Multiple Sclerosis Clinical Trial

Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)

Summary

This is a prospective, multicenter, open-label, single-arm, phase 3b study which evaluates effectiveness and safety of ocrelizumab in participants with early stage RRMS. The study will consist of an open-label treatment period of 192 weeks and follow-up period of at least 48 weeks.

The optional shorter infusion substudy will evaluate the safety of a shorter infusion of ocrelizumab in a subgroup of participants with early stage RRMS enrolled in the main MA30143 study. Approximately 700 patients will be enrolled in the substudy, and will receive additional 600 mg ocrelizumab administered in a shorter time frame.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Have a definite diagnosis of RRMS, as per the revised McDonald 2010 criteria
Have a length of disease duration, from first documented clinical attack consistent with MS disease of less than or equal to ( Within the last 12 months one or more clinically reported relapse(s) or one or more signs of MRI activity
EDSS of 0.0 to 3.5 inclusive, at screening
An agreement to use an acceptable birth control method for women of childbearing potential, during the treatment period and for at least 6 months or longer after the last dose of study drug

Exclusion Criteria:

Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
Inability to complete an MRI
Known presence of other neurological disorders

Exclusions Related to General Health:

Pregnancy or lactation
Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug
Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study
History or currently active primary or secondary immunodeficiency
Lack of peripheral venous access
History of severe allergic or anaphylactic reactions to humanized or murine monoclonal antibodies
Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study
Congestive heart failure (New York Heart Association III or IV functional severity)
Known active bacterial, viral, fungal, mycobacterial infection or other infection, (excluding fungal infection of nail beds) or any major episode of infection requiring hospitalization or treatment with IV antibiotics within 4 weeks prior to screening or oral antibiotics 2 weeks prior to screening
History of malignancy, major opportunistic infections, alcohol or drug abuse, recurrent or chronic infection, and/or coagulation disorders

Exclusions Related to Medications:

Received any prior approved disease modifying treatment (DMT) with a label for MS, for example, interferons, glatiramer acetate, natalizumab, alemtuzumab, daclizumab, fingolimod, teiflunomide and dimethylfumarate
Receipt of a live vaccine or attenuated live vaccine within 6 weeks prior to the baseline visit
Previous treatment with B-cell targeted therapies (i.e., rituximab, ocrelizumab, atacicept, belimumab, or ofatumumab)
Any previous treatment with immunosuppressants/ immunomodulators/ antineoplastic therapies (cyclophosphamide, azathioprine, mycophenolate mofetil, cyclosporine, methotrexate, cladribine, mitoxantrone, laquinimod, total body irradiation, or bone marrow transplantation)
Treatment with investigational DMT
Treatment with fampridine/dalfamipridine unless on stable dose for >/=30 days prior to screening

Exclusion related to Shorter Infusion Substudy:

- Any previous serious IRRs experienced with ocrelizumab treatment

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1239

Study ID:

NCT03085810

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 191 Locations for this study

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University of California Irvine
Irvine California, 92697, United States
Palo Alto Medical Foundation Research Center
Sunnyvale California, 94086, United States
University of Colorado Denver
Aurora Colorado, 80045, United States
Advanced Neurology of Colorado, LLC
Fort Collins Colorado, 80528, United States
KI Health Partners, LLC; New England Institute for Clinical Research
Stamford Connecticut, 06905, United States
Georgetown University Medical Center
Washington District of Columbia, 20007, United States
University of South Florida - Bradenton
Tampa Florida, 33612, United States
Shepherd Center Inc.
Atlanta Georgia, 30309, United States
College Park Family Care Ctr
Overland Park Kansas, 66212, United States
The NeuroMedical Center
Baton Rouge Louisiana, 70810, United States
Maine Medical Center
Scarborough Maine, 04074, United States
University of Maryland Medical Center; Department of Neurology
Baltimore Maryland, 21201, United States
Neurology Center of New England
Foxboro Massachusetts, 02035, United States
Dragonfly Research, LLC
Wellesley Massachusetts, 02481, United States
Minneapolis Clinic of Neurology
Golden Valley Minnesota, 55422, United States
Cleveland Clinic Lou Ruvo; Center for Brain Research
Las Vegas Nevada, 89106, United States
Columbia University Medical Center
New York New York, 10032, United States
Island Neurological Associates, P.C.
Plainview New York, 11803, United States
Neurology Associates PA
Hickory North Carolina, 28602, United States
Wake Forest University Health Sciences
Winston-Salem North Carolina, 27157, United States
Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40
Cleveland Ohio, 44195, United States
Neurology Specialists, Inc
Dayton Ohio, 45417, United States
Vanderbilt University Medical Center
Nashville Tennessee, 37212, United States
Kane Hall Barry Neurology
Bedford Texas, 76021, United States
MultiCare Health System Institute for Research and Innovation
Tacoma Washington, 98405, United States
Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders
Milwaukee Wisconsin, 53215, United States
Centro de Especialidades Neurológicas y Rehabilitación - CENyR
Buenos Aires , C1424, Argentina
Hospital Churruca Visca
Buenos Aires , C1437, Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario , S2000, Argentina
Brain and Mind Centre
Camperdown New South Wales, 2050, Australia
Liverpool Hospital
Liverpool New South Wales, 2170, Australia
John Hunter Hospital
New Lambton New South Wales, 2305, Australia
Royal North Shore Hospital; Department of Neurology
St Leonards New South Wales, 2065, Australia
Princess Alexandra Hospital
Woolloongabba Queensland, 4102, Australia
Box Hill Hospital; Department of Neurology
Box Hill Victoria, 3128, Australia
Austin Hospital; Department of Neurology
Heidelberg Victoria, 3084, Australia
Royal Melbourne Hospital; Department of Neurology
Parkville Victoria, 3050, Australia
Perron Institute for Neurological and Translational Science
Nedlands Western Australia, 6009, Australia
Medizinische Universität Graz; Universitätsklinik für Neurologie
Graz , 8036, Austria
Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie
Innsbruck , 6020, Austria
Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie
Salzburg , 5020, Austria
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Wien , 1090, Austria
AZ Sint Jan
Brugge , 8000, Belgium
UZ Brussel
Brussel , 1090, Belgium
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
UZ Antwerpen
Edegem , 2650, Belgium
CHU Tivoli
La Louvière , 7100, Belgium
CHU Sart-Tilman
Liège , 4000, Belgium
Revalidatie en MS Centrum
Overpelt , 3900, Belgium
Hospital das Clinicas - UFMG
Belo Horizonte MG, 31270, Brazil
Instituto de Neurologia de Curitiba
Curitiba PR, 81210, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
Hospital das Clinicas - FMUSP
Sao Paulo SP, 05403, Brazil
Shat Np Sveti Naum; 3Rd Clinic of Neurology
Sofia , 1113, Bulgaria
Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.
Sofia , 1309, Bulgaria
UMHAT Alexandrovska, EAD; Neurology
Sofia , 1431, Bulgaria
UBC Hospital; Div of Neurology, Dept of Medicine
Vancouver British Columbia, V6T 1, Canada
London Health Sciences Centre Uni Campus
London Ontario, N6A 5, Canada
Ottawa Hospital Research Institute
Ottawa Ontario, K1Y 4, Canada
Sunnybrook Health Science Centre
Toronto Ontario, M4N 3, Canada
Clinique NeuroOutaouais
Gatineau Quebec, J8Y 1, Canada
Recherche Sepmus Inc.
Greenfield Park Quebec, J4V 2, Canada
Montreal Neurological Institute and Hospital
Montreal Quebec, H3A 2, Canada
Clinical Hospital Centre Zagreb
Zagreb , 10000, Croatia
Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.
Aalborg , 9000, Denmark
Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken
Aarhus N , 8200, Denmark
Rigshospitalet; Neurologisk Klinik Glostrup
Glostrup , 2600, Denmark
CHU de Besancon Hopital Jean Minjoz; Service de Neurologie
Besançon , 25030, France
Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie
Bordeaux , 33076, France
Hopital Pierre Wertheimer; Neurologie D
Bron , 69677, France
CHU de Caen Hopital Cote de Nacre
Caen , 14033, France
CHU Hopital Gabriel Montpied; Service de Neurologie
Clermont Ferrand , 63003, France
CH de Gonesse; Neurologie
Gonesse , 95503, France
CHU de Grenoble; Neurologie
La Tronche , 38700, France
Hopital Gui de Chauliac; Neurologie
Montpellier , 34295, France
Hopital Central - CHU de Nancy; Service de Neurologie
Nancy , 54035, France
Hôpital Guillaume et René Laënnec; Service Neurologie
Nantes , 44805, France
Hôpital Pasteur; Service de Neurologie
Nice , 06002, France
CHU de Nîmes Hopital Caremeau; Service de Neurologie
Nimes , 30900, France
Hôpital de Poissy; Service neurologie
Poissy , 78300, France
Centre Hospitalier Universitaire de Rennes
Rennes , 35033, France
CHU de Rouen Hopital; Service de Neurologie
Rouen , 76031, France
CHU de Strasbourg
Strasbourg , 67098, France
Hopital Foch; Neurologie
Suresnes , 92151, France
HIA de Toulon hôpital militaire; Neurologie
Toulon , 83041, France
CHU toulouse - Hôpital Purpan; Departement de Neurologie
Toulouse , 31059, France
CHRU - Hôpital Bretonneau; Neurologie
Tours , 37000, France
Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie
Barsinghausen , 30890, Germany
Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
Berlin , 13347, Germany
St. Josef-Hospital, Klinik für Neurologie
Bochum , 44791, Germany
Studienzentrum für Neurologie und Psychiatrie
Böblingen , 71034, Germany
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden , 01307, Germany
Universitätsklinikum Düsseldorf; Klinik für Neurologie
Düsseldorf , 40225, Germany
NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich
Erbach/Odenwald , 64711, Germany
Universitätsklinikum Essen (AöR); Klinik für Neurologie
Essen , 45147, Germany
MultipEL Studies - Institut für klinische Studien
Hamburg , 22179, Germany
Universitaetsklinikum Heidelberg
Heidelberg , 69120, Germany
Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische
Kassel , 34121, Germany
Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie
Kiel , 24105, Germany
Universitaetsklinikum Marburg; Klinik fuer Neurologie
Marburg , 35043, Germany
Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum
München , 81675, Germany
Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie
Münster , 48149, Germany
Praxis Dr. med. Bergmann
Neuburg , 86633, Germany
Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie
Seesen , 38723, Germany
Universitätsklinikum Tübingen, Zentrum für Neurologie
Tübingen , 72076, Germany
Semmelweis Egyetem AOK; Neurologiai Klinika
Budapest , 1083, Hungary
Budapesti Uzsoki Utcai Kórház
Budapest , 1145, Hungary
Jahn Ferenc Dél-Pesti Kórház
Budapest , 1204, Hungary
VALEOMED Diagnosztikai Központ
Esztergom , 2500, Hungary
Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika
Szeged , 6725, Hungary
A.O.U. Mater Domin; U.O. NEUROLOGIA
Catanzaro Calabria, 88100, Italy
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
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
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
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari Lombardia, 25018, Italy
IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla
Pozzilli Molise, 86077, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla
Catania Sicilia, 95123, Italy
AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
Palermo Sicilia, 90146, Italy
AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
Firenze Toscana, 50134, Italy
Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia
Grosseto Toscana, 58100, Italy
Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche
Siena Toscana, 53100, Italy
Ibn Sina Hospital; Neurology Department
Kuwait , 10002, Kuwait
American University of Beirut - Medical Center
Beirut , 1107 , Lebanon
Neurociencias Estudios Clinicos S.C.
Culiacán Sinaloa, 80020, Mexico
Hospital General de Mexico
Mexico Tlaxcala, 06726, Mexico
Unidad de investigacion en salud (UIS); Neurociencias
Ciudad de México , 14050, Mexico
Jeroen Bosch Ziekenhuis
'S Hertogenbosch , 5223 , Netherlands
VU Medisch Centrum; Afdeling Neurologie
Amsterdam , 1081 , Netherlands
Groene Hart Ziekenhuis
Gouda , 2803 , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen , 6162 , Netherlands
Akershus universitetssykehus HF; Nevroklinikken S203
Lørenskog , 1478, Norway
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger , 4011, Norway
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz , 85-79, Poland
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
Gdansk , 80-80, Poland
Care Clinic
Katowice , 40-56, Poland
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
Krakow , 31-63, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz , 90-32, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin , 20-41, Poland
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Warszawa , 02-09, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warszawa , 02-95, Poland
Hospital Garcia de Orta; Servico de Neurologia
Almada , 2801-, Portugal
Hospital de Braga; Servico de Neurologia
Braga , 4710-, Portugal
HUC; Servico de Neurologia
Coimbra , 3000-, Portugal
Hospital Beatriz Angelo; Servico de Neurologia
Loures , 2674-, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto , 4099-, Portugal
Spitalul Universitar de Urgenta Bucuresti
Bucharest , 11172, Romania
Spitalul Clinic Judetean Sibiu
Sibiu , 55024, Romania
Spitalul Clinic Judetean de Urgenta Mures
Targu-Mures , 54013, Romania
Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB
Bratislava , 813 6, Slovakia
Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB
Bratislava , 826 0, Slovakia
GB NeuroPRAKTIK, s.r.o
Nitra , 949 1, Slovakia
Fakultna nemocnica Trnava
Trnava , 917 7, Slovakia
University Medical Centre; Neurology
Ljubljana , 1000, Slovenia
University Medical Centre Maribor
Maribor , 2000, Slovenia
Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia
Santa Cruz De Tenerife Tenerife, 38010, Spain
Hospital de Cruces; Servicio de Neurologia
Barakaldo Vizcaya, 48903, Spain
Hospital General Universitario de Alicante; Servicio de Neurología
Alicante , 03010, Spain
Hospital del Mar; Servicio de Neurologia
Barcelona , 08003, Spain
Hospital Vall d'Hebron; Servicio de Neurología
Barcelona , 08035, Spain
Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología
Madrid , 28222, Spain
Hospital General Universitario Morales Meseguer; Servicio de Neurología
Murcia , 30008, Spain
Sahlgrenska Sjukhuset; Neurology
Göteborg , 413 4, Sweden
Centralsjukhuset; Neurologi och rehabiliteringskliniken
Karlstad , 651 8, Sweden
Centrum för Neurologi
Stockholm , 113 4, Sweden
Universitätsspital Basel; Neurologie
Basel , 4031, Switzerland
Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
Bern , 3010, Switzerland
Ospedale Regionale di Lugano - Civico; Neurologia
Lugano , 6903, Switzerland
Luzerner Kantonsspital Luzern Medizin Neurologie
Luzern , 6004, Switzerland
Kantonsspital; Neurologische Klinik
St. Gallen , 9007, Switzerland
Hacettepe University Medical Faculty; Neurology
Ankara , 06100, Turkey
Gazi University Medical Faculty; Departmant of Norology
Ankara , 06500, Turkey
Mustafa Kemal Ataturk UTF; Department of norology
Hatay , 31001, Turkey
Istanbul University Istanbul Medical Faculty; Neurology
Istanbul , 34093, Turkey
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
Istanbul , 34098, Turkey
Istanbul Bilim Universty Medical Fac.
Istanbul , 34394, Turkey
Selcuk University Medical Faculty; Norology department
Istanbul , 42131, Turkey
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun , 55139, Turkey
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon , 61080, Turkey
Cambridge University Hospitals NHS Foundation Trust
Cambridge , CB2 0, United Kingdom
Queen Elizabeth University Hospital
Glasgow , G51 4, United Kingdom
Royal Free Hospital
London , NW3 2, United Kingdom
King'S College Hospital
London , SE5 9, United Kingdom
Charing Cross Hospital
London , W6 8R, United Kingdom
National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
London , WC1 3, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne , NE1 4, United Kingdom
Derriford Hospital
Plymouth , PL6 8, United Kingdom
Salford Royal NHS Foundation Trust
Salford , M6 8H, United Kingdom
Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
Swansea , SA6 6, United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

1239

Study ID:

NCT03085810

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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