Top-down Infliximab in Kids with Crohn's disease (TISKids)
Research type
Research Study
Full title
Top-Down Infliximab Study in Kids with Crohn's disease (TISKids)
IRAS ID
195666
Contact name
Christos Tzivinikos
Contact email
Sponsor organisation
Erasmus Medical Center
Eudract number
2014-005702-37
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
NL52030.078.15, NL-number
Duration of Study in the UK
5 years, 10 months, 31 days
Research summary
Background: Crohn’s disease (CD) is an incurable, debilitating inflammatory bowel disorder (IBD) which presents during childhood and adolescence in 25% of its patients. CD requires lifelong medication and is accompanied by severe complications. The use of anti-TNF antibodies has significantly improved CD management. Infliximab (IFX) is the first anti-TNF antibody registered for pediatric CD. Currently, IFX is reserved for immunomodulator refractory patients. We hypothesize that top-down IFX use (instead of the current step-up approach) with introduction of IFX at an early stage of disease, is more effective in the treatment of pediatric CD patients.
Objective: to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.
Study design: An international multicenter open-label randomised controlled trial
Study population: Children (age 3-17 years) with new-onset, untreated, CD with moderate-to-severe disease activity
Intervention: Patients will be randomised to either top-down IFX treatment or conventional step-up treatment. Treatment arm 1: Top-down IFX treatment will consist of a total of 5 IFX infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks) combined with oral azathioprine (AZA) 2-3 mg/kg once daily. AZA therapy will continue after the last IFX infusion to maintain remission. Treatment arm 2: Step-up treatment will consist of standard induction treatment by either oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, followed by tapering in 6 weeks until stop, or exclusive enteral nutrition (EEN) with polymeric feeding for 6 to 8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. Prednisolone and EEN will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment.
Primary outcome: Clinical remission at 52 weeks without need for additional CD related therapy or surgery.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
16/NW/0731
Date of REC Opinion
20 Jan 2017
REC opinion
Further Information Favourable Opinion