EUCTR2021-002369-17-FR进行中（未招募）1 期
Management of moderate POstoperative recurrence in Crohn's disease: a randoMizEd contROLled trial, the POMEROL trial.
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- GETAID
- 入组人数
- 180
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •-Age > 18 years
- •-Diagnosis of Crohn's disease according to usual criteria
- •-Intestinal resection with ileocolonic anastomosis removing all Crohn’s disease inflammatory lesions performed within the last 6-12 months (patients who underwent a two stage surgical procedure are also eligible if the endoscopic evaluation is performed 6-12 months after restoration of the fecal stream)
- •-Postoperative endoscopy performed between 6 and 12 months +/- 2 months after ileocolonic anastomosis reaching the neoterminal ileum
- •-Postoperative endoscopic recurrence classified i2 according to the Rutgeerts score at 6-12 months, validated by a blinded central reading
- •-The patient is willing to start infliximab CT-P13 at a fixed schedule of 2 intravenous infusions at week 0 and week 2 followed by subcutaneous CT-P13 every other week from week 6 onwards
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 180
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •-Patients with an ostomy
- •-Patients with ulcerative colitis or IBD type unclassified
- •-Patients with an ileorectal or ileal pouch-anal anastomosis
- •-Patients exposed to infliximab before index surgery with a primary non-response (no clinical effect after 2 infusions or at the discretion of the treating gastroenterologist) or history of infusion reactions to infliximab or history of detectable anti-infliximab antibodies
- •-Patients with symptoms of active CD, defined as average daily SF = 3.5 and average daily AP score = 1.5, having started after a free interval without symptoms of one month after surgery
- •-Patients with obstructive symptoms of CD defined by a CDOS > 4 (15) (see Appendix for description of the score). Asymptomatic patients receiving an endoscopic dilatation for a non-passable stenosis at baseline endoscopy in centres where it is a current practice to estimate the lesions extent can be included.
- •-Patients treated with any biological therapy (except for intraocular injections) or an investigational medical product after index surgery
- •-Patients having started thiopurines or methotrexate more than 6 weeks after ileocolonic anastomosis with restoration of the faecal stream
- •-Patients in whom not all inflammatory lesions have been removed at index surgery: e.g. incomplete ileo-colonic resections, active colitis.
- •-Patients with active perianal Crohn's disease
- •-Patients with a contraindication to infliximab: cancer in the 5 years prior to inclusion, excluding non-melanoma skin cancer, active tuberculosis or untreated latent tuberculosis, moderate or severe heart failure, HIV or HBV infection (serology < 3 months), recent live vaccination (within 4 weeks of baseline).
- •-Pregnant women
- •-Patients under legal protection or unable to express their consent.
- •-Patients not affiliated to a health insurance system.
- •-Patients deprived of liberty by judiciary or administrative decision or hospitalized without consent or admitted in a sanitary or social institution for another reason than research.
研究者
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