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

Study Description

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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. Infliximab with immunomodulation
2. Infliximab alone

Condition or disease	Intervention/treatment	Phase
Crohn Disease	Drug: Infliximab with azathioprine (IIFX + AZA); Drug: Infliximab (IFX alone)	Phase 3

  Show Detailed Description

Study Design

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	100 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	November 2008
Estimated Primary Completion Date :	April 2012
Estimated Study Completion Date :	December 2012

Arms and Interventions

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: IFX TG	Drug: Infliximab with azathioprine (IIFX + AZA); Infliximab with azathioprine during whole one year study
Active Comparator: IFX alone	Drug: Infliximab (IFX alone); Infliximab continuously; azathioprine stopped in 26 week

Outcome Measures

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Clinical disease activity [ Time Frame: 14 week and one year ]

Secondary Outcome Measures :

1. endoscopic disease activity [ Time Frame: 14 week and one year ]

Eligibility Criteria

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	7 Years to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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 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

Contacts and Locations

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

Poland
Department of Gastroenterology, Hepatology and Feeding Disorders
Warsaw, Poland, 04-730

Sponsors and Collaborators

Children's Memorial Health Institute, Poland

Investigators

Principal Investigator:	Jaroslaw Kierkus, MD PhD	The Children's Memorial Institute

More Information

Go to 

Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	JAROSLAW KIERKUS, MD, PhD, Children's Memorial Health Institute, Poland
ClinicalTrials.gov Identifier:	NCT01559142 History of Changes
Other Study ID Numbers:	IP CZD 2008-01-14
First Posted:	March 21, 2012
Last Update Posted:	April 4, 2012
Last Verified:	April 2012

Keywords provided by JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland:

Crohn Disease; infliximab; azathioprine

Additional relevant MeSH terms:

Crohn Disease; Inflammatory Bowel Diseases; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Infliximab; Azathioprine; Dermatologic Agents	Gastrointestinal Agents; Antirheumatic Agents; Antimetabolites; Molecular Mechanisms of Pharmacological Action; Antimetabolites, Antineoplastic; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Physiological Effects of Drugs