EUCTR2012-004222-25-BE进行中（未招募）1 期
A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 4-parallel groups, phase 2b/3 study to compare efficacy and safety of masitinib to placebo, in the treatment of moderate Crohn’s disease in patients intolerant or with unsatisfactory response to immunosuppressive drugs and/or TNF-inhibitors - AB1010 in treatement of patients with moderate Crohn's disease
AB Science0 个研究点目标入组 450 人开始时间: 2013年1月14日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 450
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •1.Patient with at least a 6-month history of Crohn’s disease (CD) from diagnosis.
- •2.Patient with CD based on clinical history and radiologic or endoscopic findings within the previous 24 months. Patients with active disease following surgical resection must have radiological or endoscopic confirmation of CD post-surgery.
- •3.Patient with a CDAI (Crohn’s disease activity index) score at baseline between 220 and 450 ([220;450]).
- •4.Patient intolerant or with unsatisfactory response to [Azathioprine or 6-mercaptopurine or methotrexate] and/or TNF-inhibitors and/or Vedolizumab. Patient with unsatisfactory response is defined as patient with active Crohn’s disease (CDAI>=220) during at least 3 months under stable dose of treatment. Patient intolerant is defined as patient who have had to discontinue treatment at any time for tolerability or safety reason
- •5.Patient with active Crohn’s disease confirmed by at least one of the following criteria:
- •level of C-reactive protein > 5 mg/L within 2 weeks prior to study treatment initiation
- •faecal calprotectin level > 250 µg within 2 weeks prior to study treatment initiation
- •ulcers demonstrated at colonoscopy within 12 weeks prior to study treatment initiation
- •small intestine or colonic inflammation defined as postcontrast parietal relative contrast enhancement after gadolinium injection and/or the presence of deep ulcerations on MRI or CT within 6 weeks prior to study treatment initiation
- •6.Patient with adequate organ function:
- •Absolute neutrophils count (ANC) = 2 x 109/L
- •Haemoglobin = 10 g/dL
- •Platelets (PTL) = 100 x 109/L
- •AST/ALT = 2.5x ULN
- •Bilirubin = 1.5x ULN
- •Creatinine clearance = 60 mL/min
- •Albuminemia > 1 x LLN
- •Proteinuria < 30 mg/dL on the dipstick; in case of proteinuria = 30 mg/dL, 24 hours proteinuria must be <1.5g/24 hours
- •7.Male or female patient aged 18 to 75 years, weight > 50 kg, BMI between 18 and 35 kg/m²
- •8. Contraception:
- •Female patient of childbearing potential (entering the study after a menstrual period and who has a negative pregnancy test), who agrees to use a highly effective method of contraception and an acceptable method of contraception by her male partner during the study and for 3 months after the last treatment intake.
- •Male patient with a female partner of childbearing potential who agrees to use a highly effective method of contraception and an acceptable method of contraception by his female partner during the study and for 3 months after the last treatment intake or who agrees to use an acceptable method of contraception and a highly effective method of contraception by his female partner during the study and for 3 months after the last treatment intake.
- •Highly effective methods of contraception include:
- •- Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, or transdermal
- •- Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, or implantable
- •- Intrauterine device (IUD)
- •- Intrauterine hormone-releasing system (IUS)
- •- Bilateral tubal occlusion
- •- Vasectomized male (azoospermia assessed medically)
- •- Sexual abstinence (Its reliability should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient)
- •Acceptable methods of contraception include:
- •- Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of a
排除标准
- •1.Patient with less than 3 months exposure to Azathioprine or 6-mercaptopurine or methotrexate.
- •2.Patient treated with biological agents (natalizumab, ...) as anti-TNF alpha or Vedolizumab
- •3.Patient with known active or draining fistula.
- •4.Patient currently receiving nasogastric/nasoenteric tube feeding, an elemental/polymeric diet or total parenteral nutrition e.g. liquid diet and oral supplements, must remain stable during the treatment phase (baseline to week 4).
- •5.Patient likely to require emergency surgery for persistent intestinal obstruction, bowel perforation, uncontrolled bleeding or abdominal abscess infection, in the investigator’s opinion and patients who have undergone bowel surgery within the 3 months prior to study treatment initiation.
- •6.Patient with previous proctocolectomy or with symptomatic stricture or with abscess
- •7.Patient with a clinically relevant short bowel syndrome, in the opinion of the investigator.
- •8.Patient whose symptoms are believed to be largely due to the presence of fixed fibrotic strictures in the opinion of the investigator.
- •9.Patient with a history of malignant neoplastic diseases of the bowel including diseases occurring more than 5 years before the inclusion in the study.
- •10.Patient with active infection (HBV, HCV, HIV, EBV, CMV)
- •11.Patient presenting with cardiac disorders defined by at least one of the following conditions:
- •Patient with recent cardiac history (within 6 months) of:
- •-Acute coronary syndrome
- •-Acute heart failure (class III or IV of the NYHA classification)
- •-Significant ventricular arrhythmia (persistent ventricular tachycardia, ventricular fibrillation, resuscitated sudden death)
- •Patient with cardiac failure class III or IV of the NYHA classification
- •Patient with severe conduction disorders which are not prevented by permanent pacing (atrio-ventricular block 2 and 3, sino-atrial block)
- •Syncope without known aetiology within 3 months
- •Uncontrolled severe hypertension, according to the judgment of the investigator, or symptomatic hypertension
- •12.Patient with life expectancy < 6 months
- •13.Patient with history of primary malignancy < 5 years; except treated basal cell skin cancer or cervical carcinoma in situ
- •14.Patient with a severe and/or uncontrolled medical condition according to judgment of the investigator
- •15.Pregnant or lactating female patient
- •16.Patient with history of poor compliance or history of drug/alcohol abuse, or excessive alcohol beverage consumption that would interfere with the ability to comply with the study protocol, or current or past psychiatric disease that might interfere with the ability to comply with the study protocol or give informed consent.
- •17.Patient with Body Mass Index (BMI) strictly above 35.
研究者
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