An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase.

Trial Profile

An Open-label, Sequential, Ascending, Repeated Dose-finding Study of Sarilumab, Administered with Subcutaneous (SC) Injection, in Children and Adolescents, Aged 1 to 17 Years, with Systemic Juvenile Idiopathic Arthritis (sJIA), Followed by an Extension Phase.

Suspended
Phase of Trial: Phase II

Latest Information Update: 14 Dec 2017

At a glance

  • Drugs Sarilumab (Primary)
  • Indications Juvenile rheumatoid arthritis
  • Focus Pharmacokinetics
  • Sponsors Sanofi
  • Most Recent Events

    • 11 Dec 2017 Status changed from recruiting to suspended in order to optimize the study design and procedures, sponsors have decided to amend the current protocol before initiating the patient recruitment
    • 11 Dec 2017 Planned End Date changed from 16 aug 2023 to 1 Aug 2023.
    • 11 Dec 2017 Planned primary completion date changed from 1 Aug 2018 to 1 Aug 2023.
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