NCT00688636已完成4 期
Infliximab for the Prevention of Recurrent Crohn's Disease After Surgery
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year
研究概览
简要总结
A randomized, placebo-controlled pilot study to determine endoscopic recurrence of Crohn's disease 12 months after curative, resective ileal or ileocolonic surgery in patients receiving post-operative infliximab or placebo
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 72 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •men/women > 18 years of age
- •curative resection/ileocolonic anastomosis for Crohn's disease
- •may have received previously received infliximab
- •if on oral aminosalicylates or corticosteroids, dose must be stable for 4 weeks prior to surgery
- •if on 6-mercaptopurine,azathioprine or methotrexate,individual must have been on it for minimum of 3 months prior to surgery with stable dose for 4 weeks
- •men and women must use adequate birth control for duration of study and for 6 months after receiving the last infusion
- •antibiotics for treatment of Crohn's disease must be discontinued within 12 weeks after surgery; antibiotics are allowable throughout study as long as primary purpose of antibiotic therapy is not for primary treatment of Crohn's disease
- •screening lab results must meet screening criteria (hemoglobin = or > 8.5g/dL; Serum glutamic oxaloacetic transaminase ,3 times upper normal limit,platelets =or> 100 x 10 9th/L; lymphocytes count =or> 0.5 x 10 9th/L and neutrophils =or> 1.0 x 10 9th/L
- •have a documented negative reaction to a purified protein derivative skin test performed within 3 months prior to baseline
- •have a normal chest radiograph results within 3 months prior to baseline
- •are capable of providing written informed consent and obtained prior to conducting any protocol-specified procedures
- •willing to adhere to the study visit schedule and other protocol requirements
- •are considered eligible according to the tuberculosis eligibility assessment, screening and early detection of reactivation rules
- •patients who undergo resective surgery and primary ileocolonic anastomosis with a temporary ileostomy upon takedown of the diverting ileostomy.
排除标准
- •patients with greater than 10 years of Crohn's disease requiring first resection of a short (<10cm) fibrostenotic stricture
- •macroscopically active disease at anastomosis at time of surgery
- •presence of stoma
- •prior severe infusion reaction to infliximab
- •history of anaphylaxis to murine products or other chimeric proteins
- •any of the following medications taken within 12 weeks of surgery: cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, investigational drugs, or medications targeted at reducing tumor necrosis factor
- •have a positive stool culture for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin and have clinically significant signs of an enteric infection at screening
- •women who are pregnant, nursing or planning pregnancy during the trial or within 6 months after the last infusion
- •patient with active tuberculosis, patient newly diagnosed with latent tuberculosis who's receiving tuberculosis prophylaxis, patient with recent close contact to individual with active tuberculosis
- •have or have had opportunistic infection within 6 months of screening
- •have chest radiograph within 3 months prior to screening that shows malignancy, infection, or abnormalities suggestive of tuberculosis
- •documentation of seropositive for HIV
- •documentation of a positive test for hepatitis B surface antigen or a history of documented hepatitis C
- •have current signs/symptoms of systemic lupus erythematosus, or severe progressive, or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral diseases
- •presence of a transplanted solid organ (with exception of corneal transplant > 3 months prior to randomization)
- •Have any current or known malignancy or have history of malignancy within 5 years of screening(except for squamous or basal cell carcinoma of the skin that has been fully excised with no evidence of recurrence)
- •have history of lymphoproliferative disease or splenomegaly
- •have known substance abuse(drug/alcohol)/dependency within the previous 3 years, history of noncompliance with medical regimens, or other condition that may interfere with adherence to protocol requirements
- •are unwilling/unable to undergo multiple venipunctures because of poor tolerability or lack of easy access
- •known history of demyelinating disease
- •a chronic or recurrent infectious disease
- •serious infection, hospitalization for infection, or treatment with IV antibiotics for infection within 2 months prior to randomization
- •a serious concomitant illness that may interfere with participation in trial
- •concomitant diagnosis/history of congestive heart failure
- •current use of prescription doses or chronic/frequent use of non-steroidal anti-inflammatory drugs
- •ulcerative colitis
- •concurrent participation in another investigative trial
- •use of any investigational drug within 30 days prior to randomization
研究组 & 干预措施
1
Active Comparator
干预措施: infliximab (Drug)
2
Placebo Comparator
干预措施: placebo (Drug)
结局指标
主要结局
Endoscopic Recurrence: the Proportion of Patients in Endoscopic Recurrence at One Year
时间窗: one year
Endoscopic recurrence was defined as i2,i3,i4. We used the Rutgeerts' Endoscopic Scoring System. Scores as follows i0, no lesions; i1, 5 or fewer aphthous lesions; i2, more than 5 aphthous lesions with normal mucosa between the lesions or skip areas of larger lesions or lesions confined to the ileocolonic anastomosis; i3, diffuse, aphthous ileitis with diffusely inflamed mucosa; and i4, diffuse inflammation with large ulcers, nodules, and/or narrowing. Endoscopic recurrence was defined as i2,i3,i4 and endoscopic remission was defined as i0 or i1.
次要结局
- Clinical Recurrence at One Year: Defined by Crohn's Disease Activity Index (CDAI) > 200(One year)
- Histological Recurrence of Crohn's Disease as Determined From Biopsies of Neo-terminal Ileum Above the Ileocolonic Anastomosis(One year)
- Mean Erythrocyte Sedimentation Rate(one year)
- C-reactive Protein Concentration as a Surrogate Marker of Inflammation(one year)
研究者
Miguel Regueiro
Professor of Medicine
University of Pittsburgh
研究点 (1)
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