An observational study in Ulcerative Colitis, sponsored by Evangelismos Hospital. Completed at 1 site in Greece. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-03-12.
Sponsored by Evangelismos Hospital · Observational
The investigators hope that the present study will highlight new transcriptomic prognostic markers of response to Ustekinumab with the ultimate goal of individualizing treatment and making a more targeted selection of UC patients who will benefit from this biological agent.
Introduction: Optimizing treatment with biological agents is an ideal goal for patients with ulcerative colitis (UC). At present, there are insufficient prognostic markers of response to each biological agent, which makes it difficult to individualize treatment. Recent data suggest that mucosal inflammation patterns and serum cytokine profiles differ between patients who respond and those who do not. These studies mainly focused on anti-TNFα agents and Vedolizumab, while there are no corresponding data for Ustekinumab, which is a monoclonal antibody to interleukins 12 and 23 and has recently been approved for the treatment of patients with UC.
Aim of the study: To highlight prognostic markers of response (clinical and endoscopic) to Ustekinumab, in patients with UC, utilizing information from their transcriptome before starting treatment.
Methods: This is a prospective, single-center cohort study that will evaluate transcriptomic markers of response to Ustekinumab in patients with active UC. The diagnosis of the disease will be based on the established clinical, endoscopic and histological criteria. The patients' recruitment will begin in April 2022, while their consent will be required. The duration of follow-up of patients will be at least 6 months from the start of biological treatment. Patients will undergo endoscopy (sigmoidoscopy or total colonoscopy) with a biopsy of the orthosigmoid before the start of biological treatment and a repeat endoscopy 6 months later. The RNA profile of the patients will be recorded after isolation of the total RNA from colon biopsies. Then, using biostatistics, the transcriptomic profiles of patients who responded to Ustekinumab and those who did not respond to 6 months of treatment, will be compared.
1,073 studies on the registry are indexed under Colitis; 131 are open to participants now.
This study's enrollment of 38 is below the median of 105 across 247 observational studies indexed under Colitis.
Browse Colitis studies →Evangelismos Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with Ulcerative Colitis treated with Ustekinumab
Exclusion Criteria:
Patients with Ulcerative Colitis treated with ustekinumab
Drug: Ustekinumab
Patients with ulcerative colitis treated with ustekinumab
the rate of clinical remission
Total Mayo score of 2 or lower and no subscore higher than 1
Time frame: 6 months
Endoscopic response rate
Reduction of the endoscopic Mayo subscore ≥1
Time frame: 6 months
Clinical response rate
Reduction in the Mayo score of at least 3 points and a decrease of at least 30% from the baseline score, with a decrease of at least 1 point on the rectal bleeding subscale or an Absolute rectal bleeding score of 0 or 1
Time frame: 6 months
Endoscopic remission rate
Endoscopic Mayo subscore 0
Time frame: 6 months
This study is completed, as verified in Mar 2025. You cannot join it, but the record below documents what was studied.
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Evangelismos Hospital