pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis

Ulcerative Colitis Clinical Trial

— APOLLO  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04990245
• Other study ID #: 200735
• Status: Completed
• Start date: July 1, 2020
• Est. completion date: July 28, 2021

Study information

• Verified date: July 2021
• Source: Imelda GI Clinical Research Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 86
• Est. completion date: July 28, 2021
• Est. primary completion date: July 28, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

INCLUSION CRITERIA:

All patients with ulcerative colitis (= 16 years) undergoing planned endoscopic assessment as part of standard of care between 01.07.2020 and 30.06.2021. Evidence of a personally signed and dated informed consent document (ICF) indicating that the subject has been informed of all aspects of the study.

EXCLUSION CRITERIA:

Subjects with a diagnosis of indeterminate colitis, ischemic colitis, radiation colitis, diverticular disease associated with colitis, microscopic colitis or Crohn's disease.

Subjects with clinical findings suggestive of CD (e.g. fistulae, granulomas on biopsy) are also excluded. Similar data collection within 8 weeks prior to endoscopic assessment

Related Conditions & MeSH terms

• Colitis
• Colitis, Ulcerative
• Ulcer
• Ulcerative Colitis

Intervention

Diagnostic Test:
• endoscopic biopsies
patients with planned endoscopy for ulcerative colitis have endosocpic data recorded aswell as biopsy sampling and blood tests

Locations

Country	Name	City	State
Belgium	Imelda GI clinical research center	Bonheiden

Sponsors (1)

Lead Sponsor	Collaborator
Imelda GI Clinical Research Center

Country where clinical trial is conducted

Belgium, 

References & Publications (8)

Bossuyt P, Hoefkens E, Pouillon L. Prime Time Was Yesterday for Patient-reported Outcomes in Daily Care of Patients With Inflammatory Bowel Diseases. Clin Gastroenterol Hepatol. 2018 Nov;16(11):1839. doi: 10.1016/j.cgh.2018.05.029. — View Citation

Colombel JF, Keir ME, Scherl A, Zhao R, de Hertogh G, Faubion WA, Lu TT. Discrepancies between patient-reported outcomes, and endoscopic and histological appearance in UC. Gut. 2017 Dec;66(12):2063-2068. doi: 10.1136/gutjnl-2016-312307. Epub 2016 Sep 2. — View Citation

Danese S, Roda G, Peyrin-Biroulet L. Evolving therapeutic goals in ulcerative colitis: towards disease clearance. Nat Rev Gastroenterol Hepatol. 2020 Jan;17(1):1-2. doi: 10.1038/s41575-019-0211-1. — View Citation

de Jong MJ, Huibregtse R, Masclee AAM, Jonkers DMAE, Pierik MJ. Patient-Reported Outcome Measures for Use in Clinical Trials and Clinical Practice in Inflammatory Bowel Diseases: A Systematic Review. Clin Gastroenterol Hepatol. 2018 May;16(5):648-663.e3. doi: 10.1016/j.cgh.2017.10.019. Epub 2017 Oct 23. — View Citation

Dragasevic S, Sokic-Milutinovic A, Stojkovic Lalosevic M, Milovanovic T, Djuranovic S, Jovanovic I, Rajic S, Stojkovic M, Milicic B, Kmezic S, Oluic B, Aleksic M, Pavlovic Markovic A, Popovic D. Correlation of Patient-Reported Outcome (PRO-2) with Endoscopic and Histological Features in Ulcerative Colitis and Crohn's Disease Patients. Gastroenterol Res Pract. 2020 Apr 2;2020:2065383. doi: 10.1155/2020/2065383. eCollection 2020. — View Citation

Marchal-Bressenot A, Salleron J, Boulagnon-Rombi C, Bastien C, Cahn V, Cadiot G, Diebold MD, Danese S, Reinisch W, Schreiber S, Travis S, Peyrin-Biroulet L. Development and validation of the Nancy histological index for UC. Gut. 2017 Jan;66(1):43-49. doi: 10.1136/gutjnl-2015-310187. Epub 2015 Oct 13. — View Citation

Rutgeerts P, Sandborn WJ, Feagan BG, Reinisch W, Olson A, Johanns J, Travers S, Rachmilewitz D, Hanauer SB, Lichtenstein GR, de Villiers WJ, Present D, Sands BE, Colombel JF. Infliximab for induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2005 Dec 8;353(23):2462-76. Erratum in: N Engl J Med. 2006 May 18;354(20):2200. — View Citation

Travis SP, Schnell D, Krzeski P, Abreu MT, Altman DG, Colombel JF, Feagan BG, Hanauer SB, Lichtenstein GR, Marteau PR, Reinisch W, Sands BE, Yacyshyn BR, Schnell P, Bernhardt CA, Mary JY, Sandborn WJ. Reliability and initial validation of the ulcerative colitis endoscopic index of severity. Gastroenterology. 2013 Nov;145(5):987-95. doi: 10.1053/j.gastro.2013.07.024. Epub 2013 Jul 25. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	correlation between histological disease activity and patient reported outcomes	histological activity is based on the Nancy score, disability is based on the IBD control in case of non remission	1 day
Primary	correlation between histological disease activity and disability	histological activity is based on the Nancy score, disability is based on the IBD disk	1 day
Secondary	correlation between histological disease activity and patient reported outcomes	histological activity is based on the Nancy score, PRO is based on the SCCAI	1 day
Secondary	correlation between histological disease activity and patient reported outcomes	histological activity is based on the Nancy score, PRO is based on the VAS	1 day
Secondary	correlation between histological disease activity and patient reported outcomes	histological activity is based on the Nancy score, PRO is based on the PRO-2	1 day
Secondary	correlation between histological disease activity and endoscopic disease activity	histological activity is based on the Nancy score, endoscopic disease activityis based on the Mayo endoscopic subscore	1 day
Secondary	correlation between histological disease activity and endoscopic disease activity	histological activity is based on the Nancy score, endoscopic disease activity is based on the UCEIS	1 day
Secondary	correlation between histological disease activity and biomarkers	histological activity is based on the Nancy score, biomarkers (CRP, hemoglobine, albumin)	1 day