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A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs

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Trial Profile

A Randomized, Double-blind, Placebo Controlled Study of Canakinumab in Patients With Hereditary Periodic Fevers (TRAPS, HIDS, or crFMF), With Subsequent Randomized Withdrawal/Dosing Frequency Reduction and Open-label Long-term Treatment Epochs

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 07 Sep 2023

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At a glance

  • Drugs Canakinumab (Primary)
  • Indications Familial Mediterranean fever; Hereditary autoinflammatory diseases; Mevalonate Kinase Deficiency
  • Focus Registrational; Therapeutic Use
  • Acronyms CLUSTER
  • Sponsors Novartis Pharmaceuticals

    • Most Recent Events

    • 05 Sep 2023 Results assessing To assess efficacy, safety, and tolerability of canakinumab in patients with tumor necrosis factor receptor-associated periodic syndrome (TRAPS) during a 72-week long-term, open-label extension of the CLUSTER study published in the Arthritis and Rheumatology
    • 01 Nov 2022 Results (n=173) assessing the feasibility of the autoinflammatory disease activity index (AIDAI) as a tool to assess disease activity in patients with hereditary recurrent fever syndromes (HRFs) treated with canakinumab published in the Joint Bone Spine
    • 23 Sep 2021 Results of an analysis assessing the long-term efficacy and safety of canakinumab in patients with mevalonate kinase deficiency (MKD) of Epoch 4 during the open label extension published in the Rheumatology
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