Safety Study of Entocort for Children With Crohn's Disease

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

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.

- Subject must be diagnosed with 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.

- Subjects with mild to moderate Crohn's disease.

- All subjects must have a stool analysis negative for Clostridium difficile toxin,
Yersinia enterolytica, Campylobacter jejuni, Salmonella, Shigella, within the 30 days
prior to visit 1.

- All subjects must have had laboratory assessments within 7 days prior to visit 1.

- All subjects must weigh >= 15 kg at time of enrollment

Exclusion Criteria:

- Subjects who have had any previous intestinal resection proximal to and including the
ascending colon

- Subjects with evidence of severe active Crohn's disease and/or, stricturing and
prestenotic dilatation, clinical evidence of obstruction, perirectal abscess,
perirectal disease with active draining fistulas, perforation, or any septic
complications

- Subjects who do not have a negative stool analysis, within the 30 days prior to visit
1

- Subjects who have been screened/or enrolled in this study previously within the last
30 days

- Subjects with morning cortisol level <150 nmol/l (5.4 ug/dl) or DHEA-S below normal
range for age and gender