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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:
ClinicalTrials.gov Identifier:
NCT01559142
First Posted: March 21, 2012
Last Update Posted: April 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
JAROSLAW KIERKUS, Children's Memorial Health Institute, Poland
  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:

  1. Infliximab with immunomodulation
  2. 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: 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

Resource links provided by NLM:


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

Information from the National Library of Medicine

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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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
First Submitted: March 19, 2012
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


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