BridgeMD
New treatment option for Ulcerative Colitis
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
- 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.
- 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. No treatment escalation of TIM or addition of IMM...
- In corticosteroid-free symptomatic remission based on validated PROs (PRO2 score) and deemed to be experiencing no other IBD-related symptoms in the...
You likely can't join if
- 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...
- 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...
- 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.
- 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...
- 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]...
- 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
- 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...
- 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
- 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.
- 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's taking place
- 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
- Chicago, Illinois, United States
- Lebanon, New Hampshire, United States
- Burnt Hills, New York, United States
- New York, New York, United States
- Rochester, New York, United States
- Oklahoma City, Oklahoma, United States
- Portland, Oregon, United States
- Providence, Rhode Island, United States
- Germantown, Tennessee, United States
- Dallas, Texas, United States
- Houston, Texas, United States
- Salt Lake City, Utah, United States
+ 1 more site(s).
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
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 - 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 - 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?
Study sites include 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 and 15 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.