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Ulcerative ColitisQUOTIENTNCT05230173

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

A study testing Pragmatic in people with Ulcerative Colitis and Crohn Disease, run by Mayo Clinic at 24 sites in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Ulcerative Colitis, Crohn Disease
What is being tested?
Pragmatic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
216 participants
Where
24 sitesUnited States
Study dates
5 Oct 2022to 1 Feb 2029
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participants must meet all of the following criteria for enrolment into the study.
  • Male or nonpregnant, nonlactating females, ≥ 18 years of age.
  • An established diagnosis of CD or UC for at least 6 months based on standard clinical criteria, confirmed by the treating provider.
  • 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.
  • 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.
  • 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:
Show all 31Show fewer
  • CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or
  • UC: PRO2, with absence of rectal bleeding (rectal bleeding score = 0) and with stool frequency score ≤1.
  • 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:
  • 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
  • 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
  • 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
  • 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
  • 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.
  • 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.
  • Able to participate fully in all aspects of this clinical trial.
  • Informed consent must be obtained and documented.

Who cannot join

  • Participants who exhibit any of the following conditions are to be excluded from the study.
  • Presence of ostomy or ileoanal pouches.
  • 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.
  • 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.
  • Prior enrolment in the current study.
  • Mild endoscopic disease activity, where treating providers would not consider switching TIM.

Trial locations and contacts

24 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Siddharth Singh, MD contact

480-301-8000

singh.siddharth@mayo.edu

Jason Hou, MD contact

713-798-8220

jkhou@bcm.edu

24 sites in 1 country

United States24 sites, 19 recruiting

  • University of Colorado

    Aurora, Colorado, 80045

    Mark Gerich, MD, 303-724-7244

    Mark Gerich, MD

    Recruiting

  • Saratoga Schenectady Gastroenterology Associates

    Burnt Hills, New York, 12027

    Mark Metwally, MD, 518-831-1500

    Mark Metwally, MD

    Recruiting

  • University of Virginia

    Charlottesville, Virginia, 22908

    Withdrawn

  • University of Chicago Medicine

    Chicago, Illinois, 60637

    David Rubin, MD, 773-702-2950

    David Rubin, MD

    Recruiting

  • University of Texas Southwestern

    Dallas, Texas, 75235

    David Fudman, MD, 214-645-6355

    David Fudman, MD

    Recruiting

  • GastroOne

    Germantown, Tennessee, 38138

    Withdrawn

  • Baylor College of Medicine

    Houston, Texas, 77030

    Jason Hou, MD, 713-798-8220

    Jason Hou, MD

    Recruiting

  • Hoag Hospital

    Irvine, California, 92618

    Caroline Hwang, MD

    Caroline Hwang, MD

    Recruiting

  • Mayo Clinic Jacksonville

    Jacksonville, Florida, 32224

    Jana Al Hashash, MD, 904-953-0131

    Jana Al Hashash, MD

    Recruiting

  • UC San Diego Health

    La Jolla, California, 92037

    Brigid Boland, MD, 858-657-7000

    Brigid Boland, MD

    Recruiting

  • Dartmouth Hitchcock

    Lebanon, New Hampshire, 03756

    Corey Siegel, MD, 603-650-5261

    Corey Siegel, MD

    Recruiting

  • Cedars-Sinai

    Los Angeles, California, 90048

    Gil Melmed, MD, 310-423-4100

    Gil Melmed, MD

    Recruiting

  • Yale University

    New Haven, Connecticut, 06510

    Jill Gaidos, MD, 203-785-4138

    Jill Gaidos, MD

    Recruiting

  • NYU Langone Health

    New York, New York, 10016

    David Hudesman, MD, 855-698-4232

    David Hudesman, MD

    Recruiting

  • Cornell University

    New York, New York, 10021

    Dana Lukin, MD, 212-746-5077

    Dana Lukin, MD

    Recruiting

  • Hightower Clinical

    Oklahoma City, Oklahoma, 73102

    Active, not recruiting

  • Advent Health

    Orlando, Florida, 32804

    Jennifer Seminerio-Diehl, MD, 407-303-9921

    Jennifer Seminerio-Diehl, MD

    Recruiting

  • Sutter Health

    Palo Alto, California, 94301

    Ryan McConnell, MD, 484-995-1640

    Ryan McConnell, MD

    Recruiting

  • Oregon Clinic

    Portland, Oregon, 97220

    Withdrawn

  • Gastroenterology Associates

    Providence, Rhode Island, 02904

    Samir Shah, MD, 401-274-4800

    Samir Shah, MD

    Recruiting

  • University of Rochester

    Rochester, New York, 14642

    Terminated

  • University of Utah Health

    Salt Lake City, Utah, 84132

    Ann Flynn, MD, 801-587-7678

    Ann Flynn, MD

    Recruiting

  • Mayo Clinic Arizona

    Scottsdale, Arizona, 85259

    Siddharth Singh, MD, 480-301-8000

    Siddharth Singh, MD

    Recruiting

  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Mark Mattar, MD, 202-444-4898

    Mark Mattar, MD

    Recruiting

Other trials in United States

About this study

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.

Read the 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.

Being tested
Pragmatic
Medical subject headings
Colitis, Ulcerative, Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • PragmaticOther

    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.

Study groups in NCT05230173
Study groupRoleWhat they receive
Switching Targeted Immunomodulators TreatmentOtherParticipants 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).
Receives: Other: Pragmatic
Continuing Index Targeted Immunomodulators TreatmentOtherParticipants randomized to a strategy of continuing TIM will continue on their concomitant therapy.
Receives: Other: Pragmatic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Time to Treatment Failure

    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

    Measured: From randomization up to 104 weeks

Secondary outcomes (5)

  1. Treatment failure as defined in the composite primary outcome

    Treatment failure as defined in the composite primary outcome

    Measured: Binary, up to 104 weeks

  2. Time to each individual component of the composite primary outcome

    Time to each individual component of the composite primary outcome

    Measured: From randomization up to 104 weeks

  3. Overall Quality of Life

    1. Scores of the SIBDQ. B) Scores of the IBD-Control. C) Scores of the PROMIS 7 scale. D) Scores of the on IBD-DI.

    Measured: Continuous, up to 104 weeks or Early Discontinuation

  4. Treatment Burden/Satisfaction

    1. Scores of Treatment Burden Questionnaire, including medication, time and administrative, lifestyle change, social life and financial burden.
    2. Scores of Treatment Satisfaction Questionnaire for Medication, measuring treatment satisfaction across domains of effectiveness, side effects, convenience and global satisfaction.
    3. Scores of the CoPaQ, including out-of-pocket costs, for management of IBD, including treatment, monitoring, outpatient visits, and any unplanned healthcare utilization.

    Measured: Continuous, up to 104 weeks or Early Discontinuation

  5. Overall Safety

    1. Treatment-related serious adverse events (SAEs) or unexpected SAEs. B) Serious infections, defined as infections requiring hospitalization and/or intravenous antibiotics.

    Measured: Continuous, up to 104 weeks or Early Discontinuation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Feb 2022
  2. Study start5 Oct 2022
  3. Primary completion1 Aug 2028 (estimated)
  4. Study completion1 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
216 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05230173
Sponsor's protocol ID
RCT01519
Acronym
QUOTIENT
Status last verified
Aug 2026
First submitted
27 Jan 2022
Last updated
7 Aug 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Singh S, Nguyen JD, Fudman DI, Gerich ME, Shah SA, Hudesman D, McConnell RA, Lukin DJ, Flynn AD, Hwang C, Sprung B, Gaidos JKJ, Mattar MC, Rubin DT, Hashash JG, Metwally M, Ali T, Ma C, Hoentjen F, Narula N, Bessissow T, Rosenfeld G, McCurdy JD, Ananthakrishnan AN, Cross RK, Rodriguez Gaytan JR, Gurrola ES, Patel S, Siegel CA, Melmed GY, Weaver SA, Power S, Zou G, Jairath V, Hou JK. Treat-to-target of endoscopic remission in patients with inflammatory bowel disease in symptomatic remission on advanced therapies (QUOTIENT): rationale, design and protocol for an open-label, multicentre, pragmatic, randomised controlled trial. BMJ Open Gastroenterol. 2025 Mar 31;12(1):e001615. doi: 10.1136/bmjgast-2024-001615.

    PubMed 40164445

Questions about this trial

What is this clinical trial studying?

A study testing Pragmatic in people with Ulcerative Colitis and Crohn Disease, run by Mayo Clinic at 24 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Siddharth Singh, MD (480-301-8000, singh.siddharth@mayo.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Time to Treatment Failure (time frame: From randomization up to 104 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05230173, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Aug 2026.

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