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Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy

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Trial Profile

Phase 3b, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Guselkumab Administered Subcutaneously in Participants With Active Psoriatic Arthritis and an Inadequate Response to Anti-Tumor Necrosis Factor Alpha (Anti-TNFα) Therapy

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Feb 2025

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At a glance

  • Drugs Guselkumab (Primary)
  • Indications Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms COSMOS
  • Sponsors Janssen; Janssen Pharmaceutica

Most Recent Events

  • 15 Nov 2023 Results of pooled analysis (n=1405 from studies DISCOVER 1&2 and COSMOS) assessing the longitudinal construct validity of the PsA-5Ts domains presented at the ACR Convergence 2023
  • 15 Nov 2023 Results of post hoc analysis assessing Guselkumab effect on achievement of clinically important improvements in patient-reported outcomes through W48 presented at the ACR Convergence 2023
  • 15 Nov 2023 Results (n=189) assessing MDA achievement in pts with PsA and inadequate response to 1 to 2 TNF inhibitors to identify PsA disease domains and factors contributing to the lack of MDA achievement at Week 48 for TNFi- R PsA pts treated with guselkumab presented at the ACR Convergence 2023

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