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Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis

Primary Purpose

Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
bowel ultrasound
colonoscopy
Sponsored by
IRCCS San Raffaele
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Ulcerative Colitis Chronic Moderate

Eligibility Criteria

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

Inclusion Criteria: Established diagnosis of UC since at least 8 weeks prior to inclusion Age ≥ 18 years Any gender/sex Active disease consistent with indication to start with systemic corticosteroids, biological agents or small molecules (defined as a patient-reported outcomes score, PRO > 2) Ability to understand and to comply with the study procedure and sign an informed consent form Exclusion Criteria: Subjects with inflammation restricted to the rectum (≤ 15 cm from the anal verge); Subjects with severe UC (defined as a Mayo global score > 12, requiring hospitalization); Subjects with an endoscopic Mayo sub-score at baseline <2; Subjects with a MUC at baseline < 6.2; Pregnancy Subjects with any contraindication to any study procedure.

Sites / Locations

  • Mariangela AlloccaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Other

Arm Label

study group: the bowel Ultrasound-based treat to target arm

control group: the routine Colonoscopy treat to target arm.

Arm Description

At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g AND/OR MUC > 6.2, treatment will be changed according to GCP and international guidelines.

At W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g, treatment will be changed according to GCP and international guidelines. If rectal bleeding > 0 + stool frequency > 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch.

Outcomes

Primary Outcome Measures

The primary objective is to evaluate the two strategies in terms of efficacy of bowel US-based strategy versus CS-based strategy in terms of remission.
Remission will be defined as global Mayo Score at week 52

Secondary Outcome Measures

Full Information

First Posted
January 27, 2023
Last Updated
February 9, 2023
Sponsor
IRCCS San Raffaele
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1. Study Identification

Unique Protocol Identification Number
NCT05735665
Brief Title
Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis
Official Title
Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
June 2023 (Anticipated)
Study Completion Date
January 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS San Raffaele

4. Oversight

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

5. Study Description

Brief Summary
UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life. Consensus guidelines recommend to go beyond resolution of clinical symptoms and achieve endoscopic remission. This long-term treatment goal in UC is commonly defined by a Mayo endoscopic subscore < 13, and is associated with prolonged clinical remission, lower rates of hospitalization and lower rates of colectomy. However, colonoscopy is an invasive and expensive procedure, unpleasant to patients, not without risks, especially during severe flares. Moreover, CS is time-consuming and expensive for the Healthcare System. Clinical symptoms correlate well with endoscopic findings, and their improvement together to normalization of FC, are currently considered the short-term and intermediate-term targets to achieve. However, while asymptomatic patients with FC < 50 mcg/g have < 5% probability to have endoscopic lesions, and conversely patients with evident rectal bleeding and persistent increased stool frequency (> 3 stools above baseline) with FC > 250 mcg/g have less than 5% chance to have endoscopic remission, in patients in the intermediate scenarios with stool frequency score (SFS) 2 or 3 or rectal bleeding score (RBS) > 0, with FC values between 50 and 250 mcg/g, the uncertainty increases and CS should not be avoided. Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice8. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process9. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC10,11. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1 Bowel US is a well-tolerated, non-invasive, patient friendly, cheap, easy-to-use tool to manage UC patients in clinical practice. In addition, its ability to be performed as point-of-care bowel US may drastically change frequency of the assessment of treatment response, speeding the clinical decision-making process. Recently, the investigators developed and externally validated non-invasive ultrasonography based criteria [Milan ultrasound criteria (MUC)] to assess and grade endoscopic activity in UC14,15. The investigators also confirmed that a MUC score > 6.2 is a valid cut-off to discriminate endoscopic activity, defined by a Mayo endoscopic subscore > 1.
Detailed Description
Prospective interventional randomized open-label study to validate the role of US-based treat-to-target strategies in the decision-making process in patients with UC. Patients seen at each participating center who are eligible for this study will be randomized 1:1 (computer generated randomization list) to enter one of two study arms up to Week 52: study group: the bowel US-based treat to target arm control group: the routine CS treat to target arm. At Week 52 ± 4, all patients in the two study arms will undergo CS, bowel US, PRO and FC as indicated for the screening phase. Patients will be followed up and will undergo the study procedures as described below: Bowel Ultrasound-based Treat to target arm At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g AND/OR MUC > 6.2, treatment will be changed according to the standard of care and international guidelines. Routine CS Treat to target arm At W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g, treatment will be changed according to the standard of care and guidelines. If rectal bleeding > 0 + stool frequency > 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch. The routine CS treat-to-target arm schedule is based on the recommendations of the STRIDE II. When appropriate, based on the investigator's judgement, CS can be replaced by a RSS. Since the two strategies are part of the standards of care, no additional procedures outside the current clinical practice will be used in this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
250 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
study group: the bowel Ultrasound-based treat to target arm
Arm Type
Experimental
Arm Description
At W12 ± 4 and W24 ± 4, subjects will perform FC and bowel US and PRO will be recorded. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g AND/OR MUC > 6.2, treatment will be changed according to GCP and international guidelines.
Arm Title
control group: the routine Colonoscopy treat to target arm.
Arm Type
Other
Arm Description
At W12 ± 4 and W24 ± 4, subjects will perform FC and PRO will be recorded for all patients. If rectal bleeding > 2 + stool frequency > 2 AND FC > 250 mcg/g, treatment will be changed according to GCP and international guidelines. If rectal bleeding > 0 + stool frequency > 2 AND FC will be ≥ 50 mcg/g and ≤ 250 mcg/g, a RSS will be done in order to decide any treatment switch.
Intervention Type
Diagnostic Test
Intervention Name(s)
bowel ultrasound
Intervention Description
Bowel US is a non-invasive tool which is able to measure intestinal inflammation by the use of emission of US from a specific probe. It is used externally, just moving the probe on the skin of the patient along the abdominal section. It does not require any contrast. The preparation used is just a fasting period of 6 hours.
Intervention Type
Diagnostic Test
Intervention Name(s)
colonoscopy
Intervention Description
Colonoscopy is an endoscopic procedure where a tube is inserted from the anus up to the ileum of the patient. It requires bowel cleansing with polyethilenglicole up to 4 liters (depending on the preparation and the desired grade of cleansing) the day before the examination. Because it may be painful, usually sedation is provided.
Primary Outcome Measure Information:
Title
The primary objective is to evaluate the two strategies in terms of efficacy of bowel US-based strategy versus CS-based strategy in terms of remission.
Description
Remission will be defined as global Mayo Score at week 52
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Established diagnosis of UC since at least 8 weeks prior to inclusion Age ≥ 18 years Any gender/sex Active disease consistent with indication to start with systemic corticosteroids, biological agents or small molecules (defined as a patient-reported outcomes score, PRO > 2) Ability to understand and to comply with the study procedure and sign an informed consent form Exclusion Criteria: Subjects with inflammation restricted to the rectum (≤ 15 cm from the anal verge); Subjects with severe UC (defined as a Mayo global score > 12, requiring hospitalization); Subjects with an endoscopic Mayo sub-score at baseline <2; Subjects with a MUC at baseline < 6.2; Pregnancy Subjects with any contraindication to any study procedure.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
MARIANGELA ALLOCCA
Phone
02 2643 2069
Email
allocca.mariangela@hsr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MARIANGELA ALLOCCA
Organizational Affiliation
IRCCS San Raffaele
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mariangela Allocca
City
Milano
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIANGELA ALLOCCA
Phone
0226432069
Email
allocca.mariangela@hsr.it

12. IPD Sharing Statement

Learn more about this trial

Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis

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