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RECRUITINGINTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: 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: ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
INCLUSION CRITERIA: 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: 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.

Treatments Being Tested

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.

Locations (20)

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