Janssen STELARA Study - Protocol CNTO1275PSO4056 (STELLAR Teens)

• Research type

  Research Study

• Full title

  An Observational Post-authorization Safety Study of Ustekinumab in the Treatment of Pediatric Patients Aged 12 Years and Older With Moderate to Severe Plaque Psoriasis

• IRAS ID

  230473

• Contact name

  Anthony Bewley

• Contact email

  anthony.bewley@bartshealth.nhs.uk

• Sponsor organisation

  Janssen-Cilag International NV

• Duration of Study in the UK

  9 years, 1 months, 1 days

• Research summary

  The STELARA Study is a prospective, observational, Post Authorisation Phase IV Study having the primary aim to monitor the long-term safety, growth and development in paediatric patients (aged 12 years to <18 years) with moderate to severe plaque psoriasis who receive treatment with the licensed drug Ustekinumab, when independently prescribed by physicians as part of their standard of care patient treatment pathway.
  Eligible patients will be invited to participate in the study at the time of initiation of Ustekinumab treatment therapy for their psoriasis. For each patient, data will be collected from the time of enrolment until he/she reaches the age of 18 years (a maximum of 6 years after enrolment, dependent on age at study entry), or until early withdrawal or study closure. As part of routine care Patients are required to attend visits approximately every 3 months (±1 month) for the first year of the study and at least every 6 months (±1 month) thereafter for a maximum of 6 years after enrolment.
  Once consented, patients will follow their routine course of treatment and only data available within clinical practice will be collected. Additional data on clinical skin response, quality of life and information relating to growth and development may be assessed using a variety of questionnaires and Scales at visits. Patients may also be asked to record any adverse events experienced between visits.

  This is a multicentre, international study with the aim of achieving approximately 75 Ustekinumab treated paediatric patients during the first 3 years of the study. The target recruitment for the United Kingdom is approximately 15 and therefore maximum duration of the study is 9 years in total.

• REC name

  South West - Cornwall & Plymouth Research Ethics Committee

• REC reference

  17/SW/0156

• Date of REC Opinion

  4 Sep 2017

• REC opinion

  Further Information Favourable Opinion