NCT03306446进行中（未招募）4 期
Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives23 个研究点 分布在 2 个国家目标入组 203 人开始时间: 2015年3月17日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 203
- 试验地点
- 23
- 主要终点
- Sustained deep remission rate
研究概览
简要总结
This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.
详细描述
The main objective will be to evaluate the sustained deep remission rate one year after discontinuation of a 12 month course of adalimumab in adult patients with early CD who have achieved deep remission at 12 months AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months. The study will also address several questions:
- What is the rate of deep remission after a 12-month course of adalimumab in early CD patients?
- What is the rate of deep remission 12 months after adalimumab discontinuation in patients with deep remission after a 12-month course of adalimumab (thus defining sustained deep remission) AND who were already in clinical remission (CDAI < 150) and biomarker remission (CRP < 5 mg/L and fecal calprotectin < 250) at 6 months?
- What are the consequences of a treatment with adalimumab on the natural course of CD and long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and patient-reported outcomes)? Therefore the study will give information on the effect of a 12-month course of adalimumab in early CD patients, impact of "drug holiday" after deep remission has been achieved, and long term effect of adalimumab on early CD course (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported outcomes). The study will also assess predictors of loss of deep remission at 2-year evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of adalimumab will be assessed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patient aged 18 years old to 75 years old
- •Patient with early luminal Crohn's disease (less than 24 months since diagnosis),
- •Patient who is
- •intolerant to immunosuppressants or steroids, or
- •primarily not responders to immunosuppressants for at least 3 months [azathioprine: at least 2.5 mg/kg/d; 6-mercaptopurine: at least 1.5 mg/kg/d; methotrexate: 25 mg/week (subcutaneous or intramuscular route)], and/or
- •not responder to steroids [prednisolone equivalent at least 40 mg/d], and/or
- •steroid-dependent [unable to reduce corticosteroids below the equivalent of prednisolone 10 mg/d or budesonide < 6 mg/d within 3 months of starting corticosteroids without recurrent active disease, or who have a relapse within 3 months of stopping corticosteroids],
- •Patient with CDAI > 150,
- •Patient with at least one ulcer in at least one affected segment (Magnetic Resonance Imaging (MRI) of gastrointestinal tract or colonoscopy or by video capsule conducted after failure of conventional therapy and within 12 weeks before inclusion in the study),
- •Patient naïve for anti-TNF,
- •Patient whose physician decides to start adalimumab as monotherapy independently from the study protocol,
- •Patient followed in a centre belonging to the GETAID network.
- •Written consent.
排除标准
- •Patient with active complex perianal fistula according to the definition of the American Gastroenterological Association (AGA) [high anal fistula, abscess, proctitis, multiple external openings],
- •Patient with stoma,
- •previous surgery in IBD
- •Pregnant or breastfeeding women, absence of contraception
- •Patient with any contra-indication to adalimumab.
- •Patient with any contra-indication to MRI
- •Minors and people unable to give their consent (because of their physical or mental state).
- •Subject who has not given his/her consent to participate.
- •Subject participating in another study.
研究组 & 干预措施
Adalimumab in monotherapy
Experimental
Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.
干预措施: Start adalimumab in monotherapy (Drug)
结局指标
主要结局
Sustained deep remission rate
时间窗: 12 months
Number of patients with sustained deep remission at one year
次要结局
- 2-year deep remission rate(2 years)
研究者
研究点 (23)
Loading locations...
相似试验
已完成
不适用
Evaluating Whether Integration of Prognostic and Predictive Algorithms Into Routine Clinical Practice Effect Whether Oncologists Order Multigene Assays in Patients With Early Stage Breast CancerBreast CancerNCT04131933Ottawa Hospital Research Institute602
招募中
不适用
Genetic and Epigenetic Background of Inner Ear Dysfunction in Turner SyndromeInner Ear DiseaseSensorineural Hearing LossTurner SyndromeNCT06507007Gødstrup Hospital150
已完成
4 期
Acoustic Coordinated Reset (CR®) Neuromodulation for the Treatment of Chronic Tonal Tinnitus ("RESET Real Life")TinnitusNCT01435317ANM Adaptive Neuromodulation GmbH200
已完成
不适用
Hearing Impairment of Nasopharyngeal CarcinomaNasopharyngeal CarcinomaNCT05330169Guangxi Medical University200
暂停
不适用
Cancer Risk Assessment in Patients With a Constitutional Alteration of the PTEN GenePTEN Gene MutationNCT05630105Institut Bergonié430