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Immunomodulator Strategy for Inflammatory Bowel Disease (QUOTIENT Trial)

N/A

Recruiting

Led By Siddharth Singh, MD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., tumour necrosis factor α [TNFα] antagonists, ustekinumab, vedolizumab) and small molecule inhibitors (e.g., Janus kinase inhibitors, ozanimod), including future TIMs that become commercially available during the conduct of the trial

Male or nonpregnant, nonlactating females, aged 18 to 80 years (inclusive)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up binary, 104 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial will compare the effectiveness of switching to a different immunomodulator drug versus continuing the same drug in patients with IBD who are in remission but have moderate to severe endoscopic inflammation.

Who is the study for?

Adults aged 18-80 with Crohn's Disease or Ulcerative Colitis, currently in symptomatic remission but still showing moderate to severe inflammation. They must be on a stable dose of an optimized targeted immunomodulator (TIM) therapy and not pregnant or breastfeeding. Excluded are those with ostomies, prior study enrollment, mild disease activity, serious non-IBD diseases, or substance abuse issues.

What is being tested?

The trial is testing whether switching to a different TIM therapy leads to endoscopic remission versus continuing the current TIM for IBD patients who are symptom-free but have significant inflammation. It will take place in a real-world setting and compare the effectiveness and safety of these strategies.

What are the potential side effects?

Potential side effects may include immune system reactions due to biologic agents like TNFα antagonists or small molecule inhibitors such as Janus kinase inhibitors. These can range from infections to allergic reactions and possibly liver toxicity.

Eligibility Criteria

Inclusion Criteria

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

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I am currently on medication for IBD, including biologics or small molecule inhibitors.

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I am a man or a woman not pregnant or breastfeeding, aged 18 to 80.

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I have been diagnosed with Crohn's disease or ulcerative colitis for at least 6 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ binary, 104 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~binary, 104 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and binary, 104 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Time to Treatment Failure

Secondary study objectives

Overall Quality of Life

Overall Safety

Time to each individual component of the composite

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups

Experimental Treatment

Group I: Switching Targeted Immunomodulators TreatmentExperimental Treatment1 Intervention

Participants randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the participants' insurance formulary as part of routine care, and at the discretion of the site investigator and treating provider. No study-related medications will be provided. For participants randomized to switch to an alternative TIM, selection of alternative agent will be determined at the discretion of the local site physician in accordance with clinical guidelines on the management of moderate to severe ulcerative colitis, and management of moderate to severe CD from the AGA and ACG.9, 34, 35 These guidelines include recommendations on positioning of TIMs for first line use (TIM-naïve patients) and second-line use (in patients with prior exposure to TIMs).

Group II: Continuing Index Targeted Immunomodulators TreatmentExperimental Treatment1 Intervention

Participants randomized to a strategy of continuing TIM will continue on their concomitant therapy.

0 / 3Eligibility criteria met