Study type

Study type

Non-interventional study

Scope of the study

Assessment of risk minimisation measure implementation or effectiveness
Effectiveness study (incl. comparative)
Non-interventional study

Non-interventional study design

Cohort
Study drug and medical condition

Medical condition to be studied

Colitis ulcerative
Population studied

Short description of the study population

A minimum of 64 patients, consisting of 32 eMayo 0 and 32 eMayo 1 patients.

Age groups

Adults (18 to < 46 years)
Adults (46 to < 65 years)
Adults (65 to < 75 years)
Adults (75 to < 85 years)
Adults (85 years and over)

Estimated number of subjects

64
Study design details

Main study objective

The primary objective of the study is to determine the accuracy of the UC-IUS index in determining the presence of endoscopic disease activity in the sigmoid by using the eMayo score as gold standard.

Outcomes

The UC-IUS score to define mild endoscopic disease activity (defined as eMayo of 1) evaluated against patients with endoscopic remission (defined as eMayo score of 0), To determine: - the accuracy of the UC-IUS score to distinguish no to mild endoscopic disease activity versus moderate to severe endoscopic disease activity - the accuracy of decrease in UC-IUS score to distinguish endoscopic response versus no endoscopic response between baseline and follow-up (between week 12 & 26) after medical treatment of known efficacy - inter-and intra-rater variability

Data analysis plan

The endoscopy and intestinal ultrasound are part of standard care, resulting in no extra burden for the patient. Preferably, patients will undergo the ultrasound when already in the hospital (e.g. for an infusion of medication, when admitted or when visiting the outpatient clinic). If this is not possible, an appointment for performing the ultrasound will be scheduled. IUS is a rapid and non-invasive imaging technique and having a reliable and standardized US activity index can be useful for facilitating the clinical decision-making process and for assessing and monitoring treatment outcomes in daily practice and in clinical trials.