eligibility_summary
Patients with PMR meeting 2012 EULAR/ACR criteria, diagnosed <12 weeks ago, on glucocorticoids ≤30 mg/day for <8 weeks, and able to consent. Excludes systemic immunosuppressants (except glucocorticoids) within 3 months, suspected giant cell arteritis or other inflammatory rheumatic diseases, conditions impacting PMR pain/mobility assessment, or RTX hypersensitivity/contraindications.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
NCT05533125 is a phase 3, parallel-group RCT in newly diagnosed polymyalgia rheumatica testing single-dose IV rituximab (1000 mg) vs placebo during glucocorticoid taper. Drug/intervention: Rituximab (biologic, chimeric monoclonal antibody) targets CD20 on B cells. Mechanism: depletes circulating CD20+ B lymphocytes via complement-dependent cytotoxicity, antibody-dependent cellular cytotoxicity, and apoptosis, intent is to reduce glucocorticoid exposure and achieve steroid-free remission. Cells/pathways targeted: CD20+ B cells (naive/memory), reducing antigen presentation and immune amplification, with expected downstream attenuation of T-cell activation and proinflammatory cytokine pathways, particularly IL-6–driven inflammation implicated in PMR. Comparator: placebo infusion.