Management of Moderate POstoperative Recurrence in Crohn's Disease: a randoMizEd contROLled Trial of Therapeutic Escalation, the POMEROL Trial. (POMEROL)
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
研究概览
简要总结
Study type : A 30 months, multicentre, open-label strategic randomized controlled trial
Population : Chron's Disease (CD) patients with an i2 endoscopic postoperative recurrence in the year following ileocolonic resection (6-12months after ileocolonic resection).
Treatments :
Stratification at inclusion according to prophylactic therapy.
Patients randomized in 2 arms:
- Status quo arm: if the patient received no prophylactic therapy, no treatment will be started; if the patient received a prophylactic therapy, the same will be continued at the same dose.
- Therapy escalation arm: infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards.
Main objective : To evaluate the proportion of CD patients without endoscopic postoperative recurrence (i0-i1) at 12 months in the arm receiving therapy escalation compared to status quo arm in patients having an i2 endoscopic postoperative recurrence 6-12months after ileocolonic anastomosis with restoration of faecal stream.
详细描述
Number of patients : 360 patients in approximatively 25 sites in France.
Recruitement period : The trial duration for each patients will be 12 months from radomization (18 to 24 months from screening (ie : post-operatively))
Endpoints:
Primary endpoints: Proportion of patients with an i0-i1 modified Rutgeerts score at 12 months.
Secondary endpoints:
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
- 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
- •Crohn's disease diagnosed according usual criteria
- •Bowel resection with ileocolonic anastomosis performed removing all inflammatory lesions
- •Postoperative endoscopy performed between 6 and 12 months after ileocolonic anastomosis reaching the neoterminal ileum (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)
- •Moderate endoscopic postoperative recurrence classified i2 according to the Rutgeerts score at 6-12 months, validated by a blinded central reading
排除标准
- •Patients with an ostomy
- •Ulcerative colitis or IBD type unclassified
- •Ileorectal or ileal pouch-anal anastomosis
- •Symptoms defined as average daily SF ≥ 3.5 and average daily AP score ≥ 1.5 having started after a free interval without symptoms of at least one month after surgery
- •Patients with obstructive symptoms of CD defined by a CDOS > 4
- •Patients exposed to infliximab before index surgery with a primary non-response (no clinical effect after 2 infusions at the discretion of the treating gastroenterologist) or history of infusion reactions to infliximab or history of detectable anti-infliximab antibodies
- •Patients treated with 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 fecal stream
- •Patients in whom not all inflammatory lesions have been removed at index surgery
- •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 < 6 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.
研究组 & 干预措施
Status quo arm
If the patient received no prophylactic therapy after resection, no treatments will be started.
If the patient received a prophylactic therapy after resection, the same will be continued at the same dose.
干预措施: Immunosuppressors (Thiopurines or Methotrexate) (Drug)
Therapy escalation arm
Infliximab-CT-P13 will be started with two intravenous infusions of 5 mg per kg bodyweight at week 0 and week 2 and subcutaneous injections of 120 mg every 2 weeks from week 6 onwards.
干预措施: Infliximab CT-P13 (Drug)
结局指标
主要结局
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
时间窗: Month12
Number of patients with an i0-i1 modified Rutgeerts score at 12 months.
次要结局
- Surgical recurrence within 12 months(Baseline, Month 4, Month 8, Month 12)
- Quality of life: EQ5D-5L questionnaires(Baseline, week 2, week 6, Month 4, Month 8, Month 12)
- Serious adverse events(Screening, Baseline, Month 4, Month 8, Month 12)
- Number of patients with an i3-i4 modified Rutgeerts score at 12 months(Month 12)
- Clinical postoperative recurrence(Baseline, Month 4, Month 8, Month 12)
- Time to clinical postoperative recurrence will be assessed(Baseline, Month 4, Month 8, Month 12)
- Proportion of patients with an i0 modified Rutgeerts score at 12 months(Month 12)
- Proportion of patients with an i2b-i3-i4 modified Rutgeerts score at 12 months(Month 12)
- Patient Reporting Outcome score at 12 months.(Screening, Baseline, week 2, week 6, Month 4, Month 8, Month 12)
- Endoscopic dilatation within 12 months(Baseline, Month 4, Month 8, Month 12)
- Work productivity and activity impairement questionnaires(Baseline, week 2, week 6, Month 4, Month 8, Month 12)