Under construction – not a live service
Sign in

2024-513193-22-00Active, not recruitingPhase 4

Personalized dosing of ocrelizumab in MS

Efficacy, safety and cost-effectiveness of B cell tailored ocrelizumab versus standard ocrelizumab in relapsing remitting multiple sclerosis (BLOOMS): a randomized controlled trial

Source: EU CTIS (euclinicaltrials.eu) · Last updated 3 Feb 2026

Next steps

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
296 (estimated)
First submitted
2 Sept 2024
Start date
16 Mar 2022
Lead sponsor
Amsterdam UMC Stichting
EU CT number
2024-513193-22-00
EudraCT number
2021-004791-34

What you commit to

  • Study type: Interventional · Phase 4
  • Planned participants: 296
  • 22 sites in 1 country
  • 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

  • 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

Other

  • Inability to undergo regular MRI scanning
  • Women who are pregnant or expect to become pregnant during the study period

Who the study is looking for

  • 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

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

Full criteria on EU CTIS (euclinicaltrials.eu)

Sites (22)

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

SiteCityCountrySite status
Noordwest Ziekenhuisgroep StichtingAlkmaarNetherlandsActive, not recruiting
Flevoziekenhuis StichtingAlmereNetherlandsActive, not recruiting
Amsterdam UMC StichtingAmsterdamNetherlandsActive, not recruiting
OLVGAmsterdamNetherlandsActive, not recruiting
Rijnstate Ziekenhuis StichtingArnhemNetherlandsActive, not recruiting
Wilhelmina Ziekenhuis AssenAssenNetherlandsActive, not recruiting
Amphia HospitalBredaNetherlandsActive, not recruiting
Reinier de Graaf GroepDelftNetherlandsActive, not recruiting
Slingeland ZiekenhuisDoetinchemNetherlandsActive, not recruiting
Medisch Spectrum TwenteEnschedeNetherlandsActive, not recruiting
Zuyderland Medisch Centrum StichtingGeleenNetherlandsActive, not recruiting
Groene Hart ZiekenhuisGoudaNetherlandsActive, not recruiting
Spaarne Gasthuis StichtingHoofddorpNetherlandsActive, not recruiting
Alrijne Zorggroep StichtingLeiderdorpNetherlandsActive, not recruiting
St. Antonius ZiekenhuisNieuwegeinNetherlandsActive, not recruiting
Erasmus Universitair Medisch Centrum Rotterdam (Erasmus MC)RotterdamNetherlandsActive, not recruiting
Maasstad Ziekenhuis StichtingRotterdamNetherlandsActive, not recruiting
Ommelander Ziekenhuis Groningen B.V.ScheemdaNetherlandsActive, not recruiting
Haga Hospital's-GravenhageNetherlandsActive, not recruiting
Jeroen Bosch Ziekenhuis Stichting'S-HertogenboschNetherlandsActive, not recruiting
Streekziekenhuis Koningin BeatrixWinterswijkNetherlandsActive, not recruiting
Isala Klinieken StichtingZwolleNetherlandsActive, not recruiting

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.