The Application of Transcriptomics for Establishing Potential Prognostic Markers of Response to Treatment of Ulcerative Colitis With Ustekinumab
概览
- 阶段
- 不适用
- 干预措施
- Ustekinumab
- 疾病 / 适应症
- Ulcerative Colitis
- 发起方
- Evangelismos Hospital
- 入组人数
- 38
- 试验地点
- 1
- 主要终点
- the rate of clinical remission
- 状态
- 已完成
- 最后更新
- 去年
概览
简要总结
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.
详细描述
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.
研究者
Nikos Viazis
Consultant Gastroenterologist, Chief Department of Gastroenterology, Evangelismos General Hospital of Athens, Athens, Greece
Evangelismos Hospital
入排标准
入选标准
- •Active UC in accordance with applicable diagnostic criteria \[25\] •
- •Aged 18 or above
排除标准
- •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
研究组 & 干预措施
Ulcerative colitis patients treated with ustekinumab
Patients with Ulcerative Colitis treated with ustekinumab
干预措施: Ustekinumab
结局指标
主要结局
the rate of clinical remission
时间窗: 6 months
Total Mayo score of 2 or lower and no subscore higher than 1
次要结局
- Endoscopic remission rate(6 months)
- Endoscopic response rate(6 months)
- Clinical response rate(6 months)