NCT01880307

Brief Summary

The purpose of this study is to determine whether a top-down treatment approach, prescribing infliximab and azathioprine at diagnose, yields better outcome in comparison to the usual step-up treatment approach, starting with prednison and azathioprine, in moderate-to-severe pediatric Crohn's disease (CD) patients.

Trial Health

40
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for phase_4

Geographic Reach
2 countries

2 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2013

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

June 7, 2013

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 18, 2013

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Last Updated

July 2, 2015

Status Verified

July 1, 2015

Enrollment Period

1.9 years

First QC Date

June 7, 2013

Last Update Submit

July 1, 2015

Conditions

Crohn's Disease

Keywords

Crohn's diseasepediatricinfliximabtop-downITSKids

Outcome Measures

Primary Outcomes (1)

  • Clinical remission without need for additional CD related therapy or surgery

    Clinical remission is defined as a Pediatric Crohn's Disease Activity Index (wPCDAI) score of less than 10 points

    52 weeks

Secondary Outcomes (11)

  • Clinical response and remission rate

    10 weeks

  • Mucosal healing

    10 and 52 weeks

  • Growth

    10 and 52 weeks

  • Therapy failure rates over time

    52 weeks

  • Cumulative therapy use

    52 weeks

  • +6 more secondary outcomes

Other Outcomes (3)

  • Pharmacokinetic properties of infliximab

    52 weeks

  • Identification of predictive biomarkers of therapy response

    52 weeks

  • Correlation between clinical disease activity, fecal calprotectin and endoscopic disease severity

    52 weeks

Study Arms (2)

Top-down

EXPERIMENTAL

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.

Drug: AzathioprineDrug: Infliximab

Step-up

ACTIVE COMPARATOR

Prednisolon and azathioprine; Patients will receive induction treatment with oral prednisolone 1 mg/kg (maximum 40 mg) once daily for 4 weeks, then tapering of prednisolone in 6 weeks until stop, and receive oral azathioprine 2-3 mg/kg, once daily as maintenance treatment.

Drug: AzathioprineDrug: Prednisolon

Interventions

AzathioprineDRUG
Also known as: Imuran
Step-upTop-down
InfliximabDRUG
Also known as: Remicade
Top-down
PrednisolonDRUG
Step-up

Eligibility Criteria

Age3 Years - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sapienza University

Rome, Italy

Location

Erasmus Medical Center

Rotterdam, South Holland, 3000 CA, Netherlands

Location

Related Links

MeSH Terms

Conditions

Crohn Disease

Interventions

AzathioprineInfliximab

Condition Hierarchy (Ancestors)

Inflammatory Bowel DiseasesGastroenteritisGastrointestinal DiseasesDigestive System DiseasesIntestinal Diseases

Intervention Hierarchy (Ancestors)

ThionucleosidesSulfur CompoundsOrganic ChemicalsMercaptopurinePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsNucleosidesNucleic Acids, Nucleotides, and NucleosidesAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Lissy Ridder, de, MD, PhD

    Erasmus Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD PhD, Pediatric gastroenterologist

Study Record Dates

First Submitted

June 7, 2013

First Posted

June 18, 2013

Study Start

January 1, 2013

Primary Completion

December 1, 2014

Last Updated

July 2, 2015

Record last verified: 2015-07

Locations

IT(1)NL(1)