N/ARecruiting

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

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.

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 pr…

Where this study is enrolling (18)

Mayo Clinic Arizona
Scottsdale, Arizona
Call 480-301-8000
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Cedars-Sinai
Los Angeles, California
Call 310-423-4100
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UC San Diego Health
La Jolla, California
Call 858-657-7000
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Sutter Health
Palo Alto, California
Call 484-995-1640
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University of Colorado
Aurora, Colorado
Call 303-724-7244
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Show all 18 locations

Yale University
New Haven, Connecticut
Call 203-785-4138
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MedStar Georgetown University Hospital
Washington D.C., District of Columbia
Call 202-444-4898
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Advent Health
Orlando, Florida
Call 407-303-9921
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Mayo Clinic Jacksonville
Jacksonville, Florida
Call 904-953-0131
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University of Chicago Medicine
Chicago, Illinois
Call 773-702-1234
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Dartmouth Hitchcock
Lebanon, New Hampshire
Call 603-650-5261
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NYU Langone Health
New York, New York
Call 855-698-4232
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Cornell University
New York, New York
Call 212-746-5077
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Saratoga Schenectady Gastroenterology Associates
Burnt Hills, New York
Call 518-831-1500
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Gastroenterology Associates
Providence, Rhode Island
Call 401-274-4800
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University of Texas Southwestern
Dallas, Texas
Call 214-645-6355
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Baylor College of Medicine
Houston, Texas
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University of Utah Health
Salt Lake City, Utah
Call 801-587-7678
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Who can participate

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.

Only the research team can confirm whether you qualify. The intake questionnaire is the best way to find out.

Completing a questionnaire on Clinably does not enroll you in a clinical trial or confirm your eligibility. Only the research team can determine whether you qualify to participate. These results are based on the information you provide and are intended to help you start a conversation with the research team.

Trial data sourced from ClinicalTrials.gov.