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The purpose of this multi-center research study is to determine if pediatric patients with inflammatory bowel disease (IBD) who have lost response to Infliximab, also known by the trade name Remicade®, at the standard approved dose every 8 weeks would benefit from an increase in their dose.
Subject to certain exclusion criteria, the study is accepting patients of both genders, ages 6 through 16 years of age, who have a biopsy-confirmed diagnosis of Crohn’s disease or ulcerative colitis and have maintained a response or have lost response to the study medication.
Boys and Girls: Ages 6 through 16 years
Participants will enter the study in one of two study groups. Patients maintaining a stable response at the FDA-approved dose will continue infliximab via intravenous (IV) infusion at a 5 mg/kg dose every 8 weeks, and patients who have lost response at 5 mg/kg will receive an IV infusion of infliximab increased to 10 mg/kg every 8 weeks.
Participants will receive infliximab every 8 weeks for a total of 8 times over a period of 56 weeks. A follow-up visit is required 8 weeks after the last dose.
Janssen Scientific Affairs
Study Description at National Institutes of Health
Inflammatory Bowel Disease
The IBD Center at Children’s Hospital of Pittsburgh of UPMC
Sapana Shah, MD
For more information about the study or enrollment, please contact:
Kathleen Calabro, RN, BSN
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One Children’s Hospital Way
4401 Penn Ave.
Pittsburgh, PA 15224
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