A Study of the Safety and Efficacy of Infliximab (Remicade) in Pediatric Patients With Crohn's Disease

• Status: Completed
• Trial end date: 2007-08-01
• Target enrollment: 0
• Participant gender: All

Summary

A study of the safety and efficacy of infliximab (Remicade) in pediatric patients with moderate to severe Crohn's Disease

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Centocor, Inc.
• Collaborator: Centocor BV
• Treatments: Infliximab

Criteria

Inclusion Criteria:

• Between the ages of 6 and 17 years

• Have had Crohn's disease diagnosed for at least 3 months prior to screening, with gastritis, duodenitis, colitis, ileitis, or ileocolitis, previously confirmed by endoscopy and biopsy

• Have active Crohn's disease despite adequate current treatment with an immunomodulator (ie, AZA, 6-MP, or MTX).

Exclusion Criteria:

• Disease complications for which surgery might be indicated

• Surgery for bowel diversion with placement of a stoma within 3 months prior to screening

• Positive stool examination for enteric pathogens including Giardia lamblia, Clostridium difficile, Shigella species, and Salmonella species.