Therapy De-escalation for Ulcerative Colitis

N/A

Waitlist Available

Led By David T Rubin, MD

Research Sponsored by University of Chicago

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Consenting patients aged 18 to 75 years with an established diagnosis of ulcerative colitis (UC) for at least 3 years

Patients in clinical, biochemical (fecal calprotectin <100), radiologic and endoscopic remission for at least 6 months

Must not have

Patients with any noted history of primary sclerosing cholangitis or dysplasia (suspected or confirmed)

Any noted active inflammation (clinical, sonographic, biochemical, endoscopic in any colonic segment)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)

Awards & highlights

No Placebo-Only Group

Summary

This trial aims to understand how to best treat people with ulcerative colitis. They will compare patients who are in remission and continue their medication to those who decrease or stop their medication. The goal

Who is the study for?

This trial is for people with ulcerative colitis who show no signs of inflammation or active disease. They must be in histological remission, meaning their endoscopy and biopsies are clear. The study excludes details not provided.

What is being tested?

The STOP-UC trial compares two approaches: continuing current medical therapy versus decreasing or stopping it altogether for those in remission from ulcerative colitis. Participants will be randomly placed into one of these groups.

What are the potential side effects?

Since the side effects depend on the specific therapies used, they can range widely but may include typical medication reactions such as gastrointestinal discomfort, potential flare-ups if treatment is reduced, and other drug-specific risks.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am between 18 and 75 years old and have been diagnosed with ulcerative colitis for at least 3 years.

Select...

My inflammatory bowel disease has been in remission for at least 6 months.

Select...

My recent tests show no signs of active inflammation in my colon.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have a history of primary sclerosing cholangitis or dysplasia.

Select...

I have active inflammation in my colon.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months)

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, at the time points when deep remission is clinically confirmed (expected at scheduled assessments at 6, 12, 18, and 24 months) for reporting.