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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Register: EUCTR
Last refreshed on: 2 May 2016
Main ID:  EUCTR2014-005702-37-NL
Date of registration: 12/02/2015
Prospective Registration: Yes
Primary sponsor: Erasmus Medical Center
Public title: Early infliximab use in kids with Crohn's disease (TISKids)
Scientific title: Top-Down Infliximab Study in Kids with Crohn's disease (TISKids) - Top-down Infliximab in Kids with Crohn's disease (TISKids)
Date of first enrolment: 08/04/2015
Target sample size: 100
Recruitment status: Authorised-recruitment may be ongoing or finished
URL:  https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2014-005702-37
Study type:  Interventional clinical trial of medicinal product
Study design:  Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2  
Phase: 
Countries of recruitment
Netherlands
Contacts
Name: Principal investigator   
Address:  Wytemaweg 80 3015 CN Rotterdam Netherlands
Telephone:
Email: l.deridder@erasmusmc.nl
Affiliation:  Erasmus Medical Center
Name: Principal investigator   
Address:  Wytemaweg 80 3015 CN Rotterdam Netherlands
Telephone:
Email: l.deridder@erasmusmc.nl
Affiliation:  Erasmus Medical Center
Key inclusion & exclusion criteria
Inclusion criteria:
Diagnosed with Crohn's disease
Moderate-to-severe disease activity
Aged 3-17
Untreated
Are the trial subjects under 18? yes
Number of subjects for this age range: 100
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:
Need for surgery
Severe comorbidity or severe infection
Active perianal fistulas
Pregnancy


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
Health Condition(s) or Problem(s) studied
Crohn's disease
Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Intervention(s)

Trade Name: Inflectra
Pharmaceutical Form: Powder for concentrate for solution for infusion
INN or Proposed INN: INFLIXIMAB
CAS Number: 170277-31-3
Current Sponsor code: CT-P13
Other descriptive name: Inflectra
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 100-

Primary Outcome(s)
Main Objective: To determine the efficacy and safety of top-down IFX treatment in moderate-to-severe pediatric CD.
Primary end point(s): Clinical remission at 52 weeks without need for additional CD related therapy or surgery.
Secondary Objective: Determination of pharmacokinetic/-dynamic profile of IFX and finding predictors of response to IFX in pediatric CD
Timepoint(s) of evaluation of this end point: 52 weeks
Secondary Outcome(s)
Secondary end point(s): Secondary efficacy endpoints
• Clinical response (decrease in wPCDAI >17.5) and remission (wPCDAI <12.5) rates at week 10
• Mucosal healing rates at week 10 assessed by endoscopy (absence of ulcers) and calprotectin (<100 µg/g), and at week 52 assessed by endoscopy (performed on a voluntary basis, or if clinically indicated) and/or calprotectin
• Growth (change in height and BMI Z-scores, bone age and pubertal development)
• Quality of life at week14 and 52 (IMPACT III)
• Therapy failure rates over time (primary non-response, loss of response and medication intolerance)
• Cumulative therapy use (steroids, immunomodulators, biologicals, etc)

Secondary safety endpoints
• Adverse events rates
• Complication rate at 52 weeks (fistulas, abscesses, strictures, surgery, extra-intestinal manifestations)

Long-term follow-up endpoints (5 years)
• Yearly clinical remission rates without need for additional CD-related therapy or surgery
• Yearly clinical response, clinical remission and mucosal healing rates
• Number of flairs
• Quality of life at 5 years
• Cumulative therapy use (steroids, immunomodulators, biologicals, etc)
• Adverse events rate
• Complication rate (fistulas, abscesses, strictures, surgery, extra-intestinal manifestations)

Sub analyses
• Correlation between clinical disease activity, fecal calprotectin and endoscopic disease severity
• Comparing efficacy and safety endpoints between the two step-up treatment options (prednisolon+AZA vs EEN+AZA)

Additional objectives
• Determination of PK/PD properties of IFX in children
• Identification of predictive biomarkers of response to IFX
• Comparing cost-efficacy of top-down versus step-up
Timepoint(s) of evaluation of this end point: Week 10, 52 and/or 260
Secondary ID(s)
TISKids
Source(s) of Monetary Support
Hospira
ZonMW
Secondary Sponsor(s)
Ethics review
Results
Results available:
Date Posted:
Date Completed:
URL:
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