Overview

This trial is active, not recruiting.

Condition crohn disease
Treatments infliximab with azathioprine (iifx + aza), infliximab (ifx alone)
Phase phase 3
Sponsor Children's Memorial Health Institute, Poland
Start date November 2008
End date April 2012
Trial size 100 participants
Trial identifier NCT01559142, IP CZD 2008-01-14

Summary

The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy:

1. Infliximab with immunomodulation

2. Infliximab alone

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(Active Comparator)
infliximab with azathioprine (iifx + aza)
Infliximab with azathioprine during whole one year study
(Active Comparator)
infliximab (ifx alone)
Infliximab continuously; azathioprine stopped in 26 week

Primary Outcomes

Measure
Clinical disease activity
time frame: 14 week and one year

Secondary Outcomes

Measure
endoscopic disease activity
time frame: 14 week and one year

Eligibility Criteria

Male or female participants from 7 years up to 17 years old.

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 mycobacteriosis 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 insufficiency 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

Additional Information

Official 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
Principal investigator Jaroslaw Kierkus, MD PhD
Description Study project Screening (Days -14 do 0): Laboratory and endoscopic (up to three months before Day 0) results will be obtained to check with inclusion/exclusion criteria. Part A (Days 1 to 71): Induction therapy with 3 doses of infliximab 5 mg/kg will be applied on days 1 - 15 - 43. Simultaneously in patients receiving steroids, steroid tapering will be performed up to 71 Day. At Day 71 clinical (PCDAI) and endoscopic assessment will be done. Patients with no clinical response will be qualified to Follow-up surveillance group. Patients with clinical response present will be randomized to two groups of maintenance therapy: 1. Infliximab with immunomodulation 2. Infliximab alone Part B (Weeks 10 - 54): Patient with both groups will have scheduled visits at Weeks 14, 22, 30, 38, 46. Infliximab infusions and laboratory tests will be performed at each visit. At Week 54 clinical (PCDAI) and endoscopic assessment will be done. Follow Up: 4 weeks after last visit - SAE monitoring Aim of the study The aim of the study is confirmation of efficacy of induction therapy with three doses of infliximab In patients with Crohn disease aged 7-17 years, and comparison of efficacy and safety of two regiment of maintenance therapy: 1. Infliximab with immunomodulation 2. Infliximab alone Drug dosing in therapy regimens. Infliximab: 5 mg/kg mc In intravenous infusion lasting over 2 hrs. Azathioprine: 1,5 - 3 mg/kg/24h Methotrexate: 10 - 25 mg/week Safety assessment AE and SAE monitoring will be conducted during whole period of the study Efficacy assessment Primary endpoint Part A: • Clinical response defined as: Decrease of PCDAI ≥ 15 points AND PCDAI less than 30 points • Remission defined as: PCDAI ≤ 10 points Part B: - Loss of clinical response defined as: Increase of PCDAI more than 15 points OR PCDAI > 30 points Secondary endpoints Part A: • Time to steroid cessation Part B: • Necessity to increase/change maintenance therapy with o Surgery o Increase of infliximab dose - Increase of immunomodulator dose - Steroids induction Statistical methods - ITT analysis - Primary endpoints: chi2 tests, Kaplan-Meier analysis - Secondary endpoints: chi2 tests, Kaplan-Meier analysis, U Mann-Whitney analysis
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by Children's Memorial Health Institute, Poland.