Top-down Infliximab Study in Kids With Crohn's Disease

NCT02517684

Last updated date
Study Location
University Hospital Brussels
Brussels, , , Belgium
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Crohn's Disease
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
3-17 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Children (age 3-17 years, both male and female, weight >10kg) with new-onset,

- untreated CD with moderate-to-severe disease activity assessed by a wPCDAI >40 will be eligible for inclusion after a diagnosis of CD was made based on the Porto criteria

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


Patients with the following characteristics will be excluded:


- immediate need for surgery,


- symptomatic stenosis or stricture in the bowel due to scarring,


- active perianal fistulas,


- severe co-morbidity,


- severe infection such as sepsis or opportunistic infections,


- positive stool culture,


- positive Clostridium difficile assay,


- positive tuberculin test or a chest radiograph consistent with tuberculosis or
malignancy,


- those already started with CD specific therapy,


- patients with a suspected or


- definitive pregnancy

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Advanced Information
Descriptive Information
Brief Title  ICMJE Top-down Infliximab Study in Kids With Crohn's Disease
Official Title  ICMJE Top-down Infliximab Study in Kids With Crohn's Disease
Brief Summary The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab (IFX) and azathioprine (AZA) at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or exclusive enteral nutrition (EEN) and AZA, in moderate-to-severe pediatric Crohn's disease (CD) patients.
Detailed Description

Objective: The purpose of this study is to determine whether a top-down treatment approach, prescribing IFX and AZA at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and AZA or EEN and AZA, in moderate-to-severe pediatric CD patients.

Sample size: We will include 100 (2 x 50) patients. With these numbers a difference of 60% and 85% (= 25) can be shown at a power of 80% (2-sided ? 0.05).

Study design: an international open-label randomised controlled trial Study population: Children (age 3-17 yrs) with new-onset, untreated, CD with moderate-to-severe disease activity (weighted Pediatric CD Index [wPCDAI] >40) Intervention: Patients will be randomised to either top-down 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 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 EEN with polymeric feeding for 6-8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. Either of these induction treatments will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment.

Main study parameters/endpoints: Clinical remission at 52 weeks without need for additional CD related therapy or surgery. Secondary endpoints include clinical response, remission and mucosal healing at week 10 and 52, growth, quality of life and adverse events.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Crohn's Disease
Intervention  ICMJE
  • Drug: Infliximab
    Other Name: Inflectra
  • Drug: Prednisolone
  • Other: Exclusive enteral nutrition
  • Drug: Azathioprine
    Other Name: Imuran
Study Arms  ICMJE
  • Experimental: Top-down
    Infliximab and azathioprine; patients will receive 5 infliximab infusions of 5 mg/kg (IFX induction at week 0, 2 and 6, followed by 2 maintenance infusions every 8 weeks). IFX will be discontinued after 5 IFX infusions. Patients will also receive oral azathioprine 2-3 mg/kg, once daily as maintenance treatment.
    Interventions:
    • Drug: Infliximab
    • Drug: Azathioprine
  • Active Comparator: Step-up
    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 EEN with polymeric feeding for 6-8 weeks after which normal foods are gradually reintroduced within 2-3 weeks. Either of these induction treatments will be combined with oral AZA 2-3 mg, once daily, as maintenance treatment.
    Interventions:
    • Drug: Prednisolone
    • Other: Exclusive enteral nutrition
    • Drug: Azathioprine
Publications * Cozijnsen MA, van Pieterson M, Samsom JN, Escher JC, de Ridder L. Top-down Infliximab Study in Kids with Crohn's disease (TISKids): an international multicentre randomised controlled trial. BMJ Open Gastroenterol. 2016 Dec 22;3(1):e000123. doi: 10.1136/bmjgast-2016-000123. eCollection 2016.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2015)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2023
Actual Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Children (age 3-17 years, both male and female, weight >10kg) with new-onset,
  • untreated CD with moderate-to-severe disease activity assessed by a wPCDAI >40 will be eligible for inclusion after a diagnosis of CD was made based on the Porto criteria

Exclusion Criteria:

Patients with the following characteristics will be excluded:

  • immediate need for surgery,
  • symptomatic stenosis or stricture in the bowel due to scarring,
  • active perianal fistulas,
  • severe co-morbidity,
  • severe infection such as sepsis or opportunistic infections,
  • positive stool culture,
  • positive Clostridium difficile assay,
  • positive tuberculin test or a chest radiograph consistent with tuberculosis or malignancy,
  • those already started with CD specific therapy,
  • patients with a suspected or
  • definitive pregnancy
Sex/Gender  ICMJE Not Provided
Ages  ICMJE 3 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   Finland,   Netherlands
Removed Location Countries Denmark,   Italy,   Poland
 
Administrative Information
NCT Number  ICMJE NCT02517684
Other Study ID Numbers  ICMJE NL52030.078.15
2014-005702-37 ( EudraCT Number )
MEC-2015-080 ( Other Identifier: Medical Ethical Trial Committee Erasmus MC )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Lissy de Ridder, Erasmus Medical Center
Study Sponsor  ICMJE Erasmus Medical Center
Collaborators  ICMJE
  • ZonMw: The Netherlands Organisation for Health Research and Development
  • Hospira, now a wholly owned subsidiary of Pfizer
Investigators  ICMJE
Principal Investigator:Lissy de Ridder, MD PhDErasmus Medical Center
PRS Account Erasmus Medical Center
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP