eligibility_summary
Eligible: Adults ≥18 with ACR/EULAR SSc and SSc‑ILD for MMF (≤1500 mg BID): severe ILD (HRCT ≥20% or FVC ≤70%), high‑risk features (age>60, male, ≤5y diffuse, Afro ancestry, anti‑Scl70, CRP≥5), or 6–24 mo progression (FVC decline ± DLCO/HRCT/dyspnea). French insurance, consent, compliance required. Exclude: major lung/heart disease, PH, walk<100 m, MMF intolerance or RTX/sulfonamide allergy, recent IS/biologics, prior MMF/RTX, therapy change <4 wks, transplant list, protected/contraception issues, infection risks/incomplete COVID vax, other trials.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drugs/interventions: Rituximab (IV chimeric monoclonal antibody) added to background mycophenolate mofetil (MMF, oral antimetabolite immunosuppressant/prodrug of mycophenolic acid) vs placebo + MMF. Mechanisms of action: Rituximab targets CD20 on B cells, inducing depletion via ADCC/CDC and apoptosis, lowering autoreactive B-cell activity and autoantibody production. MMF inhibits inosine monophosphate dehydrogenase (IMPDH), blocking de novo guanine synthesis and selectively suppressing proliferation of activated T and B lymphocytes. Cells/pathways targeted: CD20+ B cells, adaptive immune pathways driving SSc-ILD (B-cell activation/autoantibody axis), lymphocyte purine synthesis (IMPDH) to reduce T- and B-cell mediated inflammation and downstream profibrotic signaling in interstitial lung disease.