Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
Start Date
10/5/2022
Completion Date
6/1/2028
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.
Detailed Description
This is a pragmatic, open-label, multicenter randomized control trial (RCT) conducted in asymptomatic patients with IBD who have persistent moderate to severe endoscopic inflammation despite optimization of index TIM. This study plans to recruit approximately 250 participants in the United States, who will either switching to treatment with alternative TIM to treat to a target of endoscopic remission or continue index optimized TIM. After randomization, patients will be followed prospectively within routine clinical practice over 2 years (104 weeks). This trial will be conducted within select active sites in the United States and Canada The primary outcome will be time from randomization to treatment failure, as a composite of: 1. Moderate severe symptomatic relapse based on PRO2 (2-item patient reported outcome), with objective confirmation of inflammation within 2 months of event (fecal calprotectin \[FC\] \>150 mcg/g, or C reactive protein \[CRP\] \>5mg/L, or endoscopy showing moderate-severe inflammation, or magnetic resonance enterography (MRE)/computed tomography enterography (CTE)/intestinal ultrasound (IUS) showing active inflammation) with need for escalation of therapy; 2. Need for rescue therapy with corticosteroids for a documented symptomatic IBD flare; 3. IBD related hospitalization; 4. IBD-related surgery; 5. IBD-related structural complications (CD: symptomatic stricture, fistula or abscess; UC: symptomatic stricture); 6. Treatment-emergent adverse event requiring drug discontinuation. Secondary outcomes will include time from randomization to each of the components in the primary outcome, quality of life (overall quality of life, fatigue, IBD-related disability), burden of treatment (financial burden, burden of monitoring, treatment side effects), treatment satisfaction, and safety. In compliance with the pragmatic methodology of this study embedded in routine clinical care, there is no study visit mandated per study protocol. Participant visit schedules will follow local SOC with any additional visits at the treating physician's discretion. Data on all effectiveness, treatment burden and safety outcomes will be captured using a REDCap (Research Electronic Data Capture) database hosted at CCF. Data for the study will be extracted from medical record information and entered into the EDC system at baseline and then approximately every 6 months (at a minimum) thereafter, up to a 2-year follow-up period. Patient-reported outcome (PRO) measures (self-assessment questionnaires) will be utilized in this study to determine primary (efficacy) and secondary (quality of life and treatment burden and satisfaction) outcomes. Participants will complete the PRO2 at baseline and approximately every 12 weeks during a 2-year follow-up period; additional questionnaires (IBD-Control, PROMIS-7, Short Inflammatory Bowel Disease Questionnaire \[SIBDQ\], IBD Disability Index \[IBD-DI\], Treatment Burden Questionnaire, and Treatment Satisfaction Questionnaire for Medication) will be completed at baseline (following randomization) and up to 3 more additional times during a 2-year follow-up period.
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Pragmatic
Conditions
Locations
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 D.C., 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