NCT00946946已完成3 期
Double-blind, Double-dummy, Randomised, Multicentre, Comparative Study on the Efficacy and Safety of Azathioprine Versus Mesalazine for Prevention of Clinical Relapses in Crohn's Disease Patients With Postoperative Moderate or Severe Endoscopic Recurrence
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 78
- 试验地点
- 2
- 主要终点
- The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction.
研究概览
简要总结
This study aims to compare azathioprine versus mesalazine tablets for the prevention of clinical relapse in postoperative Crohn's disease (CD) patients with moderate or severe endoscopic recurrence.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed informed consent,
- •Man or woman between 18 and 70 years of age,
- •Diagnosis of Crohn's disease confirmed by endoscopic and histological, or endoscopic and radiological criteria within one year or by histopathological criteria during resection,
- •Clinical remission defined as Crohn´s Disease Activity Index (CDAI) < 200, within the last two weeks. No clinical relapse due to Crohn's disease since resection,
- •Moderate (i2a) or severe endoscopic recurrence (i3-i4) within 6 to 24 months after curative resection of the terminal ileum and partial colectomy with ileocolonic resection for complications of ileal Crohn´s disease and with a construction of an ileocolonic anastomosis,
- •Within the neoterminal ileum at least more than 5 aphthous lesions with normal mucosa between the lesions, or skip areas of larger lesions,
- •Negative pregnancy test at screening visit in females of childbearing potential,
- •Use of appropriate contraceptive methods for females of childbearing potential and males with procreative capacity during treatment and at least up to 3 months after the end of treatment.
排除标准
- •Lesions confined to the ileocolonic anastomosis (i.e., < 1 cm in length)
- •Short bowel syndrome,
- •Serious secondary illnesses of an acute or chronic nature, which in the opinion of the Investigator renders the patient unsuitable for inclusion into the study,
- •Serum creatinine levels exceeding 1.5 mg/dL or 130 umol/L,
- •Presence of an ileo-/colonic stoma,
- •Genotype: thiopurine methyltransferase (TPMT) -/-,
- •Known previous or concurrent malignancy (other than that considered surgically cured, with no evidence for recurrence for 5 years),
- •Treatment with cytostatics or immunosuppressants, methotrexate, cyclosporine, 6-MP, Azathioprine, 6-TG or anti-TFN-alpha therapy since resection; postoperative treatment with corticosteroids for more than 4 weeks or postoperative treatment with oral antibiotics (e.g., metronidazole, ciprofloxacin) for more than 4 weeks,
- •Application of non-steroidal anti-inflammatory drugs (NSAIDS) within 2 weeks before Screening visit except low dose acetylsalicylic acid and except paracetamol,
- •Known intolerance/hypersensitivity to study drugs or drugs of similar chemical structure or pharmacological profile,
- •Scheduled or intended active immunisation with living vaccines within the next 12 months,
- •Well-founded doubt about the patient's cooperation,
- •Existing pregnancy, lactation, or intended pregnancy or impregnation within the next 15 months,
- •Non-use of appropriate contraceptives in males with procreative capacity and females of childbearing potential (e.g. condoms for males, intrauterine device [IUD], hormonal contraception for females, or a means of contraception for a particular patient considered adequate by the responsible investigator) during treatment and within 3 months after the end of treatment,
- •Participation in another clinical trial within the last 30 days, simultaneous participation in another clinical trial, or previous participation in this trial,
- •Present stricture plasty (no exclusion if the present stricture plasty was macroscopically without any relevant finding of inflammation seen during index surgery.
研究组 & 干预措施
Mesalazine
Active Comparator
4g mesalazine tablets/day AND azathioprine placebo tablets
干预措施: Mesalazine (Drug)
Azathioprine
Experimental
2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets
干预措施: Azathioprine (Drug)
Azathioprine
Experimental
2.0-2.5 mg/kg/BW azathioprine tablets/day AND mesalazine placebo tablets
干预措施: Mesalazine placebo (Drug)
Mesalazine
Active Comparator
4g mesalazine tablets/day AND azathioprine placebo tablets
干预措施: Azathioprine placebo (Drug)
结局指标
主要结局
The primary endpoint was therapeutic failure at one year, defined as CDAI score ≥200 and an increase of ≥60 points from baseline, or study drug discontinuation due to lack of efficacy or intolerable adverse drug reaction.
时间窗: 12 months
次要结局
- endoscopic improvement at month 12, defined as ≥1 point reduction in Rutgeerts' score.(12 months)
- change in CDAI score(12 months)
- adverse events(12 months)
研究者
研究点 (2)
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