Personalized dosing of ocrelizumab in MS
Key facts
- Where
- 's-Gravenhage, 'S-Hertogenbosch, Alkmaar, Almere, Amsterdam, Arnhem, Assen, Breda, Delft, Doetinchem, Enschede, Geleen, Gouda, Hoofddorp, Leiderdorp, Nieuwegein, Rotterdam, Scheemda, Winterswijk és Zwolle, HollandiaSee the 22 sites
- Phase
- 4. fázis
Where in Hollandia
- Haga Hospital's-Gravenhage, HollandiaNo longer taking part
- Jeroen Bosch Ziekenhuis Stichting'S-Hertogenbosch, HollandiaNo longer taking part
- Noordwest Ziekenhuisgroep StichtingAlkmaar, HollandiaNo longer taking part
- Flevoziekenhuis StichtingAlmere, HollandiaNo longer taking part
- Amsterdam UMC StichtingAmsterdam, HollandiaNo longer taking part
- OLVGAmsterdam, HollandiaNo longer taking part
- Rijnstate Ziekenhuis StichtingArnhem, HollandiaNo longer taking part
- Wilhelmina Ziekenhuis AssenAssen, HollandiaNo longer taking part
- Amphia HospitalBreda, HollandiaNo longer taking part
- Reinier de Graaf GroepDelft, HollandiaNo longer taking part
- Slingeland ZiekenhuisDoetinchem, HollandiaNo longer taking part
- Medisch Spectrum TwenteEnschede, HollandiaNo longer taking part
- Zuyderland Medisch Centrum StichtingGeleen, HollandiaNo longer taking part
- Groene Hart ZiekenhuisGouda, HollandiaNo longer taking part
- Spaarne Gasthuis StichtingHoofddorp, HollandiaNo longer taking part
- Alrijne Zorggroep StichtingLeiderdorp, HollandiaNo longer taking part
- St. Antonius ZiekenhuisNieuwegein, HollandiaNo longer taking part
- Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)Rotterdam, HollandiaNo longer taking part
- Maasstad Ziekenhuis StichtingRotterdam, HollandiaNo longer taking part
- Ommelander Ziekenhuis Groningen B.V.Scheemda, HollandiaNo longer taking part
- Streekziekenhuis Koningin BeatrixWinterswijk, HollandiaNo longer taking part
- Isala Klinieken StichtingZwolle, HollandiaNo 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
- Amsterdam UMC Stichting
- Trial code
- EU 2024-513193-22-00
- Record updated
- 2026. február 3.
- Original description
With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity compared to the standard (fixed 24 week interval) treatment.Read full original descriptionShow less
Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis (BLOOMS): a randomized controlled trial
With this study we aim to prove that personalized B cell tailored ocrelizumab treatment is non-inferior in the suppression of MS disease activity compared to the standard (fixed 24 week interval) treatment.
Inclusion: A current diagnosis of relapsing remitting multiple sclerosis according to the 2017 McDonald criteria; Age of 18 or older; EDSS score of 0 to 6.5 inclusive; Treatment with ocrelizumab for a minimum of 48 weeks (two 300 mg infusions and one 600 mg infusion); Last ocrelizumab interval not extended, maximum of 7,5 months between the infusions.
Exclusion: Previous treatment with alemtuzumab, cladribine or stem cell transplantation; Relapse in the past 3 months prior to inclusion; Subsequent treatment with another DMT next to ocrelizumab in the past 6 months prior to inclusion; Inability to undergo regular MRI scanning; Women who are pregnant or expect to become pregnant during the study period.