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

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513193-22-00

Enrollment

296

Registered

2024-09-17

Start date

2022-03-16

Completion date

Unknown

Last updated

2024-09-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.

Interventions

DRUGOcrevus 300 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
The two co-primary end points are the difference of percentage of confirmed relapse-free patients between the two treatment groups after 96 weeks follow-up and the difference of percentage of patients without new/enlarging T2 MRI lesions between the two treatment groups after 96 weeks follow-up.	—

Countries

Netherlands

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026