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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.
Last refreshed on: 19 February 2015
Main ID:  NCT01559142
Date of registration: 19/03/2012
Prospective Registration: No
Primary sponsor: Children's Memorial Health Institute, Poland
Public title: Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
Scientific title: Efficacy and Safety of Induction Therapy With Three Doses of Infliximab in Patients With Crohn Disease Aged 7-17 Years-multicenter Open Study. Efficacy and Safety of Two Regimens of Maintenance Therapy in Patients With Crohn Disease Aged 7-17 Years-multicenter Randomized Study
Date of first enrolment: November 2008
Target sample size: 100
Recruitment status: Active, not recruiting
Study type:  Interventional
Study design:  Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment  
Phase:  Phase 3
Countries of recruitment
Name:     Jaroslaw Kierkus, MD PhD
Affiliation:  The Children's Memorial Institute
Key inclusion & exclusion criteria

Inclusion Criteria:

1. Patients with severe Crohn disease (PCDAI in anamnesis more than 51 points), with
PCDAI currently over 30 points, with no or loss of response for previous therapy
(except biological agents). Patients may have active fistulas.

2. Efficient methods of contraception in patients of childbearing potential during study
period and six months after.

3. Patients will be enrolled to Part B of the study whether they finish Part A with
clinical remission or clinical response.

Exclusion Criteria:

1. Hypersensitivity to infliximab

2. Pregnancy and breastfeeding

3. Active tuberculosis or other severe infection: sepsis, opportunistic infections,
active CMV, yersinia pseudotuberculosis, pneumocystis carini, atypical

4. VZV infection, hepatitis, pneumonia during 3 months before Day 0 of the study

5. pancytopaenia and aplastic anemia

6. moderate and severe heart insufficiency (NYHA class III/IV), or unstable coronary
heart disease

7. chronic pulmonary insufficiency, chronic renal insufficiency, chronic liver

8. HIV infection

9. Presence of severe diseases of nervous system or severe endocrinological,
hematological, psychiatric diseases.

10. Demyelinisation syndrome or symptoms resembling Demyelinisation syndrome

11. Malignancy or premalignant conditions during 5 years before Day 0 of the study.

12. Severe infection currently present

13. Malignancy currently present

Age minimum: 7 Years
Age maximum: 17 Years
Gender: Both
Health Condition(s) or Problem(s) studied
Crohn Disease
Drug: Infliximab (IFX alone)
Drug: Infliximab with azathioprine (IIFX + AZA)
Primary Outcome(s)
Clinical disease activity [Time Frame: 14 week and one year]
Secondary Outcome(s)
endoscopic disease activity [Time Frame: 14 week and one year]
Secondary ID(s)
IP CZD 2008-01-14
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Ethics review
Results available:
Date Posted:
Date Completed:
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