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

Part of paid clinical trials in Irvine, California.

Sponsor: University of California, San Diego
Study ID: NCT05230173
Status: Recruiting

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Conditions

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Pragmatic — OTHER
Patients randomized to a strategy of switching TIM will be switched to one of the preferred agents recommended by clinical guidelines and covered by the patients' 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. Patients (and their providers) in either treatment arm will be allowed to stop or start new TIMs and other IBD-directed therapies in case of symptomatic relapse or intolerance to therapies, at the discretion of the treating provider-patient team.

Study Details

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.

Key Dates

Start date: Oct 5, 2022
Status verified: Apr 2024
Primary completion: Mar 1, 2028
Completion: Jun 1, 2028

Study Design

Enrollment: 250 participants (estimated)
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

Arms

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.

Primary Outcome Measure

Time to Treatment Failure [ Time Frame: From randomization up to 104 weeks ]

Central Contacts

Siddharth Singh, MD
858-246-2352
[email protected]
Jason Hou, MD
713-798-8220
[email protected]

Locations (22)

Facility	City	State	ZIP	Site coordinators
Hoag Hospital	Irvine	California	92618	Caroline Hwang, MD Caroline Hwang, MD (PRINCIPAL_INVESTIGATOR)
UC San Diego Health	La Jolla	California	92037	Siddharth Singh, MD 858-246-2352 Siddharth Singh, MD (PRINCIPAL_INVESTIGATOR)
Cedars-Sinai	Los Angeles	California	90048	Gil Melmed, MD 310-423-4100 Gil Melmed, MD (PRINCIPAL_INVESTIGATOR)
Sutter Health	Palo Alto	California	94301	Ryan McConnell, MD 484-995-1640 Ryan McConnell, MD (PRINCIPAL_INVESTIGATOR)
University of Colorado	Aurora	Colorado	80045	Mark Gerich, MD 303-724-7244 Mark Gerich, MD (PRINCIPAL_INVESTIGATOR)
Yale University	New Haven	Connecticut	06510	Jill Gaidos, MD 203-785-4138 Jill Gaidos, MD (PRINCIPAL_INVESTIGATOR)
MedStar Georgetown University Hospital	Washington D.C.	District of Columbia	20007	Mark Mattar, MD 202-444-4898 Mark Mattar, MD (PRINCIPAL_INVESTIGATOR)
Mayo Clinic Jacksonville	Jacksonville	Florida	32224	Jana Al Hashash, MD 904-953-0131 Jana Al Hashash, MD (PRINCIPAL_INVESTIGATOR)
University of Chicago Medicine	Chicago	Illinois	60637	David Rubin, MD 773-702-2950 David Rubin, MD (PRINCIPAL_INVESTIGATOR)
Dartmouth Hitchcock	Lebanon	New Hampshire	03756	Corey Siegel, MD 603-650-5261 Corey Siegel, MD (PRINCIPAL_INVESTIGATOR)
Saratoga Schenectady Gastroenterology Associates	Burnt Hills	New York	12027	Mark Metwally, MD 518-831-1500 Mark Metwally, MD (PRINCIPAL_INVESTIGATOR)
Cornell University	New York	New York	10021	Dana Lukin, MD 212-746-5077 Dana Lukin, MD (PRINCIPAL_INVESTIGATOR)
NYU Langone Health	New York	New York	10016	David Hudesman, MD 855-698-4232 David Hudesman, MD (PRINCIPAL_INVESTIGATOR)
University of Rochester	Rochester	New York	14642	Brandon Sprung, MD Brandon Sprung, MD (PRINCIPAL_INVESTIGATOR)
Hightower Clinical	Oklahoma City	Oklahoma	73102	Tauseef Ali, MD Tauseef Ali, MD (PRINCIPAL_INVESTIGATOR)
Oregon Clinic	Portland	Oregon	97220	-
Gastroenterology Associates	Providence	Rhode Island	02904	Samir Shah, MD 401-274-4800 Samir Shah, MD (PRINCIPAL_INVESTIGATOR)
GastroOne	Germantown	Tennessee	38138	-
University of Texas Southwestern	Dallas	Texas	75235	David Fudman, MD 214-645-6355 David Fudman, MD (PRINCIPAL_INVESTIGATOR)
Baylor College of Medicine	Houston	Texas	77030	Jason Hou, MD 713-798-8220 Jason Hou, MD (PRINCIPAL_INVESTIGATOR)
University of Utah Health	Salt Lake City	Utah	84132	Ann Flynn, MD 801-587-7678 Ann Flynn, MD (PRINCIPAL_INVESTIGATOR)
University of Virginia	Charlottesville	Virginia	22908	-

Find similar trials in Irvine, CA

By condition

Crohn's disease Ulcerative colitis

By specialty

Gastroenterology Inflammatory bowel disease Autoimmune disease

By research site

Hoag Hospital· Irvine, CA UC San Diego Health· La Jolla, CA Cedars-Sinai· Los Angeles, CA Sutter Health· Palo Alto, CA University of Colorado· Aurora, CO Yale University· New Haven, CT

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