Safety and Maintenance Study of Entocort for Children With Crohn's Disease

Study Overview
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Brief Summary
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A Safety for Maintenance of Entocort EC for children with mild to moderate Crohn's Disease.

Detailed Description
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A Multicenter, Open label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Official Title
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A Multicenter, Open Label, Non-comparative Study to Evaluate the Safety of Entocort EC as a Maintenance Treatment for Crohn's Disease in Paediatric Subjects Aged 5 to 17 Years, Inclusive

Conditions
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Crohn's Disease

Intervention / Treatment
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* Drug: Entocort


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All male and female subjects must be aged 5 to 17, inclusive, and must not have reached their 18th birthday by the estimated final office visit. All subjects must weight >= 15 kg at the time of enrollment. Subjects must have been diagnosed and treated for active Crohn's disease of the ileum and/or ascending colon confirmed by endoscopic and/or radiographic evidence, and/or evidence of mucosal erosions and/or histology and have a PCDAI <= 10 Exclusion Criteria: Subjects who have had any previous intestinal resection proximal to and including the ascending colon. Subjects with evidence of active Crohn's disease (PCDAI > 10) and/or stricturing, prestenotic dilatation, clinical evidence of obstruction, perirectal abscess, perirectal disease with active draining fistulas, perforation, or any septic complications. Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal range for age and gender (NOTE: Subjects from the induction protocol with abnormal morning cortisol/DHEA-S levels at Visit 4, who otherwise meet the eligibility criteria, may be enrolled if the investigator decides that Entocort 6 mg is an appropriate therapy option.

Ages Eligible for Study
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Minimum Age: 5 Years
Maximum Age: 17 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Entocort<br>Study Medication | Drug: Entocort<br>* Entocort capsules, taken orally, 6 mg daily.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Event | Any kind of adverse event | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PCDAI | Pediatric Crohn's Disease Activity Index. The scale ranges from 0 (no activity) to 100 (high activity) | 12 weeks | 
| IMPACT 3 | IMPACT-III - A QUALITY OF LIFE QUESTIONNAIRE FOR CHILDREN WITH INFLAMMATORY BOWEL DISEASE | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Crohn's Disease