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| ID | Type | Description | Link |
|---|---|---|---|
| 2017-004886-29 | EudraCT Number |
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This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).
This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ocrelizumab | Experimental | Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ocrelizumab | Drug | Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks | Up to 2 Years | |
| Percentage of participants who have confirmed disability improvement (CDI), CDP for at least 24 weeks and for at least 48 weeks yearly and over the duration of the treatment | Up to 2 years | |
| Percentage of participants who have improved, stable or worsened disability compared with baseline | Improved, stable or worsened disability is measured by expanded disability status scale (EDSS) (annually/by epoch and over duration of the study) Stable EDSS is defined as EDSS change +/- 0.5. Worsening is > 0.5 increase of EDSS, Improvement is >0.5 decrease of EDSS | Up to 2 years |
| Mean change from inclusion in parent study in EDSS score over the course of the treatment | Up to 2 years | |
| Time to 20% increase in timed 25-foot walk test (T25FWT) | Time to 20% increase in timed nine-hole peg test (9HPT) sustained for at least 24 weeks and for at least 48 weeks, and proportion of patients achieving a sustained increase assessed yearly and at the end treatment | Up to 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Time to first protocol-defined event of disease activity | Up to 2 Years | |
| Time to first relapse | Up to 2 Years | |
| Annualized relapse rate |
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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 |
|---|---|---|---|---|---|---|
| Hospital Churruca Visca | Buenos Aires | C1437JCP | Argentina | |||
| Centro de Especialidades Neurológicas y Rehabilitación - CENyR |
| 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. |
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For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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| Up to 2 Years |
| Percentage of participants relapse free, yearly and over the course of the treatment | Up to 2 Years |
| Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment | Disease activity is defined as at least one the following events: protocol-defined relapse; 24 weeks CDP based on increases in EDSS; a T1 Gadolinium (Gd)-enhanced lesion; or a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI). | Up to 2 Years |
| Percentage of participants with no evidence of progression (NEP) | NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (CDP; 20% increase in timed T25FWT; 20% increase in timed 9HPT yearly and over the course of the treatment | Up to 2 Years |
| Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD) | NEPAD is defined as no progression on all of the three components of NEP (CDP, T25FWT, 9HPT), no new relapse and no enlarging or new T2 or T1 Gd-enhancing lesion yearly and over the course of the treatment | Up to 2 Years |
| Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT) | Up to 2 Years |
| Total number of T1 Gd-enhancing lesions as detected by brain MRI over time | Up to 2 Years |
| Total number of new and/or enlarging T2 lesion as detected by brain MRI over time | Up to 2 Years |
| Change in total T1 hypointense lesion volume over time | Up to 2 Years |
| Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time | Up to 2 Years |
| Change in brain volume (grey and white matter) as detected by brain MRI over time | Up to 2 Years |
| Presence and evolution of leptomeningeal follicles as detected by MRI | Up to 2 Years |
| Time to treatment discontinuation/switch | Up to 2 Years |
| Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI]) | Up to 2 Years |
| Participant reported outcomes: SymptoMScreen Score | Up to 2 Years |
| Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29) | Up to 2 Years |
| Percentage of Participants with Adverse Events | Up to 2 Years |
| Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period | Up to 2 years |
| Ciudad Autonoma Buenos Aires |
| C1061ABD |
| Argentina |
| Fundacion Rosarina de Neurorehabilitacion | Rosario | 2000 | Argentina |
| AZ Sint Jan | Bruges | 8000 | Belgium |
| UZ Antwerpen | Edegem | 2650 | Belgium |
| CHU Tivoli | La Louvière | 7100 | Belgium |
| CHU de Liège (Sart Tilman) | Liège | 4000 | Belgium |
| Revalidatie en MS Centrum | Overpelt | 3900 | Belgium |
| Instituto de Neurologia de Curitiba | Curitiba | Paraná | 81210-310 | Brazil |
| Hospital Sao Lucas - PUCRS | Porto Alegre | Rio Grande do Sul | 90610-000 | Brazil |
| Hospital das Clinicas - FMUSP | São Paulo | São Paulo | 05403-900 | Brazil |
| Shat Np Sveti Naum | Sofia | 1113 | Bulgaria |
| Multiprofile Hosp. for Active Treatment | Sofia | 1309 | Bulgaria |
| University of British Columbia | Vancouver | British Columbia | V6T 1Z4 | Canada |
| London Health Sciences Centre Uni Campus | London | Ontario | N6A 5A5 | Canada |
| The Ottawa Hospital - General Campus | Ottawa | Ontario | K1H 8L6 | Canada |
| Sunnybrook Health Sciences Centre | Toronto | Ontario | M4N 3M5 | Canada |
| Clinique NeuroOutaouais | Gatineau | Quebec | J8Y 1W2 | Canada |
| Recherche Sepmus Inc. | Greenfield Park | Quebec | J4V 2J2 | Canada |
| Montreal Neurological Institute and Hospital | Montreal | Quebec | H3A 2B4 | Canada |
| Clinical Hospital Centre Zagreb | Zagreb | 10000 | Croatia |
| Fakultni nemocnice u sv. Anny | Brno | 656 91 | Czechia |
| Nemocnice Jihlava | Jihlava | 58633 | Czechia |
| VFN Praha Poliklinika Rs Centrum - Budova A | Prague | 12808 | Czechia |
| Fakultni nemocnice v Motole | Prague | 150 06 | Czechia |
| Aalborg Universitetshospital | Aalborg | 9000 | Denmark |
| Aarhus Universitetshospital | Aarhus N | 8200 | Denmark |
| Rigshospitalet Glostrup | Glostrup Municipality | 2600 | Denmark |
| Odense Universitetshospital, Neurologisk Afdeling N | Odense C | 5000 | Denmark |
| Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken | Sønderborg | 6400 | Denmark |
| East Tallinn Central Hospital | Tallinn | 10138 | Estonia |
| West Tallinn Central Hospital | Tallinn | 10617 | Estonia |
| Tartu University Hospital | Tartu | 51014 | Estonia |
| Mehiläinen Neo Turku | Turku | 20520 | Finland |
| CHU de Besancon Hopital Jean Minjoz | Besançon | 25030 | France |
| Groupe Hospitalier Pellegrin | Bordeaux | 33076 | France |
| Hopital neurologique Pierre Wertheimer - CHU Lyon | Bron | 69677 | France |
| Hopital Gabriel Montpied CHU de Clermont-Ferrand | Clermont-Ferrand | 63003 | France |
| CH de Gonesse | Gonesse | 95503 | France |
| CHU de Grenoble | La Tronche | 38700 | France |
| Hopital Roger Salengro Service de Neurologie | Lille | 59037 | France |
| CHU de la Timone - Hopital d Adultes | Marseille | 13005 | France |
| Hopital Gui de Chauliac | Montpellier | 34295 | France |
| Hopital Central - CHU de Nancy | Nancy | 54035 | France |
| Hôpital Pasteur | Nice | 06002 | France |
| CHU de Nîmes Hopital Caremeau | Nîmes | 30900 | France |
| Groupe Hospitalier Pitié- Salpétrière | Paris | 75651 | France |
| Hôpital de Poissy | Poissy | 78300 | France |
| CHU de Rouen Hopital | Rouen | 76031 | France |
| Höpital Hautepierre | Strasbourg | 67098 | France |
| HIA de Toulon hôpital militaire | Toulon | 83041 | France |
| Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet | Budapest | 1204 | Hungary |
| VALEOMED Diagnosztikai Központ | Esztergom | 2500 | Hungary |
| St Vincents University Hospital | Dublin | Ireland |
| Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla | Chieti | Abruzzo | 66013 | Italy |
| Ospedale San Salvatore | L’Aquila | Abruzzo | 67100 | Italy |
| IRCCS Ospedale Casa Sollievo Della Sofferenza | San Giovanni Rotondo | Apulia | 71013 | Italy |
| A. O. U. Federico II | Naples | Campania | 80131 | Italy |
| Università degli Studi della Campania Luigi Vanvitelli | Naples | Campania | 80131 | Italy |
| Ospedale Bellaria | Bologna | Emilia-Romagna | 40139 | Italy |
| Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla | Rome | Lazio | 00133 | Italy |
| Ospedale S.Camillo Forlanini | Rome | Lazio | 00152 | Italy |
| Policlinico Universitario A. Gemelli | Rome | Lazio | 00168 | Italy |
| Azienda Ospedaliera Sant'Andrea | Rome | Lazio | 00189 | Italy |
| Irccs A.O.U.San Martino Ist | Genoa | Liguria | 16132 | Italy |
| ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla | Bergamo | Lombardy | 24127 | Italy |
| Ospedale S.Antonio Abate | Gallarate | Lombardy | 21013 | Italy |
| Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico | Milan | Lombardy | 20122 | Italy |
| IRCCS Ospedale San Raffaele | Milan | Lombardy | 20132 | Italy |
| Fond. Istituto Neurologico C.Besta | Milan | Lombardy | 20133 | Italy |
| Ospedale Civile di Montichiari | Montichiari | Lombardy | 25018 | Italy |
| IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla | Pavia | Lombardy | 27100 | Italy |
| IRCCS Istituto Neurologico Neuromed | Pozzilli | Molise | 86077 | Italy |
| Ospedale Binaghi | Cagliari | Sardinia | 09126 | Italy |
| AOU Policlinico V. Emanuele - P.O G. Rodolico | Catania | Sicily | 95123 | Italy |
| Fondazione Istituto S. Raffaele - Giglio | Cefalù | Sicily | 90015 | Italy |
| AOU Policlinico Giaccone | Palermo | Sicily | 90129 | Italy |
| AO Ospedali Riuniti Villa Sofia-Cervello | Palermo | Sicily | 90146 | Italy |
| AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi | Ancona | The Marches | 60100 | Italy |
| AOU Careggi | Florence | Tuscany | 50134 | Italy |
| AOUC Azienda Ospedaliero-Universitaria Careggi | Florence | Tuscany | 50134 | Italy |
| AOU Senese - Presidio Ospedaliero Le Scotte | Siena | Tuscany | 53100 | Italy |
| AO di Perugia - Ospedale S. Maria della Misericordia | Perugia | Umbria | 06156 | Italy |
| Azienda Ospedaliera di Padova | Padova | Veneto | 35128 | Italy |
| Policlinico G.B. Rossi | Verona | Veneto | 37134 | Italy |
| Ibn Sina Hospital | Kuwait City | 10002 | Kuwait |
| Hospital General de México | Mexico City | Mexico CITY (federal District) | 06726 | Mexico |
| Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC | Culiacán | Sinaloa | 80020 | Mexico |
| Unidad de investigacion en salud (UIS) | Mexico City | 14050 | Mexico |
| Jeroen Bosch Ziekenhuis | 's-Hertogenbosch | 5223 GZ | Netherlands |
| Amsterdam UMC Location VUMC | Amsterdam | 1081 HV | Netherlands |
| Amphia Ziekenhuis | Breda | 4819 EV | Netherlands |
| Groene Hart Ziekenhuis | Gouda | 2803 HH | Netherlands |
| Maasstadziekenhuis | NL -rotterdam | 3079 DZ | Netherlands |
| Zuyderland Medisch Centrum - Sittard Geleen | Sittard-Geleen | 6162 BG | Netherlands |
| Elisabeth-TweeSteden Ziekenhuis | Tilburg | 5022 GC | Netherlands |
| Haukeland universitetssykehus | Bergen | 5021 | Norway |
| Sykehuset Buskerud HF | Drammen | 3004 | Norway |
| Stavanger Universitetssykehus, Helse Stavanger HF | Stavanger | 4011 | Norway |
| Neurocentrum Bydgoszcz sp. z o.o | Bydgoszcz | 85-796 | Poland |
| COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika | Gdansk | 80-803 | Poland |
| Care Clinic | Katowice | 40-568 | Poland |
| Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o. | Krakow | 31-637 | Poland |
| Centrum Neurologii Krzysztof Selmaj | Lodz | 90-324 | Poland |
| Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. | Lublin | 20-410 | Poland |
| Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie | Warsaw | 02-097 | Poland |
| Instytut Psychiatrii i Neurologii II Klinika Neurologiczna | Warsaw | 02-957 | Poland |
| Hospital de Braga | Braga | 4710-243 | Portugal |
| HUC | Coimbra | 3000-075 | Portugal |
| Hospital Beatriz Angelo | Loures | 2674-514 | Portugal |
| Hospital Geral de Santo Antonio | Porto | 4099-001 | Portugal |
| Univerzitna nemocnica Bratislava | Bratislava | 813 69 | Slovakia |
| Univerzitna nemocnica Bratislava Nemocnica Ruzinov | Bratislava | 826 06 | Slovakia |
| Fakultna nemocnica Trnava | Trnava | 917 75 | Slovakia |
| University Medical Centre | Ljubljana | 1000 | Slovenia |
| University Medical Centre Maribor | Maribor | 2000 | Slovenia |
| Hospital Universitari de Bellvitge | L'Hospitalet de Llobregat | Barcelona | 08907 | Spain |
| Hospital General de Castellon | Castellon | Castellon | 12004 | Spain |
| Complejo Hospitalario Universitario A Coruña (CHUAC) | A Coruña | LA Coruna | 15006 | Spain |
| Hospital Universitari Arnau de Vilanova de Lleida | Lleida | Lerida | 25198 | Spain |
| Hospital Quiron de Madrid | Pozuelo de Alarcón | Madrid | 28223 | Spain |
| Complejo Hospitalario Universitario de Vigo - Xeral Cies | Vigo | Pontevedra | 36312 | Spain |
| Hospital Universitario Central de Asturias | Oviedo | Principality of Asturias | Spain |
| Hospital Vall d'Hebron | Barcelona | 08035 | Spain |
| Hospital Puerta del Mar | Cadiz | 11009 | Spain |
| Hospital Universitari de Girona Dr. Josep Trueta | Girona | 17007 | Spain |
| Universitario de La Princesa | Madrid | 28006 | Spain |
| Hospital Universitario Clínico San Carlos | Madrid | 28040 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | 28041 | Spain |
| Hospital Universitario La Paz | Madrid | 28046 | Spain |
| Hospital Universitario Virgen de Arrixaca | Murcia | Spain |
| Hospital Clinico Universitario de Valencia | Valencia | 46010 | Spain |
| Hospital Universitario la Fe | Valencia | 46026 | Spain |
| Sahlgrenska Sjukhuset | Gothenburg | 413 45 | Sweden |
| Centralsjukhuset | Karlstad | 65185 | Sweden |
| Centrum för Neurologi | Stockholm | 113 41 | Sweden |
| Hacettepe University Medical Faculty | Ankara | 06100 | Turkey (Türkiye) |
| Gazi University Medical Faculty | Ankara | 06500 | Turkey (Türkiye) |
| Mustafa Kemal Ataturk UTF | Hatay | 31001 | Turkey (Türkiye) |
| Istanbul University Istanbul School of Medicine | Istanbul | 34093 | Turkey (Türkiye) |
| Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi | Istanbul | 34098 | Turkey (Türkiye) |
| Selcuk University Medical Faculty | Konya | 42131 | Turkey (Türkiye) |
| Ondokuz Mayis University School of Medicine | Samsun | 55139 | Turkey (Türkiye) |
| Karadeniz Tecnical Uni. Med. Fac. | Trabzon | 61080 | Turkey (Türkiye) |
| 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 1BB | United Kingdom |
| Royal Free Hospital | London | NW3 2QS | United Kingdom |
| Kings College Hospital | London | SE5 9RS | United Kingdom |
| St George's Hospital | London | SW17 0QT | United Kingdom |
| Charing Cross Hospital | London | W6 8RF | United Kingdom |
| National Hospital for Neurology and Neurosurgery, | London | WC1 3BG | 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 |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| 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 |
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| ID | Term |
|---|---|
| C533411 | ocrelizumab |
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