Clinical trial NCT03599245: This is an Extension Study of the Roche P-trials to Investigate Safety and Effectiveness of Ocrelizumab in Participants With Multiple Sclerosis (MS)
Official title: A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE3
Conditions: Multiple Sclerosis
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2018-07-26
Enrollment: 1500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Time to onset of CDP sustained for at least 24 weeks and for at least 48 weeks
timeFrame: Up to 2 Years
measure: 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
timeFrame: Up to 2 years
measure: Percentage of participants who have improved, stable or worsened disability compared with baseline
timeFrame: Up to 2 years
measure: Mean change from inclusion in parent study in EDSS score over the course of the treatment
timeFrame: Up to 2 years
measure: Time to 20% increase in timed 25-foot walk test (T25FWT)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Time to first protocol-defined event of disease activity
timeFrame: Up to 2 Years
measure: Time to first relapse
timeFrame: Up to 2 Years
measure: Annualized relapse rate
timeFrame: Up to 2 Years
measure: Percentage of participants relapse free, yearly and over the course of the treatment
timeFrame: Up to 2 Years
measure: Percentage of participants with no evidence of protocol-defined disease activity (NEDA) yearly and over the duration of the treatment
timeFrame: Up to 2 Years
measure: Percentage of participants with no evidence of progression (NEP)
timeFrame: Up to 2 Years
measure: Percentage of participants with no evidence of progression sustained for at least 24 weeks and no active disease (NEPAD)
timeFrame: Up to 2 Years
measure: Change from baseline in cognitive performance as measured by the Symbol digit modalities test (SDMT)
timeFrame: Up to 2 Years
measure: Total number of T1 Gd-enhancing lesions as detected by brain MRI over time
timeFrame: Up to 2 Years
measure: Total number of new and/or enlarging T2 lesion as detected by brain MRI over time
timeFrame: Up to 2 Years
measure: Change in total T1 hypointense lesion volume over time
timeFrame: Up to 2 Years
measure: Total number of fluid-attenuated inversion-recovery (FLAIR) late enhancing lesions as detected by brain MRI over time
timeFrame: Up to 2 Years
measure: Change in brain volume (grey and white matter) as detected by brain MRI over time
timeFrame: Up to 2 Years
measure: Presence and evolution of leptomeningeal follicles as detected by MRI
timeFrame: Up to 2 Years
measure: Time to treatment discontinuation/switch
timeFrame: Up to 2 Years
measure: Participant reported outcomes: Employment status (Work Productivity and Activity Impairment Questionnaire [WPAI])
timeFrame: Up to 2 Years
measure: Participant reported outcomes: SymptoMScreen Score
timeFrame: Up to 2 Years
measure: Participant reported outcomes: Quality of life (QoL) (Multiple Sclerosis Impact Scale [MSIS]-29)
timeFrame: Up to 2 Years
measure: Percentage of Participants with Adverse Events
timeFrame: Up to 2 Years
measure: Total number of FLAIR late enhancing lesions as detected by brain MRI at the end of the treatment period
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Hospital Churruca Visca
city: Ciudad Autonoma Buenos Aires
country: Argentina
facility: Centro de Especialidades Neurológicas y Rehabilitación - CENyR
city: Rosario
country: Argentina
facility: Fundacion Rosarina de Neurorehabilitacion
city: Brugge
country: Belgium
facility: AZ Sint Jan
city: Edegem
country: Belgium
facility: UZ Antwerpen
city: La Louvière
country: Belgium
facility: CHU Tivoli
city: Liège
country: Belgium
facility: CHU Sart-Tilman
city: Overpelt
country: Belgium
facility: Revalidatie en MS Centrum
city: Curitiba
country: Brazil
facility: Instituto de Neurologia de Curitiba
state: Paraná
city: Porto Alegre
country: Brazil
facility: Hospital Sao Lucas - PUCRS
state: Rio Grande Do Sul
city: Sao Paulo
country: Brazil
facility: Hospital das Clinicas - FMUSP
state: São Paulo
city: Sofia
country: Bulgaria
facility: Shat Np Sveti Naum
city: Sofia
country: Bulgaria
facility: Multiprofile Hosp. for Active Treatment
city: Vancouver
country: Canada
facility: University of British Columbia
state: British Columbia
city: London
country: Canada
facility: London Health Sciences Centre Uni Campus
state: Ontario
city: Ottawa
country: Canada
facility: The Ottawa Hospital - General Campus
state: Ontario
city: Toronto
country: Canada
facility: Sunnybrook Health Sciences Centre
state: Ontario
city: Gatineau
country: Canada
facility: Clinique NeuroOutaouais
state: Quebec
city: Greenfield Park
country: Canada
facility: Recherche Sepmus Inc.
state: Quebec
city: Montreal
country: Canada
facility: Montreal Neurological Institute and Hospital
state: Quebec
city: Zagreb
country: Croatia
facility: Clinical Hospital Centre Zagreb
city: Brno
country: Czechia
facility: Fakultni nemocnice u sv. Anny
city: Jihlava
country: Czechia
facility: Nemocnice Jihlava
city: Prague
country: Czechia
facility: VFN Praha Poliklinika Rs Centrum - Budova A
city: Praha 5
country: Czechia
facility: Fakultni nemocnice v Motole
city: Aalborg
country: Denmark
facility: Aalborg Universitetshospital
city: Aarhus N
country: Denmark
facility: Aarhus Universitetshospital
city: Glostrup
country: Denmark
facility: Rigshospitalet Glostrup
city: Odense C
country: Denmark
facility: Odense Universitetshospital, Neurologisk Afdeling N
city: Sønderborg
country: Denmark
facility: Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
city: Tallinn
country: Estonia
facility: East Tallinn Central Hospital
city: Tallinn
country: Estonia
facility: West Tallinn Central Hospital
city: Tartu
country: Estonia
facility: Tartu University Hospital
city: Turku
country: Finland
facility: Mehiläinen Neo Turku
city: Besançon
country: France
facility: CHU de Besancon Hopital Jean Minjoz
city: Bordeaux
country: France
facility: Groupe Hospitalier Pellegrin
city: Bron
country: France
facility: Hopital neurologique Pierre Wertheimer - CHU Lyon
city: Clermont-Ferrand
country: France
facility: Hopital Gabriel Montpied CHU de Clermont-Ferrand
city: Gonesse
country: France
facility: CH de Gonesse
city: La Tronche
country: France
facility: CHU de Grenoble
city: Lille
country: France
facility: Hopital Roger Salengro Service de Neurologie
city: Marseille
country: France
facility: CHU de la Timone - Hopital d Adultes
city: Montpellier
country: France
facility: Hopital Gui de Chauliac
city: Nancy
country: France
facility: Hopital Central - CHU de Nancy
city: Nantes
country: France
facility: Hôpital Guillaume et René Laënnec
city: Nice
country: France
facility: Hôpital Pasteur
city: Nimes
country: France
facility: CHU de Nîmes Hopital Caremeau
city: Paris
country: France
facility: Groupe Hospitalier Pitié- Salpétrière
city: Poissy
country: France
facility: Hôpital de Poissy
city: Rouen
country: France
facility: CHU de Rouen Hopital
city: Strasbourg
country: France
facility: Höpital Hautepierre
city: Toulon
country: France
facility: HIA de Toulon hôpital militaire
city: Budapest
country: Hungary
facility: Budapesti Jahn Ferenc Dél-pesti Kórház és Rendel?intézet
city: Esztergom
country: Hungary
facility: VALEOMED Diagnosztikai Központ
city: Dublin 4
country: Ireland
facility: St Vincents University Hospital
city: Chieti
country: Italy
facility: Ospedale SS. Annunziata - Clinica Neurologica - Centro Sclerosi Multipla
state: Abruzzo
city: L'Aquila
country: Italy
facility: Ospedale San Salvatore
state: Abruzzo
city: Napoli
country: Italy
facility: A. O. U. Federico II
state: Campania
city: Napoli
country: Italy
facility: Università degli Studi della Campania Luigi Vanvitelli
state: Campania
city: Bologna
country: Italy
facility: Ospedale Bellaria
state: Emilia-Romagna
city: Roma
country: Italy
facility: Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
state: Lazio
city: Roma
country: Italy
facility: Ospedale S.Camillo Forlanini
state: Lazio
city: Roma
country: Italy
facility: Policlinico Universitario A. Gemelli
state: Lazio
city: Roma
country: Italy
facility: Azienda Ospedaliera Sant'Andrea
state: Lazio
city: Genova
country: Italy
facility: Irccs A.O.U.San Martino Ist
state: Liguria
city: Bergamo
country: Italy
facility: ASST PAPA GIOVANNI XXIII Neurologia USS Malattie Autoimmuni Centro Sclerosi Multipla
state: Lombardia
city: Gallarate
country: Italy
facility: Ospedale S.Antonio Abate
state: Lombardia
city: Milano
country: Italy
facility: Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
state: Lombardia
city: Milano
country: Italy
facility: IRCCS Ospedale San Raffaele
state: Lombardia
city: Milano
country: Italy
facility: Fond. Istituto Neurologico C.Besta
state: Lombardia
city: Montichiari
country: Italy
facility: Ospedale Civile di Montichiari
state: Lombardia
city: Pavia
country: Italy
facility: IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
state: Lombardia
city: Ancona
country: Italy
facility: AOU Ospedali Riuniti Umberto I-G.M. Lancisi-G. Salesi
state: Marche
city: Pozzilli
country: Italy
facility: IRCCS Istituto Neurologico Neuromed
state: Molise
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Ospedale Casa Sollievo Della Sofferenza
state: Puglia
city: Cagliari
country: Italy
facility: Ospedale Binaghi
state: Sardegna
city: Catania
country: Italy
facility: AOU Policlinico V. Emanuele - P.O G. Rodolico
state: Sicilia
city: Cefalù
country: Italy
facility: Fondazione Istituto S. Raffaele - Giglio
state: Sicilia
city: Palermo
country: Italy
facility: AOU Policlinico Giaccone
state: Sicilia
city: Palermo
country: Italy
facility: AO Ospedali Riuniti Villa Sofia-Cervello
state: Sicilia
city: Firenze
country: Italy
facility: AOU Careggi
state: Toscana
city: Firenze
country: Italy
facility: AOUC Azienda Ospedaliero-Universitaria Careggi
state: Toscana
city: Siena
country: Italy
facility: AOU Senese - Presidio Ospedaliero Le Scotte
state: Toscana
city: Perugia
country: Italy
facility: AO di Perugia - Ospedale S. Maria della Misericordia
state: Umbria
city: Padova
country: Italy
facility: Azienda Ospedaliera di Padova
state: Veneto
city: Verona
country: Italy
facility: Policlinico G.B. Rossi
state: Veneto
city: Kuwait
country: Kuwait
facility: Ibn Sina Hospital
city: Mexico City
country: Mexico
facility: Hospital General de México
state: Mexico CITY (federal District)
city: Culiacán
country: Mexico
facility: Hospital Angeles de Culiacán, Neurociencias Estudios Clínicos SC
state: Sinaloa
city: Ciudad de México
country: Mexico
facility: Unidad de investigacion en salud (UIS)
city: 'S Hertogenbosch
country: Netherlands
facility: Jeroen Bosch Ziekenhuis
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC Location VUMC
city: Breda
country: Netherlands
facility: Amphia Ziekenhuis
city: Gouda
country: Netherlands
facility: Groene Hart Ziekenhuis
city: NL -rotterdam
country: Netherlands
facility: Maasstadziekenhuis
city: Sittard-Geleen
country: Netherlands
facility: Zuyderland Medisch Centrum - Sittard Geleen
city: Tilburg
country: Netherlands
facility: Elisabeth-TweeSteden Ziekenhuis
city: Bergen
country: Norway
facility: Haukeland universitetssykehus
city: Drammen
country: Norway
facility: Sykehuset Buskerud HF
city: Stavanger
country: Norway
facility: Stavanger Universitetssykehus, Helse Stavanger HF
city: Bydgoszcz
country: Poland
facility: Neurocentrum Bydgoszcz sp. z o.o
city: Gdansk
country: Poland
facility: COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika
city: Katowice
country: Poland
facility: Care Clinic
city: Krakow
country: Poland
facility: Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
city: Lodz
country: Poland
facility: Centrum Neurologii Krzysztof Selmaj
city: Lublin
country: Poland
facility: Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
city: Warszawa
country: Poland
facility: Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
city: Warszawa
country: Poland
facility: Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
city: Braga
country: Portugal
facility: Hospital de Braga
city: Coimbra
country: Portugal
facility: HUC
city: Loures
country: Portugal
facility: Hospital Beatriz Angelo
city: Porto
country: Portugal
facility: Hospital Geral de Santo Antonio
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava
city: Bratislava
country: Slovakia
facility: Univerzitna nemocnica Bratislava Nemocnica Ruzinov
city: Trnava
country: Slovakia
facility: Fakultna nemocnica Trnava
city: Ljubljana
country: Slovenia
facility: University Medical Centre
city: Maribor
country: Slovenia
facility: University Medical Centre Maribor
city: Oviedo
country: Spain
facility: Hospital Universitario Central de Asturias
state: Asturias
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelona
city: Castelló de la Plana
country: Spain
facility: Hospital General de Castellon
state: Castellon
city: Coruña
country: Spain
facility: Complejo Hospitalario Universitario A Coruña (CHUAC)
state: LA Coruna
city: Lleida
country: Spain
facility: Hospital Universitari Arnau de Vilanova de Lleida
state: Lerida
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Quiron de Madrid
state: Madrid
city: Vigo
country: Spain
facility: Complejo Hospitalario Universitario de Vigo - Xeral Cies
state: Pontevedra
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
city: Cadiz
country: Spain
facility: Hospital Puerta del Mar
city: Girona
country: Spain
facility: Hospital Universitari de Girona Dr. Josep Trueta
city: Madrid
country: Spain
facility: Universitario de La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Clínico San Carlos
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Madrid
country: Spain
facility: Hospital Universitario La Paz
city: Murcia
country: Spain
facility: Hospital Universitario Virgen de Arrixaca
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen Macarena
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valencia
country: Spain
facility: Hospital Universitario la Fe
city: Göteborg
country: Sweden
facility: Sahlgrenska Sjukhuset
city: Karlstad
country: Sweden
facility: Centralsjukhuset
city: Stockholm
country: Sweden
facility: Centrum för Neurologi
city: Ankara
country: Turkey
facility: Hacettepe University Medical Faculty
city: Ankara
country: Turkey
facility: Gazi University Medical Faculty
city: Hatay
country: Turkey
facility: Mustafa Kemal Ataturk UTF
city: Istanbul
country: Turkey
facility: Istanbul University Istanbul School of Medicine
city: Istanbul
country: Turkey
facility: Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi
city: Konya
country: Turkey
facility: Selcuk University Medical Faculty
city: Samsun
country: Turkey
facility: Ondokuz Mayis University School of Medicine
city: Trabzon
country: Turkey
facility: Karadeniz Tecnical Uni. Med. Fac.
city: Exeter
country: United Kingdom
facility: Royal Devon and Exeter Hospital (Wonford)
city: Glasgow
country: United Kingdom
facility: Queen Elizabeth University Hospital
city: Inverness
country: United Kingdom
facility: Raigmore Hospital
city: Leeds
country: United Kingdom
facility: Leeds Teaching Hospitals NHS Trust
city: London
country: United Kingdom
facility: The Royal London Hospital
city: London
country: United Kingdom
facility: Royal Free Hospital
city: London
country: United Kingdom
facility: Kings College Hospital
city: London
country: United Kingdom
facility: St George's Hospital
city: London
country: United Kingdom
facility: Charing Cross Hospital
city: London
country: United Kingdom
facility: National Hospital for Neurology and Neurosurgery,
city: Newcastle upon Tyne
country: United Kingdom
facility: Royal Victoria Infirmary
city: Salford
country: United Kingdom
facility: Salford Royal NHS Foundation Trust
city: Sheffield
country: United Kingdom
facility: Royal Hallamshire Hospita
city: Swansea
country: United Kingdom
facility: Morriston Hospital
city: Truro
country: United Kingdom
facility: Royal Cornwall Hospital
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: