de-escalation group 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

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.

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

The goal of this study is to better understand treatment strategies for people with ulcerative colitis (UC). Researchers will compare patients with UC in histologic remission (no evidence of inflammation or active disease on endoscopy and biopsies) who continue to take medical therapy to patients with UC who de-escalate (decrease or discontinue) medical therapy. Both treatment strategies are considered within regular medical practice. Researchers want to find out whether remission can be maintained after de-escalation of therapy. Participants will be: * randomly assigned to continue medical therapy or de-escalate medical therapy * clinically managed according to regular medical care * asked to provide blood, stool (poop), and tissue samples for study purposes

Eligible Conditions

Ulcerative Colitis

Eligibility Criteria

Inclusion Criteria

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

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.