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A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

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Trial Profile

A Multicenter, Open-label (Part A) Followed by a Randomized, Double-blind, Parallel-group, Placebo Controlled Study (Part B) to Evaluate Maintenance of Remission in Subjects With Active Axial Spondyloarthritis (axSpA) Receiving Either Certolizumab Pegol 200 mg Q2W or 200 mg Q4W as Compared to Placebo

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 11 Jul 2023

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At a glance

  • Drugs Certolizumab pegol (Primary)
  • Indications Ankylosing spondylitis; Axial spondyloarthritis; Non-radiographic axial spondyloarthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms C-OPTIMISE
  • Sponsors UCB Biosciences

Most Recent Events

  • 03 Jun 2023 Post hoc analysis results presented at the 24th Annual Congress of the European League Against Rheumatism.
  • 14 Nov 2022 Post hoc analysis results presented at the ACR Convergence 2022.
  • 09 Nov 2021 Results of a post hoc analysis assessing the disease activity and clinical markers of inflammation in patients who did not experience a disease flare following randomization to certolizumab pegol full maintenance dose, certolizumab pegol reduced maintenance dose or placebo during the maintenance period presented at the ACR Convergence 2021

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