- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01559142
Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
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
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
Study Overview
Status
Conditions
Intervention / Treatment
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:
- Infliximab with immunomodulation
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
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
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Warsaw, Poland, 04-730
- Department of Gastroenterology, Hepatology and Feeding Disorders
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: IFX TG
|
Infliximab with azathioprine during whole one year study
|
Active Comparator: IFX alone
|
Infliximab continuously; azathioprine stopped in 26 week
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Clinical disease activity
Time Frame: 14 week and one year
|
14 week and one year
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
endoscopic disease activity
Time Frame: 14 week and one year
|
14 week and one year
|
Collaborators and Investigators
Investigators
- Principal Investigator: Jaroslaw Kierkus, MD PhD, The Children's Memorial Institute
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Gastrointestinal Diseases
- Gastroenteritis
- Intestinal Diseases
- Inflammatory Bowel Diseases
- Crohn Disease
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antimetabolites, Antineoplastic
- Antimetabolites
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Gastrointestinal Agents
- Dermatologic Agents
- Infliximab
- Azathioprine
Other Study ID Numbers
- IP CZD 2008-01-14
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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