Trial | NCT01559142  Report issue

Title

Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
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

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    infliximab azathioprine ...

  • Study Participants

    100
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:

Infliximab with immunomodulation
Infliximab alone
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:

Infliximab with immunomodulation

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
Study Started
Nov 30
2008
Primary Completion
Apr 30
2012
Anticipated
Study Completion
Dec 31
2012
Anticipated
Last Update
Apr 04
2012
Estimate

Drug Infliximab with azathioprine (IIFX + AZA)

Infliximab with azathioprine during whole one year study

Drug Infliximab (IFX alone)

Infliximab continuously; azathioprine stopped in 26 week

IFX TG Active Comparator

IFX alone Active Comparator

Criteria 

Inclusion Criteria:

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.
Efficient methods of contraception in patients of childbearing potential during study period and six months after.
Patients will be enrolled to Part B of the study whether they finish Part A with clinical remission or clinical response.

Exclusion Criteria:

Hypersensitivity to infliximab
Pregnancy and breastfeeding
Active tuberculosis or other severe infection: sepsis, opportunistic infections, active CMV, yersinia pseudotuberculosis, pneumocystis carini, atypical mycobacteriosis
VZV infection, hepatitis, pneumonia during 3 months before Day 0 of the study
pancytopaenia and aplastic anemia
moderate and severe heart insufficiency (NYHA class III/IV), or unstable coronary heart disease
chronic pulmonary insufficiency, chronic renal insufficiency, chronic liver insufficiency
HIV infection
Presence of severe diseases of nervous system or severe endocrinological, hematological, psychiatric diseases.
Demyelinisation syndrome or symptoms resembling Demyelinisation syndrome
Malignancy or premalignant conditions during 5 years before Day 0 of the study.
Severe infection currently present
Malignancy currently present
No Results Posted