Infliximab as firsdt treatment instead of second line treatment in Crohns disease

Conditions: Crohn's disease
Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Registration Number: EUCTR2012-000645-13-BE

Lead Sponsor: ErasmusMC

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 90

Inclusion Criteria

Children (age 1-17 yrs, both male and female) with new-onset, untreated CD with moderate-to-severe disease activity assessed by a PCDAI > 30 will be eligible for inclusion after a diagnosis of CD based on oesophagogastroduodenoscopy, ileocolonoscopy including histology of multiple biopsies and small bowel imaging, according to the Porto criteria.
Are the trial subjects under 18? yes
Number of subjects for this age range: 90
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Patients with immediate need for surgery, symptomatic stenosis or stricture in the bowel due to scarring, severe co-morbidity, severe infection such as sepsis and opportunistic infections, positive stool culture or Clostridium difficile assay, a positive tuberculin test or a chest radiograph consistent with tuberculosis or a malignancy will be excluded. Patients that have already started drug treatment will be excluded

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of our study is to determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD. ;Secondary Objective: Secondary objectives are determination of pharmacokinetic data and predictors of response to IFX in pediatric CD. ;Primary end point(s): The primary endpoint at 52 weeks is steroid free clinical remission. <br><br>;Timepoint(s) of evaluation of this end point: 52 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Secondary endpoints will be: <br>•Mucosal healing at 10 weeks assessed by endoscopy<br>•Endoscopy at 52 weeks will be performed to assess mucosal healing in case of persisting complaints <br>•Faecal calprotectin performed at both 10 and 52 weeks as an exploratory endpoint. Duration of clinical remission and clinical response assessed by PCDAI since induction <br>•Number of flares <br>•Prevention of complications (fistulas, strictures, need for surgery) at 52 weeks and at long-term follow-up (5 years after last visit)<br>•Growth <br>•Cumulative use of steroids (apart from steroids prescribed in induction phase of treatment arm 2)<br>•Cumulative use of IFX <br>•Loss of IFX response <br>•PK data<br>;Timepoint(s) of evaluation of this end point: 52 weeks