TUMMY-CD

Development and evaluation of the TUMMY-CD Index: a signs and symptoms index for pediatric Crohn’s disease.

Co-Principal Investigators:
Anthony Otley, MD, MSc, FRCPC
Division of Gastroenterology, Department of Pediatrics
IWK Health Centre and Dalhousie University

Dr. Dan Turner
Head of Pediatric Gastroenterology
Shaare Zedek Medical Centre

Study sponsors:
NASPGHAN Foundation
AbbVie Inc.

Inclusion/exclusion criteria:
Diagnosed with Crohn’s disease
Is between the ages of four and 17

Purpose: To create a validated patient reported signs and symptoms index for pediatric Crohn’s disease.

Recent regulatory guidance mandates that items measuring the signs and symptoms of Crohn’s Disease in clinical trials should be scored directly from the patient without a proxy. We therefore aim to develop a Patient Reported Outcome (PRO) for pediatric CD in which items will be generated based on the reported level of importance according to patients. The index is intended to be to be used in pediatric CD clinical trials to evaluate signs and symptoms over time. The scoring of the TUMMY-CD index will yield a new PRO score. An additional observer reported outcome (ObsRO) measure will be created for those children who cannot self-report.

Approximately 175 children and teenagers who have Crohn’s disease, and one of their caregivers (350 participants total) are being asked to participate in the study at sites in Canada, the United States, Ireland, the United Kingdom and Israel. The study is being conducted in three phases (Phase 1: Concept elicitation, Phase 2: Cognitive debriefing, and Phase 3: Evaluation). It is currently in Phase 2 and is enrolling participants into the study.