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ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA (CARUC-ASA)

Primary Purpose

Ulcerative Colitis

Status
Recruiting
Phase
Phase 4
Locations
Belgium
Study Type
Interventional
Intervention
5-ASA
Sponsored by
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis focused on measuring remission, 5-aminosalicylate acid (5-ASA)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Male or female ≥ 18 years Confirmed diagnosis of UC Patients with PRO-2 ≤ 1, with ≤ 1 for stool frequency and 0 for rectal bleeding in the last 3 days before the visit. Recruitment during a routine follow-up visit. Subjects to whom 5-ASA treatment has been prescribed for at least 6 months (any type of oral and/or rectal 5 ASA, any dosage) and with the dose of 5-ASA stable for at least 2 weeks (including suppositories) prior to inclusion. Prescription of 5-ASA is within the locally approved Summary of Product Characteristics (SmPCs) Subjects free of concomitant UC medication (corticosteroids, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs) for at least 3 months Subject or the subject's legally acceptable representative have the capacity to understand and (voluntary) sign an informed consent form Be able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Any subject who meets one of the following criteria will not qualify for entry in the study: Subjects currently treated by immunomodulators, biologics, JAK inhibitors, S1PR modulator and investigational drugs and within the last three months. A history of immunomodulator or biologic or JAK inhibitor or S1PR modulator and investigational drugs use in the past is not an exclusion criteria. Subjects recruited during hospitalization, or via the urgency department for active UC, or during an unscheduled visit for emergency reasons. UC patients with a total colectomy, with or without IPAA Patients with indetermined colitis (IBDU) Women that are pregnant

Sites / Locations

  • Imelda ZiekenhuisRecruiting
  • Hôpital ErasmeRecruiting
  • Universitair Ziekenhuis AntwerpenRecruiting
  • Ziekenhuis Oost-LimburgRecruiting
  • AZ Sint-Lucas GentRecruiting
  • Universitair Ziekenhuis GentRecruiting
  • AZ GroeningeRecruiting
  • CHU de Liège - Site Sart TilmanRecruiting
  • Groupe santé CHC Clinique du MontLégiaRecruiting
  • AZ Voorkempen MalleRecruiting
  • AZ DamiaanRecruiting
  • AZ DeltaRecruiting
  • Sint-Andries ziekenhuis TieltRecruiting
  • AZ VesaliusRecruiting
  • AZ TurnhoutRecruiting
  • CHU UCL Namur -Site Mont GodinneRecruiting

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

UC patients

Arm Description

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

Outcomes

Primary Outcome Measures

Complete clinical remission
Complete clinical remission is defined by a PRO-2 = 0 and no bowel urgency
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
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
Deep remission
Deep remission will be defined by the combination of complete clinical, complete endoscopic and histological remission

Secondary Outcome Measures

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)
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]
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)
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.
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)
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)
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)
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
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
Adherence associated to the absence of deep remission
Adherence based on Medication Adherence Report Scale (MARS-5)
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.
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)
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.
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)
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)).
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)
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.

Full Information

First Posted
December 13, 2022
Last Updated
August 11, 2023
Sponsor
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborators
Ferring Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT05992142
Brief Title
ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
Acronym
CARUC-ASA
Official Title
ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA
Study Type
Interventional

2. Study Status

Record Verification Date
August 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 25, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
March 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
Collaborators
Ferring Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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.
Detailed Description
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: to identify the factors associated to the absence of deep remission (demographic, UC history, clinical, biological, endoscopic, histological, 5-ASA regimen, adherence) to describe the adherence of the patients to the 5-ASA medications and its impact on the remission status. to describe the regimen of 5-ASA prescription (dosage, oral/local form) and its impact on the remission status. to describe the quality of life of the patients with UC on 5-ASA and its correlation with the level of remission. to understand the implication of patient's perspective and physician's perspective in patient lacking deep remission. to analyze the reasons of non-deep remission This study is a national, multicenter, transversal, interventional study conducted in Belgium (16 centers will participate). The trial design is as follows: All subjects will undergo screening procedures. The screening visit of eligible patients will include the review of inclusion and exclusion criteria, and the informed consent form procedure. After screening, if the patient fulfils all inclusion and none of the exclusion criteria, and is willing to participate, the inclusion visit will be performed at the same time. The gastroenterologist will record the characteristics of patients and of the disease, medical history, current and past UC treatments in the last year before inclusion, and the PRO-2 score and bowel urgency in the last 3 days before the visit. A sigmoidoscopy with 2 biopsies (taken in the most inflamed area) as well as a fecal calprotectin measurement will be performed during the inclusion visit. The sigmoidoscopy procedure will be scored locally by the gastroenterologist with the endoscopic Mayo score and the UCEIS score. The Geboes score will be calculated centrally. The patient will complete the Short Health Scale and the Medication Adherence Report Scale. Biochemistry (including hematocrit, hemoglobin, platelets count, leucocytes, CRP, urea and serum creatinine) is not obligatory, but if it is planned in the routine management of the patient, these data will be recorded for study purposes. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis
Keywords
remission, 5-aminosalicylate acid (5-ASA)

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
transversal study
Masking
None (Open Label)
Allocation
N/A
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
UC patients
Arm Type
Other
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
5-ASA
Intervention Description
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
Primary Outcome Measure Information:
Title
Complete clinical remission
Description
Complete clinical remission is defined by a PRO-2 = 0 and no bowel urgency
Time Frame
week 0
Title
Endoscopic remission
Description
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
Title
Histological remission
Description
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
Title
Deep remission
Description
Deep remission will be defined by the combination of complete clinical, complete endoscopic and histological remission
Time Frame
week 0
Secondary Outcome Measure Information:
Title
Demographic factors associated to the absence of deep remission
Description
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
Title
Disease characteristics associated to the absence of deep remission
Description
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
Title
Medical history associated to the absence of deep remission
Description
Medical history questionnaire with a list of current and past concomitant medical conditions including extra-intestinal manifestations (yes/no)
Time Frame
week 0
Title
Medication history associated to the absence of deep remission
Description
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
Title
Disease activity based on PRO-2 score associated to the absence of deep remission
Description
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
Title
Disease activity based on bowel urgency associated to the absence of deep remission
Description
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
Title
Disease activity based on endoscopic score associated to the absence of deep remission
Description
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
Title
Disease activity based on histological Geboes score associated to the absence of deep remission
Description
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
Title
Disease activity based on objective markers associated to the absence of deep remission
Description
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
Title
Adherence associated to the absence of deep remission
Description
Adherence based on Medication Adherence Report Scale (MARS-5)
Time Frame
week 0
Title
The percentage of adherent patients on 5-ASA medications
Description
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
Title
The impact of adherence on the remission status
Description
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
Title
The percentage of prescription of the different 5-ASA regimens
Description
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
Title
The impact of the prescription rate of the different 5-ASA regimens on the remission status
Description
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
Title
Quantification of the quality of life of the patients with UC on 5-ASA
Description
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
Title
Correlation of the quality of life scores with the level of remission
Description
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
Title
The factors associated with non-deep remission coming from either physician management or patient perception
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female ≥ 18 years Confirmed diagnosis of UC Patients with PRO-2 ≤ 1, with ≤ 1 for stool frequency and 0 for rectal bleeding in the last 3 days before the visit. Recruitment during a routine follow-up visit. Subjects to whom 5-ASA treatment has been prescribed for at least 6 months (any type of oral and/or rectal 5 ASA, any dosage) and with the dose of 5-ASA stable for at least 2 weeks (including suppositories) prior to inclusion. Prescription of 5-ASA is within the locally approved Summary of Product Characteristics (SmPCs) Subjects free of concomitant UC medication (corticosteroids, immunomodulators, biologics, JAK inhibitors, S1PR modulator or investigational drugs) for at least 3 months Subject or the subject's legally acceptable representative have the capacity to understand and (voluntary) sign an informed consent form Be able to adhere to the study visit schedule and other protocol requirements Exclusion Criteria: Any subject who meets one of the following criteria will not qualify for entry in the study: Subjects currently treated by immunomodulators, biologics, JAK inhibitors, S1PR modulator and investigational drugs and within the last three months. A history of immunomodulator or biologic or JAK inhibitor or S1PR modulator and investigational drugs use in the past is not an exclusion criteria. Subjects recruited during hospitalization, or via the urgency department for active UC, or during an unscheduled visit for emergency reasons. UC patients with a total colectomy, with or without IPAA Patients with indetermined colitis (IBDU) Women that are pregnant
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ingrid Arijs, PhD
Phone
+32499317005
Email
ingrid.arijs@birdgroup.be
First Name & Middle Initial & Last Name or Official Title & Degree
Laura Vansteenkiste
Phone
+32470851337
Email
laura.vansteenkiste@birdgroup.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Catherine Reenaers, MD, PhD
Organizational Affiliation
Study Principal Investigator
Official's Role
Principal Investigator
Facility Information:
Facility Name
Imelda Ziekenhuis
City
Bonheiden
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lieven Pouillon
Email
lieven.pouillon@imelda.be
Facility Name
Hôpital Erasme
City
Bruxelles
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anneline Cremer
Email
Anneline.Cremer@erasme.ulb.ac.be
Facility Name
Universitair Ziekenhuis Antwerpen
City
Edegem
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michaël Somers
Email
Michael.Somers@uza.be
Facility Name
Ziekenhuis Oost-Limburg
City
Genk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Evelien Humblet
Email
Evelien.Humblet@zol.be
Facility Name
AZ Sint-Lucas Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Beatrijs Strubbe
Email
Beatrijs.Strubbe@AZSTLUCAS.BE
Facility Name
Universitair Ziekenhuis Gent
City
Gent
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jeroen Geldof
Email
Jeroen.Geldof@uzgent.be
Facility Name
AZ Groeninge
City
Kortrijk
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Billiet
Email
THOMAS.BILLIET@azgroeninge.be
Facility Name
CHU de Liège - Site Sart Tilman
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Reenaers
Email
catherine.reenaers@chuliege.be
Facility Name
Groupe santé CHC Clinique du MontLégia
City
Liège
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arnaud Colard
Email
arnaud.colard@chc.be
Facility Name
AZ Voorkempen Malle
City
Malle
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies Verreth
Email
Annelies.Verreth@Emmaus.be
Facility Name
AZ Damiaan
City
Oostende
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guy Lambrecht
Email
glambrecht@azdamiaan.be
Facility Name
AZ Delta
City
Roeselare
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Filip Baert
Email
filip.baert@azdelta.be
Facility Name
Sint-Andries ziekenhuis Tielt
City
Tielt
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Astrid De Zutter
Email
astrid.de.zutter@sintandriestielt.be
Facility Name
AZ Vesalius
City
Tongeren
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies Posen
Email
Annelies.Posen@azvesalius.be
Facility Name
AZ Turnhout
City
Turnhout
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christophe Claessens
Email
Christophe.Claessens@azturnhout.be
Facility Name
CHU UCL Namur -Site Mont Godinne
City
Yvoir
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Francois Rahier
Email
jfrahier@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.birdgroup.be/en
Description
BIRD website

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ChAracterizing the Remission Status in Patients With Ulcerative Colitis Treated by 5-ASA

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