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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.

Verified April 2012 by JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland.
Recruitment status was: Active, not recruiting

Sponsor:

Information provided by (Responsible Party):

JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland

ClinicalTrials.gov Identifier:

NCT01559142

First received: March 19, 2012

Last updated: April 2, 2012

Last verified: April 2012

History of Changes

Purpose

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

Condition	Intervention	Phase
Crohn Disease	Drug: Infliximab with azathioprine (IIFX + AZA) Drug: Infliximab (IFX alone)	Phase 3


Study Type:	Interventional
Study Design:	Allocation: Randomized Intervention Model: Parallel Assignment Masking: 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

Resource links provided by NLM:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Azathioprine Azathioprine Sodium Infliximab

U.S. FDA Resources

Further study details as provided by JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland:

Primary Outcome Measures:

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

Secondary Outcome Measures:

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


Enrollment:	100
Study Start Date:	November 2008
Estimated Study Completion Date:	December 2012
Estimated Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Show Detailed Description

Eligibility


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

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

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01559142

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


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
Study First Received:	March 19, 2012
Last Updated:	April 2, 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

ClinicalTrials.gov processed this record on August 16, 2017

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