A Phase 4 interventional study of 5-ASA in Ulcerative Colitis, sponsored by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW. Completed at 16 sites in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-03-21.
Sponsored by Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW · Phase 4, Interventional, and Treatment
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:
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 200 is above the median of 60 across 771 interventional studies indexed under Colitis.
Browse Colitis studies →Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW is the lead sponsor of 5 studies on the registry; 1 is open to participants now.
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Exclusion Criteria:
Any subject who meets one of the following criteria will not qualify for entry in the study:
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
Drug: 5-ASA
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
Complete clinical remission
Complete clinical remission is defined by a PRO-2 = 0 and no bowel urgency
Time frame: 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
Time frame: 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
Time frame: week 0
Deep remission
Deep remission will be defined by the combination of complete clinical, complete endoscopic and histological remission
Time frame: week 0
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)
Time frame: week 0
Disease characteristics associated to the absence of deep remission
Disease characteristics questionnaire: diagnosis date ('DD-MMMM-YYYY') and UC Montreal classification \[E1 (Ulcerative proctitis), E2 (left-sided UC), E3 (Extensive) or Pancolitis\]
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)
Time frame: 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)
Time frame: 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
Time frame: 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
Time frame: week 0
Adherence associated to the absence of deep remission
Adherence based on Medication Adherence Report Scale (MARS-5)
Time frame: 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.
Time frame: 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)
Time frame: 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.
Time frame: 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)
Time frame: 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)).
Time frame: 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)
Time frame: 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.
Time frame: week 0
Plan to share: No
This study is completed, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW