REDUCE PMR: Rituximab Effect on Decreasing glUcoCorticoid Exposition in newly diagnosed PolyMyalgia Rheumatica

简要总结

主要结局

次要结局

• Proportion of patients in GC free remission at week 21.
• Proportion of patients with low dose GC (≤5mg/day) remission at week 21, week 52, 1.5 and 2 years
• PMR-AS at each visit.
• number of disease relapses/recurrences up to week 52.
• proportion of patients with a disease relapse/recurrence at week 52.
• The time from baseline to GC free remission and to relapse.
• GC cumulative dose at 52 weeks, 1.5 and 2 years.
• Proportion of patients with RTX/PCB retreatment.
• Proportion of patients who start methotrexate, leflunomide, tocilizumab or sarilumab or possible other bDMARD being registered for PMR
• Sex differences in frequencies of GC-remission and adverse events
• Changes in patient reported outcomes, concerning pain, fatigue, stiffness and physical function
• Medical consumption and productivity loss.
• (Changes in) modified glucocorticoid toxicity index (which excludes bone mineral density scan to improve feasibility).
• Frequency, types, proportion of patients with and total numbers of (especially GC- and RTX-related) AE during the 52 week study.
• Proportion of patients in GC free remission 1.5 years after RTX/PCB infusion
• Proportion of patients in GC free remission 2 years after RTX/PCB infusion
• The number of disease relapses/recurrences up to 2 years.
• The proportion of patients with a disease relapse/recurrence at 2 years.
• The proportion of patients lost-to follow-up and the reason for loss to follow-up at 1.5 and 2 years
• The proportion of patients that had a (different) DMARD started (and reason for starting the DMARD) at 1.5 and 2 years
• The proportion (and number) of patients in which a (concomitant) rheumatic (inflammatory) disease was diagnosed at 1.5 and 2 years