STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission

Launched by UNIVERSITY OF CHICAGO · Nov 14, 2024

Keywords

ClinConnect Summary

The STOP-UC clinical trial is studying how to manage treatment for people with ulcerative colitis (UC), a condition that causes inflammation in the colon. The researchers want to find out if patients who have shown no signs of active inflammation (called histological remission) can safely reduce or stop their medication without causing their condition to worsen. They will compare two groups: one group will continue their current treatment, while the other group will decrease or stop their medication. This trial aims to see if it’s possible to maintain a state of good health without the full medication regimen.

To participate in this trial, individuals must be between the ages of 18 and 75, have been diagnosed with UC for at least three years, and have been in a stable state of remission for at least six months. Participants will be randomly assigned to one of the two treatment groups and will receive regular medical care as part of the study. They will also need to provide samples of blood, stool, and tissue for further research. This trial is not yet recruiting participants, but it represents an important step in understanding how to safely manage UC treatment.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years.
• • 2. Patients in deep remission, defined by the absence of endoscopic and histologic signs of active inflammation (i.e. histological normalization or histological quiescence) in all biopsies obtained during colonoscopy, within the last 12 months.
• • 3. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission for at least 6 months.
• Exclusion Criteria:
• • 1. Any noted active inflammation \[clinical, sonographic, biochemical, endoscopic (in any colonic segment)\].
• • 2. Patients with any changes in therapy after colonoscopy showing histological normalization or quiescence.
• • 3. Corticosteroid use after colonoscopy showing histologic normalization or quiescence.
• • 4. Patients with any noted history of primary sclerosing cholangitis or dysplasia (suspected or confirmed).
• • 5. Inability to follow the proposed sample collection and monitoring protocol.