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Research project

Top-down Infliximab Study in Kids with Crohn’s disease

Status: Ongoing

Crohn's disease is a chronic inflammatory disease of the gastrointestinal tract. The inflammation causes abdominal pain, diarrhoea, fatigue and weight loss, among other things.

What we do

About our project

Background information 

Infliximab is the first anti-TNF antibody registered for pediatric Crohn’s disease when conventional therapy (such as prednisolone and azathioprine) has failed. This is the only patient population studied prospectively. As the evidence is still scarce, the optimal use of Infliximab in pediatric moderate-to-severe CD remains unknown, and additional prospective trials are needed for optimization of anti-TNF therapy.

Overall aim 

The aim of TISKIDS is to improve the treatment strategy for new-onset pediatric Crohn’s disease patients with moderate-to-severe disease activity

Research method 

TISKIDS is an international, multicenter, randomised clinical trial for children (age 3-17 years) with new-onset, untreated, Crohn’s disease with moderate-to-severe disease activity. Top-down treatment (Infliximab combined with Azathioprine) will be compared to step-up treatment (conventional treatment, exclusive enteral nutrition or prednisone combined with Azathioprine). The total follow up will be 5 years.

Desirable outcome

We hypothesize that top-down treatment infliximab use, (instead of the current step-up approach) with introduction of Infliximab at an early stage of disease, is more effective in the treatment of children with Crohn’s disease.

Top down Infliximab

Collaborations

Collaborations within Erasmus MC

  • Lab KG.
  • Pediatric Gastroenterology and Hepatology.

Publications