drugset / Trial / NCT05116228

Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission

NCT05116228

Phase 4 Terminated 21 enrolled Medical University of Vienna
RandomizedParallel-groupDouble-blindTreatment

Summary

To investigate whether a reduced-dose dosing regimen (1x500mg semiannually) of rituximab (RTX) (Mabthera®) is non-inferior in patients with rheumatoid arthritis (RA) whose disease is in persistent low disease activity (LDA) or clinical remission (REM) (pLDA/pREM) as compared to the standard dosing regimen of 1x1000mg semi-annual infusions.

Timeline

Start
2015-09-01
Primary completion
2021-11-01
Completion
2021-11-01

Drugs

EvaluationDrugModalityDoseRoute
Comparator Rituximab Monoclonal antibody 500 mg
Comparator Rituximab Monoclonal antibody 1000 mg

Indications