The SHIFT-IBD Study is being conducted at multiple medical centers across Canada to evaluate how well guselkumab (Tremfya) works for people with inflammatory bowel disease (IBD) who haven't responded well enough to ustekinumab. Patients will begin guselkumab based on their doctor's decision. If eligible, they may be invited to participate in the study, which involves monitoring symptoms, test results, and overall health over the course of one year. Guselkumab will be given according to local medical guidelines. Doctors can adjust the treatment as needed, just like in routine care. Researchers believe that switching to guselkumab may be as effective as other advanced treatments. For those who saw some improvement on ustekinumab but not enough, guselkumab may offer better symptom control-without worsening results on medical tests like endoscopy. The goal is to explore better treatment options for people whose IBD has not been well controlled with current therapies.
Study Type
OBSERVATIONAL
Enrollment
200
Switching to Guselkumab (Tremfya) in People With Active IBD Previously Treated With Ustekinumab.
MA MacMillan
Fredericton, New Brunswick, Canada
RECRUITINGBarrie GI Associates
Barrie, Ontario, Canada
RECRUITINGBrampton Gastroenterology Research Group Inc
Brampton, Ontario, Canada
RECRUITINGGNRR Digestive Clinics and Research Center Inc.
Brampton, Ontario, Canada
RECRUITINGLDDI Clinical Trials Inc. dba London Digestive Disease Institute
London, Ontario, Canada
NOT_YET_RECRUITINGWest Gta Research Inc.
Mississauga, Ontario, Canada
RECRUITINGAbp Research Services Corporation
Oakville, Ontario, Canada
RECRUITINGTaunton Surgical Center
Oshawa, Ontario, Canada
RECRUITINGToronto Immune and Digestive Health Institute
Toronto, Ontario, Canada
RECRUITINGRate of participants achieving deep remission in IBD patients treated with guselkumab after switching from ustekinumab
Deep remission is defined as both absence of symptomatic worsening and endoscopic remission. Outcomes will be reported as the proportion of participants achieving deep remission at Week 52.
Time frame: Week 52
Rate of participants achieving deep remission, stratified by cohorts
Deep remission is defined as both absence of symptomatic worsening and endoscopic remission. Outcomes will be reported as the proportion of participants achieving deep remission at Week 52 and stratified by Early Switch Cohort (ESC) and Exhausted Ustekinumab Cohort (EUC).
Time frame: Week 52
Rate of participants with absence of symptomatic worsening
Absence of symptomatic worsening defined as the absence of: 1. For Crohn's disease: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily abdominal pain score (APS) compared to Baseline. 2. For ulcerative colitis: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily rectal bleeding score (RBS) compared to Baseline.
Time frame: Week 52
Rate of participants achieving endoscopic remission
Endoscopic remission is defined as follows: 1. For Crohn's disease: A Simple Endoscopic Score for Crohn's Disease (SDS-CD) of 4 or less, or a score of 2 or less in the ileal segment (excluding the narrowing component) in cases of disease limited to the ileum, with an ulceration subscore of 0. 2. For ulcerative colitis: A Ulcerative Colitis Endoscopic Index of Severity (UCEIS) of 1 or less, with a bleeding subscore of 0 and an erosions/ulcers subscore of 0.
Time frame: Week 52
Rate of participants achieving endoscopic response
Endoscopic response is defined as follows: 1. For Crohn's disease: A reduction of 50 percent or more in the Simple Endoscopic Score for Crohn's Disease (SDS-CD) compared to Baseline (excluding the narrowing component). 2. For ulcerative colitis: A reduction of 2 points or more in the Ulcerative Colitis Endoscopic Index of Severity (UCEIS) compared to baseline.
Time frame: Week 52
Rate of participants with absence of symptomatic worsening
Absence of symptomatic worsening defined as the absence of: 1. For Crohn's disease: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily abdominal pain score (APS) compared to the baseline value. 2. For ulcerative colitis: An increase of 30 percent or more in the average daily stool frequency score (SFS) and/or an increase of 30 percent or more in the average daily rectal bleeding score (RBS) compared to Baseline.
Time frame: Any study visit (Week 4, Week 12, Week 32, Week 52)
Rate of participants achieving symptomatic remission among those not in remission at baseline
Time frame: Week 12 and Week 52
Rate of participants achieving steroid-free remission among corticosteroid users at baseline
Steroid-free remission defined as no corticosteroid use and meeting symptomatic remission criteria
Time frame: Week 52
Rate of participants discontinuing guselkumab therapy
Time frame: Any study visit (Week 4, Week 12, Week 32, Week 52)
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