Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Primary outcome Main Study: Percentage of patients in deep remission 1 year after debut (defined as Mayo score ≤2, endoscopic Mayo score =0, and RHI <3.
研究概览
简要总结
Debut of Ulcerative Colitis: selective Top-down strategy - the DUCT trial.
This is a proof-of-concept study to evaluate selective top-down treatment algorithm for a subgroup of patients with ulcerative colitis identified as probable severe 1-year outcome by a bio-signature. Positive bio-signature defined as mucosal TNF transcript ≥ 14100 copies/ug RNA and RHI ≥ 9.
Hypothesis: For the most severe cases early biologic therapy (top-down) has a higher chance of achieving deep remission at one year after debut than the regular step-up regimen.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Participant must be 18 to 65 years of age inclusive, at the time of signing the informed consent.
- •Participants who are newly diagnosed with ulcerative colitis (colonscopy and biopsy that confirm the diagnosis)
- •Capable of giving signed informed consent as described in Appendix 1 which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol
- •Women with childbearing potential must use highly efficient contraception during and 5 months after the last adalimumab administration
排除标准
- •Any condition that by standard clinical practice preclude the use of biologic therapy as per local guidelines, including but not exclusive: a. Malignancies declared healed less than 5 years earlier b. Evidence of ongoing or latent tuberculosis according to IGRA test, TB-SPOT or similar local testing practice c. Evidence of ongoing or latent untreated HBV or HCV infection
- •Fulminant colitis
- •Severe infections such as sepsis, abscesses or opportunistic infections
- •Moderate to severe heart failure (NYHA class III/IV)
- •Alternative diagnosis like C difficile or enteropathogenic infection likely to affect the clinical presentation
- •Pregnant or planned pregnancy during the study period.
- •Participation in other clinical trials or research studies that may interfere with the current study.
- •Participants who are required to recive live vaccines during the study period
结局指标
主要结局
Primary outcome Main Study: Percentage of patients in deep remission 1 year after debut (defined as Mayo score ≤2, endoscopic Mayo score =0, and RHI <3.
Primary outcome Main Study: Percentage of patients in deep remission 1 year after debut (defined as Mayo score ≤2, endoscopic Mayo score =0, and RHI <3.
Sub-study: Percentage of patients who starts with biological medication or undergo surgical intervention during det first year after debut of disease
Sub-study: Percentage of patients who starts with biological medication or undergo surgical intervention during det first year after debut of disease
次要结局
- Secondary outcomes: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review.
- Secondary endpoint: Patient reported outcomes (IBD-QoL, SCCAI), evaluate change in scores from baseline. Medical expenditures based on retrospective questionnaire and medical records review after 3 years.
- Exploratory outcomes: Improvement of the proposed biosignature based on data from all 200 included subjects.
研究者
Rasmus Goll
Scientific
Universitetssykehuset Nord-Norge HF