Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
NCT ID: NCT05230173
Last Updated: 2024-04-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
250 participants
INTERVENTIONAL
2022-10-05
2028-06-01
Brief Summary
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Detailed Description
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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 a 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 a 2-year follow-up period.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
NONE
Study Groups
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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).
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.
Continuing Index Targeted Immunomodulators Treatment
Participants randomized to a strategy of continuing TIM will continue on their concomitant therapy.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
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Baylor College of Medicine
OTHER
Crohn's and Colitis Foundation
OTHER
Western University
OTHER
Patient-Centered Outcomes Research Institute
OTHER
University of California, San Diego
OTHER
Responsible Party
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Siddharth Singh
Associate Professor of Medicine
Principal Investigators
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Siddharth Singh, MD
Role: PRINCIPAL_INVESTIGATOR
UC San Diego Health
Locations
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Hoag Hospital
Irvine, California, United States
UC San Diego Health
La Jolla, California, United States
Cedars-Sinai
Los Angeles, California, United States
Sutter Health
Palo Alto, California, United States
University of Colorado
Aurora, Colorado, United States
Yale University
New Haven, Connecticut, United States
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States
Mayo Clinic Jacksonville
Jacksonville, Florida, United States
University of Chicago Medicine
Chicago, Illinois, United States
Dartmouth Hitchcock
Lebanon, New Hampshire, United States
Saratoga Schenectady Gastroenterology Associates
Burnt Hills, New York, United States
NYU Langone Health
New York, New York, United States
Cornell University
New York, New York, United States
University of Rochester
Rochester, New York, United States
Hightower Clinical
Oklahoma City, Oklahoma, United States
Oregon Clinic
Portland, Oregon, United States
Gastroenterology Associates
Providence, Rhode Island, United States
GastroOne
Germantown, Tennessee, United States
University of Texas Southwestern
Dallas, Texas, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah Health
Salt Lake City, Utah, United States
University of Virginia
Charlottesville, Virginia, United States
Countries
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Central Contacts
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Facility Contacts
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Caroline Hwang, MD
Role: primary
Siddharth Singh, MD
Role: primary
Gil Melmed, MD
Role: primary
Ryan McConnell, MD
Role: primary
Mark Gerich, MD
Role: primary
Jill Gaidos, MD
Role: primary
Mark Mattar, MD
Role: primary
Jana Al Hashash, MD
Role: primary
David Rubin, MD
Role: primary
Corey Siegel, MD
Role: primary
Mark Metwally, MD
Role: primary
David Hudesman, MD
Role: primary
Dana Lukin, MD
Role: primary
Brandon Sprung, MD
Role: primary
Tauseef Ali, MD
Role: primary
Samir Shah, MD
Role: primary
David Fudman, MD
Role: primary
Jason Hou, MD
Role: primary
Ann Flynn, MD
Role: primary
References
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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.
Other Identifiers
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RCT01519
Identifier Type: -
Identifier Source: org_study_id
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