An open-label extension study evaluating long-term safety, tolerability and effectiveness of ofatumumab in subjects with RMS
Key facts
- Where
- Budapest, Budapest IV, Budapest XV, Kistarcsa, Pécs és Szeged, MagyarországSee the 7 sites
- Phase
- 3. fázis
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 18 and 64 years old?
Where in Magyarország
- Budapesti Bajcsy-Zsilinszky Korhaz Es RendelointezetBudapest, MagyarországNo longer taking part
- Jahn Ferenc Del-Pesti Korhaz es RendelointezetBudapest, MagyarországNo longer taking part
- S-Medicon Kft.Budapest IV, MagyarországNo longer taking part
- Uno Medical Trials Kft.Budapest XV, MagyarországNo longer taking part
- Kistarcsai Flor Ferenc KorhazKistarcsa, MagyarországNo longer taking part
- University of PecsPécs, MagyarországNo longer taking part
- University of SzegedSzeged, MagyarországNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Novartis Pharma AG
- Trial code
- EU 2023-507906-15-00
- Record updated
- 2026. augusztus 5.
- Original description
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 ofatumumabRead full original descriptionShow less
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)
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
Inclusion: 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.
Exclusion: 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; 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)); Subjects with neurological findings consistent with Progressive Multifocal Leukoencephalopathy (PML) or confirmed PML.