eligibility_summary
Eligibility: age 5–18 with Sjögren’s syndrome per AECG/Japan, refractory after ≥2 immunosuppressants or prednisone+IS ≥3 months, with systemic involvement, B‑cell activation, or persistent inflammation, agrees to rituximab+belimumab. Exclude: prior rituximab (<6 mo)/other biologics, other trials (<6 mo), eGFR<30, active/latent infections or high infection risk, immunodeficiency, malignancy, severe uncontrolled organ disease, non‑SS steroid need, IgG<4 g/L or IgA<0.1 g/L, WBC<1.5×10^9/L or ANC<1×10^9/L.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Trial tests sequential biologic therapy in resistant primary juvenile Sjogren’s syndrome: rituximab followed by belimumab. Rituximab: chimeric anti-CD20 monoclonal antibody (B-cell–depleting biologic) that eliminates CD20+ B cells via complement-dependent cytotoxicity, antibody-dependent cell-mediated cytotoxicity, and apoptosis, given weekly until deep B-cell depletion (B%<0.5% or B#<20×10^6/L). Belimumab: human IgG1 monoclonal antibody against BAFF/BLyS (B-cell survival cytokine), given every 4 weeks starting 4 weeks post-rituximab to suppress BAFF signaling and prevent autoreactive B-cell repopulation. Targets: CD20+ B lymphocytes and the BAFF/BLyS–BAFF-R/TACI/BCMA pathway, reducing B-cell activation and autoantibody production.