leeds Teaching Hospitals NHS Trust
Leeds, LS9 7AU, United Kingdom
The Royal London Hospital
London, E1 1FR, United Kingdom
Kings College Hospital
London, SW9 8RR, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
Royal Hallamshire Hospita
Sheffield, S10 2JF, United Kingdom
Morriston Hospital
Swansea, SA6 6NL, United Kingdom
Royal Cornwall Hospital
Truro, TR1 3LQ, United Kingdom
Related Publications (1)
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.
PMID: 34748672DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 5, 2016
First Posted
August 10, 2016
Study Start
September 9, 2016
Primary Completion
October 25, 2019
Study Completion
December 15, 2020
Last Updated
January 27, 2022
Results First Posted
February 3, 2021
Record last verified: 2022-01