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

NCT05992142 | Completed Phase 4 DMC

• 2 other identifiers: BIRD20220012022-001683-10
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 16

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.

Conditions

Ulcerative Colitis

Keywords

remission; 5-aminosalicylate acid (5-ASA)

Outcome Measures

Primary Outcomes (4)

• 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

Secondary Outcomes (17)

• Demographic factors associated to the absence of deep remission

  week 0

• Disease characteristics associated to the absence of deep remission

  week 0

• Medical history associated to the absence of deep remission

  week 0

• Medication history associated to the absence of deep remission

  week 0

• Disease activity based on PRO-2 score associated to the absence of deep remission

  week 0

Study Arms (1)

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

Drug: 5-ASA

Interventions

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

UC patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Belgian Inflammatory Bowel Disease Research and Development (BIRD) VZW: lead
• Ferring Pharmaceuticals: collaborator

Study Sites (16)

Imelda Ziekenhuis

Bonheiden, Belgium

Location

Hôpital Erasme

Brussels, Belgium

Location

Universitair Ziekenhuis Antwerpen

Edegem, Belgium

Location

Ziekenhuis Oost-Limburg

Genk, Belgium

Location

AZ Sint-Lucas Gent

Ghent, Belgium

Location

Universitair Ziekenhuis Gent

Ghent, Belgium

Location

AZ Groeninge

Kortrijk, Belgium

Location

CHU de Liège - Site Sart Tilman

Liège, Belgium

Location

Groupe santé CHC Clinique du MontLégia

Liège, Belgium

Location

AZ Voorkempen Malle

Malle, Belgium

Location

AZ Damiaan

Ostend, Belgium

Location

AZ Delta

Roeselare, Belgium

Location

Sint-Andries ziekenhuis Tielt

Tielt, Belgium

Location

AZ Vesalius

Tongeren, Belgium

Location

AZ Turnhout

Turnhout, Belgium

Location

CHU UCL Namur -Site Mont Godinne

Yvoir, Belgium

Location

Related Links

• BIRD website

MeSH Terms

Conditions

Colitis, Ulcerative

Condition Hierarchy (Ancestors)

Colitis; Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Inflammatory Bowel Diseases; Colonic Diseases; Intestinal Diseases

Study Officials

• Catherine Reenaers, MD, PhD

  Study Principal Investigator

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: transversal study

Study Record Dates

• First Submitted: December 13, 2022
• First Posted: August 15, 2023
• Study Start: January 17, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: March 21, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

BE (16)