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

August 4, 2026 updated by: Sid Singh, Mayo Clinic
The purpose of this study is to compare the effectiveness and safety of a strategy of switching to an alternative targeted immunomodulator (TIM) therapy to treat to a target of endoscopic remission, versus continuing index TIM in patients with inflammatory bowel disease (IBD) (Crohn's disease or ulcerative colitis [UC]) in symptomatic remission with moderate to severe endoscopic inflammation despite optimization of index TIM in a real-world setting.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This is a pragmatic, open-label, multicenter randomized control trial (RCT) conducted in asymptomatic patients with IBD who have persistent moderate to severe endoscopic inflammation despite optimization of index TIM. This study plans to recruit approximately 216 participants in the United States, who will either switching to treatment with alternative TIM to treat to a target of endoscopic remission or continue index optimized TIM. After randomization, patients will be followed prospectively within routine clinical practice for up to 2 years (104 weeks); 156 patients will be followed for the full 104 weeks, whereas 60 patients will be followed for a variable time period between 52 to 104 weeks. This trial will be conducted within select active sites in the United States and Canada

The primary outcome will be time from randomization to treatment failure, as a composite of:

  1. Moderate severe symptomatic relapse based on PRO2 (2-item patient reported outcome), with objective confirmation of inflammation within 2 months of event (fecal calprotectin [FC] >150 mcg/g, or C reactive protein [CRP] >5mg/L, or endoscopy showing moderate-severe inflammation, or magnetic resonance enterography (MRE)/computed tomography enterography (CTE)/intestinal ultrasound (IUS) showing active inflammation) with need for escalation of therapy;
  2. Need for rescue therapy with corticosteroids for a documented symptomatic IBD flare;
  3. IBD related hospitalization;
  4. IBD-related surgery;
  5. IBD-related structural complications (CD: symptomatic stricture, fistula or abscess; UC: symptomatic stricture);
  6. Treatment-emergent adverse event requiring drug discontinuation.

Secondary outcomes will include time from randomization to each of the components in the primary outcome, quality of life (overall quality of life, fatigue, IBD-related disability), burden of treatment (financial burden, burden of monitoring, treatment side effects), treatment satisfaction, and safety.

In compliance with the pragmatic methodology of this study embedded in routine clinical care, there is no study visit mandated per study protocol. Participant visit schedules will follow local SOC with any additional visits at the treating physician's discretion. Data on all effectiveness, treatment burden and safety outcomes will be captured using a REDCap (Research Electronic Data Capture) database hosted at CCF. Data for the study will be extracted from medical record information and entered into the EDC system at baseline and then approximately every 6 months (at a minimum) thereafter, up to a 2-year follow-up period. Patient-reported outcome (PRO) measures (self-assessment questionnaires) will be utilized in this study to determine primary (efficacy) and secondary (quality of life and treatment burden and satisfaction) outcomes. Participants will complete the PRO2 at baseline and approximately every 12 weeks during the up to 2-year follow-up period; additional questionnaires (IBD-Control, PROMIS-7, Short Inflammatory Bowel Disease Questionnaire [SIBDQ], IBD Disability Index [IBD-DI], Treatment Burden Questionnaire, and Treatment Satisfaction Questionnaire for Medication) will be completed at baseline (following randomization) and up to 3 more additional times during the up to 2-year follow-up period.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Jason Hou, MD
  • Phone Number: 713-798-8220
  • Email: jkhou@bcm.edu

Study Contact Backup

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259
        • Recruiting
        • Mayo Clinic Arizona
        • Principal Investigator:
          • Siddharth Singh, MD
        • Contact:
          • Siddharth Singh, MD
          • Phone Number: 480-301-8000
    • California
      • Irvine, California, United States, 92618
        • Recruiting
        • Hoag Hospital
        • Contact:
          • Caroline Hwang, MD
        • Principal Investigator:
          • Caroline Hwang, MD
      • La Jolla, California, United States, 92037
        • Recruiting
        • UC San Diego Health
        • Contact:
          • Brigid Boland, MD
          • Phone Number: 858-657-7000
        • Principal Investigator:
          • Brigid Boland, MD
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai
        • Contact:
          • Gil Melmed, MD
          • Phone Number: 310-423-4100
        • Principal Investigator:
          • Gil Melmed, MD
      • Palo Alto, California, United States, 94301
        • Recruiting
        • Sutter Health
        • Contact:
          • Ryan McConnell, MD
          • Phone Number: 484-995-1640
        • Principal Investigator:
          • Ryan McConnell, MD
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Recruiting
        • University of Colorado
        • Contact:
          • Mark Gerich, MD
          • Phone Number: 303-724-7244
        • Principal Investigator:
          • Mark Gerich, MD
    • Connecticut
      • New Haven, Connecticut, United States, 06510
        • Recruiting
        • Yale University
        • Contact:
          • Jill Gaidos, MD
          • Phone Number: 203-785-4138
        • Principal Investigator:
          • Jill Gaidos, MD
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20007
        • Recruiting
        • MedStar Georgetown University Hospital
        • Contact:
          • Mark Mattar, MD
          • Phone Number: 202-444-4898
        • Principal Investigator:
          • Mark Mattar, MD
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Recruiting
        • Mayo Clinic Jacksonville
        • Contact:
          • Jana Al Hashash, MD
          • Phone Number: 904-953-0131
        • Principal Investigator:
          • Jana Al Hashash, MD
      • Orlando, Florida, United States, 32804
        • Recruiting
        • Advent Health
        • Principal Investigator:
          • Jennifer Seminerio-Diehl, MD
        • Contact:
          • Jennifer Seminerio-Diehl, MD
          • Phone Number: 407-303-9921
    • Illinois
      • Chicago, Illinois, United States, 60637
        • Recruiting
        • University of Chicago Medicine
        • Principal Investigator:
          • David Rubin, MD
        • Contact:
          • David Rubin, MD
          • Phone Number: 773-702-2950
    • New Hampshire
      • Lebanon, New Hampshire, United States, 03756
        • Recruiting
        • Dartmouth Hitchcock
        • Contact:
          • Corey Siegel, MD
          • Phone Number: 603-650-5261
        • Principal Investigator:
          • Corey Siegel, MD
    • New York
      • Burnt Hills, New York, United States, 12027
        • Recruiting
        • Saratoga Schenectady Gastroenterology Associates
        • Contact:
          • Mark Metwally, MD
          • Phone Number: 518-831-1500
        • Principal Investigator:
          • Mark Metwally, MD
      • New York, New York, United States, 10016
        • Recruiting
        • NYU Langone Health
        • Contact:
          • David Hudesman, MD
          • Phone Number: 855-698-4232
        • Principal Investigator:
          • David Hudesman, MD
      • New York, New York, United States, 10021
        • Recruiting
        • Cornell University
        • Principal Investigator:
          • Dana Lukin, MD
        • Contact:
          • Dana Lukin, MD
          • Phone Number: 212-746-5077
      • Rochester, New York, United States, 14642
        • Terminated
        • University of Rochester
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Active, not recruiting
        • Hightower Clinical
    • Oregon
      • Portland, Oregon, United States, 97220
        • Withdrawn
        • Oregon Clinic
    • Rhode Island
      • Providence, Rhode Island, United States, 02904
        • Recruiting
        • Gastroenterology Associates
        • Principal Investigator:
          • Samir Shah, MD
        • Contact:
          • Samir Shah, MD
          • Phone Number: 401-274-4800
    • Tennessee
      • Germantown, Tennessee, United States, 38138
        • Withdrawn
        • GastroOne
    • Texas
      • Dallas, Texas, United States, 75235
        • Recruiting
        • University of Texas Southwestern
        • Contact:
          • David Fudman, MD
          • Phone Number: 214-645-6355
        • Principal Investigator:
          • David Fudman, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Baylor College of Medicine
        • Contact:
          • Jason Hou, MD
          • Phone Number: 713-798-8220
        • Principal Investigator:
          • Jason Hou, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah Health
        • Contact:
          • Ann Flynn, MD
          • Phone Number: 801-587-7678
        • Principal Investigator:
          • Ann Flynn, MD
    • Virginia
      • Charlottesville, Virginia, United States, 22908
        • Withdrawn
        • University of Virginia

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

INCLUSION CRITERIA:

Participants must meet all of the following criteria for enrolment into the study.

  1. Male or nonpregnant, nonlactating females, ≥ 18 years of age.
  2. An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.
  3. Current treatment with an approved TIM for treatment of IBD, including biologic agents (e.g., 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.
  4. Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy/radiology. No treatment escalation of TIM or addition of IMM, corticosteroid, or mesalamines after the qualifying endoscopy/radiology procedure up to randomization is permitted. Dose de-escalation after qualifying procedure is permissible at the discretion of the treating provider.

  5. In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experiencing no other IBD-related symptoms in the opinion of the treating provider. Includes patients who may be in medically induced remission (on index TIM); or surgically induced remission with post-op initiation of index TIM for prophylaxis and colonoscopy/imaging performed at least 3 months after initiation/optimization of TIM showing moderate-severe bowel inflammation. Validated PROs are defined as:

    1. CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or
    2. UC: PRO2, with absence of rectal bleeding (rectal bleeding score = 0) and with stool frequency score ≤1.

  6. Evidence of moderate to severe bowel inflammation on local reading of colonoscopy, flexible sigmoidoscopy, balloon-assisted enteroscopy, capsule endoscopy or MR, CT enterography, or intestinal ultrasound, performed within 6 months prior to screening, defined at the investigator's discretion or as follows:

    1. CD: Colonoscopy showing moderately to severely active inflammation based on 1 of the following variables/scores:

      • Simple Endoscopic Score for Crohn's Disease (SES-CD) score ≥7 or score ≥4 for those with isolated ileal disease, or
      • Presence of mucosal ulcers >5 mm in size if SES-CD has not been recorded, or
      • Simplified Endoscopic Mucosal Assessment for Crohn's Disease (SEMA-CD) score ≥2, or
      • Rutgeerts score i2b or higher for patients in surgically induced remission with post-operative endoscopic recurrence [Note, either SES-CD or Rutgeerts score can be used for participants with post-operative recurrence]; or

    2. CD: MRE or CTE showing moderately to severely active inflammation based on 1 of the following variables:

      • Increased bowel wall thickness, or
      • Mural hyperenhancement, or
      • Peri-enteric fat stranding, or
      • Radiographic features of ulceration, or
      • Intramural T2 signal on fat suppressed images; or
    3. CD: Capsule endoscopy showing moderately to severely active small bowel disease based on Lewis score >790 (in case the disease is not accessible via endoscopy), or per local endoscopist if Lewis score is not reported; or

    4. CD: Gastrointestinal ultrasound showing at least 1 of the following variables:

      • Increased bowel wall thickness >5 mm, or
      • Color doppler score >5/cm2, or
      • Bowel stenosis, or
      • Bowel stratification, or
      • Fatty wrapping; or
    5. UC: modified MES score of 2 to 3, or documentation of any endoscopic feature that would define an MES of 2 to 3 (e.g., friability, ulceration, spontaneous bleeding, complete loss of vascular pattern), if an MES has not been recorded.
  7. Eligible to receive at least 1 alternative TIM (excluding their index TIM) for the treatment of their disease per approved drug label, based on clinical and reimbursement guidelines.
  8. Able to participate fully in all aspects of this clinical trial.
  9. Informed consent must be obtained and documented.

EXCLUSION CRITERIA:

Participants who exhibit any of the following conditions are to be excluded from the study.

  1. Presence of ostomy or ileoanal pouches.
  2. Serious underlying disease other than UC or CD that in the opinion of the investigator may interfere with the participant's ability to participate fully in the study.
  3. History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the participant's ability to comply with the study procedures.
  4. Prior enrolment in the current study.
  5. Mild endoscopic disease activity, where treating providers would not consider switching TIM.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Switching Targeted Immunomodulators Treatment

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).
Other: Pragmatic

Patients randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the patients' 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.

Patients (and their providers) in either treatment arm will be allowed to stop or start new TIMs and other IBD-directed therapies in case of symptomatic relapse or intolerance to therapies, at the discretion of the treating provider-patient team.
Other: Continuing Index Targeted Immunomodulators Treatment
Participants randomized to a strategy of continuing TIM will continue on their concomitant therapy.
Other: Pragmatic

Patients randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the patients' 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.

Patients (and their providers) in either treatment arm will be allowed to stop or start new TIMs and other IBD-directed therapies in case of symptomatic relapse or intolerance to therapies, at the discretion of the treating provider-patient team.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to Treatment Failure
Time Frame: From randomization up to 104 weeks
Time to treatment failure, as a composite of: (1) moderate severe symptomatic relapse based on PRO2, with objective confirmation of inflammation within 2 months of event (FC >250 mcg/g, or CRP >5mg/L, or endoscopy showing moderate-severe inflammation, or MRE/CTE/IUS showing active inflammation) with need for escalation of therapy; (2) need for rescue therapy with corticosteroids for a documented symptomatic IBD flare; (3) IBD related hospitalization; (4) IBD-related surgery; (5) IBD-related structural complications (CD: symptomatic stricture, fistula or abscess; UC: symptomatic stricture); (6) treatment-emergent adverse event requiring drug discontinuation
From randomization up to 104 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time to each individual component of the composite primary outcome
Time Frame: From randomization up to 104 weeks
Time to each individual component of the composite primary outcome
From randomization up to 104 weeks
Treatment failure as defined in the composite primary outcome
Time Frame: Binary, up to 104 weeks
Treatment failure as defined in the composite primary outcome
Binary, up to 104 weeks
Overall Quality of Life
Time Frame: Continuous, up to 104 weeks or Early Discontinuation
A) Scores of the SIBDQ. B) Scores of the IBD-Control. C) Scores of the PROMIS 7 scale. D) Scores of the on IBD-DI.
Continuous, up to 104 weeks or Early Discontinuation
Treatment Burden/Satisfaction
Time Frame: Continuous, up to 104 weeks or Early Discontinuation

A) Scores of Treatment Burden Questionnaire, including medication, time and administrative, lifestyle change, social life and financial burden.

B) Scores of Treatment Satisfaction Questionnaire for Medication, measuring treatment satisfaction across domains of effectiveness, side effects, convenience and global satisfaction.

C) Scores of the CoPaQ, including out-of-pocket costs, for management of IBD, including treatment, monitoring, outpatient visits, and any unplanned healthcare utilization.
Continuous, up to 104 weeks or Early Discontinuation
Overall Safety
Time Frame: Continuous, up to 104 weeks or Early Discontinuation
A) Treatment-related serious adverse events (SAEs) or unexpected SAEs. B) Serious infections, defined as infections requiring hospitalization and/or intravenous antibiotics.
Continuous, up to 104 weeks or Early Discontinuation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Collaborators

Patient-Centered Outcomes Research Institute
Baylor College of Medicine
Western University
Crohn's and Colitis Foundation

Investigators

  • Principal Investigator: Siddharth Singh, MD, Mayo Clinic

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 5, 2022

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

February 1, 2029

Study Registration Dates

First Submitted

January 27, 2022

First Submitted That Met QC Criteria

January 27, 2022

First Posted (Actual)

February 8, 2022

Study Record Updates

Last Update Posted (Actual)

August 7, 2026

Last Update Submitted That Met QC Criteria

August 4, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RCT01519

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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