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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03599245
Other study ID # MN39158
Secondary ID 2017-004886-29
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date July 12, 2018
Est. completion date September 23, 2025

Study information

Verified date April 2024
Source Hoffmann-La Roche
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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).


Description:

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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1500
Est. completion date September 23, 2025
Est. primary completion date February 23, 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years to 65 Years
Eligibility Inclusion Criteria: - Signed Informed Consent Form - Able to comply with the study protocol, in the investigator's judgment - Completed the treatment period of Roche sponsored ocrelizumab P-trials Exclusion Criteria: - Hypersensitivity to ocrelizumab or to any of its excipients. - Participantss in a severely immunocompromised state until the condition resolves. - Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation. - Existence of a contra-indication as per SmPC - Prohibited concomitant medication as specified in protocol - Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ocrelizumab
Participants will receive a 600-mg infusion of Ocrelizumab every 24 months for two years.

Locations

Country Name City State
Argentina Centro de Especialidades Neurológicas y Rehabilitación - CENyR Buenos Aires
Argentina Hospital Churruca Visca Buenos Aires
Argentina Fundacion Rosarina de Neurorehabilitacion Rosario
Belgium AZ Sint Jan Brugge
Belgium UZ Antwerpen Edegem
Belgium CHU Tivoli La Louvière
Belgium CHU Sart-Tilman Liège
Belgium Revalidatie en MS Centrum Overpelt
Brazil Instituto de Neurologia de Curitiba Curitiba PR
Brazil Hospital Sao Lucas - PUCRS Porto Alegre RS
Brazil Hospital das Clinicas - FMUSP Sao Paulo SP
Bulgaria Multiprofile Hosp. for Active Treatment;National Cardiology Hosp. Sofia
Bulgaria Shat Np Sveti Naum; 3Rd Clinic of Neurology Sofia
Canada Clinique NeuroOutaouais Gatineau Quebec
Canada Recherche Sepmus Inc. Greenfield Park Quebec
Canada London Health Sciences Centre Uni Campus London Ontario
Canada Montreal Neurological Institute and Hospital Montreal Quebec
Canada The Ottawa Hospital - General Campus; Department of Neurology - Multiple Sclerosis Ottawa Ontario
Canada Sunnybrook Health Sciences Centre Toronto Ontario
Canada University of British Columbia Vancouver British Columbia
Croatia Clinical Hospital Centre Zagreb Zagreb
Czechia Fakultni nemocnice u sv. Anny; Neurologicka klinika Brno
Czechia Nemocnice Jihlava; NEU-Neurologicke oddeleni Jihlava
Czechia VFN Praha Poliklinika Rs Centrum - Budova A Prague
Czechia Fakultni nemocnice v Motole; Neurologicka klinika 2. LF UK a FN Motol Praha 5
Denmark Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken Aabenraa
Denmark Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb. Aalborg
Denmark Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken Aarhus N
Denmark Rigshospitalet Glostrup; Neurologisk Klinik Glostrup
Denmark Odense Universitetshospital, Neurologisk Afdeling N; Neurologisk Ambulatorium N5; Skleroseklinikken Odense C
Estonia East Tallinn Central Hospital; Neurology Department Tallinn
Estonia West Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
Finland Mehiläinen Neo Turku Turku
France CHU de Besancon Hopital Jean Minjoz; Service de Neurologie Besançon
France Groupe Hospitalier Pellegrin; Service de neurochirurgie B Bordeaux
France Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie Bron
France Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B Clermont-Ferrand
France CH de Gonesse; Neurologie Gonesse
France CHU de Grenoble; Neurologie La Tronche
France Hopital Roger Salengro Service de Neurologie Lille
France CHU de la Timone - Hopital d Adultes; Service de Neurologie Marseille
France Hopital Gui de Chauliac; Neurologie Montpellier
France Hopital Central - CHU de Nancy; Service de Neurologie Nancy
France Hôpital Guillaume et René Laënnec; Service Neurologie Nantes
France Hôpital Pasteur; Service de Neurologie Nice
France CHU de Nîmes Hopital Caremeau; Service de Neurologie Nimes
France Groupe Hospitalier Pitié- Salpétrière; Service Neurologie Paris
France Hôpital de Poissy; Service neurologie Poissy
France CHU de Rouen Hopital; Service de Neurologie Rouen
France Höpital Hautepierre; Pediatrie1 Strasbourg
France HIA de Toulon hôpital militaire; Neurologie Toulon
Hungary Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet Budapest
Hungary VALEOMED Diagnosztikai Központ Esztergom
Ireland St Vincents University Hospital Dublin 4
Italy AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi; SOD Clinica Neurologica-Am.Sclerosi Multipla Ancona Marche
Italy ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla Bergamo Lombardia
Italy Ospedale Bellaria; Istituto delle Scienze Neurologiche - UO RIABILITAZIONE SCLEROSI MULTIPLA Bologna Emilia-Romagna
Italy Ospedale Binaghi; Centro Sclerosi Multipla Cagliari Sardegna
Italy AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla Catania Sicilia
Italy Fondazione Istituto S. Raffaele - Giglio; UO Neurologia Cefalù Sicilia
Italy Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla Chieti Abruzzo
Italy AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA) Firenze Toscana
Italy AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2 Firenze Toscana
Italy Ospedale S.Antonio Abate; Neurologia 2 ? Sclerosi Multipla e Recupero Neurologico Gallarate Lombardia
Italy Irccs A.O.U.San Martino Ist; Dinogmi Genova Liguria
Italy Ospedale San Salvatore; Clinica Neurologica - Centro Sclerosi Multipla L'Aquila Abruzzo
Italy Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari Milano Lombardia
Italy Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico; UOSD Malattie Neurodegenerative Milano Lombardia
Italy IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla Milano Lombardia
Italy Ospedale Civile di Montichiari; Centro Sclerosi Multipla Montichiari Lombardia
Italy A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche Napoli Campania
Italy Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur Napoli Campania
Italy Azienda Ospedaliera di Padova; Clinica Neurologica Padova Veneto
Italy AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia Palermo Sicilia
Italy AOU Policlinico Giaccone; UOC Neurologia e Neurofisiopatologia-Amb Sclerosi Multipla Palermo Sicilia
Italy IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla Pavia Lombardia
Italy AO di Perugia - Ospedale S. Maria della Misericordia; Clinica Neurologica Perugia Umbria
Italy IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla Pozzilli Molise
Italy Azienda Ospedaliera Sant'Andrea; UOC Neurologia Roma Lazio
Italy Ospedale S.Camillo Forlanini; UOSD Day Hospital Neurologico e Neurochirurgico Roma Lazio
Italy Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla Roma Lazio
Italy Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla Roma Lazio
Italy IRCCS Ospedale Casa Sollievo Della Sofferenza; SC Neurologia San Giovanni Rotondo Puglia
Italy AOU Senese - Presidio Ospedaliero Le Scotte; UOSA Neurologia Sperimentale Siena Toscana
Italy Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla Verona Veneto
Kuwait Ibn Sina Hospital; Neurology Department Kuwait
Mexico Unidad de investigacion en salud (UIS); Neurociencias Ciudad de México
Mexico Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC Culiacán Sinaloa
Mexico Hospital General de México Mexico City Mexico CITY (federal District)
Netherlands Jeroen Bosch Ziekenhuis 'S Hertogenbosch
Netherlands Amsterdam UMC Location VUMC Amsterdam
Netherlands Amphia Ziekenhuis Breda
Netherlands Groene Hart Ziekenhuis Gouda
Netherlands Maasstadziekenhuis Rotterdam
Netherlands Zuyderland Medisch Centrum - Sittard Geleen Sittard-Geleen
Netherlands Elisabeth-TweeSteden Ziekenhuis Tilburg
Norway Haukeland universitetssykehus; Nevrologisk avdeling Bergen
Norway Sykehuset Buskerud HF; Nevrologisk avdeling Drammen
Norway Stavanger Universitetssykehus, Helse Stavanger HF Stavanger
Poland Neurocentrum Bydgoszcz sp. z o.o Bydgoszcz
Poland COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny Gdansk
Poland Care Clinic Katowice
Poland Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o. Krakow
Poland Centrum Neurologii Krzysztof Selmaj Lodz
Poland Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak. Lublin
Poland Instytut Psychiatrii i Neurologii II Klinika Neurologiczna Warszawa
Poland Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie Warszawa
Portugal Hospital de Braga; Servico de Neurologia Braga
Portugal HUC; Servico de Neurologia Coimbra
Portugal Hospital Beatriz Angelo; Servico de Neurologia Loures
Portugal Hospital Geral de Santo Antonio; Servico de Neurologia Porto
Slovakia Univerzitna nemocnica Bratislava Bratislava
Slovakia Univerzitna nemocnica Bratislava Nemocnica Ruzinov Bratislava
Slovakia Fakultna nemocnica Trnava Trnava
Slovenia University Medical Centre; Neurology Ljubljana
Slovenia University Medical Centre Maribor Maribor
Spain Hospital Vall d'Hebron; Servicio de Neurología Barcelona
Spain Hospital Puerta del Mar; Sevicio de Neurologia Cadiz
Spain Hospital General de Castellon; Servicio de Neurología Castelló de la Plana Castellon
Spain Complejo Hospitalario Universitario A Coruña (CHUAC); Servicio de Neurologia Coruña LA Coruña
Spain Hospital Universitario Virgen de Arrixaca; Servicio de Neurología EL Palmar (EL Palmar) Murcia
Spain Hospital Universitari de Bellvitge; Servicio de Neurologia L'Hospitalet de Llobregat Barcelona
Spain Hospital Universitari Arnau de Vilanova de Lleida; Servicio de Neurología Lleida Lerida
Spain Hospital Universitario 12 de Octubre; Servicio de Neurologia Madrid
Spain Hospital Universitario Clínico San Carlos; Servicio de Neurología Madrid
Spain Hospital Universitario La Paz; Servicio de Neurologia Madrid
Spain Universitario de La Princesa; Servicio de Neurología Madrid
Spain Hospital Universitario Central de Asturias; Servicio de Neurología Oviedo Asturias
Spain Hospital Quiron de Madrid; Servicio de Neurologia Pozuelo de Alarcon Madrid
Spain Hospital Universitari de Girona Dr. Josep Trueta; Servicio de Neurologia Salt Girona
Spain Hospital Universitario Virgen Macarena; Servicio de Neurologia Sevilla
Spain Hospital Clinico Universitario de Valencia; Servicio de Neurologia Valencia
Spain Hospital Universitario la Fe; Servicio de Neurologia Valencia
Spain Complejo Hospitalario Universitario de Vigo - Xeral Cies; Servicio de Neurologia Vigo Pontevedra
Sweden Sahlgrenska Sjukhuset; Neurology Göteborg
Sweden Centralsjukhuset; Neurologi och rehabiliteringskliniken Karlstad
Sweden Centrum för Neurologi Stockholm
Sweden Karolinska Universitetssjukhuset Solna Neurology Stockholm
Turkey Gazi University Medical Faculty; Departmant of Norology Ankara
Turkey Hacettepe University Medical Faculty; Neurology Ankara
Turkey Mustafa Kemal Ataturk UTF; Department of norology Hatay
Turkey Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali Istanbul
Turkey Istanbul University Istanbul School of Medicine; Neurology Istanbul
Turkey Selcuk University Medical Faculty; Norology department Istanbul
Turkey Ondokuz Mayis University School of Medicine; Neurology Samsun
Turkey Karadeniz Tecnical Uni. Med. Fac.; Neurology Trabzon
United Kingdom Royal Devon and Exeter Hospital (Wonford) Exeter
United Kingdom Queen Elizabeth University Hospital Glasgow
United Kingdom Raigmore Hospital Inverness
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds
United Kingdom Charing Cross Hospital London
United Kingdom Kings College Hospital London
United Kingdom National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases London
United Kingdom Royal Free Hospital London
United Kingdom St George's Hospital London
United Kingdom The Royal London Hospital London
United Kingdom Royal Victoria Infirmary Newcastle upon Tyne
United Kingdom Salford Royal NHS Foundation Trust Salford
United Kingdom Royal Hallamshire Hospita Sheffield
United Kingdom Morriston Hospital Swansea
United Kingdom Royal Cornwall Hospital Truro

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

Argentina,  Belgium,  Brazil,  Bulgaria,  Canada,  Croatia,  Czechia,  Denmark,  Estonia,  Finland,  France,  Hungary,  Ireland,  Italy,  Kuwait,  Mexico,  Netherlands,  Norway,  Poland,  Portugal,  Slovakia,  Slovenia,  Spain,  Sweden,  Turkey,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks Up to 2 Years
Primary 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
Primary 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
Primary Mean change from inclusion in parent study in EDSS score over the course of the treatment Up to 2 years
Primary 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
Secondary Time to first protocol-defined event of disease activity Up to 2 Years
Secondary Time to first relapse Up to 2 Years
Secondary Annualized relapse rate Up to 2 Years
Secondary Percentage of participants relapse free, yearly and over the course of the treatment Up to 2 Years
Secondary 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
Secondary 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
Secondary 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
Secondary Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT) Up to 2 Years
Secondary Total number of T1 Gd-enhancing lesions as detected by brain MRI over time Up to 2 Years
Secondary Total number of new and/or enlarging T2 lesion as detected by brain MRI over time Up to 2 Years
Secondary Change in total T1 hypointense lesion volume over time Up to 2 Years
Secondary Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time Up to 2 Years
Secondary Change in brain volume (grey and white matter) as detected by brain MRI over time Up to 2 Years
Secondary Presence and evolution of leptomeningeal follicles as detected by MRI Up to 2 Years
Secondary Time to treatment discontinuation/switch Up to 2 Years
Secondary Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI]) Up to 2 Years
Secondary Participant reported outcomes: SymptoMScreen Score Up to 2 Years
Secondary Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29) Up to 2 Years
Secondary Percentage of Participants with Adverse Events Up to 2 Years
Secondary Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period Up to 2 years
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