Infliximab top-down in pediatric Crohn's disease
Recruiting
- Conditions
- Crohn's diseaseInflammatory Bowel Disease10017969
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 50
Inclusion Criteria
Children (age 3-17 yrs) with new-onset CD with moderate-to-severe disease activity assessed by a PCDAI (pediatric Crohn's disease activity score) >= 30 after a diagnosis of Crohn's disease.
Exclusion Criteria
Patients with disease limited to the ileocoecal region, immediate need for surgery, symptomatic stenosis or stricture in the bowel due to scarring, severe co-morbidity, infection, a positive tuberculin test or a chest radiograph consistent with tuberculosis or a malignancy. Patients that have already started drug treatment.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint at 52 weeks is steroid free remission. </p><br>
- Secondary Outcome Measures
Name Time Method <p>The secondary endpoints will be mucosal healing at 10 weeks assessed by<br /><br>endoscopy. Endoscopy at 52 weeks will be performed to assess mucosal healing in<br /><br>case of persisting complaints. Faecal calprotectin will be performed at both<br /><br>10, 52 weeks and at flare as an exploratory endpoint. Other secondary endpoints<br /><br>will be duration of clinical remission and clinical response assessed by PCDAI<br /><br>since induction, number of flares, prevention of complications (fistulas,<br /><br>strictures, need for surgery), growth, cumulative use of steroids and<br /><br>cumulative use of IFX and loss of IFX response. In patients with fistulizing<br /><br>disease from onset response will be defined as a reduction of at least 50<br /><br>percent from baseline in the number of draining fistulas at 52 weeks.</p><br>