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An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever (Cohort 2 (treatment naive patients) only applicable in countries where approved)

Trial Profile

An open-label extension study of canakinumab (ACZ885) in patients with Systemic Juvenile Idiopathic Arthritis (SJIA) and active systemic manifestations who participated in studies ACZ885G2301 and ACZ885G2305; and response characterisation study in canakinumab treatment-naive patients with active SIJA with and without fever (Cohort 2 (treatment naive patients) only applicable in countries where approved)

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 10 Feb 2021

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At a glance

  • Drugs Canakinumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms Beta-SPECIFIC-3; G2301E1
  • Sponsors Novartis; Novartis Pharmaceuticals
  • Most Recent Events

    • 10 Feb 2021 Results (n=54) assessing identification of potential serum biomarkers predicting response to canakinumab therapy in SJIA patients, published in the Rheumatology.
    • 10 Jul 2020 Results (n=123) assessing long-term efficacy, safety of canakinumab and explore prediction of response in systemic juvenile idiopathic arthritis patients with and without fever, published in the Arthritis and Rheumatology.
    • 31 Aug 2018 Biomarkers information updated
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