Therapy De-escalation for Ulcerative Colitis

Overseen By Research Coordinator

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Chicago

Must not be taking: Corticosteroids

Disqualifiers: Active inflammation, Primary sclerosing cholangitis, Dysplasia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 24 months

200 Participants Needed

Trial Summary

What is the purpose of this trial?

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

Will I have to stop taking my current medications?

The trial involves some participants continuing their current medications while others may decrease or stop them. It doesn't specify if you must stop your medications, but you might be assigned to either group.

What data supports the effectiveness of de-escalation of therapy for ulcerative colitis?

There is no direct evidence supporting the effectiveness of de-escalation of therapy for ulcerative colitis, but studies on similar treatments suggest that dose escalation is often needed to maintain effectiveness, indicating that de-escalation might not be beneficial without further research. ^{1 2 3 4 5}

Is therapy de-escalation for ulcerative colitis safe?

De-escalation of therapy for ulcerative colitis, which involves reducing or stopping medication once remission is achieved, is considered safe when done carefully. It is important to monitor patients closely to manage any potential risks, as some medications can have significant side effects if used indefinitely. ^{6 7 8 9 10}

How is the treatment de-escalation for ulcerative colitis different from other treatments?

The treatment de-escalation for ulcerative colitis is unique because it involves reducing the dosage or stopping certain medications once remission (a period without symptoms) is achieved, aiming to minimize side effects and costs while maintaining disease control. This approach is different from standard treatments that often involve continuous medication use. ^{2 7 11 12 13}

Research Team

David T Rubin, MD

Principal Investigator

University of Chicago

Eligibility Criteria

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.

Inclusion Criteria

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

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

Exclusion Criteria

My treatment changed after a colonoscopy showed my colon is now normal or inactive.

I am using corticosteroids after my colonoscopy showed normal or inactive disease.

I have a history of primary sclerosing cholangitis or dysplasia.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are randomized to either de-escalation of therapy or continuation of current therapy and monitored for 24 months

24 months

Regular visits as per clinical practice

Follow-up

Participants who remain in remission will continue 5 years of longitudinal data collection from routine clinical care

5 years

Treatment Details

Interventions

• De-escalation of Therapy

Trial Overview 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.

Participant Groups

Group I: de-escalation group Active Control 1 Intervention

de-escalation or discontinuation of therapy

Group II: Control group Active Control 1 Intervention

continuation of current therapy

Who Is Running the Clinical Trial?

University of Chicago

Lead Sponsor

Trials

1,086

Recruited

844,000+

Findings from Research

A systematic review of 83 randomized controlled trials involving 17,737 patients with ulcerative colitis revealed significant variability in the definitions of clinical response and remission, with over 50 different definitions used.

Despite advancements in trial design, there is a need for a standardized core outcome set to improve the consistency of efficacy and safety reporting in clinical trials for ulcerative colitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set. Ma, C., Panaccione, R., Fedorak, RN., et al.[2019]

A systematic review of seven randomized controlled trials involving biologic drugs for ulcerative colitis found no significant differences in the rate of adverse events among adalimumab, golimumab, and vedolizumab during the induction phase, and infliximab, adalimumab, golimumab, and vedolizumab during the maintenance phase.

Vedolizumab showed the most favorable safety profile during the induction phase, while infliximab was favored during the maintenance phase, suggesting that while all biologics are generally safe, some may have advantages in specific treatment phases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis. Moćko, P., Kawalec, P., Pilc, A.[2018]

Anti-TNF therapies have significantly improved outcomes for patients with inflammatory bowel disease (IBD), but issues like primary failure and side effects can limit their long-term use.

New targeted therapies are emerging that may offer better safety profiles and the potential for combination treatments, but more research is needed to determine their optimal use and long-term safety in managing IBD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

IBD therapeutics: what is in the pipeline? Toskas, A., Akbar, A.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Lack of benefit for early escalation to advanced therapies in ulcerative colitis: critical appraisal of current evidence. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Incidence and Predictors of Success of Adalimumab Dose Escalation and De-escalation in Ulcerative Colitis: a Real-World Belgian Cohort Study. [2019]

3. England pubmed.ncbi.nlm.nih.gov

Dose Escalation of Biologics in Biologic-Naïve Patients With Ulcerative Colitis: Outcomes From the ODESSA-UC Study. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Ulcerative colitis: an update. [2021]

5. England pubmed.ncbi.nlm.nih.gov

Dose escalation and switching of biologics in ulcerative colitis: a systematic literature review in real-world evidence. [2020]

6. United States pubmed.ncbi.nlm.nih.gov

Heterogeneity in Definitions of Endpoints for Clinical Trials of Ulcerative Colitis: A Systematic Review for Development of a Core Outcome Set. [2019]

7. Netherlands pubmed.ncbi.nlm.nih.gov

De-escalation of immunomodulator and biological therapy in inflammatory bowel disease. [2020]

8. United States pubmed.ncbi.nlm.nih.gov

Safety Profile of Biologic Drugs in the Therapy of Ulcerative Colitis: A Systematic Review and Network Meta-Analysis. [2018]

9. England pubmed.ncbi.nlm.nih.gov

Safety and Monitoring of Inflammatory Bowel Disease Advanced Therapies. [2023]

10. England pubmed.ncbi.nlm.nih.gov

IBD therapeutics: what is in the pipeline? [2023]

11. United States pubmed.ncbi.nlm.nih.gov

De-escalation from Dose-Intensified Anti-TNF Therapy Is Successful in the Majority of IBD Patients at 12 Months. [2022]

12. England pubmed.ncbi.nlm.nih.gov

De-escalation of biological therapy in inflammatory bowel disease patients following prior dose escalation. [2023]

13. United States pubmed.ncbi.nlm.nih.gov

A User's Guide to De-escalating Immunomodulator and Biologic Therapy in Inflammatory Bowel Disease. [2021]