Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis
Ulcerative Colitis Chronic Moderate, Ulcerative Colitis Chronic Severe
About this trial
This is an interventional supportive care trial for Ulcerative Colitis Chronic Moderate
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.
Sites / Locations
- Mariangela AlloccaRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Other
study group: the bowel Ultrasound-based treat to target arm
control group: the routine Colonoscopy 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 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.