Treat-to-Target of Endoscopic Remission in Patients With IBD in Symptomatic Remission
- Conditions
- Ulcerative ColitisCrohn Disease
- Interventions
- Other: Pragmatic
- Registration Number
- NCT05230173
- Lead Sponsor
- University of California, San Diego
- Brief 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 250
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Switching Targeted Immunomodulators Treatment Pragmatic 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). Continuing Index Targeted Immunomodulators Treatment Pragmatic Participants randomized to a strategy of continuing TIM will continue on their concomitant therapy.
- Primary Outcome Measures
Name Time Method Time to Treatment Failure From randomization up to 104 weeks Time to treatment failure, as a composite of: (1) moderate severe symptomatic relapse based on PRO2, with objective confirmation of inflammation within 2 months of event (FC \>250 mcg/g, or CRP \>5mg/L, or endoscopy showing moderate-severe inflammation, or MRE/CTE/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 Outcome Measures
Name Time Method Treatment failure as defined in the composite primary outcome Binary, 104 weeks Treatment failure as defined in the composite primary outcome
Overall Quality of Life Continuous, until 104 weeks or Early Discontinuation A) Scores of the SIBDQ. B) Scores of the IBD-Control. C) Scores of the PROMIS 7 scale. D) Scores of the on IBD-DI.
Time to each individual component of the composite primary outcome From randomization up to 104 weeks Time to each individual component of the composite primary outcome
Overall Safety Continuous, until 104 weeks or Early Discontinuation A) Treatment-related serious adverse events (SAEs) or unexpected SAEs. B) Serious infections, defined as infections requiring hospitalization and/or intravenous antibiotics.
Treatment Burden/Satisfaction Continuous, until 104 weeks or Early Discontinuation A) Scores of Treatment Burden Questionnaire, including medication, time and administrative, lifestyle change, social life and financial burden.
B) Scores of Treatment Satisfaction Questionnaire for Medication, measuring treatment satisfaction across domains of effectiveness, side effects, convenience and global satisfaction.
C) Scores of the CoPaQ, including out-of-pocket costs, for management of IBD, including treatment, monitoring, outpatient visits, and any unplanned healthcare utilization.
Trial Locations
- Locations (22)
Cedars-Sinai
🇺🇸Los Angeles, California, United States
Saratoga Schenectady Gastroenterology Associates
🇺🇸Burnt Hills, New York, United States
University of Texas Southwestern
🇺🇸Dallas, Texas, United States
Gastroenterology Associates
🇺🇸Providence, Rhode Island, United States
Hoag Hospital
🇺🇸Irvine, California, United States
Mayo Clinic Jacksonville
🇺🇸Jacksonville, Florida, United States
MedStar Georgetown University Hospital
🇺🇸Washington, District of Columbia, United States
GastroOne
🇺🇸Germantown, Tennessee, United States
UC San Diego Health
🇺🇸La Jolla, California, United States
Sutter Health
🇺🇸Palo Alto, California, United States
Dartmouth Hitchcock
🇺🇸Lebanon, New Hampshire, United States
Cornell University
🇺🇸New York, New York, United States
University of Virginia
🇺🇸Charlottesville, Virginia, United States
University of Rochester
🇺🇸Rochester, New York, United States
NYU Langone Health
🇺🇸New York, New York, United States
University of Chicago Medicine
🇺🇸Chicago, Illinois, United States
University of Colorado
🇺🇸Aurora, Colorado, United States
Yale University
🇺🇸New Haven, Connecticut, United States
Hightower Clinical
🇺🇸Oklahoma City, Oklahoma, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
Oregon Clinic
🇺🇸Portland, Oregon, United States
University of Utah Health
🇺🇸Salt Lake City, Utah, United States