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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
21
Patients will receive 1x500mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24
Patients will receive 1x1000mg RTX (Mabthera) at baseline (time-point of their upcoming semi-annual infusion) and at months 6, 12, 18 and 24
Medical University of Vienna
Vienna, Austria
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 24
Radiographic progression
Sharp modified van der Heijde (SvdH) score, Scale 0 (best) - 488 (worse)
Time frame: month 12
Radiographic progression
Sharp modified van der Heijde (SvdH) score, Scale 0 (best) - 488 (worse)
Time frame: month 24
Physical function
Health assessment questionnaire disability index (HAQ-DI), Scale 0 (best) - 3.0 worse
Time frame: months 12
Physical function
Health assessment questionnaire disability index (HAQ-DI), Scale 0 (best) - 3.0 worse
Time frame: months 24
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 21
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 18
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 15
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 12
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 9
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 6
Proportion of flare
Disease activity score 28-Erythrocyte sedimentation sate (DAS28-ESR), Scale 0 (best) - 10 (worse)
Time frame: month 3