Dose finding study of Sarilumab in children with sJIA

• Research type

  Research Study

• Full title

  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

• IRAS ID

  199019

• Contact name

  Muthana Al Obaidi

• Contact email

  Muthana.AlObaidi@gosh.nhs.uk

• Sponsor organisation

  sanofi-aventis recherche & développement

• Eudract number

  2015-004000-35

• Duration of Study in the UK

  2 years, 11 months, 14 days

• Research summary

  The aim of this study is to find the dose of Sarilumab required to treat children with systemic juvenile idiopathic arthritis (sJIA). Juvenile idiopathic arthritis (JIA) is the most common rheumatic disease of childhood, by definition being arthritis of unknown cause with onset before 16 years. sJIA represents only 10% of JIA, but it is the most dramatic in presentation of the subtypes. It is defined as arthritis in ≥1 joint for at least 6 weeks duration with or preceded by fever of at least 2 weeks duration.
  Interleukin-6 is a cytokine in the body, which in large quantities causes inflammation and joint destruction. Preventing IL-6 from binding to its receptor with a drug such as tociluzumab, reduces it action and therefore, the inflammation and joint destruction is reduced. Sarilumab has a very similar action to tociluzumab and has been demonstrated as an effective treatment in adult rheumatoid arthritis.
  The body size and weight variation is much greater in children than adults; therefore adjusted doses are needed in children of different weights. For this population of patients 3 doses of sarilumab will be tested in order to determine
  the appropriate dose. There are 2 phases in this study, a dose-finding phase over a 12 week period and an extension phase up to 92weeks, followed by a 6 week follow up period. Approximately 36 patients aged 1 to 17 will be recruited and divided
  into 2 groups depending upon their weight. Each weight group will be split into 3 groups and each patient will receive different doses which have been calculated carefully.

• REC name

  London - South East Research Ethics Committee

• REC reference

  16/LO/1960

• Date of REC Opinion

  24 Feb 2017

• REC opinion

  Further Information Favourable Opinion