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

• Register: EUCTR
• Last refreshed on: 5 August 2014
• Main ID: EUCTR2012-000645-13-NL
• Date of registration: 12/07/2012
• Prospective Registration: Yes
• Primary sponsor: ErasmusMC
• Public title: Infliximab as first treatment instead of second line treatment in Crohns disease
• Scientific title: Infliximab Top-down Study in Kids with Crohn’s disease - ITSKIDS
• Date of first enrolment: 17/10/2012
• Target sample size: 90
• Recruitment status: Authorised-recruitment may be ongoing or finished
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2012-000645-13
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: no Other: yes Other specify the comparator: Different treatment regimen Number of treatment arms in the trial: 2

Countries of recruitment

Belgium, Italy, Netherlands

Contacts

• Name: L. de Ridder
• Affiliation: ErasmusMC-Sophia

• Name: L. de Ridder
• Affiliation: ErasmusMC-Sophia

Key inclusion & exclusion criteria

Inclusion criteria:
Children (age 3-17 years, 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


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

Therapeutic area: Diseases [C] - Digestive System Diseases [C06]

Crohn's disease

Intervention(s)

Trade Name: Remicade
Pharmaceutical Form: Powder for concentrate for solution for infusion

Primary Outcome(s)

Secondary Objective: Secondary objectives are determination of pharmacokinetic data and predictors of response to IFX in pediatric CD.

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.

Primary end point(s): The primary endpoint at 52 weeks is steroid free clinical remission.

Timepoint(s) of evaluation of this end point: 52 weeks

Secondary Outcome(s)

Timepoint(s) of evaluation of this end point: 10 weeks, 52 weeks, 260 weeks

Secondary end point(s): Secondary endpoints will be:
• Mucosal healing at 10 weeks assessed by endoscopy
• Endoscopy at 52 weeks will be performed to assess mucosal healing in case of persisting complaints
• Faecal calprotectin performed at both 10 and 52 weeks as an exploratory endpoint.
• Duration of clinical remission (PCDAI <=10) and clinical response (decrease from baseline in the PCDAI score = 15 points; total score =30) assessed by PCDAI since induction
• Steroid free clinical remission at 260 weeks (5 years)
• Biological free clinical remission at 52 weeks and at 260 weeks (5 years)
• Number of flares
• Prevention of complications (fistulas, strictures, need for surgery) at 52 weeks and at long-term follow-up (5 years after last visit)260 weeks (5 years
• Growth
• Quality of life measuring at 0, 14, 52 and 260 weeksd using the Impact-II score
• Cumulative use of steroids (apart from steroids prescribed in induction phase of treatment arm 2)
• Cumulative use of IFX (apart from infliximab prescribed in induction phase of treatment arm 1)
• Loss of IFX response
• PK data
• Safety of prescribed medication and adverse events will be checked and documented at every patient visit and at long-term follow-up (yearly, for 5 years after last visit). There will be special attention to infections, allergic reactions and abnormalities of the full blood count.

Secondary ID(s)

NCT01880307

ITSKids

Source(s) of Monetary Support

ZonMw