pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis — APOLLO  

Ulcerative Colitis Clinical Trial

Official title: APOLLO Study: pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

Status Completed

Clinical Trial Summary

Background and rationale:

In ulcerative colitis, treating beyond endoscopic healing has shown a reduction of relapse and hospitalization, pushing for histological remission in daily clinical practice.1 However, very little is known on how histological remission is associated with patient reported outcomes (PROMs).2,3 In recent years, several questionnaires have been developed to assess what really matters to patients: symptoms and the burden UC exerts on them.4 As PROMs are getting more and more attention during drug development programs and drug approval by international organizations, including FDA and EMA, the link between objective outcome measures (endoscopic, histological, biochemical) and PROMs should therefore be better characterized.

Objectives and design:

To investigate prospectively the association of patient reported outcomes (PROMs) and biochemical, endoscopic and histological outcome measures in patients with ulcerative colitis.

Clinical Trial Description

After informed consent, patients will undergo endoscopic assessment evaluating endoscopic disease activity using established scoring systems

• Mayo endoscopic sub-score5

• Ulcerative Colitis Endoscopic Index of Severity [UCEIS]6 All endoscopic assessments will be recorded, allowing blinded scoring by independent endoscopists afterwards. Study protocol APOLLO - 2 During endoscopy, colonic biopsies will be taken according to standard of care from the most inflamed area of the colon and normal area if applicable, 0-60cm from the anal verge. All biopsies will be scored histologically using the Nancy Index.7 During the same study visit, clinical symptoms (Simple clinical colitis activity index [SCCAI]) and patient reported outcomes (PROMs) will be evaluated digitally using validated scoring systems8

• IBD disk

• PRO-2

• Visual Analogue Scale

• IBD control in case of non-remission Finally, patients will be biochemically (C-reactive protein, hemoglobin, albumin) evaluated, including measurement of drug level (infliximab, adalimumab, vedolizumab) in case of ongoing exposure to biological agents. All evaluations are part of standard-of-care. Definitions

• Endoscopic remission: Mayo endoscopic sub-score 0 AND UCEIS 0

• Endoscopic response according to

• Mayo score: decrease in Mayo endoscopic sub-score ≥ 1

• UCEIS: decrease in UCEIS ≥ 2

• Endoscopic improvement: Mayo endoscopic sub-score 1

• Histological remission: Nancy histological index 0

• Absence of active/acute histological inflammation: Nancy histological index 0-1

• Histological response: Nancy histological index > 1

• PRO2 remission: stool frequency ≤ 1 (absolute stool frequency ≤ 3 OR 1-2 stools more than usual) AND rectal bleeding score of 0 (average of 3 days prior to endoscopy)

• IBD disk remission per item:

• Abdominal pain

• Regulating defecation

• Interpersonal interactions

• Education and work

• Sleep

• Energy

• Emotions

• Body Image

• Sexual function

• Joint pain ;

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

• NCT number: NCT04990245
• Study type: Observational
• Source: Imelda GI Clinical Research Center
• Status: Completed
• Start date: July 1, 2020
• Completion date: July 28, 2021