eligibility_summary
Adults (≥18) with sarcoidosis (non‑caseating granulomas, other causes excluded), on infliximab ≥6 mo and steroids ≤10 mg/day, inactive disease (ePOST=0) ≥6 mo, normal ACE/calcemia, consented and covered by French social security. Exclude: pregnancy/breastfeeding, untreated positive IGRA, active infection, NYHA III–IV HF, severe hepatic/renal disease, alcoholism, blood dyscrasias, cancer <5 y (except NMSC), live vaccines, inability to consent/legal protection, no contraception, other Cat‑1 trial.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Phase 3 randomized trial in refractory sarcoidosis compares continuing vs withdrawing infliximab while keeping background methotrexate or azathioprine and low‑dose steroids. Infliximab: chimeric IgG1 monoclonal antibody (biologic) that neutralizes soluble and transmembrane TNF‑α, suppressing TNFR1/2→NF‑κB signaling, macrophage activation, and Th1/Th17‑driven granuloma maintenance. Methotrexate: antimetabolite/folate antagonist, inhibits DHFR/AICAR‑TF, increases adenosine, reducing T‑cell proliferation and macrophage cytokines. Azathioprine: purine antimetabolite (6‑MP prodrug) that blocks de novo purine synthesis, limiting T‑ and B‑cell expansion. Prednisone: glucocorticoid receptor agonist broadly suppressing cytokine transcription. Targeted cells/pathways: TNF‑α signaling in macrophages/epithelioid cells, CD4+ Th1/Th17 cells, dendritic cells, NF‑κB inflammatory cascade and granuloma formation.