Adalimumab on Preventing Postoperative Recurrence of Crohn's Disease
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 86
- 试验地点
- 22
- 主要终点
- Number of endoscopic recurrences
研究概览
简要总结
The present study objective is evaluate Adalimumab efficacy versus Azathioprine efficacy on prevention of endoscopic recurrence (Rutgeerts Index= 2b, 3 or 4) in Crohn´s Disease patients after 52 weeks of treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 18 years of age at the time of signing informed consent.
- •Patients with Crohn's disease who have undergone an ileocecal/ileocolic resection (L1 or L3). The study and the treatment must be initiated within the two first weeks after the resection (+/- 5 days).
- •Patients with surgical reconstruction by ileocolic anastomosis.
- •Women of childbearing age must not be breastfeeding and must have a negative urine pregnancy test and must agree to use contraceptive methods with a <1% failure rate (e.g., sexual abstinence, oral contraceptives, double barrier methods, intrauterine devices), unless they only have one partner who is sterile.
- •Patients who have signed and dated the informed consent form before performing any specific screening study procedure.
排除标准
- •Resection that requieres Temporal ileostomy.
- •Urgency resection which doesn´t permit the initial assessment protocol completion.
- •Resection due to inactive short indolent stenosis (<10 cm).
- •Resection with mucosal macroscopic residual disease in anastomosis.
- •Previous intolerance or adverse reaction (moderate or severe) to adalimumab or azathioprine.
- •Any contraindications or unwillingness to perform the scheduled colonoscopies or resonances.
- •Contraindications to Adalimumab treatment, among which the following are included: active tuberculosis, severe infections such as sepsis or opportunistic infections, moderate or severe heart failure (NYHA class III or IV), central nervous system demyelinating diseases, history of malignant neoplasm or autoimmune diseases.
- •Severe associated Extraintestinal manifestations.
- •Previous postoperative recurrence prevention treatments with adalimumab, asathiprine o mercaptopurine which resulted in failure.
- •Any other disease or patient condition that according to investigator criteria, inadequates patient´s participation in the study.
研究组 & 干预措施
Metronidazole + Azathioprine.
Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.
干预措施: Azathioprine (Drug)
Metronidazole + Azathioprine.
Metronidazole, oral intake. 250 mg/8h. 3 months. Azathioprine, 2.5 mg/weight kg/day, oral intake. All study.
干预措施: Metronidazole (Drug)
Metronidazole + Adalimumab
Metronidazole Oral Intake. 250 mg/8h. During 3 months. Adalimumab Subcutaneous 160 mg and 80 mg 2wk. Then 40 mg during 2wk as maintenance.
干预措施: Metronidazole (Drug)
Metronidazole + Adalimumab
Metronidazole Oral Intake. 250 mg/8h. During 3 months. Adalimumab Subcutaneous 160 mg and 80 mg 2wk. Then 40 mg during 2wk as maintenance.
干预措施: Adalimumab (Drug)
结局指标
主要结局
Number of endoscopic recurrences
时间窗: 52 weeks after the begin of the study
Evaluation of the effectiveness on prevention of endoscopic recurrence evaluated as changes in the Rutgeerts Index.
次要结局
- Number of postsurgical recurrences(52 week)
- Number of Crohns´disease remission(52 weeks)
- SIBDQ and EuroQOL indexes(52 weeks)
- number of hospitalized patients(52 weeks)
- Concentration of activity markers(52 weeks)
- Number of surgeries(Until 52 week)
- Number of Adverse event reports(52 weeks)