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| ID | Type | Description | Link |
|---|---|---|---|
| 2022-001683-10 | EudraCT Number |
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| Name | Class |
|---|---|
| Ferring Pharmaceuticals | INDUSTRY |
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For the last years the aim of the management of ulcerative colitis (UC) has become more ambitious including not only clinical remission but also the achievement of biological remission, endoscopic and histological healing, which are associated with less flares, hospitalizations and surgeries. About 50% of the patients with UC followed in routine are treated by 5-aminosalicylate acid (5-ASA) (oral and/or topical). The aim of the study is to describe the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, that report to be in clinical remission during a routine follow-up visit. The factors associated with different levels of remission (demographic, 5-ASA regimen, biologic, endoscopic, histologic) will be studied. Adherence and quality of life will be examined through patient questionnaires.
The management of inflammatory bowel diseases aims to induce not only a clinical corticosteroid-free remission but also a deep remission defined by the achievement of mucosal healing. In ulcerative colitis (UC), mucosal healing has been nicely correlated with a better outcome of the disease. A lack of mucosal healing after a first steroid course is associated with a bad outcome including higher hospitalizations and more clinical relapses after 1 year. The absence of mucosal healing has also been correlated with higher rates of colectomy. Mucosal healing is defined by the absence of ulcers and includes patients with an endoscopic Mayo subscore of zero and one. Recently, a significantly better outcome has been demonstrated in patients having an endoscopic Mayo subscore of zero instead of one as well as a histological healing on the biopsies. The fecal biomarkers, especially the fecal calprotectin, have a high accuracy for the prediction of ongoing endoscopic and histologic inflammation in patients in clinical remission. Fecal calprotectin is well correlated with the Mayo endoscopic subscore and can discriminate patients with an endoscopic Mayo subscore of zero versus one or more by using a cut-off of 150 microgram/gram. A residual histologic inflammation is associated with a fecal calprotectin of 155 microgram/gram or more. Subsequently the management of UC has evolved and aims to induce a tighter control of the disease including a complete endoscopic response and a histological healing. It is currently not known how well these patients who report being in clinical remission are actually in objectively defined remission. As a deep remission is so important for the future evaluation of the disease, it is important to understand the factors linked to the absence of such remission.
The primary objective of this study is to describe the percentage of the different levels of remission (clinical, endoscopic, histological), in UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit.
The secondary objectives of this study are:
This study is a national, multicenter, transversal, interventional study conducted in Belgium (16 centers will participate). The trial design is as follows:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| UC patients | Other | UC patients, treated by 5-ASA for at least 6 months, free of concomitant UC medications for at least 3 months and presenting for a routine follow-up visit |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 5-ASA | Drug | Assessment of the different levels of remission (clinical, endoscopic, histological) in UC patients treated only by 5-ASA, who report to be in clinical remission during a routine follow-up visit |
| Measure | Description | Time Frame |
|---|---|---|
| Complete clinical remission | Complete clinical remission is defined by a PRO-2 = 0 and no bowel urgency | week 0 |
| Endoscopic remission | Endoscopic remission is defined by an endoscopic MAYO subscore of 0 or 1 and/or by a Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 0 or 1 | week 0 |
| Histological remission | Histological remission will be defined by the absence of any acute inflammatory activity on the biopsies according to the Geboes score, including Geboes 0-1 | week 0 |
| Deep remission | Deep remission will be defined by the combination of complete clinical, complete endoscopic and histological remission | week 0 |
| Measure | Description | Time Frame |
|---|---|---|
| Demographic factors associated to the absence of deep remission | Demographic factors questionnaire: year of birth, sex (male/female), ethnic origin (Caucasian/Black/Hispanic/Asian/Other) and smoking status (Smoker with > 1 cigarette/day, Non-smoker or Former smoker) | week 0 |
| Disease characteristics associated to the absence of deep remission |
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Inclusion Criteria:
Exclusion Criteria:
Any subject who meets one of the following criteria will not qualify for entry in the study:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine Reenaers, MD, PhD | Study Principal Investigator | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Imelda Ziekenhuis | Bonheiden | Belgium | ||||
| Hôpital Erasme |
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| Label | URL |
|---|---|
| BIRD website | View source |
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transversal study
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Disease characteristics questionnaire: diagnosis date ('DD-MMMM-YYYY') and UC Montreal classification [E1 (Ulcerative proctitis), E2 (left-sided UC), E3 (Extensive) or Pancolitis] |
| week 0 |
| Medical history associated to the absence of deep remission | Medical history questionnaire with a list of current and past concomitant medical conditions including extra-intestinal manifestations (yes/no) | week 0 |
| Medication history associated to the absence of deep remission | A questionnaire (yes/no) about UC medication history prescribed the year before inclusion and current medication use including corticosteroids including local forms, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs): brand name, date of start and stop, frequency, route of administration and dosage. Details on past and current 5-ASA use will be recorded: brand name, date of start and stop, formulation (oral, rectal, enema), dosage, frequency. | week 0 |
| Disease activity based on PRO-2 score associated to the absence of deep remission | Disease activity measurement based on Two component Patient Reported Outcome (PRO-2) score (stool frequency and rectal bleeding; average score of the last 3 days before the visit), using a grading scale from 0 (normal) to 3 (for rectal bleeding: blood alone passed and for stool frequency: >= 5 stools more than normal) | week 0 |
| Disease activity based on bowel urgency associated to the absence of deep remission | Disease activity measurement based on bowel urgency for the past 24 hours using a VAS scale from 0 (no urgency) to 10 (worst possible urgency) | week 0 |
| Disease activity based on endoscopic score associated to the absence of deep remission | Disease activity measurement based on Mayo and UCEIS endoscopic score, using a grading scale from 0 (normal/inactive) to 3 (active) | week 0 |
| Disease activity based on histological Geboes score associated to the absence of deep remission | Disease activity measurements based on histological Geboes score, with grade 0-1=inactive/absent, grade 2= chronic inflammation and grade 3-5 = acute inflammation | week 0 |
| Disease activity based on objective markers associated to the absence of deep remission | Disease activity measurement based on the objective markers fecal calprotectine value (microg/g) and C-reactive protein (CRP) value (mg/L) if available | week 0 |
| Adherence associated to the absence of deep remission | Adherence based on Medication Adherence Report Scale (MARS-5) | week 0 |
| The percentage of adherent patients on 5-ASA medications | The percentage of adherent patients on 5-ASA medications, and an adherent patient is defined by a total Medication Adherence Report Scale (MARS-5) score of 21 or by a MARS-5 score of 4 for each individual question. | week 0 |
| The impact of adherence on the remission status | The percentage of adherent patients on 5-ASA medications will be compared between the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission) | week 0 |
| The percentage of prescription of the different 5-ASA regimens | The percentage of prescription of the different 5-ASA regimens, and the prescription rate of the different 5-ASA regimens depends on the dosage (grams), oral and/or topical form. | week 0 |
| The impact of the prescription rate of the different 5-ASA regimens on the remission status | The prescription rate of the different 5-ASA regimens will be compared between the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission) | week 0 |
| Quantification of the quality of life of the patients with UC on 5-ASA | Quality of life based on validated Short Health Scale (a four-part visual analogue scale questionnaire using open-ended questions that are designed to assess the impact of IBD on a health related quality of life, with score between 0 and 40; lower score, better quality of life)). | week 0 |
| Correlation of the quality of life scores with the level of remission | Quality of life scores will be correlated with the different levels of remission (clinical remission, endoscopic remission, histological remission, deep remission, non-deep remission) | week 0 |
| The factors associated with non-deep remission coming from either physician management or patient perception | In patients not achieving complete endoscopic remission (Endoscopic Mayo subscore >0), an exploratory questionnaire will be answered by the physician about "physician perspective" regarding the treatment strategy to explore the supposed reasons of the absence of UC remission. Depending on the answer, an exploratory questionnaire can be directed towards the patient exploring the reason for possible low adherence or deliberately refusing other medications. | week 0 |
| Brussels |
| Belgium |
| Universitair Ziekenhuis Antwerpen | Edegem | Belgium |
| Ziekenhuis Oost-Limburg | Genk | Belgium |
| AZ Sint-Lucas Gent | Ghent | Belgium |
| Universitair Ziekenhuis Gent | Ghent | Belgium |
| AZ Groeninge | Kortrijk | Belgium |
| CHU de Liège - Site Sart Tilman | Liège | Belgium |
| Groupe santé CHC Clinique du MontLégia | Liège | Belgium |
| AZ Voorkempen Malle | Malle | Belgium |
| AZ Damiaan | Ostend | Belgium |
| AZ Delta | Roeselare | Belgium |
| Sint-Andries ziekenhuis Tielt | Tielt | Belgium |
| AZ Vesalius | Tongeren | Belgium |
| AZ Turnhout | Turnhout | Belgium |
| CHU UCL Namur -Site Mont Godinne | Yvoir | Belgium |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jul 7, 2026 |
| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D015212 | Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
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