drugset / Trial / NCT05116228
Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis in Low Disease Activity and Remission
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rituximab | Monoclonal antibody | 500 mg | — |
| Comparator | Rituximab | Monoclonal antibody | 1000 mg | — |