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

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

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.