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Evaluating a new treatment for paediatric patients with ulcerative colitis.

The purpose of this study is to evaluate the effectiveness of guselkumab in pediatric participants with moderately to severely active ulcerative colitis through open label induction and through maintenance therapy among participants who were induction responders.

What you need to know

Who can take part?

Must be:

  • Aged 14 -17 at enrolment
  • Weigh more than 10 kg
  • Biopsy confirmed UC
  • Moderate to severely active UC confirmed by biopsy at time of screening
  • Medically stable
  • Inadequate response/loss of response to biologic and/or conventional therapies or be corticosteroid dependent

Must Not:

  • Have UC limited to the rectum only or to less than (s Disease (CD)

What is involved for me?

  • Regular clinic visits
  • Blood tests
  • Stool tests
  • Diary completion
  • Colonoscopy
  • Questionnaires
  • Medicine by infusion
  • Medicine by injection
  • Pregnancy tests

Please note: All participants must reside within a reasonable distance of Mater Hospital Brisbane and be available for regular visits.

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