eligibility_summary
Inclusion: active RA (DMARD/MTX inadequate or severe MTX‑naïve), AS/PsA with inadequate response, or mod–sev plaque Ps failing/intolerant/contraindicated to systemic tx. SC: switch from IFX IV/other biologics or already on SC. IV: switch from other biologics or maintain/switch IFX IV. Bio‑naïve allowed in both. Exclude: hypersensitivity, per SmPC: active/untreated TB, chronic infections (HIV/HBV/HCV), NYHA III–IV HF, malignancy<5y/TNF‑α concerns. No SC→IV.
trial_source
clinical_trials.gov from Dec 2, 2025
annotation_status
ai
ai_summary
Drug/intervention: Remsima (CT-P13) given subcutaneously (SC) or intravenously (IV). Type: biologic, chimeric (human–murine) IgG1 monoclonal antibody biosimilar to infliximab (Remicade). Mechanism of action: anti–TNF-α mAb that binds soluble and transmembrane TNF-α, neutralizing TNFR1/TNFR2 signaling, thereby dampening NF-κB/MAPK pathways, reducing pro‑inflammatory cytokines (e.g., IL‑1, IL‑6) and adhesion molecules, can induce apoptosis and CDC/ADCC against TNF‑expressing cells. Target cells/pathways: TNF‑α pathway in immune/inflammatory cells—macrophages/monocytes, activated T cells, dendritic cells—and TNF‑responsive stromal cells (e.g., synovial fibroblasts, keratinocytes). Indications: RA, AS, PsA, Ps. Study: observational, prospective cohort assessing safety (AESIs) during routine care.