2023-507906-15-00Active, not recruitingPhase 3

An open-label extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS

An open-label, single arm, multi-center extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with relapsing multiple sclerosis (RMS)

Source: EU CTIS (euclinicaltrials.eu) · Last updated 5 Aug 2026

Next steps

Brief summary (registry, in English)

Evaluate the long-term safety and tolerability of ofatumumab 20 mg sc once every 4 weeks in subjects with RMS from the first dose of ofatumumab

Status (registry): Active, not recruiting
Phase (registry): Phase 3
Study type: Interventional
Enrollment: 963 (estimated)
First submitted: 13 Jun 2024
Start date: 30 Jan 2019
Lead sponsor: Novartis Pharma AG
Diseases: Multiple sclerosis
EU CT number: 2023-507906-15-00
EudraCT number: 2017-004703-51

What you commit to

Study type: Interventional · Phase 3
Planned participants: 963
110 sites in 21 countries
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of EU CTIS (euclinicaltrials.eu). It describes the study design.

Who cannot take part

Copied verbatim from EU CTIS (euclinicaltrials.eu) and grouped by topic. Only the trial team decides who can take part.

Prior treatment

Premature discontinuation from previous ofatumumab study or from study treatment in previous ofatumumab study
Subjects that have had their previous ofatumumab study end of study (EOS) > 6 months prior to screening and/or been given another MS disease-modifying therapy (DMT) between EOS of previous study and screening of this study
Less than 3.5-month washout of teriflunomide for subjects that will not complete the accelerated elimination procedure (AEP) prior to Day 1. Only applicable to subjects completing studies COMB157G2301 and COMB157G2302
Subjects that have any unresolved adverse event (AE) or condition from the previous study that necessitates temporary interruption of the study treatment, until such time as the event or condition has resolved (the subject will be monitored within the safety follow-up (SFU) of the previous study during this time)
Emergence of any clinically significant condition/disease during previous ofatumumab study in which study participation might result in safety risk for subjects
Subjects that have developed or have had reactivation of syphilis or tuberculosis during previous ofatumumab study

Other illness

Subjects with a history of not being able or willing to cooperate or comply with study protocol requirements in the opinion of the Investigator
Subjects with active systemic bacterial, viral or fungal infections, or chronic infection (e.g. Acquired Immune Deficiency Syndrome (AIDS))

Other

Subjects with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML

Who the study is looking for

Must have participated in a Novartis MS study: • which dosed ofatumumab 20 mg sc q4 weeks, • was an adult (≥ 18 years of age) study in RMS, • must have completed the study on study treatment
Written informed consent

Age in the registry: 18 years to 64 years · Sex: All · Does not accept healthy volunteers

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (110)

Sites in registry order. Save your city in your profile to sort them by distance.

Site	City	Country	Site status
Medical University of Vienna	Vienna	Austria	Completed
Az St-Jan Brugge-Oostende A.V.	Brugge	Belgium	Active, not recruiting
Antwerp University Hospital	Edegem	Belgium	Active, not recruiting
Universitair Ziekenhuis Gent	Gent	Belgium	Active, not recruiting
Universite Catholique de Louvain	Sint-Lambrechts-Woluwe	Belgium	Active, not recruiting
Medical Center Medconsult Pleven OOD	Pleven	Bulgaria	Active, not recruiting
University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD	Pleven	Bulgaria	Active, not recruiting
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD	Sofia	Bulgaria	Active, not recruiting
Alexandrovska University Hospital	Sofia	Bulgaria	Active, not recruiting
University Multiprofile Hospital For Active Treatment St. Ivan Rilski EAD	Sofia	Bulgaria	Active, not recruiting
MHAT National Heart Hospital EAD	Sofiya	Bulgaria	Active, not recruiting
Fakultni Nemocnice U Sv Anny V Brne	Brno-Stred	Czechia	Active, not recruiting
Nemocnice Jihlava prispevkova organizace	Jihlava 1	Czechia	Active, not recruiting
Fakultni Nemocnice Hradec Kralove	Novy Hradec Kralove	Czechia	Active, not recruiting
University Hospital Olomouc	Olomouc	Czechia	Active, not recruiting
Nemocnice Pardubickeho kraje a.s.	Pardubice	Czechia	Active, not recruiting
Fakultní Nemocnice Královské Vinohrady	Prague 10	Czechia	Active, not recruiting
Vseobecna Fakultni Nemocnice V Praze	Prague 2	Czechia	Active, not recruiting
Fakultni Thomayerova nemocnice	Prague 4	Czechia	Active, not recruiting
Neurospol s.r.o.	Slezska Ostrava	Czechia	Active, not recruiting
Krajska zdravotni a.s.	Teplice	Czechia	Active, not recruiting
Klinikum Bayreuth GmbH	Bayreuth	Germany	Active, not recruiting
Neurozentrum Bielefeld	Bielefeld	Germany	Active, not recruiting
Universitaetsklinikum Carl Gustav Carus Dresden an der Technischen Universitaet Dresden AöR	Dresden	Germany	Active, not recruiting
Universitaetsklinikum Essen (AoR)	Essen	Germany	Active, not recruiting
MultipEL Studies	Hamburg	Germany	Active, not recruiting
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany	Active, not recruiting
Universitaet Leipzig	Leipzig	Germany	Active, not recruiting
Universitaetsklinikum Giessen und Marburg GmbH	Marburg	Germany	Active, not recruiting
Klinikum der Universitaet Muenchen AöR	Munich	Germany	Active, not recruiting
St. Josef-Hospital	Potsdam	Germany	Active, not recruiting
ZNS GmbH Zentrum fuer Neurologisch-Psychiatrische Studien Gutachten und medizinische Fortbildung Siegen	Siegen	Germany	Active, not recruiting
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH	Ulm	Germany	Active, not recruiting
Rigshospitalet	Glostrup	Denmark	Active, not recruiting
Odense University Hospital	Odense C	Denmark	Active, not recruiting
Laane-Tallinna Keskhaigla AS	Pohja-Tallinna Linnaosa	Estonia	Active, not recruiting
Tartu University Hospital	Tartu Linn	Estonia	Active, not recruiting
Hospital Universitario de Cruces	Barakaldo	Spain	Active, not recruiting
Hospital Clinic de Barcelona	Barcelona	Spain	Active, not recruiting
Hospital Universitari Vall d'Hebron	Barcelona	Spain	Active, not recruiting
Hospital de la Santa Creu i Sant Pau	Barcelona	Spain	Active, not recruiting
Hospital Universitario Puerta del Mar	Cadiz	Spain	Active, not recruiting
Hospital Nisa Sevilla Aljarafe	Castilleja De La Cuesta	Spain	Active, not recruiting
Hospital Universitario Donostia	Donostia	Spain	Active, not recruiting
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain	Active, not recruiting
Hospital Universitario Ramón y Cajal	Madrid	Spain	Active, not recruiting
Hospital Universitario de la Princesa	Madrid	Spain	Active, not recruiting
Hospital Clínico San Carlos	Madrid	Spain	Active, not recruiting
Fundacion Para La Investigacion Biomedica Del Hospital Universitario Puerta De Hierro Majadahonda	Majadahonda	Spain	Active, not recruiting
Hospital Universitario Regional de Málaga	Málaga	Spain	Active, not recruiting
University Clinical Hospital Virgen De La Arrixaca	Murcia	Spain	Active, not recruiting
Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcón	Spain	Active, not recruiting
Hospital Santa Caterina Ias	Salt	Spain	Active, not recruiting
Hospital Universitario Virgen De La Macarena	Sevilla	Spain	Active, not recruiting
Hospital Universitario Y Politecnico La Fe	Valencia	Spain	Active, not recruiting
Mehilaeinen Oy	Helsinki	Finland	Active, not recruiting
Suomen Terveystalo Oy	Tampere	Finland	Active, not recruiting
Centre Hospitalier Universitaire De Lille	Lille Cedex	France	Active, not recruiting
Centre Hospitalier Universitaire De Montpellier	Montpellier Cedex 5	France	Active, not recruiting
Centre Hospitalier Universitaire de Nice	Nice	France	Active, not recruiting
Centre Hospitalier Universitaire De Nimes	Nimes Cedex 9	France	Active, not recruiting
Hopital Universitaire Pitie Salpetriere	Paris Cedex 13	France	Active, not recruiting
Centre Hospitalier Universitaire de Nantes	Saint-Herblain	France	Active, not recruiting
Les Hopitaux Universitaires De Strasbourg	Strasbourg Cedex 2	France	Active, not recruiting
401 General Military Hospital of Athens	Athens	Greece	Active, not recruiting
University General Hospital of Thessaloniki - AHEPA	Thessaloniki	Greece	Active, not recruiting
KBC Zagreb	Grad Zagreb	Croatia	Active, not recruiting
Klinički bolnički centar Osijek	Osijek	Croatia	Active, not recruiting
Clinical Hospital Centre Rijeka	Rijeka	Croatia	Active, not recruiting
Victus Polyclinic	Zagreb	Croatia	Active, not recruiting
Budapesti Bajcsy-Zsilinszky Korhaz Es Rendelointezet	Budapest	Hungary	Active, not recruiting
Jahn Ferenc Del-Pesti Korhaz es Rendelointezet	Budapest	Hungary	Active, not recruiting
S-Medicon Kft.	Budapest IV	Hungary	Active, not recruiting
Uno Medical Trials Kft.	Budapest XV	Hungary	Active, not recruiting
Kistarcsai Flor Ferenc Korhaz	Kistarcsa	Hungary	Active, not recruiting
University of Pecs	Pécs	Hungary	Active, not recruiting
University of Szeged	Szeged	Hungary	Active, not recruiting
Lietuvos sveikatos mokslu universiteto ligonine Kauno klinikos	Kaunas	Lithuania	Active, not recruiting
Vilniaus universiteto ligonine Santaros klinikos VšĮ	Vilnius	Lithuania	Active, not recruiting
Rigas Austrumu kliniska universitates slimnica SIA	Riga	Latvia	Active, not recruiting
Pauls Stradins Clinical University Hospital	Riga	Latvia	Active, not recruiting
Latvijas Juras medicinas centrs AS	Riga	Latvia	Active, not recruiting
Amsterdam UMC Stichting	Amsterdam	Netherlands	Active, not recruiting
Zuyderland Medisch Centrum Stichting	Geleen	Netherlands	Active, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)	Rotterdam	Netherlands	Active, not recruiting
Drammen Sykehus	Drammen	Norway	Active, not recruiting
Neurocentrum Bydgoszcz sp. z o.o	Bydgoszcz	Poland	Active, not recruiting
Copernicus Podmiot Leczniczy Sp. z o.o	Gdansk	Poland	Active, not recruiting
Uniwersyteckie Centrum Kliniczne	Gdansk	Poland	Active, not recruiting
Nowe Techniki Medyczne Szpital Specjalistyczny Imienia Swietej Rodziny Sp. z o.o.	Glogow Malopolski	Poland	Active, not recruiting
MA-LEK Clinical Sp. z o.o.	Katowice	Poland	Active, not recruiting
Resmedica Sp. z o.o.	Kielce	Poland	Active, not recruiting
Centrum Neurologii Krzysztof Selmaj	Łódź	Poland	Active, not recruiting
Centrum Medyczne Medyk Sp. z o.o. S.K.	Rzeszow	Poland	Active, not recruiting
Instytut Psychiatrii I Neurologii	Warsaw	Poland	Active, not recruiting
WroMedica I Bielicka A Strzalkowska s c	Wroclaw	Poland	Active, not recruiting
Samodzielny Publiczny Szpital Kliniczny Nr 1 Im.Prof.Stanislawa Szyszko Slaskiego Uniwersytetu Medycznego W Katowicach	Zabrze	Poland	Active, not recruiting
CCAB Centro Clinico Academico Braga Associacao	Braga	Portugal	Active, not recruiting
Unidade Local de Saúde de Coimbra, E.P.E.	Coimbra	Portugal	Active, not recruiting
Hospital da Luz, S.A	Lisbon	Portugal	Active, not recruiting
Hospital Beatriz Ângelo	Loures	Portugal	Active, not recruiting
Centro Hospitalar De Entre O Douro E Vouga E.P.E.	Santa Maria Da Feira	Portugal	Active, not recruiting
Unidade Local De Saude De Matosinhos E.P.E.	Senhora Da Hora	Portugal	Active, not recruiting
Sahlgrenska University Hospital-Vaestra Goetalandsregionen	Goteborg	Sweden	Active, not recruiting
Region Stockholm – SLSO	Stockholm	Sweden	Active, not recruiting
F D Roosevelt University General Hospital Of Banska Bystrica	Banska Bystrica	Slovakia	Active, not recruiting
University Hospital Bratislava	Bratislava	Slovakia	Active, not recruiting
Univerzitna nemocnica Martin	Martin	Slovakia	Active, not recruiting
Fakultna Nemocnica Nitra	Nitra	Slovakia	Active, not recruiting
Fakultna nemocnica Trnava	Trnava	Slovakia	Active, not recruiting

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