This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
- Registration Number
- NCT03599245
- Lead Sponsor
- Hoffmann-La Roche
- Brief 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).
- Detailed 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 & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 1500
- 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
- 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
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ocrelizumab Ocrelizumab Participants will receive a single 600-mg infusion of Ocrelizumab every 24 weeks up to Week 72 of this study.
- Primary Outcome Measures
Name Time Method Mean change from inclusion in parent study in EDSS score over the course of the treatment Up to 2 years 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 Up to 2 years 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
Time to 20% increase in timed 25-foot walk test (T25FWT) Up to 2 years 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
- Secondary Outcome Measures
Name Time Method Time to first protocol-defined event of disease activity Up to 2 Years Time to first relapse Up to 2 Years Annualized relapse rate 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 Up to 2 Years 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).
Percentage of participants with no evidence of progression (NEP) Up to 2 Years 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
Presence and evolution of leptomeningeal follicles as detected by MRI Up to 2 Years Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD) Up to 2 Years 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
Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT) 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 T1 Gd-enhancing lesions as detected by brain MRI over time 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 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 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 Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period Up to 2 years
Trial Locations
- Locations (161)
Instituto de Neurologia de Curitiba
🇧🇷Curitiba, Paraná, Brazil
Hospital Sao Lucas - PUCRS
🇧🇷Porto Alegre, Rio Grande Do Sul, Brazil
Hospital das Clinicas - FMUSP
🇧🇷Sao Paulo, São Paulo, Brazil
Shat Np Sveti Naum
🇧🇬Sofia, Bulgaria
Hopital Gabriel Montpied CHU de Clermont-Ferrand
🇫🇷Clermont-Ferrand, France
CH de Gonesse
🇫🇷Gonesse, France
CHU de Grenoble
🇫🇷La Tronche, France
Hopital Roger Salengro Service de Neurologie
🇫🇷Lille, France
CHU de Nîmes Hopital Caremeau
🇫🇷Nimes, France
CHU de la Timone - Hopital d Adultes
🇫🇷Marseille, France
Hopital Gui de Chauliac
🇫🇷Montpellier, France
Hôpital Guillaume et René Laënnec
🇫🇷Nantes, France
Hopital Central - CHU de Nancy
🇫🇷Nancy, France
Hôpital Pasteur
🇫🇷Nice, France
Groupe Hospitalier Pitié- Salpétrière
🇫🇷Paris, France
Hôpital de Poissy
🇫🇷Poissy, France
CHU de Rouen Hopital
🇫🇷Rouen, France
Höpital Hautepierre
🇫🇷Strasbourg, France
HIA de Toulon hôpital militaire
🇫🇷Toulon, France
St Vincents University Hospital
🇮🇪Dublin 4, Ireland
Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
🇭🇺Budapest, Hungary
VALEOMED Diagnosztikai Központ
🇭🇺Esztergom, Hungary
Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
🇮🇹Chieti, Abruzzo, Italy
Ospedale San Salvatore
🇮🇹L'Aquila, Abruzzo, Italy
A. O. U. Federico II
🇮🇹Napoli, Campania, Italy
AO Ospedali Riuniti Villa Sofia-Cervello
🇮🇹Palermo, Sicilia, Italy
AOU Careggi
🇮🇹Firenze, Toscana, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
🇮🇹Firenze, Toscana, Italy
AOU Senese - Presidio Ospedaliero Le Scotte
🇮🇹Siena, Toscana, Italy
AO di Perugia - Ospedale S. Maria della Misericordia
🇮🇹Perugia, Umbria, Italy
Azienda Ospedaliera di Padova
🇮🇹Padova, Veneto, Italy
Policlinico G.B. Rossi
🇮🇹Verona, Veneto, Italy
Ibn Sina Hospital
🇰🇼Kuwait, Kuwait
Hospital Universitari de Bellvitge
🇪🇸L'Hospitalet de Llobregat, Barcelona, Spain
Hospital General de Castellon
🇪🇸Castelló de la Plana, Castellon, Spain
Complejo Hospitalario Universitario A Coruña (CHUAC)
🇪🇸Coruña, LA Coruna, Spain
Hospital Universitari Arnau de Vilanova de Lleida
🇪🇸Lleida, Lerida, Spain
Hospital Quiron de Madrid
🇪🇸Pozuelo de Alarcon, Madrid, Spain
Complejo Hospitalario Universitario de Vigo - Xeral Cies
🇪🇸Vigo, Pontevedra, Spain
Hospital Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Puerta del Mar
🇪🇸Cadiz, Spain
Hospital Universitari de Girona Dr. Josep Trueta
🇪🇸Girona, Spain
Universitario de La Princesa
🇪🇸Madrid, Spain
Hospital Universitario Clínico San Carlos
🇪🇸Madrid, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario La Paz
🇪🇸Madrid, Spain
Hospital Universitario Virgen de Arrixaca
🇪🇸Murcia, Spain
Hospital Universitario Virgen Macarena
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Universitario la Fe
🇪🇸Valencia, Spain
Sahlgrenska Sjukhuset
🇸🇪Göteborg, Sweden
Centralsjukhuset
🇸🇪Karlstad, Sweden
Centrum för Neurologi
🇸🇪Stockholm, Sweden
Hacettepe University Medical Faculty
🇹🇷Ankara, Turkey
Gazi University Medical Faculty
🇹🇷Ankara, Turkey
Mustafa Kemal Ataturk UTF
🇹🇷Hatay, Turkey
Istanbul University Istanbul School of Medicine
🇹🇷Istanbul, Turkey
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
🇹🇷Istanbul, Turkey
Selcuk University Medical Faculty
🇹🇷Konya, Turkey
Ondokuz Mayis University School of Medicine
🇹🇷Samsun, Turkey
Karadeniz Tecnical Uni. Med. Fac.
🇹🇷Trabzon, Turkey
Royal Devon and Exeter Hospital (Wonford)
🇬🇧Exeter, United Kingdom
Queen Elizabeth University Hospital
🇬🇧Glasgow, United Kingdom
Raigmore Hospital
🇬🇧Inverness, United Kingdom
Kings College Hospital
🇬🇧London, United Kingdom
AZ Sint Jan
🇧🇪Brugge, Belgium
UZ Antwerpen
🇧🇪Edegem, Belgium
CHU Tivoli
🇧🇪La Louvière, Belgium
CHU Sart-Tilman
🇧🇪Liège, Belgium
Revalidatie en MS Centrum
🇧🇪Overpelt, Belgium
Hopital neurologique Pierre Wertheimer - CHU Lyon
🇫🇷Bron, France
St George's Hospital
🇬🇧London, United Kingdom
Charing Cross 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, United Kingdom
Hospital Churruca Visca
🇦🇷Buenos Aires, Argentina
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
🇦🇷Ciudad Autonoma Buenos Aires, Argentina
Fundacion Rosarina de Neurorehabilitacion
🇦🇷Rosario, Argentina
Multiprofile Hosp. for Active Treatment
🇧🇬Sofia, Bulgaria
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
London Health Sciences Centre Uni Campus
🇨🇦London, Ontario, Canada
The Ottawa Hospital - General Campus
🇨🇦Ottawa, Ontario, Canada
Sunnybrook Health Sciences Centre
🇨🇦Toronto, Ontario, Canada
Clinique NeuroOutaouais
🇨🇦Gatineau, Quebec, Canada
Recherche Sepmus Inc.
🇨🇦Greenfield Park, Quebec, Canada
Montreal Neurological Institute and Hospital
🇨🇦Montreal, Quebec, Canada
Clinical Hospital Centre Zagreb
🇭🇷Zagreb, Croatia
Fakultni nemocnice u sv. Anny
🇨🇿Brno, Czechia
Nemocnice Jihlava
🇨🇿Jihlava, Czechia
VFN Praha Poliklinika Rs Centrum - Budova A
🇨🇿Prague, Czechia
Fakultni nemocnice v Motole
🇨🇿Praha 5, Czechia
Aalborg Universitetshospital
🇩🇰Aalborg, Denmark
Aarhus Universitetshospital
🇩🇰Aarhus N, Denmark
Rigshospitalet Glostrup
🇩🇰Glostrup, Denmark
Odense Universitetshospital, Neurologisk Afdeling N
🇩🇰Odense C, Denmark
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
🇩🇰Sønderborg, Denmark
East Tallinn Central Hospital
🇪🇪Tallinn, Estonia
West Tallinn Central Hospital
🇪🇪Tallinn, Estonia
Tartu University Hospital
🇪🇪Tartu, Estonia
Mehiläinen Neo Turku
🇫🇮Turku, Finland
CHU de Besancon Hopital Jean Minjoz
🇫🇷Besançon, France
Groupe Hospitalier Pellegrin
🇫🇷Bordeaux, France
Università degli Studi della Campania Luigi Vanvitelli
🇮🇹Napoli, Campania, Italy
Ospedale Bellaria
🇮🇹Bologna, Emilia-Romagna, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
🇮🇹Roma, Lazio, Italy
Ospedale S.Camillo Forlanini
🇮🇹Roma, Lazio, Italy
Policlinico Universitario A. Gemelli
🇮🇹Roma, Lazio, Italy
Azienda Ospedaliera Sant'Andrea
🇮🇹Roma, Lazio, Italy
Irccs A.O.U.San Martino Ist
🇮🇹Genova, Liguria, Italy
ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
🇮🇹Bergamo, Lombardia, Italy
Ospedale S.Antonio Abate
🇮🇹Gallarate, Lombardia, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
🇮🇹Milano, Lombardia, Italy
IRCCS Ospedale San Raffaele
🇮🇹Milano, Lombardia, Italy
Fond. Istituto Neurologico C.Besta
🇮🇹Milano, Lombardia, Italy
Ospedale Civile di Montichiari
🇮🇹Montichiari, Lombardia, Italy
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
🇮🇹Pavia, Lombardia, Italy
AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi
🇮🇹Ancona, Marche, Italy
IRCCS Istituto Neurologico Neuromed
🇮🇹Pozzilli, Molise, Italy
IRCCS Ospedale Casa Sollievo Della Sofferenza
🇮🇹San Giovanni Rotondo, Puglia, Italy
Ospedale Binaghi
🇮🇹Cagliari, Sardegna, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
🇮🇹Catania, Sicilia, Italy
Fondazione Istituto S. Raffaele - Giglio
🇮🇹Cefalù, Sicilia, Italy
AOU Policlinico Giaccone
🇮🇹Palermo, Sicilia, Italy
Hospital General de México
🇲🇽Mexico City, Mexico CITY (federal District), Mexico
Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
🇲🇽Culiacán, Sinaloa, Mexico
Unidad de investigacion en salud (UIS)
🇲🇽Ciudad de México, Mexico
Jeroen Bosch Ziekenhuis
🇳🇱'S Hertogenbosch, Netherlands
Amsterdam UMC Location VUMC
🇳🇱Amsterdam, Netherlands
Amphia Ziekenhuis
🇳🇱Breda, Netherlands
Groene Hart Ziekenhuis
🇳🇱Gouda, Netherlands
Maasstadziekenhuis
🇳🇱NL -rotterdam, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
🇳🇱Sittard-Geleen, Netherlands
Elisabeth-TweeSteden Ziekenhuis
🇳🇱Tilburg, Netherlands
Haukeland universitetssykehus
🇳🇴Bergen, Norway
Sykehuset Buskerud HF
🇳🇴Drammen, Norway
Stavanger Universitetssykehus, Helse Stavanger HF
🇳🇴Stavanger, Norway
Neurocentrum Bydgoszcz sp. z o.o
🇵🇱Bydgoszcz, Poland
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
🇵🇱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
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
🇵🇱Warszawa, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
🇵🇱Warszawa, Poland
Hospital de Braga
🇵🇹Braga, Portugal
HUC
🇵🇹Coimbra, Portugal
Hospital Beatriz Angelo
🇵🇹Loures, Portugal
Hospital Geral de Santo Antonio
🇵🇹Porto, Portugal
Univerzitna nemocnica Bratislava
🇸🇰Bratislava, Slovakia
Univerzitna nemocnica Bratislava Nemocnica Ruzinov
🇸🇰Bratislava, Slovakia
Fakultna nemocnica Trnava
🇸🇰Trnava, Slovakia
University Medical Centre
🇸🇮Ljubljana, Slovenia
University Medical Centre Maribor
🇸🇮Maribor, Slovenia
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Leeds Teaching Hospitals NHS Trust
🇬🇧Leeds, United Kingdom
The Royal London Hospital
🇬🇧London, United Kingdom
Royal Free Hospital
🇬🇧London, United Kingdom
National Hospital for Neurology and Neurosurgery,
🇬🇧London, United Kingdom