PRognOstiC valuE of rEd Density in Ulcerative Colitis

Completed

• Conditions: Ulcerative Colitis
• Interventions: Diagnostic Test: Red Density

• Registration Number: NCT04408703
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

Brief Summary

Observational prospective multicenter study: baseline assessement of the disease activity by an automated endoscopic tool and follow up of 52 weeks to evaluate sustained clinical remission.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-25
• Study First Submitted QC: 2020-05-25
• Study First Posted: 2020-05-29
• Study Start: 2020-08-03
• Primary Completion: 2021-06-01
• Study Completion: 2022-06-01
• Last Update Submitted: 2024-06-26
• Last Update Posted: 2024-06-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 243

Inclusion Criteria

• Confirmed diagnosis of UC for at least 3 months
• Clinical remission with SCCAI <3 at baseline and stable remission for the last 3 months
• Ability to give informed consent by the patient or legal representative in case of minority.

Exclusion Criteria

• Any contraindication for sigmoidoscopy or undergoing biopsies of the rectosigmoid.
• Uncontrolled coagulopathy.
• Any planned change in UC related treatment (both escalation and de-escalation) after the baseline endoscopy
• Planned UC related surgery
• Previous subtotal or total colectomy
• Short bowel, ileostomy or colostomy
• Pregnancy at baseline
• Age younger than 16 years

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Ulcerative colitis in clinical remission	Red Density	Clinical remission with SCCAI \<3 at baseline and stable remission for the last 3 months

Primary Outcome Measures

Name	Time	Method
sustained clinical remission	week 52	Number of patients with sustained clinical remission at week 52, defined as simple clinical colitis activity index (SCCAI) \<3 AND no need for initiation of new treatment, escalation of therapy, UC related hospitalization or colectomy correlated to the RD score at baseline.

Secondary Outcome Measures

Name	Time	Method
endoscopic remission UCEIS	week 52	Number of patients with UCEIS of 0 after 52 weeks correlated to the RD score at baseline.
endoscopic remission Mayo	week 52	Number of patients with Mayo endoscopic subscore of 0 after 52 weeks correlated to the RD score at baseline.

Trial Locations

Locations (2)

UZ Leuven; 🇧🇪 Leuven, Belgium

Imelda GI clinical research center; 🇧🇪 Bonheiden, Belgium