Polymyalgia rheumatica (PMR) is prevalent among elderly. Untreated, it leads to major reduction in quality of life. Glucocorticoids are the cornerstone of treatment, but have drawbacks, warranting glucocorticoid sparing treatment. A proof of concept study on Rituximab (RTX) vs placebo showed efficacy in 48 vs 21%(p=0.049) in glucocorticoid free remission after 21 weeks (Marsman et al. 2021). Though promising, the short study duration, small sample size and only few relapsing patients included in this study require further confirmation. Therefore a larger randomised controlled trial with longer follow up will be performed on RTX efficacy on glucocorticoid free remission in relapsing PMR patients during glucocorticoid taper.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
174
1000mg rituximab in 250ml NaCl 0.9% intravenously
Placebo in 250ml NaCl 0.9% intravenously
Sint Maartensklineik
Ubbergen, Gelderland, Netherlands
Between group difference in percentage of patients in glucocorticoid-free remission
Between group difference in percentage of patients in glucocorticoid-free remission (PMR activity score \< 10) at week 52
Time frame: At week 52
Percentage of patients in glucocorticoid-free remission
Percentage of patients in glucocorticoid-free remission
Time frame: 21 weeks
Percentage of patients with glucocorticoid dose of ≤5mg/day
Percentage of patients with glucocorticoid dose of ≤5mg/day
Time frame: 52 weeks
Number of relapses
Number of relapses
Time frame: 52 weeks
Time to glucocorticoid-free remission
Time to glucocorticoid-free remission in days during the study period
Time frame: 52 weeks
Time to relapse
Time to relapse in days during the study period
Time frame: 52 weeks
Cumulative glucocorticoid dose
Cumulative glucocorticoid dose
Time frame: 52 weeks
Percentage of patients needing RTX/Placebo retreatment
Percentage of patients needing RTX/Placebo retreatment
Time frame: 52 weeks
Adverse events
Adverse events
Time frame: 52 weeks
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