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.
Subjects of any gender aged ≥ 18.
Confirmed diagnosis of IBD (CD, UC, or IBDU) for at least 6 months prior to baseline visit. Subjects with IBDU will be grouped with subjects with UC. The CD proportion of patients will be capped at 75%.
Subjects have received ustekinumab for at least 14 weeks and who are currently on or recently discontinued ustekinumab therapy.
For subjects that have recently discontinued ustekinumab, the last dose of ustekinumab must have been within 12 weeks before Week 0, and no other advanced therapy (i.e., infliximab, adalimumab, golimumab, certolizumab pegol, vedolizumab, natalizumab, risankizumab, mirikizumab, tofacitinib, upadacitinib, ozanimod, etrasimod) was started since stopping ustekinumab.
History of prior exposure to any anti-p19 inhibitor (risankizumab or mirikizumab).
Subjects with formal contraindication to guselkumab per the drug label.
Use of guselkumab for an off-label indication, dosing regimen, or route of administration. Subjects who did not receive guselkumab induction will be excluded.
Subjects with an ostomy or ileo-anal pouch.
IBD patients who had inadequate response to ustekinumab and switched therapy to guselkumab.
Cohort
Prospective
Guselkumab (Tremfya)
Biological/VaccineSwitching to Guselkumab (Tremfya) in People With Active IBD Previously Treated With Ustekinumab.
Rate 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.
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).
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.
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.
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.
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.
Rate of participants achieving early symptomatic response among those not in symptomatic remission at baseline
Early symptomatic response at week 4 among patients who were not in symptomatic remission at baseline is defined as follows: 1. For Crohn's disease: A decrease of 30 percent or more in the average daily stool frequency score (SFS) and/or a decrease of 30 percent or more in the average daily abdominal pain score (APS), with both scores not worse than 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.
Rate of participants achieving biochemical remission
Biochemical remission at among patients with available fecal calprotectin (FCAL) and C-reactive protein (CRP). Biochemical remission is defined as FCAL ≤250 ug/g AND a CRP ≤5 mg/L among patients with available either an elevated FCAL or CRP at baseline.
Rate of participants achieving biochemical remission
Biochemical remission at among patients with available fecal calprotectin (FCAL) and C-reactive protein (CRP). Biochemical remission is defined as FCAL ≤250 ug/g AND a CRP ≤5 mg/L among patients with available either an elevated FCAL or CRP at baseline.
Change from baseline in quality of life
Quality of Life (QoL) outcomes will be reported as the change from baseline, using the following assessments: EuroQoL 5-Dimension 5-Level questionnaire (EQ-5D-5L): This tool evaluates five dimensions of health, each rated on a scale from 1 to 5. Higher scores indicate worse health status. Short Form Health Survey (SF-36): This questionnaire measures eight health domains, with each domain scored from 0 to 100. Higher scores reflect better health status.
Click on the lead sponsor to view all of their trials.
TIDHI Innovation Inc.
Lead sponsor
Janssen Inc.
Collaborator
