Ulcerative Colitis study: Pragmatic
Official title Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
ClinicalTrials.gov ID: NCT05230173
What this study is testing
- What it's testing
- This study is testing whether changing to a new targeted medicine can improve gut lining health and safety compared to staying on the current medicine.
- Who it's for
- You may be able to join if you have Crohn’s disease or ulcerative colitis, feel better, but still have moderate to severe gut lining inflammation.
- What's involved
- You will be asked to switch to a new medicine or keep your current one. You will have regular check‑ups and gut exams to see how your lining looks.
- Time commitment
- The study lasts about a year, with several visits and gut exams during that time.
- Time commitment: about 2 years
Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 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...
- Dose of TIM should be stable for 3 or more months prior to qualifying endoscopy/radiology.
- CD: PRO2 (2-item patient reported outcome) mean daily score of abdominal pain score ≤1 and stool frequency score ≤ 3; or
You likely can't join if
- 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...
- History of alcohol or drug abuse or any other medical or health condition that in the opinion of the investigator may interfere with the...
- Prior enrolment in the current study.
- Mild endoscopic disease activity, where treating providers would not consider switching TIM.
See the full eligibility criteria
- 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)...
- 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...
- 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.
- 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]
- 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
- 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Scottsdale, Arizona, United States
- Irvine, California, United States
- La Jolla, California, United States
- Los Angeles, California, United States
- Palo Alto, California, United States
- Aurora, Colorado, United States
- New Haven, Connecticut, United States
- Washington D.C., District of Columbia, United States
- Jacksonville, Florida, United States
- Orlando, Florida, United States
- Chicago, Illinois, United States
- Lebanon, New Hampshire, United States
- Burnt Hills, New York, United States
- New York, New York, United States
- Providence, Rhode Island, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
Compensation & support
This study's listing mentions compensation or reimbursement.
No amount is published here because ClinicalTrials.gov has no reliable field for payment or travel support. Ask the study team what's actually covered (payment for your time, travel, parking, or other study costs), and never join a trial for the compensation alone.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team, so confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Scottsdale, Arizona, United States; Irvine, California, United States; La Jolla, California, United States; Los Angeles, California, United States; Palo Alto, California, United States; Aurora, Colorado, United States and 12 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.