Actively Recruiting
Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
Led by University of California, San Diego · Updated on 2024-04-15
250
Participants Needed
22
Research Sites
295 weeks
Total Duration
On this page
Sponsors
U
University of California, San Diego
Lead Sponsor
B
Baylor College of Medicine
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or nonpregnant, nonlactating females aged 18 years or older
- Established diagnosis of Crohn's disease or ulcerative colitis for at least 6 months confirmed by provider
- Currently treated with an approved targeted immunomodulator (TIM) for IBD
- Stable TIM dose for at least 3 months before qualifying endoscopy or radiology
- In corticosteroid-free symptomatic remission based on validated patient-reported outcomes
- Evidence of moderate to severe bowel inflammation on recent endoscopy or imaging within 6 months
- Eligible to receive at least one alternative TIM for treatment based on guidelines
- Able to fully participate in all aspects of the clinical trial
- Informed consent obtained and documented
You will not qualify if you...
- Presence of ostomy or ileoanal pouches
- Serious diseases other than Crohn's disease or ulcerative colitis interfering with participation
- History of alcohol or drug abuse or other health conditions interfering with compliance
- Previous enrollment in this study
- Mild endoscopic disease activity where providers would not consider switching TIM
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 22 locations
1
Hoag Hospital
Irvine, California, United States, 92618
Actively Recruiting
2
UC San Diego Health
La Jolla, California, United States, 92037
Actively Recruiting
3
Cedars-Sinai
Los Angeles, California, United States, 90048
Actively Recruiting
4
Sutter Health
Palo Alto, California, United States, 94301
Actively Recruiting
5
University of Colorado
Aurora, Colorado, United States, 80045
Actively Recruiting
6
Yale University
New Haven, Connecticut, United States, 06510
Actively Recruiting
7
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, United States, 20007
Actively Recruiting
8
Mayo Clinic Jacksonville
Jacksonville, Florida, United States, 32224
Actively Recruiting
9
University of Chicago Medicine
Chicago, Illinois, United States, 60637
Actively Recruiting
10
Dartmouth Hitchcock
Lebanon, New Hampshire, United States, 03756
Actively Recruiting
11
Saratoga Schenectady Gastroenterology Associates
Burnt Hills, New York, United States, 12027
Actively Recruiting
12
NYU Langone Health
New York, New York, United States, 10016
Actively Recruiting
13
Cornell University
New York, New York, United States, 10021
Actively Recruiting
14
University of Rochester
Rochester, New York, United States, 14642
Actively Recruiting
15
Hightower Clinical
Oklahoma City, Oklahoma, United States, 73102
Not Yet Recruiting
16
Oregon Clinic
Portland, Oregon, United States, 97220
Withdrawn
17
Gastroenterology Associates
Providence, Rhode Island, United States, 02904
Actively Recruiting
18
GastroOne
Germantown, Tennessee, United States, 38138
Withdrawn
19
University of Texas Southwestern
Dallas, Texas, United States, 75235
Actively Recruiting
20
Baylor College of Medicine
Houston, Texas, United States, 77030
Actively Recruiting
21
University of Utah Health
Salt Lake City, Utah, United States, 84132
Actively Recruiting
22
University of Virginia
Charlottesville, Virginia, United States, 22908
Withdrawn
Research Team
S
Siddharth Singh, MD
CONTACT
J
Jason Hou, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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