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Clinical trial

The Application of Transcriptomics for Establishing Potential Prognostic Markers of Response to Treatment of Ulcerative Colitis With Ustekinumab

ID
Name
479/15-12-2022
Description
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.
Trial arms
Trial start
2022-04-01
Estimated PCD
2023-10-31
Trial end
2024-06-30
Status
Active (not recruiting)
Treatment
Ustekinumab
Patients with ulcerative colitis treated with ustekinumab
Arms:
Ulcerative colitis patients treated with ustekinumab
Size
38
Primary endpoint
the rate of clinical remission
6 months
Eligibility criteria
Inclusion Criteria: * Active UC in accordance with applicable diagnostic criteria \[25\] • * Aged 18 or above Exclusion Criteria: * Prior surgical history for UC * Toxic megacolon * Infectious complications (Cl. Difficile, CMV infection) * Patients who received any approved biologic agent (e.g. Infliximab, adalimumab, vedolizumab, golimumab) within the previous 8 weeks or any investigational biologic or other agent in the last 35 days
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 38, 'type': 'ACTUAL'}}
Updated at
2024-02-28

1 organization

1 product

1 indication

Organization
Evangelismos Hospital
Product
Ustekinumab
Indication
ulcerative colitis