eligibility_summary
Adults 18–80 with new, moderate-to-severe pemphigus vulgaris/foliaceus confirmed by biopsy+direct IF, able to receive prednisone+rituximab, COVID-19 vaccinated, contraception per protocol, able to comply/insured. Exclude: nonconsent, other autoimmune blistering disease, contraindications to study meds, no venous access, pregnancy/lactation, major comorbidities, recent steroids/immunosuppressants/IVIG/plasmapheresis/cyclophosphamide/B-cell therapy, active infection, HIV, HBV/HCV, recent cancer, substance abuse, major surgery, live vaccine, abnormal labs, other trial, legal incapacity.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 4 parallel trial in pemphigus comparing standard rituximab + prednisone vs biomarker-guided rituximab maintenance. Drugs/interventions: Rituximab (chimeric anti-CD20 monoclonal antibody biologic) depletes CD20+ B cells via ADCC/complement/apoptosis to lower pathogenic autoantibody production. Prednisone (systemic glucocorticoid, small-molecule steroid) suppresses immune/inflammatory gene transcription (e.g., NF-κB/AP-1), reducing lymphocyte and cytokine activity. Standard arm: Ritux-3 (1 g Day 1 & 14, 500 mg at months 12 & 18) + oral prednisone taper. Personalized arm: same base regimen plus 1 g rituximab at month 6 if anti-Dsg1/3 remain high or disease severe, and re-dosing (≤2/yr) when anti-Dsg1 >20 IU/mL or anti-Dsg3 >50 IU/mL. Cells/pathways targeted: CD20+ B cells, B cell–driven humoral autoimmunity to desmoglein 1/3, keratinocyte desmosomal adhesion (Dsg1/Dsg3) monitored via anti-Dsg antibodies.