An observational study in Inflammatory Bowel Disease (IBD), Crohn Disease (CD) and Ulcerative Colitis (UC), sponsored by TIDHI Innovation Inc.. Recruiting at 14 sites in Canada. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-31.
Sponsored by TIDHI Innovation Inc. · Observational
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.
IBD patients who had inadequate response to ustekinumab and switched therapy to guselkumab.
Subjects who have evidence of ongoing endoscopic evidence of disease activity within 3 months prior to Week 0, defined as:
Exclusion Criteria:
Patients with CD or UC who had inadequate response to on-label maintenance ustekinumab (90 mg every 8 weeks) that requires a change in advanced therapy, as determined by the treating physician. Inadequate response could be either loss of response, partial response, or persistent endoscopic activity.
Biological: Guselkumab (Tremfya)
Patients with CD or UC who had inadequate response to off-label maintenance ustekinumab (90 mg every 6 or 4 weeks) that requires a change in advanced therapy, as determined by the treating physician. Inadequate response could be either loss of response, partial response, or persistent endoscopic activity.
Biological: Guselkumab (Tremfya)
Switching 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.
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)
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.
Time frame: Week 4
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.
Time frame: Week 52
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.
Time frame: Week 12
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.
Time frame: Week 52
Change from baseline in work productivity
Work Productivity outcomes will be reported as the change from baseline, assessed using the Work Productivity and Activity Impairment questionnaires specific to Crohn's disease (WPAI-CD) and ulcerative colitis (WPAI-UC). Scores range from 0 to 100 percent, with higher percentages indicating greater impairment in work and daily activities.
Time frame: Week 52
Change from baseline in mental health (anxiety)
Mental Health (anxiety) outcomes will be reported as the change from baseline, assessed using the Generalized Anxiety Disorder 7-item Scale (GAD-7): Scores range from 0 to 21, with higher scores indicating more severe anxiety symptoms.
Time frame: Week 52
Change from baseline in mental health (depression)
Mental Health (depression) outcomes will be reported as the change from baseline, assessed using the Patient Health Questionnaire-9 (PHQ-9): Scores range from 0 to 27, with higher scores indicating more severe depressive symptoms.
Time frame: Week 52
Change from baseline in fatigue
Fatigue outcomes will be reported as the change from baseline, assessed using the Functional Assessment of Chronic Illness Therapy-Fatigue scale (FACIT-F). Scores range from 0 to 52, with higher scores indicating less fatigue and better functioning.
Time frame: Week 52
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TIDHI Innovation Inc.