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

Rheumatoid Arthritis Clinical Trial

Official title: Randomized, Prospective, Active-comparator Controlled, Patient-blinded Study to Demonstrate Non-inferiority of Reduced-dose Rituximab in Rheumatoid Arthritis Patients in Low Disease Activity and Remission - the REDOREM Study

Status Terminated

Clinical Trial 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.

Clinical Trial Description

Randomized, controlled, single-centre study with 1x500mg or 1x1000 semi-annual infusions of RTX (Mabthera) as intervention and a follow-up period of 2 years. Patients as well as assessors will be blinded to the type of treatment. Patients in the 1x500mg group who experience a flare as defined by the disease activity score 28-ESR (DAS28) will receive 1x1000mg RTX (Mabthera) at their upcoming scheduled infusion appointment. Patients in the 1x1000mg group whose disease activity reaches DAS28 >3.2 during the duration of the study will be re-evaluated for a change in biological therapy and will discontinue the study. ;

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Remission
• Rheumatoid Arthritis

• NCT number: NCT05116228
• Study type: Interventional
• Source: Medical University of Vienna
• Status: Terminated
• Phase: Phase 4
• Start date: September 1, 2015
• Completion date: November 1, 2021