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

Status: Recruiting
Location: See all (22) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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), including future TIMs that become commercially available during the conduct of the trial.

• 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.

• 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:

‣ 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 within 6 months prior to screening, defined at the investigator's discretion or as follows:

‣ 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

⁃ 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; or

⁃ 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 been recorded.

• 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.

Locations
United States
California
Hoag Hospital
RECRUITING
Irvine
UC San Diego Health
RECRUITING
La Jolla
Cedars-Sinai
RECRUITING
Los Angeles
Sutter Health
RECRUITING
Palo Alto
Colorado
University of Colorado
RECRUITING
Aurora
Connecticut
Yale University
RECRUITING
New Haven
Washington, D.c.
MedStar Georgetown University Hospital
RECRUITING
Washington D.c.
Florida
Mayo Clinic Jacksonville
RECRUITING
Jacksonville
Illinois
University of Chicago Medicine
RECRUITING
Chicago
New Hampshire
Dartmouth Hitchcock
RECRUITING
Lebanon
New York
Saratoga Schenectady Gastroenterology Associates
RECRUITING
Burnt Hills
Cornell University
RECRUITING
New York
NYU Langone Health
RECRUITING
New York
University of Rochester
RECRUITING
Rochester
Oklahoma
Hightower Clinical
NOT_YET_RECRUITING
Oklahoma City
Oregon
Oregon Clinic
WITHDRAWN
Portland
Rhode Island
Gastroenterology Associates
RECRUITING
Providence
Tennessee
GastroOne
WITHDRAWN
Germantown
Texas
University of Texas Southwestern
RECRUITING
Dallas
Baylor College of Medicine
RECRUITING
Houston
Utah
University of Utah Health
RECRUITING
Salt Lake City
Virginia
University of Virginia
WITHDRAWN
Charlottesville
Contact Information
Primary
Siddharth Singh, MD
sis040@health.ucsd.edu
858-246-2352
Backup
Jason Hou, MD
jkhou@bcm.edu
713-798-8220
Time Frame
Start Date: 2022-10-05
Estimated Completion Date: 2028-06-01
Participants
Target number of participants: 250
Treatments
Other: Switching Targeted Immunomodulators Treatment
Participants randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the participants' insurance formulary as part of routine care, and at the discretion of the site investigator and treating provider. No study-related medications will be provided.~For participants randomized to switch to an alternative TIM, selection of alternative agent will be determined at the discretion of the local site physician in accordance with clinical guidelines on the management of moderate to severe ulcerative colitis, and management of moderate to severe CD from the AGA and ACG.9, 34, 35 These guidelines include recommendations on positioning of TIMs for first line use (TIM-naïve patients) and second-line use (in patients with prior exposure to TIMs).
Other: Continuing Index Targeted Immunomodulators Treatment
Participants randomized to a strategy of continuing TIM will continue on their concomitant therapy.
Authors
Sponsors
Collaborators: Western University, Baylor College of Medicine, Crohn's and Colitis Foundation, Patient-Centered Outcomes Research Institute
Leads: University of California, San Diego

This content was sourced from clinicaltrials.gov

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