Multiple Sclerosis Clinical Trial

A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

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.

View Eligibility Criteria

Eligibility Criteria

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 is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1300

Study ID:

NCT05269004

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 234 Locations for this study

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Barrow Neurological Institute
Phoenix Arizona, 85013, United States
Arizona Neuroscience Research LLC
Phoenix Arizona, 85032, United States
MS Center of California
Laguna Hills California, 92653, United States
Stanford Hospital and Clinics
Palo Alto California, 94304, United States
University of California San Francisco
San Francisco California, 94117, United States
University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
Aurora Colorado, 80045, United States
Advanced Neurosciences Research LLC
Fort Collins Colorado, 80528, United States
University of Miami
Miami Florida, 33136, United States
Neurological Services of Orlando
Orlando Florida, 32806, United States
University of South Florida
Tampa Florida, 33612, United States
Vero Beach Neurology and Research Institute
Vero Beach Florida, 32960, United States
Atlanta Neuroscience Institute
Atlanta Georgia, 30327, United States
Northwestern University
Chicago Illinois, 60611, United States
Consultants in Neurology Ltd
Northbrook Illinois, 60062, United States
Indiana Univ School of Med
Indianapolis Indiana, 46202, United States
Kansas University Medical Center
Kansas City Kansas, 66103, United States
Massachusetts General Hospital
Boston Massachusetts, 02114, United States
Wayne State University
Detroit Michigan, 48201, United States
Henry Ford Hospital
Detroit Michigan, 48202, United States
Michigan Institute for Neurological Disorders
Farmington Hills Michigan, 48334, United States
Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
University of Minnesota; Clin. Neuro Research Unit
Minneapolis Minnesota, 55414, United States
Washington University
Saint Louis Missouri, 63128, United States
University of Nebraska Medical Center
Omaha Nebraska, 68198, United States
Rutgers New Jersey Medical School Department of Neurology
Newark New Jersey, 07103, United States
Holy Name Hospital
Teaneck New Jersey, 07666, United States
University of New Mexico
Albuquerque New Mexico, 87131, United States
South Shore Neurologic Associates PC
Patchogue New York, 11772, United States
SUNY at Stony Brook
Stony Brook New York, 11790, United States
The Neurological Institute PA
Charlotte North Carolina, 28204, United States
Atrium Health
Charlotte North Carolina, 28209, United States
OnSite Clinical Solutions LLC
Charlotte North Carolina, 28277, United States
Neurology Associates PA
Hickory North Carolina, 28602, United States
Raleigh Neurology Associates
Raleigh North Carolina, 27607, United States
University Neurology Inc.
Cincinnati Ohio, 45219, United States
Columbus Neuroscience
Columbus Ohio, 43801, United States
Oklahoma Medical Research Foundation
Oklahoma City Oklahoma, 73104, United States
Providence Neurological Specialties
Portland Oregon, 97225, United States
Abington Neurological Associates
Abington Pennsylvania, 19001, United States
Rhode Island Hospital
Providence Rhode Island, 02903, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
Sibyl Wray MD Neurology PC
Knoxville Tennessee, 37934, United States
Baylor College of Medicine
Houston Texas, 77030, United States
Uni of Texas Health Science Center At Houston
Houston Texas, 77030, United States
Bhupesh Dihenia M.D. P.A.
Lubbock Texas, 79410, United States
Central Texas Neurology Consultants
Round Rock Texas, 78681, United States
Neurology Center of San Antonio
San Antonio Texas, 78258, United States
University of Vermont Medical Center; Neurology
Burlington Vermont, 05405, United States
Swedish Neuroscience Institute
Seattle Washington, 98122, United States
MultiCare Health System Institute for Research and Innovation
Tacoma Washington, 98405, United States
Hospital Español
Ciudad Autonoma Bs As , C1209, Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario , S2000, Argentina
Royal North Shore Hospital
St. Leonards New South Wales, 2065, Australia
St Vincent's Hospital Melbourne
Fitzroy Victoria, 3065, Australia
Medizinische Universität Innsbruck
Innsbruck , 6020, Austria
Barmherzige Brueder Konventspital
Linz , 4040, Austria
AKH - Medizinische Universität Wien; Neurology
Wien , 1090, Austria
Grodno University Hospital
Grodno Brestskaya Voblasts', 23003, Belarus
Vitebsk Regional Clinical Hospital
Vitebsk Vitsyebskaya Voblasts', 21003, Belarus
State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology
Minsk , 22000, Belarus
AZ Sint Jan
Brugge , 8000, Belgium
Cliniques Universitaires Saint-Luc
Bruxelles , 1200, Belgium
UZA
Edegem , 2650, Belgium
Algemeen Ziekenhuis Alma
Eeklo , 9900, Belgium
AZ Delta Campus Westlaan
Roeselare , 8800, Belgium
Clinica Neurológica e Neurocirúrgica de Joinville
Joinville AP, 89202, Brazil
HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro
Rio de Janeiro BA, 21941, Brazil
IMV Pesquisa Neurologica Sociedade Simples Ltda
Porto Alegre RJ, 90110, Brazil
Hospital Universitario Gaffree e Guinle; Neurologia
Rio de Janeiro RJ, 20270, Brazil
Hospital Sao Lucas da PUCRS*X
Porto Alegre RS, 90610, Brazil
HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
Campinas SP, 13083, Brazil
MHAT Avis Medica OOD Department of Neurology
Pleven , 5800, Bulgaria
MHATNP Sveti Naum EAD
Sofia , 1113, Bulgaria
University First MHAT-Sofia St. Joan Krastitel EAD
Sofia , 1142, Bulgaria
National Heart Hospital EAD
Sofia , 1309, Bulgaria
Acibadem City Clinic Tokuda Hospital Ead
Sofia , 1407, Bulgaria
Military Medical Academy MHAT Sofia Department of Rheumatology; Department of Rheumatology
Sofia , 1606, Bulgaria
Calgary MS Clinic
Calgary Alberta, T2N 2, Canada
University of Alberta; Northern Alberta Trials & Research Centre
Edmonton Alberta, T6G 2, Canada
UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials
Vancouver British Columbia, V6T 2, Canada
The Ottawa Hospital - General Campus
Ottawa Ontario, K1H 8, Canada
St Michael Hospital; Hematology and Oncology
Toronto Ontario, M5B 1, Canada
Clinique Neuro Outaouais
Gatineau Quebec, J8Y 1, Canada
Recherche Sepmus Inc.
Greenfield Park Quebec, J4V 2, Canada
Montreal Neurological Institute and Hospital; Pharmacy Department
Montreal Quebec, H3A 2, Canada
General Hospital Varazdin
Varazdin , 42000, Croatia
University Hospital Center Zagreb
Zagreb , 10000, Croatia
Fakultni nemocnice Brno
Brno , 613 0, Czechia
Fakultni nemocnice u sv. Anny v Brne
Brno , 656 9, Czechia
Neurospol s.r.o.
Havirov , 736 0, Czechia
Fakultni nemocnice Hradec Kralove
Hradec Kralove , 500 0, Czechia
Nemocnice Jihlava
Jihlava , 586 3, Czechia
Pardubicka krajska nemocnice a.s.
Pardubice , 532 0, Czechia
Vseobecna fakultni nemocnice v Praze
Praha 2 , 128 0, Czechia
Krajska zdravotni a.s. - Nemocnice Teplice o.z.
Teplice , 415 2, Czechia
West Tallinn Central Hospital
Tallinn , 10617, Estonia
Tartu University Hospital
Tartu , 51014, Estonia
Tammer Tutka Oy
Tampere , 33200, Finland
Groupe Hospitalier Pellegrin
Bordeaux , 33000, France
Hopital Neurologique Pierre Wertheimer
Bron , 69500, France
CHU de Caen Hopital Cote de Nacre
Caen , 14033, France
CHU Hopital Gabriel Montpied
Clermont Ferrand , 63003, France
Hopital Roger Salengro Service de Neurologie
Lille , , France
CHU Nancy Hôpital Central
Nancy , 54035, France
CHU Nantes Hopital Nord Laënnec; Pharmacy
Nantes , 44093, France
CHU Nice - Hôpital Pasteur 2
Nice , 06000, France
Centre Hospitalier Intercommunal de Poissy
Poissy , 78300, France
CHU Strasbourg Hôpital Hautepierre
Strasbourg , 67098, France
Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie; Klinik für Neurologie
Bayreuth , 95445, Germany
Charité Universitaetsmedizin Berlin - Campus Ch
Berlin , 10117, Germany
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin , 13347, Germany
Neurologie in Bonn
Bonn , 53111, Germany
Universitaetsklinikum Carl Gustav Carus TU Dresden
Dresden , 01307, Germany
Universitaetsklinikum Duesseldorf
Dusseldorf , 40225, Germany
Zentrum fuer ambulante Neurologie
Essen , 45138, Germany
Klinikum der Johann Wolfgang Goethe-Universitaet
Frankfurt , 60590, Germany
Universitaetsklinikum Giessen und Marburg GmbH; Zytostatikaabteilung
Gießen , 35392, Germany
Universitaetsklinikum Leipzig
Leipzig , 04103, Germany
Pharmakologisches Studienzentrum
Mittweida , 09648, Germany
Universitaetsklinikum Muenster
Muenster , 48149, Germany
Klinikum rechts der Isar der TU Muenchen
München , 81675, Germany
Medizinische Einrichtungen des Bezirks Oberpfalz GmbH
Regensburg , 93053, Germany
Universitaetsklinikum Tuebingen
Tuebingen , 72076, Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
Ulm , 89073, Germany
Universitätsklinikum Ulm; Klinik für Neurologie
Ulm , 89081, Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede , 26655, Germany
S-Medicon Egeszsegugyi Szolgaltato Kft.
Budapest , 1138, Hungary
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet
Budapest , 1204, Hungary
Pecsi Tudomanyegyetem
Pecs , 7624, Hungary
Hadassah University Hospital - Ein Kerem
Jerusalem , 91120, Israel
Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
Petach Tiqwa , 49100, Israel
Chaim Sheba Medical Center
Ramat Gan , 52662, Israel
Chaim Sheba Medical Center; Neurology Department
Ramat-Gan , 52620, Israel
Tel Aviv Sourasky Medical Center; Department of Neurology
Tel Aviv , 64239, Israel
Azienda Ospedaliera Universitaria Policlinico Tor Vergata
Roma Lazio, 00133, Italy
Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
Roma Lazio, 189, Italy
Ospedale Policlinico San Martino
Genova Liguria, 16132, Italy
Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
Brescia Lombardia, 25100, Italy
Hospital San Raffaele
Milano Lombardia, 20132, Italy
Fondazione IRCCS Istituto Neurologico Carlo Besta
Milano Lombardia, 20133, Italy
Azienda Ospedaliero Universitaria Ospedali Riuniti
Torrette Di Ancona Marche, 60126, Italy
Azienda Sanitaria Ospedaliera S Luigi Gonzaga
Orbassano Piemonte, 10043, Italy
Ospedale degli Infermi
Ponderano Piemonte, 13875, Italy
Fondazione Istituto G. Giglio di Cefalu
Cefalù Sicilia, 90015, Italy
Azienda Socio Sanitaria Territoriale della Valle Olona (pres
Gallarate Valle D?Aosta, 21013, Italy
Pauls Stradins Clinical University Hospital
R?ga , LV-10, Latvia
Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
Riga , 1015, Latvia
Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
Kaunas , 50009, Lithuania
Klaipeda University Hospital Public Institution
Klaipeda , 92288, Lithuania
Vilnius University Hospital Santaros Klinikos
Vilnius , 8406, Lithuania
Mexico Centre for Clinical Research
Ciudad de México Mexico CITY (federal District), 03100, Mexico
Grupo Medico Camino
DF Mexico CITY (federal District), , Mexico
Hospital Mexico Americano
Guadalajara Mexico CITY (federal District), 44610, Mexico
Clinical Research Institute
Tlalnepantla de Baz Mexico CITY (federal District), 54055, Mexico
Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
Monterrey Nuevo LEON, 64460, Mexico
Centro de Estudios Clinicos y Especialidades Medicas S C
Monterrey Nuevo LEON, 64620, Mexico
Hospital Angeles Culiacan
Culiacan Sinaloa, 80020, Mexico
Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Aguascalientes
Aguascalientes , 20010, Mexico
Hospital Angeles Chihuahua
Chihuahua , 31238, Mexico
Zuyderland Medisch Centrum - Sittard-Geleen'
Sittard-Geleen , 6162 , Netherlands
Waikato Hospital
Hamilton , 3248, New Zealand
Haukeland Universitetssykehus
Bergen , 5053, Norway
NZOZ Vitamed
Bydgoszcz , 85-07, Poland
COPERNICUS Podmiot Leczniczy Sp z o o
Gda?sk , 80-80, Poland
M.A. LEK A.M.Maciejowscy SC.
Katowice , 40-57, Poland
Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
Katowice , 40-58, Poland
Neuro-Medic Janusz Zbrojkiewicz
Katowice , 40-68, Poland
Centrum Neurologii Klinicznej
Krakow , 31-50, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz , 90-32, Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin , 20-95, Poland
Wojewodzki Specjalistyczny Szpital w Olsztynie
Olsztyn , 10-56, Poland
Neurologiczny NZOZ Centrum Leczenia SM
Plewiska , 62-06, Poland
Neuro-Care Gabriela Klodowska
Siemianowice ?l?skie , 41-10, Poland
Centrum Medyczne NeuroProtect
Warszawa , 01-68, Poland
Hospital Garcia de Orta; Servico de Neurologia
Almada , 2801-, Portugal
Hospital de Braga
Braga , 4710-, Portugal
Centro Hospitalar E Universitário de Coimbra EPE
Coimbra , 3041-, Portugal
Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
Lisboa , 1649-, Portugal
Spitalul Universitar de Urgenta Elias; Oncologie Medicala
Bucuresti , 01146, Romania
SC Clubul Sanatatii SRL
Campulung , 11510, Romania
Siberian Medical Center
Barnaul Altaj, 65604, Russian Federation
SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"
Saransk Mordovija, 43003, Russian Federation
FGBU FNKC FMBA of Russia
Moskva Moskovskaja Oblast, 11568, Russian Federation
SBIH City Polyclinic 2 of the Department of Health of the City of Moscow
Moskva Moskovskaja Oblast, 12912, Russian Federation
SBIH of Nizhniy Novgorod region "City Clinical Hospital # 3"
Nizhny Novgorod Niznij Novgorod, 60315, Russian Federation
FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
Sankt-peterburg Sankt Petersburg, 19404, Russian Federation
SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
Sankt-peterburg Sankt Petersburg, 19435, Russian Federation
Pavlov First Saint Petersburg State Medical University
St. Petersburg Sankt Petersburg, 19702, Russian Federation
SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk; Neurology Department
Pyatigorsk Stavropol, 35753, Russian Federation
Sverdlovsk Regional Clinical Hospital 1
Yekaterinburg Sverdlovsk, 62010, Russian Federation
Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
Tyumen Tjumen, 62504, Russian Federation
SAHI "Interregional Clinical and Diagnostic Center"
Kazan Vologda, 42010, Russian Federation
SAIH "Kemerovo Regional Clinical Hospital"
Kemerovo , 65006, Russian Federation
Kirov RSBIH "Kirov City Clinical Hospital # 1"
Kirov , 61001, Russian Federation
FSBIH Siberian Clinical Center of FMBA of Novosibirsk
Novosibirsk , 63000, Russian Federation
Perm SMA n.a. academ. E.A. Vagner
Perm , 61499, Russian Federation
SBEI HPE "Samara State Medical University" of the MoH of the RF
Samara , 44309, Russian Federation
RSBIH "Smolensk Regional Clinical Hospital"
Smolensk , 21401, Russian Federation
Saratov State Medical University
Stavropol , 35501, Russian Federation
Clinical Center Kragujevac
Kragujevac , 34000, Serbia
Clinical Center Nis
NIS , 18000, Serbia
MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
Banska Bystrica , 974 0, Slovakia
Univerzitna nemocnica Bratislava Nemocnica Ruzinov
Bratislava , 826 0, Slovakia
Fakultna nemocnica s poliklinikou Zilina
Zilina , 012 0, Slovakia
Hospital Universitari de Bellvitge; Servicio de Neurologia
L'Hospitalet de Llobregat Barcelona, 08907, Spain
Hospital Santa Caterina
Salt Girona, 17190, Spain
Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
Santiago de Compostela LA Coruña, 15706, Spain
Hospital Universitario Puerta de Hierro - Majadahonda
Majadahonda Madrid, 28220, Spain
Hospital Universitario Virgen Macarena
Seville Sevilla, 41071, Spain
Hospital de Basurto Servicio de Neurologia
Bilbao Vizcaya, 48013, Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona , 08035, Spain
Hospital Universitario de la Princesa; Servicio de Neurologia
Madrid , 28006, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Universitario Clínico San Carlos; Servicio de Neurología
Madrid , 28040, Spain
Hospital Regional Universitario de Malaga
Malaga , 29010, Spain
Sahlgrenska Sjukhuset
Mölnlycke , 435 3, Sweden
Akademiskt Specialist Centrum
Solna , 171 6, Sweden
Karolinska Universitetssjukhuset Huddinge
Stockholm , 171 6, Sweden
Universitaetsspital Basel
Basel , 4031, Switzerland
Ospedale Regionale di Lugano
Lugano , 6900, Switzerland
Hopital Razi
Mannouba , 2010, Tunisia
Hopital Universitaire Fattouma Bourguiba
Monastir , 5000, Tunisia
Istanbul University Cerrahpasa Medical Faculty
Istanbul , 34000, Turkey
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun , 55139, Turkey
Karadeniz Tecnical Uni. Med. Fac
Trabzon , 61080, Turkey
Medical Center of Limited Liability Company Medical Center Saliutem
Vinnytsia Chernihiv Governorate, 21050, Ukraine
Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine
Kharkiv Kharkiv Governorate, 61068, Ukraine
Medical Center of Limited Liability Company Medbud-Clinic
Kyiv Kharkiv Governorate, 03037, Ukraine
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv Kharkiv Governorate, 79010, Ukraine
CMPI Chernihiv Regional Hospital; Reg.Cen.for Inflam.&demyelin.dis.of the CNS
Chernihiv KIEV Governorate, 14029, Ukraine
CE I.I.Mechnykov Dnipropetrovsk RC Hosp Dept of Neurology DSMU
Dnipro KIEV Governorate, 49005, Ukraine
CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
Ivano Frankivsk KIEV Governorate, 76008, Ukraine
CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
Lviv KIEV Governorate, 79010, Ukraine
CNE Odesa Regional Clinical Hospital of Odesa Regional Council
Odesa KIEV Governorate, 65025, Ukraine
Royal Devon and Exeter Hospital (Wonford)
Exeter , EX2 5, United Kingdom
Walton Centre For Neurology and Neurosurgery
Liverpool , L9 7L, United Kingdom
Barts Health NHS Trust
London , E1 2E, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne , NE1 4, United Kingdom
Nottingham University Hospitals Queen's Medical Centre
Nottingham , NG7 2, United Kingdom
Morriston Hospital
Swansea , SA6 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1300

Study ID:

NCT05269004

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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