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Noisy Rebels; Non-inferiority study of rituximab compared to ocrelizumab in relapsing MS

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2022-502664-21-00
Enrollment
200
Registered
2023-03-03
Start date
2023-05-01
Completion date
Unknown
Last updated
2025-10-14

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 proportion of patients with no new or enlarged T2 lesions on brain MRI between month 6 and month 24 of treatment in each arm.

Detailed description

• The annual relapse rate between baseline to month 24 • The annual relapse rate between month 6 to month 24 • Proportion of patients with no relapses from baseline to month 24 • Proportion of patients with no relapses from month 6 to month 24 • Time to first relapse • Proportion of patients with no contrast enhancing lesions between baseline and month 24 • Proportion of patients with no contrast enhancing lesions between month 6 and month 24 • The average number of new/enlarged T2 lesions betwe

Interventions

DRUGRixathon 100 mg concentrate for solution for infusion
DRUGMabThera 100 mg concentrate for solution for infusion
DRUGRixathon 500 mg concentrate for solution for infusion
DRUGOcrevus 300 mg concentrate for solution for infusion
DRUGRuxience 100 mg concentrate for solution for infusion
DRUGMabThera 500 mg concentrate for solution for infusion
DRUGTruxima 100 mg concentrate for solution for infusion
DRUGRuxience 500 mg concentrate for solution for infusion
DRUGTruxima 500 mg concentrate for solution for infusion

Sponsors

Amsterdam UMC
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
• The proportion of patients with no new or enlarged T2 lesions on brain MRI between month 6 and month 24 of treatment in each arm.—

Secondary

MeasureTime frame
• The annual relapse rate between baseline to month 24 • The annual relapse rate between month 6 to month 24 • Proportion of patients with no relapses from baseline to month 24 • Proportion of patients with no relapses from month 6 to month 24 • Time to first relapse • Proportion of patients with no contrast enhancing lesions between baseline and month 24 • Proportion of patients with no contrast enhancing lesions between month 6 and month 24 • The average number of new/enlarged T2 lesions betwe—

Countries

Netherlands

Outcome results

None listed

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