An extension to an open label study of canakinumab in paediatrics

• Research type

  Research Study

• Full title

  An open-label extension study to assess the efficacy, safety and tolerability of canakinumab and the efficacy and safety of childhood vaccinations in patients with Cryopyrin Associated Periodic Syndromes (CAPS)

• IRAS ID

  96297

• Contact name

  Paul Brogan

• Sponsor organisation

  Novartis Pharmaceuticals UK Ltd

• Eudract number

  2011-005154-57

• ISRCTN Number

  ISRCTN

• Research summary

  This longer term (Phase III) extension study will provide longterm effectiveness, safety and tolerability information in young patients (under 5 years) who have the genetic inflammatory disease ??CAPS? (which stands for ??cryopyrin associated periodic fever syndrome?) treated with the anti-inflammatory drug canakinumab. In particular, the effectiveness of killed vaccines that are routinely received by these young children will be studied to understand if canakinumab prevents these vaccines working properly. The young patients to be studied have already been receiving canakinumab for 12 months to treat their CAPS and have completed the CACZ885D2307 study. As stated in the original application, this next phase will offer the same treatment to these children for a longer period if they agree to rollover into the extension study. Data from this extension study will also be used to fulfill commitments to the European Medicines Agency (EMA) to study CAPS patients 1 year of age and older in order to increase the experience in children with CAPS treated with canakinumab, as well as to continue studying the effectiveness and safety of childhood vaccinations in this population with a maturing immune system. The total treatment duration will be determined by when the patient enters the study, however the minimum treatment duration will be 6 months and the maximum treatment duration will be 24 months. Upon availability of the approved and marketed drug for the paediatric CAPS population, patients will be offered to complete the study and rollover into an open label registry study (CACZ885D2401), which will allow for the longterm assessment of safety and effectiveness for treating CAPS in years to come.

• REC name

  London - Central Research Ethics Committee

• REC reference

  12/LO/0138

• Date of REC Opinion

  9 Mar 2012

• REC opinion

  Favourable Opinion