Fact CheckerSign in

NCT05992142CompletedPhase 4

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

Source: ClinicalTrials.gov · Last updated 21 Mar 2024

Brief summary (registry, in English)

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.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
200 (actual)
First submitted
13 Dec 2022
Start date
17 Jan 2023
Primary completion date
1 Feb 2024
Lead sponsor
Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW
NCT number
NCT05992142
EudraCT number
2022-001683-10

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 200
  • From 17 Jan 2023 to the primary completion date, 1 Feb 2024
  • 16 sites in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 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.

Other

  • Any subject who meets one of the following criteria will not qualify for entry in the study:
  • 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

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (16)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Imelda Ziekenhuis
Coordinator of this site? Confirm its status
BonheidenBelgiumUnknown status
Hôpital Erasme
Coordinator of this site? Confirm its status
BrusselsBelgiumUnknown status
Universitair Ziekenhuis Antwerpen
Coordinator of this site? Confirm its status
EdegemBelgiumUnknown status
Ziekenhuis Oost-Limburg
Coordinator of this site? Confirm its status
GenkBelgiumUnknown status
AZ Sint-Lucas Gent
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
Universitair Ziekenhuis Gent
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
AZ Groeninge
Coordinator of this site? Confirm its status
KortrijkBelgiumUnknown status
CHU de Liège, site Sart Tilman
Coordinator of this site? Confirm its status
LiègeBelgiumUnknown status
Groupe Sante CHC/Clinique du MontLegia
Coordinator of this site? Confirm its status
LiègeBelgiumUnknown status
AZ Voorkempen Malle
Coordinator of this site? Confirm its status
MalleBelgiumUnknown status
AZ Damiaan
Coordinator of this site? Confirm its status
OstendBelgiumUnknown status
AZ Delta
Coordinator of this site? Confirm its status
RoeselareBelgiumUnknown status
Sint-Andries ziekenhuis Tielt
Coordinator of this site? Confirm its status
TieltBelgiumUnknown status
AZ Vesalius
Coordinator of this site? Confirm its status
TongerenBelgiumUnknown status
AZ Turnhout
Coordinator of this site? Confirm its status
TurnhoutBelgiumUnknown status
CHU UCL Namur -Site Mont Godinne
Coordinator of this site? Confirm its status
YvoirBelgiumUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.