Observational Study to Validate a PRO and Imaging in Crohn's Disease
Research type
Research Study
Full title
Prospective Observational Study to Validate a Novel PRO Tool and Imaging Index Items in Stricturing Crohn’s Disease
IRAS ID
322173
Contact name
Gordon Moran
Contact email
Sponsor organisation
Alimentiv Inc
Clinicaltrials.gov Identifier
N/A, N/A
Duration of Study in the UK
1 years, 1 months, 2 days
Research summary
The purpose of this study is to support the development and validation of two different disease assessment methods (STARPRO and Imaging Index Items) for use in future research related to stricturing Crohn’s disease (CD). Data and results collected during this study can help develop these assessments, which may help doctors to better treat stricturing CD in the future.
Patient-reported outcome (PRO) measures, health status as reported directly from the patient without interpretation of anyone else, are an essential component for patient care. Although several PRO instruments have been developed in the inflammatory bowel disease (IBD) therapeutic area, there is currently no validated PRO measure for stricturing CD. There is a need for validated outcome measures to assess stricuring disease activity in CD clinical trials and to facilitate drug development for antifibrotic therapies.
The aims of the current study are to perform quantitative testing of the STARPRO tool in a prospective observational study and to assess the responsiveness of the imaging items (descriptors) and refine the stricture radiology index (SRI) developed from STARWP2.
This study will involve up to a maximum of 165 participants in the EU, North America and the UK.
After the completion of this study, participants will continue with their regular care.
The study is sponsored by Alimentiv and funded by Helmsley Charitable Trust.REC name
East Midlands - Nottingham 1 Research Ethics Committee
REC reference
24/EM/0010
Date of REC Opinion
3 May 2024
REC opinion
Further Information Favourable Opinion