Efficacy and Safety of Two Regimens of Maintenance Therapy in Children With Crohn Disease
This study is ongoing, but not recruiting participants.
Sponsor:
Children's Memorial Health Institute, Poland
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
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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 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:
Genetics Home Reference related topics:
Crohn disease
MedlinePlus related topics:
Crohn's Disease
U.S. FDA Resources
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
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 7 Years to 17 Years |
| Genders Eligible for Study: | Both |
| 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
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 Azathioprine Infliximab Antimetabolites Molecular Mechanisms of Pharmacological Action Pharmacologic Actions |
Antimetabolites, Antineoplastic Antineoplastic Agents Therapeutic Uses Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Antirheumatic Agents Dermatologic Agents Gastrointestinal Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on May 22, 2013