2023-508154-25-00招募中4 期
Comparison of Vedolizumab treatment to Adalimumab dose intensification in Crohn’s disease patients with loss of response or biomarker activity to Adalimumab on first line with therapeutic drug concentration: A randomized, multicentre, controlled VEDIAN trial.
适应症
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 220
- 试验地点
- 17
- 主要终点
- The primary objective will be to compare the proportion of clinical and biomarker remission (composite score) in the two groups of CD patients by 24 weeks after inclusion (ADA optimized versus Vedolizumab as second line).
研究概览
简要总结
Evaluate the efficacy, in terms of clinical remission and biomarkers at S24, of a treatment strategy with Vedolizumab compared to a treatment strategy with Adalimumab dose optimization (ADA) in CD patients with loss of secondary response and/or high biomarker activity and/or imaging evidence of activity (MRI or bowel ultrasound or ileocolonoscopy or videocapsule) on standard-dose Adalimumab maintenance therapy with therapeutic drug levels.
研究设计
- 分配方式
- Randomized
- 主要目的
- Treatment
- 盲法
- None
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
- •Major patient and having given consent to participate in the study
- •Patients with Crohn's disease who have responded primarly to Adalimumab princeps or similar bio with loss of response to Adalimumab (40 mg every two weeks) with therapeutically adequate levels of ADA (> 7.5 μg/mL).
- •Patient affiliated to or entitled under a social security scheme
- •If the subject is receiving oral corticosteroids other than budesonide or beclometasone dipropionate, the dose must be ≤ 20 mg/day of prednisone or its equivalent and have been stable for at least 2 weeks. The use of corticosteroids is prohibited after week 12.
排除标准
- •Pregnant woman
- •Patient with short small bowel syndrome as determined by investigator
- •Patients receiving enteral nutrition
- •Patients receiving total parenteral nutrition (TPN).
- •Participation in a therapeutic study
- •Patient under legal protection or unable to give consent
- •Hemorrhagic rectocolitis or indeterminate colitis
- •Patient treated with a concomitant immunosuppressive agent at the time of inclusion. The patient may have been treated with an immunosuppressive agent, but this must have been discontinued at least 4 weeks prior to the screening visit.
- •Patient treated with an optimized dose of adalimumab
- •Primary non-responder to Adalimumab
- •Patient previously treated with ustekinumab before adalimumab
- •Patients with exclusive anoperineal Crohn's disease
- •Severe relapse defined by CDAI > 330
- •Crohn's disease patient with transient or permanent stoma
- •Patients on intravenous corticosteroid therapy
- •Previous or current use of vedolizumab or ustekinumab for Crohn's disease
- •Concomitant use of immunomodulators
- •History of cancer
- •History of human immunodeficiency virus (HIV), immunodeficiency syndrome, central nervous system (CNS) demyelinating disease (including myelitis), neurological symptoms suggestive of demyelinating disease, chronic recurrent infection, active tuberculosis (received or untreated), severe infections such as sepsis and opportunistic infections.
- •Patient with ileoanal pouchitis or ileorectal anastomosis
结局指标
主要结局
The primary objective will be to compare the proportion of clinical and biomarker remission (composite score) in the two groups of CD patients by 24 weeks after inclusion (ADA optimized versus Vedolizumab as second line).
The primary objective will be to compare the proportion of clinical and biomarker remission (composite score) in the two groups of CD patients by 24 weeks after inclusion (ADA optimized versus Vedolizumab as second line).
次要结局
- Compare rates of clinical and biomarker remission at W52
- rate of Mucosal remission at W24
- Compare deep remission defined as clinical remission (clinical activity score < 150 with fecal calprotectin < 250 mcg/g stools and CRP < 5mg/L and either CDEIS <3 using ileocolonoscopy or Lewis score < 135 in the small bowel using VCE or no disease activity on MRE (defined by segmental Maria score < 7) or no bowel thickness on US according to the previous tools used at inclusion at W24.
- Compare treatment failure at W24 or W52 in the 2 groups
- Compare the percentage of adverse events in both arms at W52
- Symptomatic remission at W24 is a composite criterion measured by PRO2 defined as: Stool frequency (SF) < 3 with abdominal pain score (AP) < 2 at W24; AND absence of therapeutic failure between inclusion and W24.
- Compare evolution of IBDQ-32 in the two groups of patients between inclusion and W24
- Compare rates of clinical and biomarker remission at W12
- Analyze the CDST (clinical decision support tool) score for prediction of remission under vedolizumab and adalimumab optimization.
研究者
Pr Xavier ROBLIN
Scientific
Centre Hospitalier Universitaire De Saint Etienne
研究点 (17)
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