STOP-UC: De-escalation of Therapy in Patients With Ulcerative Colitis With Histological Remission
NCT ID: NCT06693310
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
200 participants
INTERVENTIONAL
2025-11-30
2027-11-30
Brief Summary
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Participants will be:
* either be randomly assigned to continue medical therapy or de-escalate medical therapy -OR- be assigned per the participant's preference
* clinically managed according to regular medical care
* asked to provide blood, stool (poop), and tissue samples for study purposes
Detailed Description
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Subjects will be given a choice to either de-escalate their therapy (de-escalation group) or continue their current therapy (control group). This study design is to enhance the feasibility and real-world applicability. By permitting participants with strong preferences to choose their assigned strategy, we anticipate higher enrollment and retention among eligible subjects who might otherwise decline participation. Participants without a clear preference will be randomized 1:1 to de-escalation versus continuation, thereby preserving the integrity of comparative analyses. This approach enhances generalizability, respects patient autonomy, and mirrors clinical decision-making in routine clinical practice while maintaining methodological rigor.
After enrollment, participants will be monitored for 24 months. After the 24-month period, participants who remain in remission will continue 5 years of longitudinal data collection from routine clinical care.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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Control group
continuation of current therapy
continuation of current therapy
continuation of current maintenance medical therapy for ulcerative colitis
de-escalation group
de-escalation or discontinuation of therapy
de-escalation or discontinuation of therapy
De-escalation of therapy, defined as a step-down from maintenance with advanced therapy (biologic or synthetic small molecule) to oral aminosalicylate-based therapy or complete discontinuation of therapy if they are allergic or intolerant to aminosalicylate-based therapy. If patients are receiving immunomodulator or oral aminosalicylate maintenance therapy, they will be de-escalated to complete discontinuation of therapy.
Interventions
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de-escalation or discontinuation of therapy
De-escalation of therapy, defined as a step-down from maintenance with advanced therapy (biologic or synthetic small molecule) to oral aminosalicylate-based therapy or complete discontinuation of therapy if they are allergic or intolerant to aminosalicylate-based therapy. If patients are receiving immunomodulator or oral aminosalicylate maintenance therapy, they will be de-escalated to complete discontinuation of therapy.
continuation of current therapy
continuation of current maintenance medical therapy for ulcerative colitis
Eligibility Criteria
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Inclusion Criteria
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.
* If the most recent colonoscopy is within the last 3 years and demonstrates normalized/quiescent pathology findings (i.e., patient is in stable remission), the patient would not be expected to undergo yearly colonoscopies. Therefore, a persistent normalized calprotectin test will be accepted as sufficient to define deep remission with no change in therapy.
3. Patients in clinical, biochemical (fecal calprotectin \<100), radiologic and endoscopic remission since the last colonoscopy.
Exclusion Criteria
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 invisible or unresected high-grade dysplasia (suspected or confirmed).
5. Pregnancy or actively trying to conceive
6. Inability to follow the proposed sample collection and monitoring protocol.
18 Years
75 Years
ALL
No
Sponsors
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University of Chicago
OTHER
Responsible Party
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Principal Investigators
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David T Rubin, MD
Role: PRINCIPAL_INVESTIGATOR
University of Chicago
Locations
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University of Chicago
Chicago, Illinois, United States
Countries
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Central Contacts
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Other Identifiers
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IRB24-0008
Identifier Type: -
Identifier Source: org_study_id