Overview

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

Status:
Unknown status
Trial end date:
2012-12-01
Target enrollment:
0
Participant gender:
All
Summary
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
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Children's Memorial Health Institute, Poland
Treatments:
Azathioprine
Infliximab
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