inflammatory bowel disease Ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Alimentiv Inc.
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • To determine the anatomic distribution of endoscopic improvement in UC patients with pancolitis treated with biologic or tofacitinib therapies. Improvement will be defined as any decrease of outcome scores form baseline to post-treatment assessment. o Measured by central reading of the Mayo Clinic Score (MCS) endoscopic subscore, Ulcerative Colitis Endoscopic Index of Severity (UCEIS), and visual analog scale (VAS), before and after biologic or tofacitinib induction therapy in at minimum 4 colonic segments (transverse colon, descending colon, sigmoid colon, rectum) • To determine the anatomic distribution of histologic improvement in UC patients with pancolitis treated with biologic or tofacitinib therapies. Improvement will be defined as any decrease of outcome scores from baseline to post-treatment assessment. o Measured by central reading of the Robarts Histopathology Index (RHI), Nancy Histological Index (NHI), and Geboes Score (GS), before and after biologic or tofacitinib induction therapy in at minimum 4 colonic segments (transverse colon, descending colon, sigmoid colon, rectum) | — |
Secondary
| Measure | Time frame |
|---|---|
| • Proportion of patients achieving endoscopic remission in all colonic segments except the distal colon, defined as: 1) endoscopic Mayo Clinic Score (MCS) = 0; 2) endoscopic MCS = 0 of 1; or 3) Ulcerative Colitis Endoscopic Index of Severity UCEIS = 1-point compared to baseline • Proportion of patients achieving histologic remission, defined as: 1) Robarts Histopathology Index (RHI) = 1-point reduction in NHI • To determine if there is a correlation between the distribution and extent of endoscopic and histologic changes with changes in levels of fecal calprotectin in UC patients with pancolitis. | — |
Countries
Netherlands
Outcome results
None listed