NCT00739986已完成2 期
A Randomized, Double-Blind, Placebo-controlled Study of CNI-1493 for Treatment of Moderate to Severe Crohn's Disease 1 or 3 Days' Treatment vs. Placebo
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 152
- 试验地点
- 27
- 主要终点
- Crohn's Disease Activity Index (CDAI) score
研究概览
简要总结
Assessment of the number of days' treatment with semapimod necessary for efficacy, as measured by response rate to CNI-1493 as compared to placebo, in patients with moderate to severe Crohn's disease (CD).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Men and women at least 18 years of age.
- •Baseline Crohn's Disease Activity Index (CDAI) 250-
- •Crohn's disease of at least 3 months duration, with colitis, ileitis, or ileocolitis, confirmed by radiography and/or endoscopy.
- •Those of childbearing potential were to use a barrier method (diaphragm or condom) of contraception and continue doing so for at least 3 months after last study medication. It was recommended that two forms be used.
- •Patients receiving medications for CD were to be on each medication for at least 8 weeks prior to screening and on stable doses of each for at least 2 weeks prior to screening, with the following exceptions:
- •those on methotrexate had to be on a stable dose for at least 4 weeks and not be receiving more than 25 mg/wk
- •those on azathioprine or 6-mercaptopurine on a stable dose for at least 10 weeks
- •those on steroids had to have been on steroids for at least 2 weeks and on a stable dose for those 2 weeks. They were not to be receiving more than 20 mg/day prednisone or equivalent
- •those on mesalazine had to have been on for at least 6 weeks and on a stable dose for at least 2 weeks
- •those on antibiotics for CD had to have been on for at least 2 weeks and on a stable dose for those 2 weeks
- •Any CD medication which had been discontinued was to have been discontinued at least 4 weeks prior to screening, with the exception of infliximab, which was to have been discontinued at least 8 weeks prior to screening.
- •The screening laboratory tests were to meet the following criteria:
- •Hgb >= 8.5 g/dL (5.3 mmol/L) WBC 3.5-20 x 109/L Neutrophils >= 1.5 x 109/L Platelets >= 100 x 109/L ALT (SGPT) <1.5 x the upper limit of normal range Alkaline phosphatase <2.5 x the upper limit of normal range Bilirubin <25 mmol/L (1.5 mg/dl) Creatinine <110 mol/L (1.2 mg/dl)
- •Patients were to be able to adhere to the study visit schedule and/or protocol requirements.
- •Patients were to be able to give informed consent and the consent was to be obtained prior to any study specific screening procedures.
排除标准
- •Treatment with any other experimental therapeutics within the last 4 weeks before enrolment.
- •History of tuberculosis, either clinically or as evidenced by a positive chest x-ray (exclusion criterion #8) or PPD.
- •Patients who had received anti-TNF therapy, such as infliximab, within 8 weeks of screening for this study. Patients who had received anti-TNF therapy >8 weeks prior to screening were eligible.
- •Patients with any ostomy, extensive bowel resection (e.g., more than 100cm of small bowel, proctocolectomy or colectomy with ileorectal anastomosis). Segmental colectomy was permitted.
- •Patients immediately in need of surgery for active gastrointestinal bleeding, peritonitis, intestinal obstruction, or intra-abdominal or pancreatic abscess requiring surgical drainage.
- •Patients with known severe fixed symptomatic stenosis of the small or large intestine.
- •Evidence at the time of enrolment of bowel obstruction or history within the preceding six months as confirmed by radiography, endoscopy, or surgery.
- •Patients with a clinically significant abnormality or granulomata or any other evidence of primary tuberculosis infection on chest X-ray
- •Patients with current signs or symptoms of clinically significant hematologic, endocrine, pulmonary, cardiac, neurologic or cerebral disease.
- •Patients with previous diagnosis of, or known, malignancies.
- •Patients with serious infections, such as hepatitis, HIV, pneumonia or pyelonephritis, within 3 months prior to screening.
- •History of opportunistic infections such as herpes zoster within 2 months prior to screening, evidence of active CMV, active Pneumocystis carinii, drug resistant atypical mycobacterium.
- •Patients with stool examination positive for enteric pathogens, pathogenic ova or parasites, or Clostridium difficile toxin.
- •Women who were pregnant or breast-feeding.
- •A psychiatric, addictive, or any disorder that compromises ability to give truly informed consent for participation in this study.
- •Patients who had received CNI-1493 in the past.
- •More than three doses of NSAIDs, including aspirin and COX-2 inhibitors, within the two weeks prior to start of study medication
研究组 & 干预措施
1
Experimental
Semapimod 60 mg IV x 1 day, placebo IV x 2 days
干预措施: Semapimod (Drug)
2
Experimental
Semapimod 60 mg IV x 3 days
干预措施: Semapimod (Drug)
3
Placebo Comparator
Placebo comparator IV x 3 days
干预措施: Placebo (Drug)
结局指标
主要结局
Crohn's Disease Activity Index (CDAI) score
时间窗: Day 29
次要结局
- Inflammatory Bowel Disease Questionnaire (IBDQ)(Day 29)
- Crohn's disease endoscopic index of severity (CDEIS)(Day 29)
- Change in level of C-reactive protein (CRP)(Day 29)
- Safety (Adverse events)(Days 29 and 57)
研究者
研究点 (27)
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