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

NCT ID: NCT03085810

Last Updated: 2025-01-15

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE3
• Total Enrollment: 1225 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-24
• Study Completion Date: 2023-04-27

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.

Conditions

Multiple Sclerosis, Relapsing-Remitting

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ocrelizumab

Ocrelizumab 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.

Group Type: EXPERIMENTAL

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Substudy Group 1

At 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

Group Type: ACTIVE_COMPARATOR

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Substudy Group 2

At 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

Group Type: EXPERIMENTAL

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Interventions

Ocrelizumab

Ocrelizumab will be administered via IV infusion as specified throughout the treatment period.

Intervention Type: DRUG

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 (</=) 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

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 55 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

University of California Irvine

Irvine, California, United States

Palo Alto Medical Foundation Research Center

Sunnyvale, California, United States

University of Colorado Denver

Aurora, Colorado, United States

Advanced Neurology of Colorado, LLC

Fort Collins, Colorado, United States

KI Health Partners, LLC; New England Institute for Clinical Research

Stamford, Connecticut, United States

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

University of South Florida - Bradenton

Tampa, Florida, United States

Shepherd Center Inc.

Atlanta, Georgia, United States

College Park Family Care Ctr

Overland Park, Kansas, United States

The NeuroMedical Center

Baton Rouge, Louisiana, United States

Maine Medical Center

Scarborough, Maine, United States

University of Maryland Medical Center; Department of Neurology

Baltimore, Maryland, United States

Neurology Center of New England

Foxborough, Massachusetts, United States

Dragonfly Research, LLC

Wellesley, Massachusetts, United States

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, United States

Cleveland Clinic Lou Ruvo; Center for Brain Research

Las Vegas, Nevada, United States

Columbia University Medical Center

New York, New York, United States

Island Neurological Associates, P.C.

Plainview, New York, United States

Neurology Associates PA

Hickory, North Carolina, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Cleveland Clinic Foundation; Cleveland Clinic Cancer Center/I40

Cleveland, Ohio, United States

Neurology Specialists, Inc

Dayton, Ohio, United States

Vanderbilt University Medical Center

Nashville, Tennessee, United States

Kane Hall Barry Neurology

Bedford, Texas, United States

MultiCare Health System Institute for Research and Innovation

Tacoma, Washington, United States

Wheaton Franciscan Healthcare - St. Francis Outpatient Center; Center for Neurological Disorders

Milwaukee, Wisconsin, United States

Centro de Especialidades Neurológicas y Rehabilitación - CENyR

Buenos Aires, , Argentina

Hospital Churruca Visca

Buenos Aires, , Argentina

Fundacion Rosarina de Neurorehabilitacion

Rosario, , Argentina

Brain and Mind Centre

Camperdown, New South Wales, Australia

Liverpool Hospital

Liverpool, New South Wales, Australia

John Hunter Hospital

New Lambton, New South Wales, Australia

Royal North Shore Hospital; Department of Neurology

St Leonards, New South Wales, Australia

Princess Alexandra Hospital

Woolloongabba, Queensland, Australia

Box Hill Hospital; Department of Neurology

Box Hill, Victoria, Australia

Austin Hospital; Department of Neurology

Heidelberg, Victoria, Australia

Royal Melbourne Hospital; Department of Neurology

Parkville, Victoria, Australia

Perron Institute for Neurological and Translational Science

Nedlands, Western Australia, Australia

Medizinische Universität Graz; Universitätsklinik für Neurologie

Graz, , Austria

Uniklinik fuer Neurologie, Medizinische Universitaet Innsbruck; Department fuer Neurologie

Innsbruck, , Austria

Christian-Doppler-Klinik - Universitätsklinikum; Universitätskliniik für Neurologie

Salzburg, , Austria

Medizinische Universität Wien; Univ.Klinik fuer Neurologie

Vienna, , Austria

AZ Sint Jan

Bruges, , Belgium

UZ Brussel

Brussels, , Belgium

Cliniques Universitaires St-Luc

Brussels, , Belgium

UZ Antwerpen

Edegem, , Belgium

CHU Tivoli

La Louvière, , Belgium

CHU Sart-Tilman

Liège, , Belgium

Revalidatie en MS Centrum

Overpelt, , Belgium

Hospital das Clinicas - UFMG

Belo Horizonte, Minas Gerais, Brazil

Instituto de Neurologia de Curitiba

Curitiba, Paraná, Brazil

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Hospital das Clinicas - FMUSP

São Paulo, São Paulo, Brazil

Shat Np Sveti Naum; 3Rd Clinic of Neurology

Sofia, , Bulgaria

Multiprofile Hosp. for Active Treatment;National Cardiology Hosp.

Sofia, , Bulgaria

UMHAT Alexandrovska, EAD; Neurology

Sofia, , Bulgaria

UBC Hospital; Div of Neurology, Dept of Medicine

Vancouver, British Columbia, Canada

London Health Sciences Centre Uni Campus

London, Ontario, Canada

Ottawa Hospital Research Institute

Ottawa, Ontario, Canada

Sunnybrook Health Science Centre

Toronto, Ontario, Canada

Clinique NeuroOutaouais

Gatineau, Quebec, Canada

Recherche Sepmus Inc.

Greenfield Park, Quebec, Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

Clinical Hospital Centre Zagreb

Zagreb, , Croatia

Aalborg Universitetshospital; Neurologisk Afdeling og Neurofysiologisk Afdeling; Skleroseamb.

Aalborg, , Denmark

Aarhus Universitetshospital; Neurologisk Afd. F, Skleroseklinikken

Aarhus N, , Denmark

Rigshospitalet; Neurologisk Klinik Glostrup

Glostrup Municipality, , Denmark

CHU de Besancon Hopital Jean Minjoz; Service de Neurologie

Besançon, , France

Hopital Pellegrin-CHU de Bordeaux; Service de Neurologie

Bordeaux, , France

Hopital Pierre Wertheimer; Neurologie D

Bron, , France

CHU de Caen Hopital Cote de Nacre

Caen, , France

CHU Hopital Gabriel Montpied; Service de Neurologie

Clermont-Ferrand, , France

CH de Gonesse; Neurologie

Gonesse, , France

CHU de Grenoble; Neurologie

La Tronche, , France

Hopital Gui de Chauliac; Neurologie

Montpellier, , France

Hopital Central - CHU de Nancy; Service de Neurologie

Nancy, , France

Hôpital Guillaume et René Laënnec; Service Neurologie

Nantes, , France

Hôpital Pasteur; Service de Neurologie

Nice, , France

CHU de Nîmes Hopital Caremeau; Service de Neurologie

Nîmes, , France

Hôpital de Poissy; Service neurologie

Poissy, , France

Centre Hospitalier Universitaire de Rennes

Rennes, , France

CHU de Rouen Hopital; Service de Neurologie

Rouen, , France

CHU de Strasbourg

Strasbourg, , France

Hopital Foch; Neurologie

Suresnes, , France

HIA de Toulon hôpital militaire; Neurologie

Toulon, , France

CHU toulouse - Hôpital Purpan; Departement de Neurologie

Toulouse, , France

CHRU - Hôpital Bretonneau; Neurologie

Tours, , France

Praxis Dr.med. Sylvia Menck, Fachärztin für Neurologie und Psychiatrie

Barsinghausen, , Germany

Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie

Berlin, , Germany

St. Josef-Hospital, Klinik für Neurologie

Bochum, , Germany

Studienzentrum Dr. Bischof GmbH

Böblingen, , Germany

Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

Dresden, , Germany

Universitätsklinikum Düsseldorf; Klinik für Neurologie

Düsseldorf, , Germany

NeuroCentrum Odenwald; Dres. Reifschneider, Unsorg, Ries, Schumann, Hoffmann, Knoblich

Erbach/Odenwald, , Germany

Universitätsklinikum Essen (AöR); Klinik für Neurologie

Essen, , Germany

MultipEL Studies - Institut für klinische Studien

Hamburg, , Germany

Universitaetsklinikum Heidelberg

Heidelberg, , Germany

Neurologische Gemeinschaftspraxis Kassel und Vellmar, Ch. Lassek, Dres. Ammerbach, Fetzer, M. Fische

Kassel, , Germany

Uniklinik Schleswig-Holstein; Neuroimmunologie, Institut für Klinische Chemie + Klinik f. Neurologie

Kiel, , Germany

Universitaetsklinikum Marburg; Klinik fuer Neurologie

Marburg, , Germany

Klinikum rechts der Isar der TU Muenchen; Neurologische Klinik und Poliklinik im Neuro-Kopf-Zentrum

München, , Germany

Universitätsklinikum Münster; Klinik und Poliklinik für Neurologie

Münster, , Germany

Praxis Dr. med. Bergmann

Neuburg am Inn, , Germany

Asklepios Kliniken Schildautal Seesen; Klinik für Neurologie

Seesen, , Germany

Universitätsklinikum Tübingen, Zentrum für Neurologie

Tübingen, , Germany

Semmelweis Egyetem AOK; Neurologiai Klinika

Budapest, , Hungary

Budapesti Uzsoki Utcai Kórház

Budapest, , Hungary

Jahn Ferenc Dél-Pesti Kórház

Budapest, , Hungary

VALEOMED Diagnosztikai Központ

Esztergom, , Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ; Neurológiai Klinika

Szeged, , Hungary

A.O.U. Mater Domin; U.O. NEUROLOGIA

Catanzaro, Calabria, Italy

A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche

Napoli, Campania, Italy

Università degli Studi della Campania Luigi Vanvitelli; Dip. Ass. Integrato Med Int-II Clinica Neur

Napoli, Campania, Italy

Ospedale Cattinara; Amb Studio Sclerosi Multipla, Clinica Neurlogica

Trieste, Friuli Venezia Giulia, Italy

Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

Rome, Lazio, Italy

Azienda Ospedaliera Sant'Andrea; UOC Neurologia

Rome, Lazio, Italy

Irccs A.O.U.San Martino Ist; Dinogmi

Genoa, Liguria, Italy

IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla

Milan, Lombardy, Italy

Fond. Istituto Neurologico C.Besta; UO Neurologia IV - Neuroimmunologia Malattie Neuromuscolari

Milan, Lombardy, Italy

Ospedale Civile di Montichiari; Centro Sclerosi Multipla

Montichiari, Lombardy, Italy

IRCCS Istituto Neurologico Neuromed; Centro per lo Studio e la Cura della Sclerosi Multipla

Pozzilli, Molise, Italy

AOU Policlinico V. Emanuele - P.O G. Rodolico; Clinica Neurologica, Centro Sclerosi Multipla

Catania, Sicily, Italy

AO Ospedali Riuniti Villa Sofia-Cervello;PO Villa Sofia - UO Neurologia - U.O.S. Neuroimmunologia

Palermo, Sicily, Italy

AOU Careggi; Neurologia 1-Dip. Neuroscienze Psicologia Area Farmaco Salute del Bambino(NEUROFARBA)

Florence, Tuscany, Italy

Ospedale Misericordia USL9 di Grosseto; U.O. Neurologia

Grosseto, Tuscany, Italy

Ospedale Le Scotte; Clinica Neurologica e Malattie Neurometaboliche

Siena, Tuscany, Italy

Ibn Sina Hospital; Neurology Department

Kuwait City, , Kuwait

American University of Beirut - Medical Center

Beirut, , Lebanon

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, Mexico

Hospital General de Mexico

Mexico, Tlaxcala, Mexico

Unidad de investigacion en salud (UIS); Neurociencias

Mexico City, , Mexico

Jeroen Bosch Ziekenhuis

's-Hertogenbosch, , Netherlands

VU Medisch Centrum; Afdeling Neurologie

Amsterdam, , Netherlands

Groene Hart Ziekenhuis

Gouda, , Netherlands

Zuyderland Medisch Centrum - Sittard Geleen

Sittard-Geleen, , Netherlands

Akershus universitetssykehus HF; Nevroklinikken S203

Lørenskog, , Norway

Stavanger Universitetssykehus, Helse Stavanger HF

Stavanger, , Norway

Neurocentrum Bydgoszcz sp. z o.o

Bydgoszcz, , Poland

COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika; Oddzia? Neurologiczny

Gdansk, , Poland

Care Clinic

Katowice, , Poland

Malopolskie Centrum Diagnostyczne MEDICAL Sp. z o. o.

Krakow, , Poland

Centrum Neurologii Krzysztof Selmaj

Lodz, , Poland

Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

Lublin, , Poland

Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

Warsaw, , Poland

Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

Warsaw, , Poland

Hospital Garcia de Orta; Servico de Neurologia

Almada, , Portugal

Hospital de Braga; Servico de Neurologia

Braga, , Portugal

HUC; Servico de Neurologia

Coimbra, , Portugal

Hospital Beatriz Angelo; Servico de Neurologia

Loures, , Portugal

Hospital Geral de Santo Antonio; Servico de Neurologia

Porto, , Portugal

Spitalul Universitar de Urgenta Bucuresti

Bucharest, , Romania

Spitalul Clinic Judetean Sibiu

Sibiu, , Romania

Spitalul Clinic Judetean de Urgenta Mures

Târgu Mureş, , Romania

Univerzitna nemocnica Bratislava, Nemocnica Staré Mesto; I. Neurologická klinika SZU a UNB

Bratislava, , Slovakia

Univerzitna nemocnica Bratislava - Nemocnica Ruzinov; Neurologicka klinika SZU a UNB

Bratislava, , Slovakia

GB NeuroPRAKTIK, s.r.o

Nitra, , Slovakia

Fakultna nemocnica Trnava

Trnava, , Slovakia

University Medical Centre; Neurology

Ljubljana, , Slovenia

University Medical Centre Maribor

Maribor, , Slovenia

Complejo Hospitalario Nuestra Señora de la Candelaria; Servicio de Neurologia

Santa Cruz de Tenerife, Tenerife, Spain

Hospital de Cruces; Servicio de Neurologia

Barakaldo, Vizcaya, Spain

Hospital General Universitario de Alicante; Servicio de Neurología

Alicante, , Spain

Hospital del Mar; Servicio de Neurologia

Barcelona, , Spain

Hospital Vall d'Hebron; Servicio de Neurología

Barcelona, , Spain

Hospital Universitario Puerta De Hierro Majadahonda; Servicio de Neurología

Madrid, , Spain

Hospital General Universitario Morales Meseguer; Servicio de Neurología

Murcia, , Spain

Sahlgrenska Sjukhuset; Neurology

Gothenburg, , Sweden

Centralsjukhuset; Neurologi och rehabiliteringskliniken

Karlstad, , Sweden

Centrum för Neurologi

Stockholm, , Sweden

Universitätsspital Basel; Neurologie

Basel, , Switzerland

Inselspital Bern Medizin Neurologie; Neurologische Poliklinik

Bern, , Switzerland

Luzerner Kantonsspital Luzern Medizin Neurologie

Lucerne, , Switzerland

Ospedale Regionale di Lugano - Civico; Neurologia

Lugano, , Switzerland

Kantonsspital; Neurologische Klinik

Sankt Gallen, , Switzerland

Hacettepe University Medical Faculty; Neurology

Ankara, , Turkey (Türkiye)

Gazi University Medical Faculty; Departmant of Norology

Ankara, , Turkey (Türkiye)

Mustafa Kemal Ataturk UTF; Department of norology

Hatay, , Turkey (Türkiye)

Istanbul University Istanbul Medical Faculty; Neurology

Istanbul, , Turkey (Türkiye)

Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi; Noroloji Anabilim Dali

Istanbul, , Turkey (Türkiye)

Istanbul Bilim Universty Medical Fac.

Istanbul, , Turkey (Türkiye)

Selcuk University Medical Faculty; Norology department

Istanbul, , Turkey (Türkiye)

Ondokuz Mayis Univ. Med. Fac.; Neurology

Samsun, , Turkey (Türkiye)

Karadeniz Tecnical Uni. Med. Fac.; Neurology

Trabzon, , Turkey (Türkiye)

Cambridge University Hospitals NHS Foundation Trust

Cambridge, , United Kingdom

Queen Elizabeth University Hospital

Glasgow, , United Kingdom

Royal Free Hospital

London, , United Kingdom

King'S College Hospital

London, , United Kingdom

Charing Cross Hospital

London, , United Kingdom

National Hospital for Neurology and Neurosurgery,; MRC Centre for Neuromuscular Diseases

London, , United Kingdom

Royal Victoria Infirmary

Newcastle upon Tyne, , United Kingdom

Derriford Hospital

Plymouth, , United Kingdom

Salford Royal NHS Foundation Trust

Salford, , United Kingdom

Abertawe and Bro Morgannwg NHS Trust; Clinical Researdh Institute

Swansea, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belgium; Brazil; Bulgaria; Canada; Croatia; Denmark; France; Germany; Hungary; Italy; Kuwait; Lebanon; Mexico; Netherlands; Norway; Poland; Portugal; Romania; Slovakia; Slovenia; Spain; Sweden; Switzerland; Turkey (Türkiye); United Kingdom

References

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.

Reference Type: DERIVED

PMID: 40629721 (View on PubMed)

Kappos 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.

Reference Type: DERIVED

PMID: 40258203 (View on PubMed)

Hartung 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.

Reference Type: DERIVED

PMID: 39626127 (View on PubMed)

Hartung 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.

Reference Type: DERIVED

PMID: 38649522 (View on PubMed)

Hartung 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.

Reference Type: DERIVED

PMID: 32503093 (View on PubMed)

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

2016-002937-31

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MA30143

Identifier Type: -

Identifier Source: org_study_id