Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
Who can join
As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.
- Age
- 18 Years and older
- Sex
- All sexes
- Healthy volunteers
- Not accepted
- Compensation
- Travel or expenses covered
Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.
What to expect
No one can promise a trial will help you personally — that is what the research is trying to find out.
What participation involves
- Time periods mentioned: 2 years
Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.
Show the study's own words
- "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."
- Compensation
- Travel or expenses covered
- Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
- Participants are monitored closely by the research team throughout the study.
- Some participants may receive access to an investigational treatment, which is still being studied.
- Your participation helps researchers learn whether this approach could help future patients.
About this study
In plain language
This study compares switching to a different targeted immune medicine with staying on the current medicine for Crohn’s disease or ulcerative colitis. It tests which approach is safer and works better to clear bowel inflammation seen during a scope exam. It is for adults whose symptoms are under control but who still have moderate to severe bowel inflammation.
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.
Compensation is read from the study's own description and may be missing — always confirm with the study team.
Eligibility
Who can join
- You are age 18 or older and are not pregnant or breastfeeding.
- You have had Crohn’s disease or ulcerative colitis for at least 6 months, confirmed by your care provider.
- You take an approved targeted immune medicine for your bowel disease.
- Your medicine dose was stable for at least 3 months before the qualifying bowel test. After that test, you cannot increase treatment or add certain bowel medicines before study group assignment.
- Your symptoms are under control without steroids, based on symptom scores and your provider’s review.
- A bowel scope exam or scan within 6 months before screening shows moderate to severe inflammation.
- You can receive at least one different targeted immune medicine under drug approval, care, and payment rules.
- You can take part in all study activities and give written consent to join.
Who can't join
- You have an ostomy (a surgically made opening for waste) or an ileoanal pouch (an internal pouch made from the small bowel).
- You have another serious disease that could keep you from taking part fully.
- You have a history of alcohol or drug abuse, or another health condition, that could keep you from following study steps.
- You have already enrolled in this study.
- Your scope exam shows only mild inflammation, and your provider would not consider switching your targeted immune medicine.
Simplified for readability. The official criteria below are what the study team uses.
Official eligibility criteria
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 sites (24)
AZ
- Mayo Clinic Arizona · Scottsdale, AZ 85259Siddharth Singh, MD · Study contact · 480-301-8000Siddharth Singh, MD · Principal investigatorMore trials in Scottsdale
CA
- Hoag Hospital · Irvine, CA 92618Caroline Hwang, MD · Study contactCaroline Hwang, MD · Principal investigatorMore trials in Irvine
- UC San Diego Health · La Jolla, CA 92037Brigid Boland, MD · Study contact · 858-657-7000Brigid Boland, MD · Principal investigatorMore trials in La Jolla
- Cedars-Sinai · Los Angeles, CA 90048Gil Melmed, MD · Study contact · 310-423-4100Gil Melmed, MD · Principal investigatorMore trials in Los Angeles
- Sutter Health · Palo Alto, CA 94301Ryan McConnell, MD · Study contact · 484-995-1640Ryan McConnell, MD · Principal investigatorMore trials in Palo Alto
CO
- University of Colorado · Aurora, CO 80045Mark Gerich, MD · Study contact · 303-724-7244Mark Gerich, MD · Principal investigatorMore trials in Aurora
CT
- Yale University · New Haven, CT 06510Jill Gaidos, MD · Study contact · 203-785-4138Jill Gaidos, MD · Principal investigatorMore trials in New Haven
DC
- MedStar Georgetown University Hospital · Washington D.C., DC 20007Mark Mattar, MD · Study contact · 202-444-4898Mark Mattar, MD · Principal investigatorMore trials in Washington D.C.
FL
- Mayo Clinic Jacksonville · Jacksonville, FL 32224Jana Al Hashash, MD · Study contact · 904-953-0131Jana Al Hashash, MD · Principal investigatorMore trials in Jacksonville
- Advent Health · Orlando, FL 32804Jennifer Seminerio-Diehl, MD · Study contact · 407-303-9921Jennifer Seminerio-Diehl, MD · Principal investigatorMore trials in Orlando
IL
- University of Chicago Medicine · Chicago, IL 60637David Rubin, MD · Study contact · 773-702-2950David Rubin, MD · Principal investigatorMore trials in Chicago
NH
- Dartmouth Hitchcock · Lebanon, NH 03756Corey Siegel, MD · Study contact · 603-650-5261Corey Siegel, MD · Principal investigatorMore trials in Lebanon
NY
- Saratoga Schenectady Gastroenterology Associates · Burnt Hills, NY 12027Mark Metwally, MD · Study contact · 518-831-1500Mark Metwally, MD · Principal investigatorMore trials in Burnt Hills
- NYU Langone Health · New York, NY 10016David Hudesman, MD · Study contact · 855-698-4232David Hudesman, MD · Principal investigatorMore trials in New York
- Cornell University · New York, NY 10021Dana Lukin, MD · Study contact · 212-746-5077Dana Lukin, MD · Principal investigatorMore trials in New York
- University of Rochester · Rochester, NY 14642More trials in Rochester
OK
- Hightower Clinical · Oklahoma City, OK 73102More trials in Oklahoma City
OR
- Oregon Clinic · Portland, OR 97220More trials in Portland
RI
- Gastroenterology Associates · Providence, RI 02904Samir Shah, MD · Study contact · 401-274-4800Samir Shah, MD · Principal investigatorMore trials in Providence
TN
- GastroOne · Germantown, TN 38138More trials in Germantown
TX
- University of Texas Southwestern · Dallas, TX 75235David Fudman, MD · Study contact · 214-645-6355David Fudman, MD · Principal investigatorMore trials in Dallas
- Baylor College of Medicine · Houston, TX 77030Jason Hou, MD · Study contact · 713-798-8220Jason Hou, MD · Principal investigatorMore trials in Houston
UT
- University of Utah Health · Salt Lake City, UT 84132Ann Flynn, MD · Study contact · 801-587-7678Ann Flynn, MD · Principal investigatorMore trials in Salt Lake City
VA
- University of Virginia · Charlottesville, VA 22908More trials in Charlottesville