RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-10-05

Study Completion:2028-06-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05230173

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	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.

Inclusion Criteria

Exclusion 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.

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.

Contacts and Locations

Study Contact

Siddharth Singh, MD

CONTACT

858-246-2352

sis040@health.ucsd.edu

Jason Hou, MD

CONTACT

713-798-8220

jkhou@bcm.edu

Principal Investigator

Siddharth Singh, MD

PRINCIPAL_INVESTIGATOR

UC San Diego Health

Study Locations (Sites)

Hoag Hospital

Irvine, California, 92618

United States

UC San Diego Health

La Jolla, California, 92037

United States

Cedars-Sinai

Los Angeles, California, 90048

United States

Sutter Health

Palo Alto, California, 94301

United States

University of Colorado

Aurora, Colorado, 80045

United States

Yale University

New Haven, Connecticut, 06510

United States

MedStar Georgetown University Hospital

Washington, District of Columbia, 20007

United States

Mayo Clinic Jacksonville

Jacksonville, Florida, 32224

United States

University of Chicago Medicine

Chicago, Illinois, 60637

United States

Dartmouth Hitchcock

Lebanon, New Hampshire, 03756

United States

Saratoga Schenectady Gastroenterology Associates

Burnt Hills, New York, 12027

United States

NYU Langone Health

New York, New York, 10016

United States

Cornell University

New York, New York, 10021

United States

University of Rochester

Rochester, New York, 14642

United States

Hightower Clinical

Oklahoma City, Oklahoma, 73102

United States

Oregon Clinic

Portland, Oregon, 97220

United States

Gastroenterology Associates

Providence, Rhode Island, 02904

United States

GastroOne

Germantown, Tennessee, 38138

United States

University of Texas Southwestern

Dallas, Texas, 75235

United States

Baylor College of Medicine

Houston, Texas, 77030

United States

University of Utah Health

Salt Lake City, Utah, 84132

United States

University of Virginia

Charlottesville, Virginia, 22908

United States

Collaborators and Investigators

Sponsor: University of California, San Diego

Siddharth Singh, MD, PRINCIPAL_INVESTIGATOR, UC San Diego Health

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-10-05

Study Completion Date2028-06-01

Study Record Updates

Study Start Date2022-10-05

Study Completion Date2028-06-01

Terms related to this study

Additional Relevant MeSH Terms

Ulcerative Colitis
Crohn Disease