Ulcerative ColitisAPOLLONCT04990245
pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis
An observational study of Ulcerative Colitis, run by Imelda GI Clinical Research Center at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Ulcerative Colitis
- What is being tested?
- endoscopic biopsies
- How many people
- 86 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Jul 2020to 28 Jul 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patient with ulcerative colitis and planned endoscopy as part of routine care
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: APOLLO Study: pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis
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.
Read more
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.
Read the detailed 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
- Conditions
- Ulcerative Colitis
- Being tested
- endoscopic biopsies
- Keywords
- ulcerative colitis, patient reported outcomes, histological scoring, disability, inflammatory bowel disease
- Medical subject headings
- Colitis, Ulcerative, Inflammatory Bowel Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
endoscopic biopsiesDiagnostic test
patients with planned endoscopy for ulcerative colitis have endosocpic data recorded aswell as biopsy sampling and blood tests
| Study group | Role | What they receive |
|---|---|---|
| patients with ulcerative colitis | patients with ulcerative colitis and planned endoscopy as part of routine care Receives: Diagnostic Test: endoscopic biopsies |
What is being measured
The primary outcome is the main question the study is designed to answer.
correlation between histological disease activity and disability
histological activity is based on the Nancy score, disability is based on the IBD disk
Measured: 1 day
Secondary outcomes (6)
correlation between histological disease activity and patient reported outcomes
histological activity is based on the Nancy score, PRO is based on the SCCAI
Measured: 1 day
correlation between histological disease activity and patient reported outcomes
histological activity is based on the Nancy score, PRO is based on the VAS
Measured: 1 day
correlation between histological disease activity and patient reported outcomes
histological activity is based on the Nancy score, PRO is based on the PRO-2
Measured: 1 day
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
Measured: 1 day
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
Measured: 1 day
correlation between histological disease activity and biomarkers
histological activity is based on the Nancy score, biomarkers (CRP, hemoglobine, albumin)
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2021
- Study start1 Jul 2020
- Primary completion28 Jul 2021
- Study completion28 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Ulcerative ColitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Lead sponsor
- Imelda GI Clinical Research Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Peter Bossuyt, MD, Principal investigator, Imelda general hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04990245
- Sponsor's protocol ID
- 200735
- Acronym
- APOLLO
- Status last verified
- Jul 2021
- First submitted
- 29 Jul 2021
- Last updated
- 4 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: up on request
Publications
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. No abstract available.
PubMed 31520081Colombel 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.
PubMed 27590995Dragasevic 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.
PubMed 32328091de 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.
PubMed 29074448Rutgeerts 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. doi: 10.1056/NEJMoa050516.
PubMed 16339095Travis 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.
PubMed 23891974Marchal-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.
PubMed 26464414Bossuyt 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. No abstract available.
PubMed 30343866
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- APOLLO Study: pAtient rePorted Outcomes Linked With histoLogy in Patients With uLcerative cOlitis
- ClinicalTrials.gov ID
- NCT04990245
- Acronym / sponsor ID
- APOLLO / 200735
- Conditions
- Ulcerative Colitis
- Keywords
- ulcerative colitis, patient reported outcomes, histological scoring, disability, inflammatory bowel disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- Imelda GI Clinical Research CenterUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 28 Jul 2021 (actual)
- Study completion
- 28 Jul 2021 (actual)
- First posted
- 4 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with ulcerative colitis | – | Diagnostic Test: endoscopic biopsiespatients with ulcerative colitis and planned endoscopy as part of routine care |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patient with ulcerative colitis and planned endoscopy as part of routine care
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| endoscopic biopsiespatients with planned endoscopy for ulcerative colitis have endosocpic data recorded aswell as biopsy sampling and blood tests | Diagnostic test | patients with ulcerative colitis |
Primary outcome
correlation between histological disease activity and disability
Time frame: 1 day
histological activity is based on the Nancy score, disability is based on the IBD disk
6 secondary outcomes
correlation between histological disease activity and patient reported outcomes
Time frame: 1 day
correlation between histological disease activity and patient reported outcomes
Time frame: 1 day
correlation between histological disease activity and patient reported outcomes
Time frame: 1 day
correlation between histological disease activity and endoscopic disease activity
Time frame: 1 day
correlation between histological disease activity and endoscopic disease activity
Time frame: 1 day
correlation between histological disease activity and biomarkers
Time frame: 1 day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2021.
- Background: PubMed 31520081Danese 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. No abstract available.
- Background: PubMed 27590995Colombel 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.
- Background: PubMed 32328091Dragasevic 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.
- Background: PubMed 29074448de 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.
- Background: PubMed 16339095Rutgeerts 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. doi: 10.1056/NEJMoa050516.
- Background: PubMed 23891974Travis 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.
- Background: PubMed 26464414Marchal-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.
- Background: PubMed 30343866Bossuyt 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. No abstract available.
- Individual participant dataSharing planned: Undecided. up on request
Related trials for Ulcerative Colitis
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Peter Bossuyt, MD principal investigator
Imelda general hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Ulcerative Colitis, run by Imelda GI Clinical Research Center at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between histological disease activity and disability (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04990245, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Aug 2021.