Prospective, Controlled, Randomized, Multicentered, Open-label Study, Comparing 2 Modalities of Follow-up of Patients With Crohn's Disease, Postoperatively Treated With Adalimumab (Immunomonitoring vs Standard Follow-up)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 42
- 试验地点
- 1
- 主要终点
- Percentage of patients with a Rutgeerts score ≥ i2
研究概览
简要总结
Study comparing 2 modalities of Crohn's disease patients postoperative follow-up treated with adalimumab (Humira® or biosimilar) : immunomonitoring of adalimumab serum levels versus standard follow-up, which is based on the clinical and biological activity of the disease.
详细描述
Patients in the experimental arm will have a post-operative follow-up based on the immunomonitoring of serum levels of adalimumab. After ileocolic resection surgery, patients will have a therapeutic optimization of their adalimumab (Humira® or biosimilar) treatment, based on their serum residual rate of adalimumab.
Patients in the control group will receive a standard post-operative follow-up, which is based on clinical and biological recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (Outcomes Assessor)
盲法说明
An endoscopy will be performed on patients of all groups 6 months after the surgery. Endoscopic results will be measured blindly by one assessor.
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
- •Patient between the ages of 18 and 75
- •Use of an effective method of contraception during treatment with adalimumab for women of childbearing age
- •Crohn's disease diagnosed according to the criteria defined by the national and international recommendations for at least 3 months
- •IIeocolic resection with ileocolic anastomosis and absence of residual macroscopic lesion, or ileocolic resection with transient ostomy and restoration of continuity
- •For anti-TNF-naive patients: negative pre-anti TNF balance
- •Indication of postoperative treatment for the prevention of recurrence of Crohn's disease (with at least 1 risk factor for recidivism):
- •active smoking (≥ 1 cigarette / day at the time of surgery)
- •hail resection> 50 cm
- •second intestinal resection
- •presence of anoperineal lesions
- •Penetrating impairment (B3 of the Montreal Classification)
- •Biotherapy treatment for more than 6 months before the surgery
- •Written and signed consent by the participant and the investigator
- •Affiliated person or beneficiary of the social security system.
排除标准
- •Intolerance or allergy to adalimumab (Humira® or biosimilar)
- •Patients to whom adalimumab (Humira® or biosimilar) is contraindicated
- •Intestinal stoma without restoration of continuity
- •Pregnant woman (dosage of positive βHCG) or breastfeeding according to article L1121-5 of the french public health law.
- •Contraindication or refusal of ileocolonoscopy at 6 months
- •Patient who could not be followed regularly for psychological, social or geographical reasons
- •Vulnerable people according to article L1121-6 of the french public health law
- •Persons subject to legal protection (guardianship, trusteeship) or unable to express their consent according to Article L1121-8 of the french public health law or under the protection of justice according to article L1122.2 of the CSP
- •Concomitant participation of the patient in another research involving the human person.
- •Patient not affiliated to the social security system (Article L.1121-11).
- •Patient unable to sign the consent form
- •Immunized patients (with anti-adalimumab antibodies > 10ng / mL and undetectable adalimumab levels, Elisa drug sensitive technique used) for patients already treated with adalimumab (Humira® or biosimilar) before surgery
- •Patients in combination therapy with azathioprine, 6-mercaptopurine or methotrexate Post-operative, or treated by another biotherapy (infliximab, vedolizumab, ustekinumab ...)
结局指标
主要结局
Percentage of patients with a Rutgeerts score ≥ i2
时间窗: 6 months
The primary endpoint will be measured by ileocolonoscopy under general anesthesia after standard preparation by PEG with video recording of the examination, carried out by one of the investigators of the study in each center. An ileocolonoscopy 6 months after intestinal resection remains the reference examination for the endoscopic diagnosis of recurrence according to the endoscopic Rutgeerts score (endoscopic recurrence if Rutgeerts score ≥ i2) and allows the adaptation or the introduction of a treatment to limit clinical recurrence at 18 months.
次要结局
- Percentage of patients with clinical recurrence(3 and 6 months)
- Percentage of patients with biological recurrence(3 and 6 months)
- Rate of adalimumab in the serum(1, 3, and 6 months)
- Percentage of patients with adverse effects(3 and 6 months)
- Rate of anti-adalimumab antibodies in the serum(1, 3, and 6 months)