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

NCT01559142 | Unknown Phase 3

• 1 other identifier: IP CZD 2008-01-14
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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. 1.Infliximab with immunomodulation
2. 2.Infliximab alone

Conditions

Crohn Disease

Keywords

Crohn Disease; infliximab; azathioprine

Outcome Measures

Primary Outcomes (1)

• Clinical disease activity

  14 week and one year

Secondary Outcomes (1)

• endoscopic disease activity

  14 week and one year

Study Arms (2)

IFX TG

ACTIVE COMPARATOR

Drug: Infliximab with azathioprine (IIFX + AZA)

IFX alone

ACTIVE COMPARATOR

Drug: Infliximab (IFX alone)

Interventions

Infliximab with azathioprine (IIFX + AZA) DRUG

Infliximab with azathioprine during whole one year study

IFX TG

Infliximab (IFX alone) DRUG

Infliximab continuously; azathioprine stopped in 26 week

IFX alone

Eligibility Criteria

• Age: 7 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Children's Memorial Health Institute, Poland: lead

Study Sites (1)

Department of Gastroenterology, Hepatology and Feeding Disorders

Warsaw, 04-730, Poland

Location

MeSH Terms

Conditions

Crohn Disease

Interventions

Infliximab; Azathioprine

Condition Hierarchy (Ancestors)

Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Thionucleosides; Sulfur Compounds; Organic Chemicals; Mercaptopurine; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Jaroslaw Kierkus, MD PhD

  The Children's Memorial Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD

Study Record Dates

• First Submitted: March 19, 2012
• First Posted: March 21, 2012
• Study Start: November 1, 2008
• Primary Completion: April 1, 2012
• Study Completion: December 1, 2012
• Last Updated: April 4, 2012

Record last verified: 2012-04

Locations

PL (1)