AzTrials
AzTrials

Multiple Sclerosis, Relapsing-RemittingPhase 3NCT02861014

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)

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Hoffmann-La Roche at 163 sites in 17 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Multiple Sclerosis, Relapsing-Remitting
What is being tested?
Ocrelizumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
681 participants
Where
163 sitesin 17 countries
Study dates
9 Sep 2016to 15 Dec 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 11Show fewer
  • 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

Trial locations and contacts

163 sites in 17 countries.

163 sites in 17 countries

Germany38 sites

  • Klinikum Augsburg, Neurologische Klinik und klinische Neurophysiologie

    Augsburg, 86156

  • Marianne-Strauß-Klinik; Behandlung Kempfen für Multip Sklero Kranke gemeinnütz GmbH

    Berg, 82335

  • Charite - Universitatsmedizin Berlin; Klinik fur Neurologie

    Berlin, 10117

  • Praxis Dr. Said Masri

    Berlin, 12099

  • Gemeinschaftspraxis Dr.med. Reinhard Ehret/Dr. med Wolfram von Pannwitz

    Berlin, 12163

  • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

    Berlin, 13347

  • Studienzentrum für Neurologie und Psychiatrie

    Böblingen, 71034

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791

  • Gesundheitszentrum St. Johannes Hospital; Neurolog. Gemeinschaftspraxis Dres. Schmidt, Neudecker etc

    Bonn, 53111

  • PNP Buchholz, Praxis für Neurologie - Psychiatrie, Dres. Dee/Gößling/Hoge

    Buchholz, 21244

  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

    Dresden, 01307

  • Gemeinschaftspraxis für Neurologie; Dr. Katrin Schulte, Dr. Nils Richter, Dr. Margarete Capito

    Düsseldorf, 40211

  • NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

    Erbach/Odenwald, 64711

  • Universitaetsklinikum Frankfurt; Klinik für Neurologie

    Frankfurt, 60528

  • Universitätsklinikum Freiburg, Klinik für Neurologie und Neurophysiologie

    Freiburg im Breisgau, 79106

  • Universiätsklinikum Hamburg-Eppendorf , Multiple Sklerose Tagesklinik u. Ambulanz Neurol. Poliklinik

    Hamburg, 20246

  • Neurologische Praxisgemeinschaft Hamburger-Straße; Dres. Müller-Habich/Emrich/Vogt

    Hamburg, 22083

  • MultipEL Studies - Institut für klinische Studien

    Hamburg, 22179

  • Henriettenstiftung Hannover; Klinik fuer Neurologie und Klinische Neurophysiologie

    Hanover, 30171

  • Neurologische Klinik, Universitätsklinikum Heidelberg

    Heidelberg, 69120

  • Oberhavel Kliniken GmbH, Klinik Hennigsdorf, Neurologie

    Hennigsdorf, 16761

  • Neurozentrum am Klosterforst in Itzehoe

    Itzehoe, 25524

  • Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

    Kassel, 34121

  • PANAKEIA - Arzneimittelforschung Leipzig GmbH

    Leipzig, 04275

  • Universitätsklinikum Magdeburg,Otto-von-Guericke-Universität A.ö.R., Klinik für Neurologie

    Magdeburg, 39120

  • Universitaetsklinikum Mainz - PS; Klinik und Poliklinik fuer Neurologie

    Mainz, 55131

  • Universitaetsklinikum Marburg; Klinik fuer Neurologie

    Marburg, 35043

  • Max-Planck-Institut für Psychiatrie

    München, 80804

  • Klinikum Grosshadern der LMU; Neuroimmunologie II

    München, 81377

  • Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

    München, 81675

  • Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

    Münster, 48149

  • Ruppiner Kliniken, Hochschulklinikum der Medizinischen Hochschule Brandenburg, Klinik für Neurologie

    Neuruppin, 16816

  • AMEOS Klinikum Oldenburg, Klinik für Neurologie und Neurophysiologie

    Oldenburg in Holstein, 23758

  • St. Josefs-Krankenhaus, Klinik für Neurologie

    Potsdam, 14471

  • NeuroConcept AG C/O mind mvz GmbH

    Stuttgart, 70182

  • Universitätsklinikum Tübingen, Zentrum für Neurologie

    Tübingen, 72076

  • NeuroPoint, Gesellschaft für vorbeugende Gesundheitspflege mbH

    Ulm, 89073

  • Studienzentrum Nordwest, Dr. med. Joachim Springub / Herr Wolfgang Schwarz

    Westerstede, 26655

Other trials in Germany

Italy32 sites

  • AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla

    Ancona, The Marches, 60100

  • Ospedale Dimiccoli Barletta; Dipartimento Testa-Collo - UO Neurologia

    Barletta, Apulia, 70051

  • ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla

    Bergamo, Lombardy, 24127

  • Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA

    Bologna, Emilia-Romagna, 40139

  • Ospedale Binaghi; Centro Sclerosi Multipla

    Cagliari, Sardinia, 09126

  • AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

    Catania, Sicily, 95123

  • Fondazione Istituto S. Raffaele - Giglio; UO Neurologia

    Cefalù, Sicily, 90015

  • Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla

    Chieti, Abruzzo, 66013

  • AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

    Florence, Tuscany, 50134

  • AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2

    Florence, Tuscany, 50134

  • Ospedale S.Antonio Abate; Neurologia 2 - Sclerosi Multipla e Recupero Neurologico

    Gallarate, Lombardy, 21013

  • Irccs A.O.U.San Martino Ist; Dinogmi

    Genoa, Liguria, 16132

  • Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla

    L’Aquila, Abruzzo, 67100

  • Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative

    Milan, Lombardy, 20122

  • IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

    Milan, Lombardy, 20132

  • Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

    Milan, Lombardy, 20133

  • Ospedale Civile di Montichiari; Centro Sclerosi Multipla

    Montichiari, Lombardy, 25018

  • A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

    Naples, Campania, 80131

  • Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

    Naples, Campania, 80131

  • Azienda Ospedaliera di Padova; Clinica Neurologica

    Padova, Veneto, 35128

  • AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla

    Palermo, Sicily, 90129

  • AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

    Palermo, Sicily, 90146

  • IRCCS Istituto Neurologico C. Mondino-Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

    Pavia, Lombardy, 27100

  • AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica

    Perugia, Umbria, 06156

  • IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

    Pozzilli, Molise, 86077

  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

    Rome, Lazio, 00133

  • Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico

    Rome, Lazio, 00152

  • Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla

    Rome, Lazio, 00168

  • Azienda Ospedaliera Sant'Andrea; UOC Neurologia

    Rome, Lazio, 00189

  • IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia

    San Giovanni Rotondo, Apulia, 71013

  • AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale

    Siena, Tuscany, 53100

  • Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B - Amb. Sclerosi Multipla

    Verona, Veneto, 37134

Other trials in Italy

Spain19 sites

  • Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia

    A Coruña, LA Coruña, 15006

  • Hospital del Mar; Servicio de Neurologia

    Barcelona, 08003

  • Hospital Vall d'Hebron; Servicio de Neurología

    Barcelona, 08035

  • Hospital Puerta del Mar; Sevicio de Neurologia

    Cadiz, 11009

  • Hospital General de Castellon; Servicio de Neurología

    Castellon, Castellon, 12004

  • Hospital Universitari de Bellvitge; Servicio de Neurologia

    L'Hospitalet de Llobregat, Barcelona, 08907

  • Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología

    Lleida, Lerida, 25198

  • Universitario de La Princesa; Servicio de Neurología

    Madrid, 28006

  • Hospital Universitario Clínico San Carlos; Servicio de Neurología

    Madrid, 28040

  • Hospital Universitario 12 de Octubre; Servicio de Neurologia

    Madrid, 28041

  • Hospital Universitario La Paz; Servicio de Neurologia

    Madrid, 28046

  • Hospital Universitario Virgen de Arrixaca; Servicio de Neurología

    Murcia

  • Hospital Universitario Central de Asturias; Servicio de Neurología

    Oviedo, Principality of Asturias

  • Hospital Quiron de Madrid; Servicio de Neurologia

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia

    Salt, Girona, 17190

  • Hospital Universitario Virgen Macarena; Servicio de Neurologia

    Seville, 41009

  • Hospital Clinico Universitario de Valencia; Servicio de Neurologia

    Valencia, 46010

  • Hospital Universitario la Fe; Servicio de Neurologia

    Valencia, 46026

  • Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia

    Vigo, Pontevedra, 36312

Other trials in Spain

France15 sites

  • CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

    Besançon, 25030

  • Groupe Hospitalier Pellegrin; Service de neurochirurgie B

    Bordeaux, 33076

  • Hopital Neurologique et Neurochirurgical Pierre Wertheimer; Service de Neurologie A

    Bron, 69677

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B

    Clermont-Ferrand, 63003

  • Hopital Roger Salengro; Service de Neurologie

    Lille

  • CHU de la Timone - Hopital d Adultes; Service de Neurologie

    Marseille, 13005

  • Hopital Gui de Chauliac; Neurologie

    Montpellier, 34295

  • Hôpital Guillaume et René Laënnec; Service Neurologie

    Nantes, 44805

  • Hôpital Pasteur; Service de Neurologie

    Nice, 06002

  • Fondation Rothschild; Service de Neurologie

    Paris, 75019

  • Groupe Hospitalier Pitié- Salpétrière; Service Neurologie

    Paris, 75651

  • Hôpital Maison Blanche; Service de Neurologie

    Reims, 51092

  • Hôpitaux Universitaires de strasbourg - hôpital civil

    Strasbourg, 67091

  • CHU toulouse - Hôpital Purpan; Departement de Neurologie

    Toulouse, 31059

  • CHRU - Hôpital Bretonneau; Neurologie

    Tours, 37000

Other trials in France

United Kingdom14 sites

  • New Queen Elizabeth Hospital Birmingham

    Birmingham, B15 2WB

  • Western General Hospital

    Edinburgh, EH4 2XU

  • Royal Devon and Exeter Hospital (Wonford)

    Exeter, EX2 5DW

  • Queen Elizabeth University Hospital

    Glasgow, G51 4TF

  • Raigmore Hospital

    Inverness, IV2 3UV

  • Leeds Teaching Hospitals NHS Trust

    Leeds, LS9 7AU

  • The Royal London Hospital

    London, E1 1FR

  • Kings College Hospital

    London, SW9 8RR

  • Charing Cross Hospital

    London, W6 8RF

  • Royal Victoria Infirmary

    Newcastle upon Tyne, NE1 4LP

  • Salford Royal NHS Foundation Trust

    Salford, M6 8HD

  • Royal Hallamshire Hospita

    Sheffield, S10 2JF

  • Morriston Hospital

    Swansea, SA6 6NL

  • Royal Cornwall Hospital

    Truro, TR1 3LQ

Other trials in United Kingdom

Belgium8 sites

  • Hospital Erasme

    Brussels, 1070

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • UZ Antwerpen

    Edegem, 2650

  • UZ Gent

    Ghent, 9000

  • CHU Tivoli

    La Louvière, 7100

  • UZ Leuven Gasthuisberg

    Leuven, 3000

  • Nationaal MS Centrum

    Melsbroek, 1820

  • Revalidatie en MS Centrum

    Overpelt, 3900

Other trials in Belgium

Turkey (Türkiye)8 sites

  • Hacettepe University Medical Faculty; Neurology

    Ankara, 06100

  • Istanbul Uni Istanbul Medical Faculty

    Istanbul, 34093

  • Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

    Istanbul, 34098

  • Ege University Medical Faculty

    Izmir, 35100

  • Kocaeli University Hospital; Department of Neurology

    Kocaeli, 41380

  • Mersin University Medical Faculty; Neurology

    Mersin, 33079

  • Ondokuz Mayis Univ. Med. Fac.; Neurology

    Samsun, 55139

  • Karadeniz Tecnical Uni. Med. Fac.; Neurology

    Trabzon, 61080

Other trials in Turkey (Türkiye)

Netherlands5 sites

  • Amphia Ziekenhuis

    Breda, 4819 EV

  • St. Antonius Ziekenhuis Nieuwegein

    Nieuwegein, 3435 CM

  • Maasstadziekenhuis

    Rotterdam, 3079 DZ

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG

  • Sint Elizabeth Ziekenhuis

    Tilburg, 5042 AD

Other trials in Netherlands

Czechia4 sites

  • Fakultni nemocnice u sv. Anny; Neurologicka klinika

    Brno, 656 91

  • Nemocnice Jihlava; NEU-Neurologicke oddeleni

    Jihlava, 58633

  • VFN Praha Poliklinika Rs Centrum - Budova A

    Prague, 12808

  • Fakultni nemocnice Motol; Neurologicka klinika

    Prague, 150 06

Other trials in Czechia

Denmark4 sites

  • Aarhus Universitetshospital, Neurologisk Afd. F, Skleroseklinikken

    Aarhus N, 8200

  • Rigshospitalet Glostrup; Neurologisk Klinik

    Glostrup Municipality, 2600

  • Odense Universitetshospital, Neurologisk Afdeling N

    Odense C, 5000

  • Sydjysk Skleroseklinik - Sønderborg

    Sønderborg, 6400

Other trials in Denmark

Estonia3 sites

  • East Tallinn Central Hospital; Neurology Department

    Tallinn, 10138

  • West Tallinn Central Hospital

    Tallinn, 10617

  • Tartu University Hospital

    Tartu, 51014

Other trials in Estonia

Ireland3 sites

  • Cork University Hospital; Clinical Research Facility

    Cork

  • Beaumont Hospital

    Dublin, 9

  • St Vincents University Hospital

    Dublin

Other trials in Ireland

Sweden3 sites

  • Sahlgrenska Sjukhuset; Neurology

    Gothenburg, 413 45

  • Länssjukhuset Ryhov; Medicinkliniken / Neurologmottagningen

    Jönköping, 55185

  • Centrum för Neurologi

    Stockholm, 113 41

Other trials in Sweden

Finland2 sites

  • Terveystalo Tampere

    Tampere, 33100

  • Mehiläinen Neo Turku

    Turku, 20520

Other trials in Finland

Norway2 sites

  • Haukeland Universitetssykehus

    Bergen, 5021

  • Sykehuset Buskerud HF; Nevrologisk avdeling

    Drammen, 3004

Other trials in Norway

Switzerland2 sites

  • Universitätsspital Basel Medizin Neurologie; Neurologische Poliklinik

    Basel, 4031

  • CHUV Lausanne Méd.Neurologie

    Lausanne, 1011

Other trials in Switzerland

Australia1 site

  • St George Hospital

    Kogarah, New South Wales, New South Wales, 2217

Other trials in Australia

About this study

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

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.

Being tested
Ocrelizumab
Medical subject headings
Multiple Sclerosis, Relapsing-Remitting

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OcrelizumabBiological

    Also called RO4964913

    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.

Study groups in NCT02861014
Study groupRoleWhat they receive
OcrelizumabExperimentalOcrelizumab 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.
Receives: Biological: Ocrelizumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  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

    Measured: Week 96

Secondary outcomes (26)

  1. Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 24 Weeks 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

    Measured: Baseline up to 24 weeks

  2. Percentage of Participants Free From a Protocol-Defined Event of Disease Activity During 48 Weeks 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

    Measured: Baseline up to 48 weeks

  3. Time to First Protocol-Defined Event of Disease Activity

    The definition of a protocol-defined event of disease activity is the occurrence of at least one of the following while on treatment with ocrelizumab:

    • A protocol-defined relapse defined as: Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors; Symptoms should be preceded by neurological stability for at least 30 days; Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment
    • 24 weeks confirmed disability progression based on increases 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.

    Measured: Baseline up to 96 Weeks

  4. Change From Baseline to Week 96 in Expanded Disability Status Scale (EDSS)

    The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.

    Measured: Baseline, Weeks: 24, 48, 72, 96

  5. Absolute Change From Baseline in EDSS Category at Week 96

    The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.

    Measured: Up to Week 96

  6. Percentage of Participants With a Baseline EDSS Score ≥2 With CDI at Week 96

    The EDSS is an ordinal clinical rating scale ranging from 0 (normal neurologic examination) to 10 (death due to MS) in half-point increments.

    Measured: Week 96

  7. Annualized Protocol-defined Relapse Rate at Week 96

    Measured: Week 96

  8. Time to Onset of 24-week Confirmed Disability Progression

    Measured: Baseline up to 96 Weeks

  9. Time to Onset of First Protocol-Defined Relapse

    A protocol-defined multiple sclerosis (MS) relapse is an occurrence of new or worsening neurological symptoms attributable to MS that meets the following criteria:

    • Symptoms must persist for >24 hours and should not be attributable to confounding clinical factors (e.g., fever, infection, injury, adverse reactions to medications)
    • Symptoms should be preceded by neurological stability for at least 30 days
    • Symptoms should be accompanied by new objective neurological worsening determined with a timely EDSS/ Functional Systems Score (FSS) assessment, consistent with an increase of at least:
    • ≥ 0.5 points on EDSS scale
    • or ≥ 2 points on one of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual
    • or ≥ 1 point on two or more of the following FSS scales: pyramidal, ambulation, cerebellar, brainstem, sensory, or visual

    Measured: Baseline up to 96 Weeks

  10. Time to Onset of First New and/or Enlarging T2 Lesion

    Measured: Baseline up to 96 Weeks

  11. Mean Number of T1 Gd-enhancing Lesions Per MRI Scan at Weeks 24, 48 and 96

    Mean number of T1 Gd-enhancing lesions per MRI scan: Total number of T1 Gd-enhanced lesions divided by the total number of interpretable MRI scans

    Measured: Weeks: 24, 48, 96

  12. Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From

    Measured: Baseline, Week 96

  13. Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI

    Measured: Baseline, Week 96

  14. Volume of New and/or Enlarging T2 Hyperintense Lesions Volume of Lesions Per MRI Scan at Weeks 24, 48, 96

    The number of new and/or enlarging T2 lesions at week 24, 48 and 96 is calculated as the sum of the individual number of new and/or enlarging lesions at each visit. Data from other unscheduled assessments is included in this summary or analysis.

    Measured: Weeks 24, 48, 96

  15. Mean Number of New and/or Enlarging T2 Hyperintense Lesions Per MRI Scan

    Mean number of new and/or enlarging T2 hyperintense lesions per MRI scan: Total number of new and/or enlarging T2 hyperintense lesions divided by the total number of interpretable MRI scans

    Measured: Weeks 24, 48, 96

  16. Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume

    Measured: Weeks 48, 96

  17. Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume

    Measured: Weeks 48, 96

  18. Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume

    Measured: Weeks 48, 96

  19. Adjusted Mean Percentage Change From Baseline in Brain Volume

    Measured: Weeks 24, 48, 96

  20. Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume

    Measured: Weeks 48, 96

  21. Adjusted Mean Percentage Change From Baseline in White Matter Volume

    Measured: Weeks 48, 96

  22. 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

    Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span. The higher the results, the better processing speed/working memory.

    Measured: Baseline, Weeks: 48, 96

  23. 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

    Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.

    Measured: Baseline, Weeks 48, 96

  24. 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

    Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Symbol Digits Modalities Test (SDMT) is assessing processing speed/working memory. The SDMT presents a series of nine symbols, each paired with a single digit in a key at the top of a standard sheet of paper. Participants are asked to voice the digit associated with each symbol as rapidly as possible for 90 sec. There is a single outcome measure - the number correct over the 90 sec time span.

    Measured: Baseline, Weeks 48, 96

  25. 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

    Brief International Cognitive Assessment for MS (BICAMS) is assessing cognitive processing speed and verbal and visual memory. Brief Visuospatial Memory Test-Revised (BVMT-R) is assessing visuospatial memory. In this test, six abstract designs are presented for 10 sec. The display is removed from view and patients render the stimuli via pencil on paper manual responses. Each design receives from 0 to 2 points representing accuracy and location. There are three learning trials, and the outcome measure is the total number of points earned over the three learning trials, thus the scale range is 0-36. The higher the result, the better visual/spatial memory.

    Measured: Baseline, Weeks: 48, 96

  26. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: Baseline up to to 96 weeks after the end of the Treatment Period

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2016 (estimated)
  2. Study start9 Sep 2016
  3. Primary completion25 Oct 2019
  4. Study completion15 Dec 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
681 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02861014
Sponsor's protocol ID
MA30005
Other IDs
2015-005597-38, 2015
Status last verified
Jan 2022
First submitted
5 Aug 2016
Last updated
27 Jan 2022

Publications

  • Vermersch P, Benedict RHB, Van Wijmeersch B, Cutter G, Kister L, Oreja-Guevara C, Siva A, Wiendl H, Wuerfel J, El Azzouzi B, Kuenzel T, Buffels R, Craveiro L, Dirks P, Comi G. Efficacy and Safety of Patients With Relapsing Multiple Sclerosis Switching to Ocrelizumab Due to Suboptimal Treatment Response: Results of the 4-Year CASTING-LIBERTO Trial. Eur J Neurol. 2026 Jun;33(6):e70628. doi: 10.1111/ene.70628.

    PubMed 42328798

  • 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.

    PubMed 34748672

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Ocrelizumab in people with Multiple Sclerosis, Relapsing-Remitting, run by Hoffmann-La Roche at 163 sites in 17 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 27 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 163 sites in Germany, Italy, Spain, France, United Kingdom and 12 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 3 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants With No Evidence of Disease Activity (NEDA) as Per Protocol Defined Events During a 96-Week Period (time frame: Week 96). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02861014, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2022.

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