Validation of the UC-IUS score

Study identification

• PURI:
  https://redirect.ema.europa.eu/resource/199001
• EU PAS number:
  EUPAS107322
• Study ID:
  199001
• Official title and acronym:
  Validation of the UC-IUS score
• DARWIN EU® study:
  No
• Study countries:
  Netherlands
• Study description:
  Rationale: Intestinal ultrasound (IUS) is a non-invasive, rapid, efficient and cost-efficient imaging technique, which has been proven to be accurate in assessing disease activity, severity and location in ulcerative colitis (UC) patients. To this date, the Milan Ultrasound score (MUC) is the only validated ultrasound index for UC and differentiates between endoscopic Mayo (eMayo) 0-1 and 2-3. The STRIDE-II study suggests an eMayo score of 0 as treatment target for endoscopic remission, which underlines the need for a more sensitive IUS index. Recently, Bots et al. proposed a point-based index (UC-IUS score) corresponding with endoscopic disease severity, making it suitable for detecting an eMayo of both 0 and 1. External validation of this index remains to be investigated in an independent cohort of prospectively followed UC patients, which this study aims to provide. Objective: The primary objective of this study is to determine the accuracy of the UC-IUS index in determining presence of endoscopic disease activity in the sigmoid by using the eMayo score as gold standard. Secondary objectives include determination of cut-off values for eMayo 0-1 vs 2-3 and response, assessing sensitivity to change after treatment and establish inter- and intra-rater agreement. Exploratory objectives include the use of the UC-IUS index as a surrogate marker for long-term complications, assess if there is a difference in UC-IUS index cut-off for individual colonic segments, compare the accuracy of complete BWT or submucosal layer alone against the eMayo score, compare the UC-IUS score to the UCEIS and to compare the accuracy of the UC-IUS to the MUC and IBUS-SAS score.
• Study status:
  Ongoing

Research institutions and networks

Institutions

Amsterdam UMC

Study timelines

Date when funding contract was signed

Planned: 01/02/2023

Study start date

Planned: 01/12/2023

Actual: 09/11/2023

Date of interim report, if expected

Planned: 01/06/2025

Date of final study report

Planned: 01/09/2026

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

AbbVie

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable