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| ID | Type | Description | Link |
|---|---|---|---|
| 2015-005597-38 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Biological | 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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:
| Week 96 |
| Measure | Description | Time Frame |
|---|---|---|
| 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:
|
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St George Hospital | Kogarah, New South Wales | New South Wales | 2217 | Australia | ||
| Hospital Erasme |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42328798 | Derived | 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. | |
| 34748672 |
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One additional participant was initially enrolled in error and the information provided is based on the ITT population.
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| ID | Title | Description |
|---|---|---|
| FG000 | Ocrelizumab | Participants received Ocrelizumab 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. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Primary Analysis |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Nov 4, 2018 | Oct 13, 2020 |
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|
| Baseline up to 24 weeks |
| 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:
| Baseline up to 48 weeks |
| 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:
| Baseline up to 96 Weeks |
| 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. | Baseline, Weeks: 24, 48, 72, 96 |
| 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. | Up to Week 96 |
| 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. | Week 96 |
| Annualized Protocol-defined Relapse Rate at Week 96 | Week 96 |
| Time to Onset of 24-week Confirmed Disability Progression | Baseline up to 96 Weeks |
| 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:
| Baseline up to 96 Weeks |
| Time to Onset of First New and/or Enlarging T2 Lesion | Baseline up to 96 Weeks |
| 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 | Weeks: 24, 48, 96 |
| Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From | Baseline, Week 96 |
| Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI | Baseline, Week 96 |
| 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. | Weeks 24, 48, 96 |
| 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 | Weeks 24, 48, 96 |
| Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | Weeks 48, 96 |
| Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | Weeks 48, 96 |
| Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | Weeks 48, 96 |
| Adjusted Mean Percentage Change From Baseline in Brain Volume | Weeks 24, 48, 96 |
| Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume | Weeks 48, 96 |
| Adjusted Mean Percentage Change From Baseline in White Matter Volume | Weeks 48, 96 |
| 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. | Baseline, Weeks: 48, 96 |
| 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. | Baseline, Weeks 48, 96 |
| 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. | Baseline, Weeks 48, 96 |
| 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. | Baseline, Weeks: 48, 96 |
| Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Baseline up to to 96 weeks after the end of the Treatment Period |
| 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 | Naples | Campania | 80131 | Italy |
| Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur | Naples | 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 | Padova | 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 |
| Derived |
| 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. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
| Safety Follow-up |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Ocrelizumab | Participants received Ocrelizumab 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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:
| The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Week 96 |
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| Secondary | 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:
| The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to 24 weeks |
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| Secondary | 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:
| The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Number | 95% Confidence Interval | Percentage of Participants | Baseline up to 48 weeks |
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| Secondary | 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:
| The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to 96 Weeks |
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| Secondary | 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. | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Mean | Standard Deviation | Points on scale | Baseline, Weeks: 24, 48, 72, 96 |
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| Secondary | 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. | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Number | Percentage of Participants | Up to Week 96 |
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| Secondary | 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. | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Number | Percentage of Participants | Week 96 |
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| Secondary | Annualized Protocol-defined Relapse Rate at Week 96 | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. | Posted | Number | 95% Confidence Interval | Relapses per participant per year | Week 96 |
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| Secondary | Time to Onset of 24-week Confirmed Disability Progression | The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to 96 Weeks |
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| Secondary | 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:
| The modified intent-to-treat (mITT) population was defined as all participants from the ITT population excluding participants with both screening and the baseline EDSS scores missing. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to 96 Weeks |
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| Secondary | Time to Onset of First New and/or Enlarging T2 Lesion | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. | Posted | Median | 95% Confidence Interval | Weeks | Baseline up to 96 Weeks |
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| Secondary | 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 | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | 95% Confidence Interval | Lesions per scan | Weeks: 24, 48, 96 |
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| Secondary | Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI From | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available. | Posted | Mean | Standard Deviation | mL | Baseline, Week 96 |
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| Secondary | Percentage Change From Baseline to Week 96 in Total T2 Lesion Volume Detected by Brain MRI | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available. | Posted | Mean | Standard Deviation | Percentage Change From Baseline | Baseline, Week 96 |
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| Secondary | 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. | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | Standard Deviation | uL | Weeks 24, 48, 96 |
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| Secondary | 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 | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | 95% Confidence Interval | Lesions per scan | Weeks 24, 48, 96 |
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| Secondary | Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | Standard Deviation | mL | Weeks 48, 96 |
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| Secondary | Percentage Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | Standard Deviation | Percentage change from baseline | Weeks 48, 96 |
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| Secondary | Adjusted Mean Change From Baseline at Week 48 and 96 in T1 Hypointense Lesion Volume | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | 95% Confidence Interval | mL | Weeks 48, 96 |
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| Secondary | Adjusted Mean Percentage Change From Baseline in Brain Volume | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | 95% Confidence Interval | Mean percentage change from baseline | Weeks 24, 48, 96 |
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| Secondary | Adjusted Mean Percentage Change From Baseline in Cortical Grey Matter Volume | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | 95% Confidence Interval | Mean percentage change from baseline | Weeks 48, 96 |
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| Secondary | Adjusted Mean Percentage Change From Baseline in White Matter Volume | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | 95% Confidence Interval | Mean percentage change from baseline | Weeks 48, 96 |
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| Secondary | 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. | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | Standard Deviation | Correct responses over 90 seconds | Baseline, Weeks: 48, 96 |
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| Secondary | 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. | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | Standard Deviation | Points on scale | Baseline, Weeks 48, 96 |
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| Secondary | 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. | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline, Weeks 48, 96 |
|
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| Secondary | 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. | All enrolled participants who received any dose of ocrelizumab were included in the ITT population. Participants who prematurely withdrew from the study for any reason and who did not perform any assessment for any reason were also included in the ITT population. Here number of analyzed participants represents participants with data available at given timepoint. | Posted | Mean | Standard Deviation | Percentage change from baseline | Baseline, Weeks: 48, 96 |
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| Secondary | Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) | Safety analyses were done on the ITT population. | Posted | Number | Percentage of Participants | Baseline up to to 96 weeks after the end of the Treatment Period |
|
|
From Baseline up to to 96 weeks after the end of the Treatment Period. Time frame includes the safety-follow-up period.
One participant discontinued the study before receiving treatment and was excluded from safety population.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ocrelizumab | Participants received Ocrelizumab 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. | 1 | 680 | 49 | 680 | 531 | 680 |
| EG001 | Ocrelizumab Safety Follow-up | Participants received Ocrelizumab 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. | 0 | 64 | 6 | 64 | 14 | 64 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| OEDEMA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HEPATITIS | Hepatobiliary disorders | MedDRA 22.1 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| INTERVERTEBRAL DISC PROTRUSION | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ABORTION SPONTANEOUS | Pregnancy, puerperium and perinatal conditions | MedDRA 22.1 | Systematic Assessment |
| |
| DEPRESSION SUICIDAL | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ENTERITIS | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| GRANULOCYTOPENIA | Blood and lymphatic system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ANGINA PECTORIS | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MYOCARDIAL INFARCTION | Cardiac disorders | MedDRA 22.1 | Systematic Assessment |
| |
| VERTIGO | Ear and labyrinth disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ABDOMINAL PAIN LOWER | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ANAL FISTULA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| COLITIS ULCERATIVE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| CROHN'S DISEASE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ENTEROCOLITIS | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| LUMBAR HERNIA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| MELAENA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| TOOTHACHE | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| OEDEMA | General disorders | MedDRA 22.1 | Systematic Assessment |
| |
| ANAL ABSCESS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| GASTROENTERITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| OESOPHAGITIS BACTERIAL | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| ORAL BACTERIAL INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| PNEUMONIA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| SEPSIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| SINUSITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| SUPERINFECTION FUNGAL | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| VARICELLA ZOSTER VIRUS INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| VIRAL INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| ANKLE FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| FACIAL BONES FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| RIB FRACTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| TENDON INJURY | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| URETERIC INJURY | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
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| UTERINE RUPTURE | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| OSTEONECROSIS | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BASAL CELL CARCINOMA | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| BENIGN NEOPLASM OF THYMUS | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
| |
| SQUAMOUS CELL CARCINOMA OF THE CERVIX | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 22.1 | Systematic Assessment |
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| CEREBRAL VENOUS SINUS THROMBOSIS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| GENERALISED TONIC-CLONIC SEIZURE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| MIGRAINE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| MULTIPLE SCLEROSIS RELAPSE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| STATUS MIGRAINOSUS | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| SUBARACHNOID HAEMORRHAGE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
| |
| COMPLETED SUICIDE | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DELIRIUM | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| DEPRESSION | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| DEPRESSION SUICIDAL | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| HALLUCINATION | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| SUICIDE ATTEMPT | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
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| HAEMORRHAGIC OVARIAN CYST | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| TESTICULAR INFARCTION | Reproductive system and breast disorders | MedDRA 22.1 | Systematic Assessment |
| |
| NASAL ULCER | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DERMATITIS ALLERGIC | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DERMATITIS ATOPIC | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| GUTTATE PSORIASIS | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| URTICARIA | Skin and subcutaneous tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| SHOCK HAEMORRHAGIC | Vascular disorders | MedDRA 22.1 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| NASOPHARYNGITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| COUGH | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| DIARRHOEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| NAUSEA | Gastrointestinal disorders | MedDRA 22.1 | Systematic Assessment |
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| FATIGUE | General disorders | MedDRA 22.1 | Systematic Assessment |
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| PYREXIA | General disorders | MedDRA 22.1 | Systematic Assessment |
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| INFLUENZA | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| ORAL HERPES | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
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| SINUSITIS | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| UPPER RESPIRATORY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| URINARY TRACT INFECTION | Infections and infestations | MedDRA 22.1 | Systematic Assessment |
| |
| INFUSION RELATED REACTION | Injury, poisoning and procedural complications | MedDRA 22.1 | Systematic Assessment |
| |
| ARTHRALGIA | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| PAIN IN EXTREMITY | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
| |
| HEADACHE | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| PARAESTHESIA | Nervous system disorders | MedDRA 22.1 | Systematic Assessment |
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| INSOMNIA | Psychiatric disorders | MedDRA 22.1 | Systematic Assessment |
| |
| OROPHARYNGEAL PAIN | Respiratory, thoracic and mediastinal disorders | MedDRA 22.1 | Systematic Assessment |
| |
| BACK PAIN | Musculoskeletal and connective tissue disorders | MedDRA 22.1 | Systematic Assessment |
|
The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Medical Communications | Hoffmann-La Roche | 800 821-8590 | genentech@druginfo.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Dec 16, 2019 | Oct 13, 2020 | SAP_001.pdf |
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C533411 | ocrelizumab |
Not provided
Not provided
Not provided
| Study terminated by sponsor |
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| Physician Decision |
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| Roll-over to a long term extension study |
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| Commercial ocrelizumab |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
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