Multiple Sclerosis Clinical Trial

A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

Summary

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS)
EDSS (Expanded Disability Status Scale) Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment
Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist
Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers
For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug

Exclusion Criteria:

Relapsing-remitting multiple sclerosis (RRMS) at screening
Inability to complete an MRI
Gadolinium (Gd) intolerance
Known presence of other neurological disorders

Exclusions Related to General Health:

Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening
Lactation
Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study
History or currently active primary or secondary immunodeficiency
Lack of peripheral venous access
Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study.
Active infections must be treated and resolved prior to the first infusion of ocrelizumab
Participants in a severely immunocompromised state until the condition resolves
Participants with known active malignancies or being actively monitored for recurrence of malignancy
Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML)

Exclusions Related to Laboratory Findings:

Positive screening tests for hepatitis B
CD4 count <250/μL
ANC <1.0 × 103/μL
AST/SGOT or ALT/SGPT ≥3.0 × ULN in combination with either an elevated total bilirubin (>2 X ULN) or clinical jaundice

Exclusions Related to Medications:

Hypersensitivity to ocrelizumab or to any of its excipients
Previous treatment with ocrelizumab
Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or immunogenicity AND if Bcell levels are above the lower limit of normal (LLN) prior to screening.
Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation
Previous treatment with natalizumab where PML has not been excluded according to specific algorithm
Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label
Systemic corticosteroid therapy within 4 weeks prior to screening
All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab, unless the local regulations allow for a shorter interval. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted
Previous treatment with daclizumab, ozanimod or figolimod in the last 8 weeks
Previous treatment with siponimod in the last 2 weeks
Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening
Previous treatment with natalizumab in the last 12 weeks.
Previous treatment with teriflunomide in the last 12 weeks. This washout period can be shortened if an accelerated elimination procedure is implemented before screening visit. One of the following elimination procedures can be used:
Cholestyramine 8 g administered 3 times daily for a period of at least 7 days (cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated)
Alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of at least 7 days.
Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks
Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS
Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks
Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

927

Study ID:

NCT03523858

Recruitment Status:

Active, not recruiting

Sponsor:

Hoffmann-La Roche

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There are 121 Locations for this study

See Locations Near You

MS Center of California
Laguna Hills California, 92653, United States
SC3 Research Group, Inc
Pasadena California, 91105, United States
University of California San Francisco
San Francisco California, 94117, United States
Yale University Multiple Sclerosis Center
New Haven Connecticut, 06473, United States
University of South Florida
Tampa Florida, 33612, United States
University of Chicago; Neurology/MC 2030
Chicago Illinois, 60637, United States
Massachusetts General Hospital; Neurological Clinical Research Institute (NCRI)
Boston Massachusetts, 02114, United States
The Elliot Lewis Center
Wellesley Massachusetts, 02481, United States
Wayne State University School of Medicine
Detroit Michigan, 48210, United States
Washington University School of Medicine
Saint Louis Missouri, 63110, United States
The MS Center of Northeastern New York
Latham New York, 12110, United States
University of Cincinnati; Department of Neurology
Cincinnati Ohio, 45219, United States
Cleveland Clinic Mellen Center; U10
Cleveland Ohio, 44195, United States
University of Pennsylvania
Philadelphia Pennsylvania, 19104, United States
Neurology Clinic PC
Cordova Tennessee, 38018, United States
Central Texas Neurology Consultants
Round Rock Texas, 78681, United States
Neurology Center of San Antonio
San Antonio Texas, 78258, United States
Swedish Multiple Sclerosis Center
Seattle Washington, 98122, United States
University Clinical Center of the Republic of Srpska; Neurology Clinic
Banja Luka , 78000, Bosnia and Herzegovina
University Hospital Mostar; Neurology Clinic
Mostar , 88000, Bosnia and Herzegovina
Clinical Center University of Sarajevo; Neurology clinic
Sarajevo , 71000, Bosnia and Herzegovina
University Clinical Center Tuzla; Neurology
Tuzla , 75000, Bosnia and Herzegovina
Instituto de Neurologia de Curitiba
Curitiba PR, 81210, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
Ribeirao Preto SP, 14051, Brazil
Hospital das Clinicas - FMUSP_X; Neurologia
Sao Paulo SP, 05403, Brazil
Fraser Health Authority - Fraser Health Multiple Sclerosis
Burnaby British Columbia, V5G 2, Canada
University of British Columbia Hospital; Division of Neurology
Vancouver British Columbia, V6T 2, Canada
London Health Sciences Centre Uni Campus
London Ontario, N6A 5, Canada
St. Michael'S Hospital
Toronto Ontario, M5B 1, Canada
Recherche Sepmus Inc.
Greenfield Park Quebec, J4V 2, Canada
Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
Montreal Quebec, H2L 4, Canada
Saskatoon City Hospital; Neurology
Saskatoon Saskatchewan, S7K 0, Canada
Organizacion Sanitas Internacional
Bogota, D.C. , 11132, Colombia
Fundacion Clinica Valle del Lili; Unidad de Investigaciones Clinicas
Cali , , Colombia
Hospital Clínica Biblica
San José , 10101, Costa Rica
Nemocnice Jihlava; NEU-Neurologicke oddeleni
Jihlava , 58633, Czechia
Fakultní Nemocnice Olomouc; Neurologicka Klinika
Olomouc , 779 0, Czechia
Fakultni nemocnice Ostrava; MS centrum
Ostrava-Poruba , 708 5, Czechia
Vseobecna fakultni nemocnice v Praze; MS Centrum, Neurologicka klinika
Praha 2 , 128 0, Czechia
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
Aabenraa , 6200, Denmark
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
Aarhus N , 8200, Denmark
Rigshospitalet; Neurologisk Klinik Glostrup
Glostrup , 2600, Denmark
Rigshospitalet; Skleroseklinikken - Glostrup
Glostrup , 2600, Denmark
Clinical Research Center-Alex university; Neurology Department
Alexandria , 21561, Egypt
Ain Shams University Hospital; Clinical Research Center (MASRI-CRC)
Cairo , 11566, Egypt
CHU Amiens Hopital Sud; Neurologie
Amiens Cedex1 , 80054, France
CHIC Cote Basque Bayonne; Neurologie
Bayonne Cedex , 64109, France
Groupe Hospitalier Pellegrin; Service de Neurologie - 3ème étage
Bordeaux , 33076, France
Hopital neurologique Pierre Wertheimer - CHU Lyon; Neurologie
Bron , 69677, France
CHU De Caen; Service De Neurologie Dejerine
Caen , 14033, France
Hopital Gabriel Montpied CHU de Clermont-Ferrand; Service de Neurologie B
Clermont-Ferrand , 63003, France
Hopital B Roger Salengro; Neurologie C
Lille , 59037, France
CHU de la Timone - Hopital d Adultes; Service de Neurologie
Marseille , 13005, France
Hopital Gui de Chauliac; Neurologie
Montpellier , 34295, France
CHRU Nancy; Service de neurologie
Nancy , 54035, France
Hopital Nord Laennec
Nantes , 44093, France
Hôpital Pasteur; Service de Neurologie
Nice , 06002, France
Groupe Hospitalo-Universitaire Caremeau; Service Neurologie
Nimes , 30029, France
Centre Hospitalier Universitaire de Rennes
Rennes , 35033, France
Hopital Civil de Strasbourg; Service de Neurologie
Strasbourg , 67091, France
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden , 01307, Germany
Universitätsmedizin Greifswald; Klinik und Poliklinik für Neurologie
Greifswald , 17475, Germany
NeuroConcept AG C/O mind mvz GmbH
Stuttgart , 70182, Germany
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
Ulm , 89073, Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede , 26655, Germany
Deutsche Klinik für Diagnostik; DKD Helios Klinik Wiesbaden, Abt. Neurologie
Wiesbaden , 65191, Germany
Nucare
Ciudad Guatemala , 01015, Guatemala
Semmelweis Egyetem AOK; Neurologiai Klinika
Budapest , 1083, Hungary
VALEOMED Diagnosztikai Központ
Esztergom , 2500, Hungary
Jósa András Oktatókórház
Nyíregyháza , 4400, Hungary
Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika; Klinikai Központ Neurológiai Klinika
Pécs , 7623, Hungary
Cork University Hospital
Cork , , Ireland
Beaumont Hospital; Clinical Research and Education Centre, Smurfit Building
Dublin , 9, Ireland
St Vincents University Hospital; Carew House-Neurology Department
Dublin , Dubli, Ireland
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Napoli Campania, 80131, Italy
Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur
Napoli Campania, 80131, Italy
Università degli studi della Campania Luigi Vanvitelli; Dip.Ass Int Med Int-I Clinica Neurologica
Napoli Campania, 80138, Italy
Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica
Trieste Friuli-Venezia Giulia, 34149, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Roma Lazio, 00133, Italy
Policlinico Universitario A. Gemelli; UOC Neurologia - Centro Sclerosi Multipla
Roma Lazio, 00168, Italy
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
Roma Lazio, 00189, Italy
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
Roma Lazio, 00189, Italy
Irccs A.O.U.San Martino Ist; Dinogmi
Genova Liguria, 16132, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano Lombardia, 20132, Italy
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Milano Lombardia, 20133, Italy
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Pavia Lombardia, 27100, Italy
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Pozzilli Molise, 86077, Italy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga; Centro Regionale Sclerosi Multipla - Neurologia II
Orbassano Piemonte, 10043, Italy
AOU Città della Salute e della Scienza; Neurologia 1
Torino Piemonte, 10126, Italy
Azienda Ospedaliero Universitaria Consorziale Policlinico di; Scienze Neurologiche
Bari Puglia, 70124, Italy
Ospedale Binaghi; Centro Sclerosi Multipla
Cagliari Sardegna, 09126, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Catania Sicilia, 95123, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi; Neurologia 2
Firenze Toscana, 50134, Italy
Policlinico G.B. Rossi; Dip. Scienze Neurologiche Biomediche - Neurologia B ? Amb. Sclerosi Multipla
Verona Veneto, 37134, Italy
American University of Beirut - Medical Center
Beirut , 1107 , Lebanon
Lebanese American University Medical Center- Rizk Hospial
Beirut , 1132 , Lebanon
Grupo Medico de Investigacion Clinica Multidisciplinaria
Mexico City Mexico CITY (federal District), 03100, Mexico
Clinstile S.A de C.V.
Mexico City Mexico CITY (federal District), 06700, Mexico
Hospital General de Mexico
Mexico Tlaxcala, 06726, Mexico
Unidad de investigacion en salud (UIS); Neurociencias
Ciudad de México , 14050, Mexico
Centre Hospitalier Universitaire Hassan II
FES , 30000, Morocco
Hopital Cheikh Zaid
Rabat , 10000, Morocco
Hopital Militaire d'Instruction Mohamed V
Rabat , 10100, Morocco
Amphia Ziekenhuis
Breda , 4818 , Netherlands
Catharina ziekenhuis
Eindhoven , 5623 , Netherlands
Maasstadziekenhuis
Rotterdam , 3079 , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen , 6162 , Netherlands
Consultorios Médicos PaItilla
Panama City , 0816 , Panama
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bia?ystok , 15-27, Poland
Szpital Uniwersytecki w Krakowie; Oddzia? kliniczny Neurologii
Kraków , 31-50, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz , 90-32, Poland
SP Swiecickiego UM Marcinkowskiego; Od. Klin. Neurologii z podod. Udarowym
Pozna? , 60-35, Poland
Centrum Medyczne "MEDYK"
Rzeszow , 35-05, Poland
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
Warszawa , 04-14, Poland
SPSK nr 1; Klinika Neurologii
Zabrze , 41-80, Poland
National Center of Social Significant Disease
Sankt-peterburg Leningrad, 19711, Russian Federation
Jusupovskaya Hospital
Moscow Moskovskaja Oblast, 11718, Russian Federation
Scientific Neurology Center; Neurological department #6?
Moscow Moskovskaja Oblast, 12536, Russian Federation
Vladimirskiy Regional Scientific Research Inst.
Moscow Moskovskaja Oblast, 12911, Russian Federation
City Clinical Hospital #24; Multipal Sclerosis department
Moskva Moskovskaja Oblast, 12701, Russian Federation
Hospital Universitario Virgen de Arrixaca; Servicio de Neurología
EL Palmar (EL Palmar) Murcia, 30120, Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona , 08035, Spain
Hospital Universitario la Fe; Servicio de Neurologia
Valencia , 46026, Spain
Cleveland Clinic Abu Dhabi
Abu Dhabi , 11241, United Arab Emirates
Rashid hospital
Dubai , 4545, United Arab Emirates

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

927

Study ID:

NCT03523858

Recruitment Status:

Active, not recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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