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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by 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
  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
Endpoint Classification: Safety/Efficacy Study
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:


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

Primary Outcome Measures:
  • Clinical disease activity [ Time Frame: 14 week and one year ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • endoscopic disease activity [ Time Frame: 14 week and one year ] [ Designated as safety issue: No ]

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

  Hide Detailed Description

Detailed Description:

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:

  1. Infliximab with immunomodulation
  2. 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
  Eligibility

Ages Eligible for Study:   7 Years to 17 Years
Genders Eligible for Study:   Both
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
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

No publications provided

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
Health Authority: Poland: Ethics Committee

Keywords provided by 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
Antibodies, Monoclonal
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Central Nervous System Agents
Immunologic Factors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents

ClinicalTrials.gov processed this record on September 22, 2014