Study Stopped
The study was terminated earlier as the study sponsor collected sufficient data to perform all analyses as per pre-specified endpoints in the study protocol.
Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Participants With Early Stage Relapsing Remitting Multiple Sclerosis (RRMS)
An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis
2 other identifiers
interventional
1,225
27 countries
187
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2017
Longer than P75 for phase_3
187 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2017
CompletedFirst Posted
Study publicly available on registry
March 21, 2017
CompletedStudy Start
First participant enrolled
March 24, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 27, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 27, 2023
CompletedResults Posted
Study results publicly available
January 15, 2025
CompletedJanuary 15, 2025
December 1, 2024
6.1 years
March 16, 2017
April 26, 2024
December 20, 2024
Conditions
Outcome Measures
Primary Outcomes (23)
Time to Onset of Confirmed Disability Progression (CDP) Sustained for at Least 24 Weeks and 48 Weeks as Measured Using Expanded Disability Status Scale (EDSS)
The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits for a minimum of 24 weeks/48 weeks.
Baseline up to 4 years
Percentage of Participants With 24-Week and 48-Week Confirmed Disability Improvement (CDI) During the Year 1 Treatment Period, as Measured Using EDSS
CDI is defined as an improvement of ≥1 point on the EDSS score confirmed at a regular scheduled visit at least 24/48 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death).
At Weeks 24 and 48 during Year 1
Percentage of Participants Event-Free for CDP Sustained for at Least 24 and 48 Weeks at Year 1, as Measured Using EDSS
The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here.
Year 1 (Weeks 24 and 48)
Percentage of Participants With 24-Week and 48-Week CDI During the Year 2 Treatment Period, as Measured Using EDSS
CDI is defined as an improvement of 1 point on the EDSS score confirmed at a regular scheduled visit at least 24/48 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death).
At Weeks 48, 72 and 96 during Year 2
Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 2, as Measured Using EDSS
The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here.
Year 2 (Weeks 72 and 96)
Percentage of Participants With 24-Week and 48-Week CDI at Year 4, as Measured Using EDSS
CDI is defined as an improvement of 1 point on the EDSS score confirmed at a regular scheduled visit at least 24 weeks after the initial documentation of neurological worsening (measured only participants with a baseline EDSS of ≥2.0). EDSS is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death).
At Weeks 144, 168 and 192 during Year 4
Percentage of Participants Event-free for CDP Sustained for at Least 24 and 48 Weeks at Year 4, as Measured Using EDSS
The EDSS-Expanded Disability Status Scale is a disability scale that ranges in 0.5-point steps from 0 (normal) to 10 (death). Disability progression as measured by EDSS is defined as ≥1 point increase in EDSS score from a baseline EDSS score of 1-5 inclusive, a 0.5-increase from a baseline EDSS score higher than 5 and a 1.5-increase from a baseline EDSS score from 0 to 1 exclusive. Disability progression was considered confirmed if a sustained change in EDSS for a minimum of 24 weeks (-2 weeks) from the initial progression event was seen i.e. the change in EDSS must have been sustained at all available visits (during Year 1) for a minimum of 24 weeks/48 weeks. Percentage of participants who did not have CPD sustained for 24 and 48 weeks are reported here.
Year 4 (Weeks 168 and 192)
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 1, As Measured Using EDSS
Year 1 (Week 48)
Percentage of Participants Who Have Improved, Stable, or Worsened Disability Compared to Baseline at Year 2, As Measured Using EDSS
Year 2 (Week 96)
Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 3, As Measured Using EDSS
Year 3
Percentage of Participants Who Have Improved, Stable, or Worsened Disability at Year 4, As Measured Using EDSS
Year 4
Mean Change From Baseline in EDSS Score at Week 24
From Baseline to Week 24
Mean Change From Baseline in EDSS Score at Week 48
From Baseline to Week 48
Mean Change From Baseline in EDSS Score at Week 72
From Baseline to Week 72
Mean Change From Baseline in EDSS Score at Week 96
Baseline, Week 96
Mean Change From Baseline in EDSS Score at Week 120
Baseline, Week 120
Mean Change From Baseline in EDSS Score at Week 144
Baseline, Week 144
Mean Change From Baseline in EDSS Score at Week 168
Baseline, Week 168
Mean Change From Baseline in EDSS Score at Week 192
Baseline, Week 192
Percentage of Participants Without Protocol-Defined Event of Disease Activity
Protocol-defined event of disease activity is defined as having at least one of the following: (1). protocol defined relapse (occurrence of new or worsening neurological symptoms attributable to Multiple Sclerosis \[MS\], as determined using EDSS/Functional Systems Score \[FSS\] assessment). (2). CDP, as determined using EDSS. (3). a T1 Gd-enhanced lesion after Week 8 (4). a new and/or enlarging T2 hyperintense lesion on magnetic resonance imaging (MRI) after Week 8 compared to the Week 8 MRI scan.
Baseline up to 4 years
Percentage of Participants Without Relapse
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment.
Baseline up to 4 years
Annualized Relapse Rate
Relapse is defined as occurrence of new or worsening neurological symptoms attributable to MS, as determined using EDSS/FSS assessment. The adjusted annualized relapse rate is reported which is: Adjusted by age at disease diagnosis, Baseline EDSS, Presence of T1 Gd-enhanced lesion at screening and Presence of relapses in the last year prior to enrollment. Log-transformed exposure time is included as an offset variable. The report contains data up to week 192 of the treatment period of each individual participant.
Baseline up to 4 years
Sub Study: Number of Participants With IRRs Occurring During or Within 24 Hours Following the First Infusion After Randomization to the Shorter Infusion Substudy
Week 24 through Week 144
Secondary Outcomes (25)
Percentage of Participants Who Are Relapse Free
Week 192
Percentage of Participants With No Evidence of Protocol Defined Disease Activity
Weeks 96, 144, 192
Percentage of Participants Without Protocol-defined Event of Evidence of Progression (NEP)
Weeks 96, 192
Percentage of Participants With no Evidence of Progression Sustained for At Least 24 Weeks and no Active Disease (NEPAD)
Weeks 96, 192
Secondary: Change From Baseline in Multiple Sclerosis Functional Composite Score (MSFC) Total
Weeks 24, 48, 72, 96, 120, 144, 168, 192
- +20 more secondary outcomes
Study Arms (3)
Ocrelizumab
EXPERIMENTALOcrelizumab will be administered intravenously (IV) as two 300-milligram (mg) infusions (infusion length=2.5 hours) on Days 1 and 15, followed by one 600-mg infusion dose every 24 weeks (+/- 14 days) for a maximum of 8 doses throughout the 192 weeks treatment period.
Substudy Group 1
ACTIVE COMPARATORAt week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 3.5 hours every 24 weeks for the remainder of the study duration
Substudy Group 2
EXPERIMENTALAt week 24 of the main study, eligible participants will be randomized to receive 600 mg ocrelizumab infused over approximately 2 hours followed by sodium chloride given as a slow infusion over the remaining 1.5 hours to mimic the standard-length infusion (3.5 hour) every 24 weeks for the remainder of the study duration
Interventions
Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.
Eligibility Criteria
You may qualify if:
- 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 (\</=) 3 years
- 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
You may not qualify if:
- Secondary progressive multiple sclerosis or history of primary progressive or progressive relapsing MS
- Inability to complete an MRI
- Known presence of other neurological disorders
- 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
- 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
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (193)
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 D.C., 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
Foxborough, 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, C1437JCP, Argentina
Fundacion Rosarina de Neurorehabilitacion
Rosario, S2000BZL, 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
Vienna, 1090, Austria
AZ Sint Jan
Bruges, 8000, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires St-Luc
Brussels, 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, Minas Gerais, 31270-901, Brazil
Instituto de Neurologia de Curitiba
Curitiba, Paraná, 81210-310, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, 90610-000, Brazil
Hospital das Clinicas - FMUSP
São Paulo, São Paulo, 05403-010, 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 1Z3, Canada
London Health Sciences Centre Uni Campus
London, Ontario, N6A 5A5, Canada
Ottawa Hospital Research Institute
Ottawa, Ontario, K1Y 4E9, Canada
Sunnybrook Health Science Centre
Toronto, Ontario, M4N 3M5, Canada
Clinique NeuroOutaouais
Gatineau, Quebec, J8Y 1W2, Canada
Recherche Sepmus Inc.
Greenfield Park, Quebec, J4V 2J2, Canada
Montreal Neurological Institute and Hospital
Montreal, Quebec, H3A 2B4, 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 Municipality, 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
Nîmes, 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 Dr. Bischof GmbH
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 am Inn, 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
Rome, Lazio, 00133, Italy
Azienda Ospedaliera Sant'Andrea; UOC Neurologia
Rome, Lazio, 00189, Italy
Irccs A.O.U.San Martino Ist; Dinogmi
Genoa, Liguria, 16132, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milan, Lombardy, 20132, Italy
Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari
Milan, Lombardy, 20133, Italy
Ospedale Civile di Montichiari; Centro Sclerosi Multipla
Montichiari, Lombardy, 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, Sicily, 95123, Italy
AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia
Palermo, Sicily, 90146, Italy
AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)
Florence, Tuscany, 50134, Italy
Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia
Grosseto, Tuscany, 58100, Italy
Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche
Siena, Tuscany, 53100, Italy
Ibn Sina Hospital; Neurology Department
Kuwait City, 10002, Kuwait
American University of Beirut - Medical Center
Beirut, 1107 2020, 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
Mexico City, 14050, Mexico
Jeroen Bosch Ziekenhuis
's-Hertogenbosch, 5223 GZ, Netherlands
VU Medisch Centrum; Afdeling Neurologie
Amsterdam, 1081 HV, Netherlands
Groene Hart Ziekenhuis
Gouda, 2803 HH, Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, 6162 BG, Netherlands
Akershus universitetssykehus HF; Nevroklinikken S203
Lørenskog, 1478, Norway
Stavanger Universitetssykehus, Helse Stavanger HF
Stavanger, 4011, Norway
Neurocentrum Bydgoszcz sp. z o.o
Bydgoszcz, 85-796, Poland
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny
Gdansk, 80-803, Poland
Care Clinic
Katowice, 40-568, Poland
Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.
Krakow, 31-637, Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, 90-324, Poland
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.
Lublin, 20-410, Poland
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie
Warsaw, 02-097, Poland
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna
Warsaw, 02-957, Poland
Hospital Garcia de Orta; Servico de Neurologia
Almada, 2801-951, Portugal
Hospital de Braga; Servico de Neurologia
Braga, 4710-243, Portugal
HUC; Servico de Neurologia
Coimbra, 3000-075, Portugal
Hospital Beatriz Angelo; Servico de Neurologia
Loures, 2674-514, Portugal
Hospital Geral de Santo Antonio; Servico de Neurologia
Porto, 4099-001, Portugal
Spitalul Universitar de Urgenta Bucuresti
Bucharest, 11172, Romania
Spitalul Clinic Judetean Sibiu
Sibiu, 550245, Romania
Spitalul Clinic Judetean de Urgenta Mures
Târgu Mureş, 540136, Romania
Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB
Bratislava, 813 69, Slovakia
Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB
Bratislava, 826 06, Slovakia
GB NeuroPRAKTIK, s.r.o
Nitra, 949 11, Slovakia
Fakultna nemocnica Trnava
Trnava, 917 75, 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
Gothenburg, 413 45, Sweden
Centralsjukhuset; Neurologi och rehabiliteringskliniken
Karlstad, 651 85, Sweden
Centrum för Neurologi
Stockholm, 113 41, Sweden
Universitätsspital Basel; Neurologie
Basel, 4031, Switzerland
Inselspital Bern Medizin Neurologie; Neurologische Poliklinik
Bern, 3010, Switzerland
Luzerner Kantonsspital Luzern Medizin Neurologie
Lucerne, 6004, Switzerland
Ospedale Regionale di Lugano - Civico; Neurologia
Lugano, 6903, Switzerland
Kantonsspital; Neurologische Klinik
Sankt Gallen, 9007, Switzerland
Hacettepe University Medical Faculty; Neurology
Ankara, 06100, Turkey (Türkiye)
Gazi University Medical Faculty; Departmant of Norology
Ankara, 06500, Turkey (Türkiye)
Mustafa Kemal Ataturk UTF; Department of norology
Hatay, 31001, Turkey (Türkiye)
Istanbul University Istanbul Medical Faculty; Neurology
Istanbul, 34093, Turkey (Türkiye)
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali
Istanbul, 34098, Turkey (Türkiye)
Istanbul Bilim Universty Medical Fac.
Istanbul, 34394, Turkey (Türkiye)
Selcuk University Medical Faculty; Norology department
Istanbul, 42131, Turkey (Türkiye)
Ondokuz Mayis Univ. Med. Fac.; Neurology
Samsun, 55139, Turkey (Türkiye)
Karadeniz Tecnical Uni. Med. Fac.; Neurology
Trabzon, 61080, Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust
Cambridge, CB2 0QQ, United Kingdom
Queen Elizabeth University Hospital
Glasgow, G51 4TF, United Kingdom
Royal Free Hospital
London, NW3 2QS, United Kingdom
King'S College Hospital
London, SE5 9RS, United Kingdom
Charing Cross Hospital
London, W6 8RF, United Kingdom
National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases
London, WC1N 3BG, United Kingdom
Royal Victoria Infirmary
Newcastle upon Tyne, NE1 4LP, United Kingdom
Derriford Hospital
Plymouth, PL6 8BT, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute
Swansea, SA6 6NL, United Kingdom
Related Publications (5)
Kappos L, Yiu S, Reucassel J, Oh J, Granziera C, Killestein J, Bermel RA, Berge C, Kazlauskaite A, Schneble HM, Dahlke F, Cree BAC. Performance of Composite Endpoints Defining Progression Independent of Relapse Activity in Multiple Sclerosis. Ann Clin Transl Neurol. 2025 Sep;12(9):1805-1812. doi: 10.1002/acn3.70111. Epub 2025 Jul 8.
PMID: 40629721DERIVEDKappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.
PMID: 40258203DERIVEDHartung HP, Benedict RHB, Berger T, Bermel RA, Brochet B, Carroll WM, Freedman MS, Holmoy T, Karabudak R, Nos C, Patti F, Perrin Ross A, Vanopdenbosch L, Vollmer T, Wuerfel J, Clinch S, Kadner K, Kuenzel T, Kulyk I, Raposo C, Thanei GA, Killestein J. Ocrelizumab in Early-Stage Relapsing-Remitting Multiple Sclerosis: The Phase IIIb ENSEMBLE 4-Year, Single-Arm, Open-Label Trial. Neurology. 2024 Dec 24;103(12):e210049. doi: 10.1212/WNL.0000000000210049. Epub 2024 Dec 3.
PMID: 39626127DERIVEDHartung HP, Berger T, Bermel RA, Brochet B, Carroll WM, Holmoy T, Karabudak R, Killestein J, Nos C, Patti F, Perrin Ross A, Vanopdenbosch L, Vollmer T, Buffels R, Garas M, Kadner K, Manfrini M, Wang Q, Freedman MS. ENSEMBLE PLUS: final results of shorter ocrelizumab infusion from a randomized controlled trial. J Neurol. 2024 Jul;271(7):4348-4360. doi: 10.1007/s00415-024-12326-z. Epub 2024 Apr 22.
PMID: 38649522DERIVEDHartung HP; ENSEMBLE Steering Committee members and study investigators. Ocrelizumab shorter infusion: Primary results from the ENSEMBLE PLUS substudy in patients with MS. Neurol Neuroimmunol Neuroinflamm. 2020 Jun 4;7(5):e807. doi: 10.1212/NXI.0000000000000807. Print 2020 Sep.
PMID: 32503093DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Medical Communications
- Organization
- Hoffmann-La Roche
Study Officials
- STUDY DIRECTOR
Clinical Trials
Hoffmann-La Roche
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2017
First Posted
March 21, 2017
Study Start
March 24, 2017
Primary Completion
April 27, 2023
Study Completion
April 27, 2023
Last Updated
January 15, 2025
Results First Posted
January 15, 2025
Record last verified: 2024-12
Data Sharing
- IPD Sharing
- Will share
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.vivli.org). Further details on Roche's criteria for eligible studies are available here (https://vivli.org/members/ourmembers/). For further details on Roche's Global Policy on the Sharing of Clinical Information and how to request access to related clinical study documents, see here (https://www.roche.com/research\_and\_development/who\_we\_are\_how\_we\_work/clinical\_trials/our\_commitment\_to\_data\_sharing.htm).