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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT05269004
Other study ID # MN43964
Secondary ID 2021-005746-15
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date May 3, 2022
Est. completion date December 31, 2029

Study information

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

Clinical Trial Summary

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 1300
Est. completion date December 31, 2029
Est. primary completion date December 31, 2029
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion criteria - Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation - For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet Exclusion criteria - Concurrent participation in any clinical trial (other than the Parent study) - Unable or unwilling to comply with the requirements of the protocol

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Ocrelizumab
Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Locations

Country Name City State
Argentina Hospital Español Ciudad Autonoma Bs As
Argentina Fundacion Rosarina de Neurorehabilitacion Rosario
Australia St Vincent's Hospital Melbourne Fitzroy Victoria
Australia Royal North Shore Hospital St. Leonards New South Wales
Austria Medizinische Universität Innsbruck Innsbruck
Austria Barmherzige Brueder Konventspital Linz
Austria AKH - Medizinische Universität Wien; Neurology Wien
Belarus Grodno University Hospital Grodno Brestskaya Voblasts'
Belarus State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology Minsk
Belarus Vitebsk Regional Clinical Hospital Vitebsk Vitsyebskaya Voblasts'
Belgium AZ Sint Jan Brugge
Belgium Cliniques Universitaires Saint-Luc Bruxelles
Belgium UZA Edegem
Belgium Algemeen Ziekenhuis Alma Eeklo
Belgium AZ Delta Campus Westlaan Roeselare
Brazil HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás Campinas SP
Brazil Clinica Neurológica e Neurocirúrgica de Joinville Joinville AP
Brazil Hospital Sao Lucas da PUCRS*X Porto Alegre RS
Brazil IMV Pesquisa Neurologica Sociedade Simples Ltda Porto Alegre RJ
Brazil Hospital Universitario Gaffree e Guinle; Neurologia Rio de Janeiro RJ
Brazil HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro Rio de Janeiro BA
Bulgaria MHAT Avis Medica OOD Department of Neurology Pleven
Bulgaria Acibadem City Clinic Tokuda Hospital Ead Sofia
Bulgaria MHATNP Sveti Naum EAD Sofia
Bulgaria Military Medical Academy MHAT Sofia Department of Rheumatology; Department of Rheumatology Sofia
Bulgaria National Heart Hospital EAD Sofia
Bulgaria University First MHAT-Sofia St. Joan Krastitel EAD Sofia
Canada Calgary MS Clinic Calgary Alberta
Canada University of Alberta; Northern Alberta Trials & Research Centre Edmonton Alberta
Canada Clinique Neuro Outaouais Gatineau Quebec
Canada Recherche Sepmus Inc. Greenfield Park Quebec
Canada Montreal Neurological Institute and Hospital; Pharmacy Department Montreal Quebec
Canada The Ottawa Hospital - General Campus Ottawa Ontario
Canada St Michael Hospital; Hematology and Oncology Toronto Ontario
Canada UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials Vancouver British Columbia
Croatia General Hospital Varazdin Varazdin
Croatia University Hospital Center Zagreb Zagreb
Czechia Fakultni nemocnice Brno Brno
Czechia Fakultni nemocnice u sv. Anny v Brne Brno
Czechia Neurospol s.r.o. Havirov
Czechia Fakultni nemocnice Hradec Kralove Hradec Kralove
Czechia Nemocnice Jihlava Jihlava
Czechia Pardubicka krajska nemocnice a.s. Pardubice
Czechia Vseobecna fakultni nemocnice v Praze Praha 2
Czechia Krajska zdravotni a.s. - Nemocnice Teplice o.z. Teplice
Estonia West Tallinn Central Hospital Tallinn
Estonia Tartu University Hospital Tartu
Finland Tammer Tutka Oy Tampere
France Groupe Hospitalier Pellegrin Bordeaux
France Hopital Neurologique Pierre Wertheimer Bron
France CHU de Caen Hopital Cote de Nacre Caen
France CHU Hopital Gabriel Montpied Clermont Ferrand
France Hopital Roger Salengro Service de Neurologie Lille
France CHU Nancy Hôpital Central Nancy
France CHU Nantes Hopital Nord Laënnec; Pharmacy Nantes
France CHU Nice - Hôpital Pasteur 2 Nice
France Centre Hospitalier Intercommunal de Poissy Poissy
France CHU Strasbourg Hôpital Hautepierre Strasbourg
Germany Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie; Klinik für Neurologie Bayreuth
Germany Charité Universitaetsmedizin Berlin - Campus Ch Berlin
Germany Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie Berlin
Germany Neurologie in Bonn Bonn
Germany Universitaetsklinikum Carl Gustav Carus TU Dresden Dresden
Germany Universitaetsklinikum Duesseldorf Dusseldorf
Germany Zentrum fuer ambulante Neurologie Essen
Germany Klinikum der Johann Wolfgang Goethe-Universitaet Frankfurt
Germany Universitaetsklinikum Giessen und Marburg GmbH; Zytostatikaabteilung Gießen
Germany Universitaetsklinikum Leipzig Leipzig
Germany Pharmakologisches Studienzentrum Mittweida
Germany Universitaetsklinikum Muenster Muenster
Germany Klinikum rechts der Isar der TU Muenchen München
Germany Medizinische Einrichtungen des Bezirks Oberpfalz GmbH Regensburg
Germany Universitaetsklinikum Tuebingen Tuebingen
Germany NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH Ulm
Germany Universitätsklinikum Ulm; Klinik für Neurologie Ulm
Germany Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz Westerstede
Hungary Jahn Ferenc Del-Pesti Korhaz es Rendelointezet Budapest
Hungary S-Medicon Egeszsegugyi Szolgaltato Kft. Budapest
Hungary Pecsi Tudomanyegyetem Pecs
Israel Hadassah University Hospital - Ein Kerem Jerusalem
Israel Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute Petach Tiqwa
Israel Chaim Sheba Medical Center Ramat Gan
Israel Chaim Sheba Medical Center; Neurology Department Ramat-Gan
Israel Tel Aviv Sourasky Medical Center; Department of Neurology Tel Aviv
Italy Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili) Brescia Lombardia
Italy Fondazione Istituto G. Giglio di Cefalu Cefalù Sicilia
Italy Azienda Socio Sanitaria Territoriale della Valle Olona (pres Gallarate Valle D?Aosta
Italy Ospedale Policlinico San Martino Genova Liguria
Italy Fondazione IRCCS Istituto Neurologico Carlo Besta Milano Lombardia
Italy Hospital San Raffaele Milano Lombardia
Italy Azienda Sanitaria Ospedaliera S Luigi Gonzaga Orbassano Piemonte
Italy Ospedale degli Infermi Ponderano Piemonte
Italy Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien Roma Lazio
Italy Azienda Ospedaliera Universitaria Policlinico Tor Vergata Roma Lazio
Italy Azienda Ospedaliero Universitaria Ospedali Riuniti Torrette Di Ancona Marche
Latvia Pauls Stradins Clinical University Hospital R?ga
Latvia Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology Riga
Lithuania Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution Kaunas
Lithuania Klaipeda University Hospital Public Institution Klaipeda
Lithuania Vilnius University Hospital Santaros Klinikos Vilnius
Mexico Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Aguascalientes Aguascalientes
Mexico Hospital Angeles Chihuahua Chihuahua
Mexico Mexico Centre for Clinical Research Ciudad de México Mexico CITY (federal District)
Mexico Hospital Angeles Culiacan Culiacan Sinaloa
Mexico Grupo Medico Camino DF Mexico CITY (federal District)
Mexico Hospital Mexico Americano Guadalajara Mexico CITY (federal District)
Mexico Centro de Estudios Clinicos y Especialidades Medicas S C Monterrey Nuevo LEON
Mexico Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León Monterrey Nuevo LEON
Mexico Clinical Research Institute Tlalnepantla de Baz Mexico CITY (federal District)
Netherlands Zuyderland Medisch Centrum - Sittard-Geleen' Sittard-Geleen
New Zealand Waikato Hospital Hamilton
Norway Haukeland Universitetssykehus Bergen
Poland NZOZ Vitamed Bydgoszcz
Poland COPERNICUS Podmiot Leczniczy Sp z o o Gda?sk
Poland M.A. LEK A.M.Maciejowscy SC. Katowice
Poland Neuro-Medic Janusz Zbrojkiewicz Katowice
Poland Specjal. Praktyka Lekarska; Prof. Grzegorz Opala Katowice
Poland Centrum Neurologii Klinicznej Krakow
Poland Centrum Neurologii Krzysztof Selmaj Lodz
Poland Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie Lublin
Poland Wojewodzki Specjalistyczny Szpital w Olsztynie Olsztyn
Poland Neurologiczny NZOZ Centrum Leczenia SM Plewiska
Poland Neuro-Care Gabriela Klodowska Siemianowice ?l?skie
Poland Centrum Medyczne NeuroProtect Warszawa
Portugal Hospital Garcia de Orta; Servico de Neurologia Almada
Portugal Hospital de Braga Braga
Portugal Centro Hospitalar E Universitário de Coimbra EPE Coimbra
Portugal Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria Lisboa
Romania Spitalul Universitar de Urgenta Elias; Oncologie Medicala Bucuresti
Romania SC Clubul Sanatatii SRL Campulung
Russian Federation Siberian Medical Center Barnaul Altaj
Russian Federation SAHI "Interregional Clinical and Diagnostic Center" Kazan Vologda
Russian Federation SAIH "Kemerovo Regional Clinical Hospital" Kemerovo
Russian Federation Kirov RSBIH "Kirov City Clinical Hospital # 1" Kirov
Russian Federation FGBU FNKC FMBA of Russia Moskva Moskovskaja Oblast
Russian Federation SBIH City Polyclinic 2 of the Department of Health of the City of Moscow Moskva Moskovskaja Oblast
Russian Federation SBIH of Nizhniy Novgorod region "City Clinical Hospital # 3" Nizhny Novgorod Niznij Novgorod
Russian Federation FSBIH Siberian Clinical Center of FMBA of Novosibirsk Novosibirsk
Russian Federation Perm SMA n.a. academ. E.A. Vagner Perm
Russian Federation SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk; Neurology Department Pyatigorsk Stavropol
Russian Federation SBEI HPE "Samara State Medical University" of the MoH of the RF Samara
Russian Federation FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF Sankt-peterburg Sankt Petersburg
Russian Federation SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery Sankt-peterburg Sankt Petersburg
Russian Federation SBIH of Republic Mordoviya "Republican Clinical Hospital # 4" Saransk Mordovija
Russian Federation RSBIH "Smolensk Regional Clinical Hospital" Smolensk
Russian Federation Pavlov First Saint Petersburg State Medical University St. Petersburg Sankt Petersburg
Russian Federation Saratov State Medical University Stavropol
Russian Federation Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology Tyumen Tjumen
Russian Federation Sverdlovsk Regional Clinical Hospital 1 Yekaterinburg Sverdlovsk
Serbia Clinical Center Kragujevac Kragujevac
Serbia Clinical Center Nis NIS
Slovakia MUDr. Beata Dupejova Neurologicka ambulancia s.r.o Banska Bystrica
Slovakia Univerzitna nemocnica Bratislava Nemocnica Ruzinov Bratislava
Slovakia Fakultna nemocnica s poliklinikou Zilina Zilina
Spain Hospital Vall d'Hebron; Servicio de Neurología Barcelona
Spain Hospital de Basurto Servicio de Neurologia Bilbao Vizcaya
Spain Hospital Universitari de Bellvitge; Servicio de Neurologia L'Hospitalet de Llobregat Barcelona
Spain Hospital Universitario Clínico San Carlos; Servicio de Neurología Madrid
Spain Hospital Universitario de la Princesa; Servicio de Neurologia Madrid
Spain Hospital Universitario Ramon y Cajal Madrid
Spain Hospital Universitario Puerta de Hierro - Majadahonda Majadahonda Madrid
Spain Hospital Regional Universitario de Malaga Malaga
Spain Hospital Santa Caterina Salt Girona
Spain Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia Santiago de Compostela LA Coruña
Spain Hospital Universitario Virgen Macarena Seville Sevilla
Sweden Sahlgrenska Sjukhuset Mölnlycke
Sweden Akademiskt Specialist Centrum Solna
Sweden Karolinska Universitetssjukhuset Huddinge Stockholm
Switzerland Universitaetsspital Basel Basel
Switzerland Ospedale Regionale di Lugano Lugano
Tunisia Hopital Razi Mannouba
Tunisia Hopital Universitaire Fattouma Bourguiba Monastir
Turkey Istanbul University Cerrahpasa Medical Faculty Istanbul
Turkey Ondokuz Mayis Univ. Med. Fac.; Neurology Samsun
Turkey Karadeniz Tecnical Uni. Med. Fac Trabzon
Ukraine CMPI Chernihiv Regional Hospital; Reg.Cen.for Inflam.&demyelin.dis.of the CNS Chernihiv KIEV Governorate
Ukraine CE I.I.Mechnykov Dnipropetrovsk RC Hosp Dept of Neurology DSMU Dnipro KIEV Governorate
Ukraine CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council Ivano Frankivsk KIEV Governorate
Ukraine Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine Kharkiv Kharkiv Governorate
Ukraine Medical Center of Limited Liability Company Medbud-Clinic Kyiv Kharkiv Governorate
Ukraine CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU Lviv KIEV Governorate
Ukraine Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital Lviv Kharkiv Governorate
Ukraine CNE Odesa Regional Clinical Hospital of Odesa Regional Council Odesa KIEV Governorate
Ukraine Medical Center of Limited Liability Company Medical Center Saliutem Vinnytsia Chernihiv Governorate
United Kingdom Royal Devon and Exeter Hospital (Wonford) Exeter
United Kingdom Walton Centre For Neurology and Neurosurgery Liverpool
United Kingdom Barts Health NHS Trust London
United Kingdom Royal Victoria Infirmary Newcastle upon Tyne
United Kingdom Nottingham University Hospitals Queen's Medical Centre Nottingham
United Kingdom Morriston Hospital Swansea
United States Abington Neurological Associates Abington Pennsylvania
United States University of New Mexico Albuquerque New Mexico
United States Atlanta Neuroscience Institute Atlanta Georgia
United States University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center) Aurora Colorado
United States Massachusetts General Hospital Boston Massachusetts
United States University of Vermont Medical Center; Neurology Burlington Vermont
United States Atrium Health Charlotte North Carolina
United States OnSite Clinical Solutions LLC Charlotte North Carolina
United States The Neurological Institute PA Charlotte North Carolina
United States Northwestern University Chicago Illinois
United States University Neurology Inc. Cincinnati Ohio
United States Columbus Neuroscience Columbus Ohio
United States Neurology Clinic PC Cordova Tennessee
United States Henry Ford Hospital Detroit Michigan
United States Wayne State University Detroit Michigan
United States Michigan Institute for Neurological Disorders Farmington Hills Michigan
United States Advanced Neurosciences Research LLC Fort Collins Colorado
United States Minneapolis Clinic of Neurology Golden Valley Minnesota
United States Neurology Associates PA Hickory North Carolina
United States Baylor College of Medicine Houston Texas
United States Uni of Texas Health Science Center At Houston Houston Texas
United States Indiana Univ School of Med Indianapolis Indiana
United States Kansas University Medical Center Kansas City Kansas
United States Sibyl Wray MD Neurology PC Knoxville Tennessee
United States MS Center of California Laguna Hills California
United States Bhupesh Dihenia M.D. P.A. Lubbock Texas
United States University of Miami Miami Florida
United States University of Minnesota; Clin. Neuro Research Unit Minneapolis Minnesota
United States Rutgers New Jersey Medical School Department of Neurology Newark New Jersey
United States Consultants in Neurology Ltd Northbrook Illinois
United States Oklahoma Medical Research Foundation Oklahoma City Oklahoma
United States University of Nebraska Medical Center Omaha Nebraska
United States Neurological Services of Orlando Orlando Florida
United States Stanford Hospital and Clinics Palo Alto California
United States South Shore Neurologic Associates PC Patchogue New York
United States Arizona Neuroscience Research LLC Phoenix Arizona
United States Barrow Neurological Institute Phoenix Arizona
United States Providence Neurological Specialties Portland Oregon
United States Rhode Island Hospital Providence Rhode Island
United States Raleigh Neurology Associates Raleigh North Carolina
United States Central Texas Neurology Consultants Round Rock Texas
United States Washington University Saint Louis Missouri
United States Neurology Center of San Antonio San Antonio Texas
United States University of California San Francisco San Francisco California
United States Swedish Neuroscience Institute Seattle Washington
United States SUNY at Stony Brook Stony Brook New York
United States MultiCare Health System Institute for Research and Innovation Tacoma Washington
United States University of South Florida Tampa Florida
United States Holy Name Hospital Teaneck New Jersey
United States Vero Beach Neurology and Research Institute Vero Beach Florida

Sponsors (1)

Lead Sponsor Collaborator
Hoffmann-La Roche

Countries where clinical trial is conducted

United States,  Argentina,  Australia,  Austria,  Belarus,  Belgium,  Brazil,  Bulgaria,  Canada,  Croatia,  Czechia,  Estonia,  Finland,  France,  Germany,  Hungary,  Israel,  Italy,  Latvia,  Lithuania,  Mexico,  Netherlands,  New Zealand,  Norway,  Poland,  Portugal,  Romania,  Russian Federation,  Serbia,  Slovakia,  Spain,  Sweden,  Switzerland,  Tunisia,  Turkey,  Ukraine,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0 Up to 44 months
Secondary Change in Expanded Disability Status Scale (EDSS) score over time Week 0, 24, 48, 72, 96, 120, 168
Secondary Change in 9-Hole Peg Test (9HPT) over time Week 0, 24, 48, 72, 96, 120, 168
Secondary Change in Timed 25-Foot Walk Test (T25FWT) over time Week 0, 24, 48, 72, 96, 120, 168
Secondary The number of T1 lesions and number of new or enlarging T2 lesions Week 0, 24, 48, 72, 96, 120, 168
Secondary The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume Week 0, 24, 48, 72, 96, 120, 168
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