IBD Treatment with Remicade®: The ADAPT Study – Phase IV

Study of Infliximab in Pediatric Participants with Inflammatory Bowel Disease (ADAPT)

Protocol Description

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.

Study Level: Phase IV

Eligibility Criteria

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

Requirements

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.

Visits: 10
Duration: 64 weeks

Status: Open to Enrollment

Source(s) of Support

Janssen Scientific Affairs

Primary Investigator

Sapana Shah, MD

Contact Information

For more information about the study or enrollment, please contact:
Kathleen Calabro, RN, BSN
412-692-6092