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

What is the Purpose of this Study?

The purpose of this study is to collect and analyze data in patients with inflammatory bowel disease (IBD) who are currently receiving IBD medication(s) that targets their immune system (targeted immunomodulator- TIM) in routine clinical care and are feeling well but have active inflammation on colonoscopy. The study aims to determine whether switching to an alternative IBD medication will improve disease outcome without increasing the burden of treatment. IBD, including ulcerative colitis and Crohn’s disease, is a chronic condition that causes inflammation of the intestinal tract. Treatment of IBD often involves long-term use of TIM therapies. This study is proposing a “treat-to-target” approach, in which treatment strategies aim to resolve bowel inflammation by switching to another TIM in patients without symptoms but with bowel inflammation in the hope of achieving endoscopic remission. Endoscopic remission may, in turn, decrease the risk of relapse, unplanned healthcare utilization, IBD-related disability, and improve quality of life, versus continuing current TIM therapy.

Eligibility

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.

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.

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Where can I participate?

Beverly

More about this Clinical Trial

What is the full name of this clinical trial?

Treat-to-Target of Endoscopic Remission in Patients with IBD in Symptomatic Remission: The QUOTIENT Trial

Study Details

Disease Type/Condition

Inflammatory Bowel Disease

Principal Investigator

Melmed, Gil

Co-Investigators

Andrea Banty, Gaurav Syal, Susie Lee

Age Group

Adult

Phase

N/A

IRB Number

STUDY00002062

ClinicalTrials.gov ID

NCT05230173

Key Eligibility

ClinicalTrials.gov

How do I learn more about this study?

clinicaltrials@cshs.org