Distribution of Endoscopic and Histologic Healing in Ulcerative Colitis

Completed

• Conditions: inflammatory bowel disease; Ulcerative colitis; 10017969

• Registration Number: NL-OMON55788
• Lead Sponsor: Alimentiv Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 15 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 10

Inclusion Criteria

1. Male or nonpregnant, nonlactating females (18 to 75 years old)
2. Confirmed diagnosis of UC (established by conventional clinical, endoscopic,
and histologic diagnostic criteria)
3. Initiating therapy with infliximab, adalimumab, golimumab, vedolizumab, or
tofacitinib
4. Clinically active disease (defined as a MCS >= 6 with rectal bleeding
subscore (RBS) >= 1)
5. Endoscopically demonstrated pancolitis involving at minimum 4 colonic
segments (transverse colon, descending colon, sigmoid colon and rectum),
(defined by an MCS endoscopic subscore >= 1 in each colonic segment)
6. Provide written informed consent

Exclusion Criteria

1. Patients who have failed 2 or more biologic therapies OR who have failed
tofacitinib and 1 or more biologic therapies
2. Patients treated concurrently with rectal corticosteroids or rectal
aminosalicylates (enemas or suppositories)
3. Patients with incomplete colonoscopy not reaching the cecum
4. Patients with inadequate or inappropriately collected biopsy specimens at
baseline
5. Pregnant or lactating women

Study & Design

• Study Type: Observational invasive
• Study Design: Not specified