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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

QUOTIENT Trial 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.Check my eligibility

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.See study design

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.

QUOTIENT Trial 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.

QUOTIENT Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Time to Treatment Failure

Secondary outcome measures

Overall Quality of Life

Overall Safety

Time to each individual component of the composite

+2 more

QUOTIENT 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

Find a Location

Who is running the clinical trial?

Baylor College of MedicineOTHER

1,001 Previous Clinical Trials

6,002,002 Total Patients Enrolled

Crohn's and Colitis FoundationOTHER

43 Previous Clinical Trials

27,647 Total Patients Enrolled

University of California, San DiegoLead Sponsor

1,121 Previous Clinical Trials

1,521,175 Total Patients Enrolled

Media Library

Pragmatic Clinical Trial Eligibility Overview. Trial Name: NCT05230173 — N/A

Crohn's Disease Research Study Groups: Switching Targeted Immunomodulators Treatment, Continuing Index Targeted Immunomodulators Treatment

Crohn's Disease Clinical Trial 2023: Pragmatic Highlights & Side Effects. Trial Name: NCT05230173 — N/A

Pragmatic 2023 Treatment Timeline for Medical Study. Trial Name: NCT05230173 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are individuals over three decades of age allowed to participate in this clinical experiment?

"According to the trial parameters, individuals between 18 and 80 are eligible for this clinical study. Additionally, there are 91 trials exclusively for those under 18 years old and 300 specifically designed for patients over 65."

Answered by AI

Am I eligible to participate in the research project?

"This clinical trial is seeking to enrol 478 patients between 18 and 80 years of age who are diagnosed with ileocolitis. To qualify, participants must have had a stable dosage of TIM for at least three months prior to the qualifying endoscopy/radiology; they should be eligible for an alternative form of treatment (not including their index TIM) based on approved labels; they need to be male or non-pregnant females; they require a diagnosis that has been established in them for six months minimum confirmed by their doctor; either remain on maximal dose during maintenance therapy under routine care or have undergone TDM within 6 months prior"

Answered by AI

Are there still opportunities for individuals to participate in the research?

"According to the clinicaltrials.gov records, this research project is not presently accepting applications from prospective participants. It was originally published on July 1st 2022 and most recently updated on June 9th 2022. However, there are 380 other trials actively seeking volunteers at present."

Answered by AI

How many North American sites are currently conducting the trial?

"Patients are being enrolled in this trial at the University of Rochester (Rochester, NY), Dartmouth Hitchcock (Lebanon, NH) and University of Utah Health (Salt Lake City, UT) as well as 21 additional sites."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission

Siddharth Singh 2022. "Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05230173.

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