EUCTR2012-004222-25-SK进行中（未招募）1 期
A 12-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 2-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: 2014年1月9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
入选标准
- •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.
- •Patient with unsatisfactory response is defined as patient with active Crohn’s disease (CDAI>=220) after 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 = 3 x ULN
- •? Bilirubin = 1.5x ULN
- •? Creatinine clearance >60 mL/min
- •? Albuminemia > 1 x LLN
- •? Proteinuria < 30 mg/dL (1+) on the dipstick; in case of proteinuria = 1+ on the dipstick, 24 hours proteinuria < 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. Female patient of childbearing potential (entering the study after a menstrual period and who have a negative pregnancy test), who agrees to use two highly effective methods (one for the patient and one for the partner) of medically acceptable forms of contraception during the study and for 3 months after the last treatment intake. Acceptable forms of contraception include:
- •AB Science AB1010
- •Clinical Study Protocol – AB11003- Version 7.0 EUR– June 24th 2015 Page 5 of 118
- •Confidential
- •? A documented placement of an intrauterine device (IUD) or intrauterine system (IUS) and the use of a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository)
- •? Documented tubal ligation (female sterilization). In addition, a barrier method (condom or occlusive cap [diaphragm or cervical/vault caps] used with spermicidal foam/gel/film/cream/suppository) should also be used
- •? Double barrier method: Condom and occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository
- •? Any other contraceptive method wi
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, ...) other than anti-TNF alpha.
- •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).
- •AB Science AB1010
- •Clinical Study Protocol – AB11003- Version 7.0 EUR– June 24th 2015 Page 6 of 118
- •Confidential
- •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.
- •PREVIOUS TREATMENTS (WASH OUT)
- •1. NSAID must be stopped within 2 weeks prior to study treatment initiation
研究者
相似试验
进行中（未招募）
1 期
Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's diseaseMedDRA version: 18.0Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's diseaseEUCTR2012-004222-25-GRAB Science450
进行中（未招募）
1 期
Comparison of efficacy of masitinib versus placebo in the treatment of Crohn's diseaseMedDRA version: 18.1Level: PTClassification code 10011401Term: Crohn's diseaseSystem Organ Class: 10017947 - Gastrointestinal disordersCrohn's diseaseEUCTR2012-004222-25-BEAB Science450
进行中（未招募）
1 期
A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicapSmouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicapsMedDRA version: 9.1 Level: LLT Classification code 10026891 Term: MastocytosisEUCTR2008-000972-25-FRAB SCIENCE200
进行中（未招募）
1 期
A 24-week with possible extension, prospective, multicentre, randomized, double blind, placebo-controlled, 2-parallel group with a randomization 1:1, Phase III study to compare efficacy and safety of masitinib at 6 mg/kg/day to placebo in treatment of patients with Smouldering Systemic, Indolent Systemic or Cutaneous Mastocytosis with handicap - NDSmouldering Systemic, Indolent Systemic or Cutaneous mastocytosis with handicapMedDRA version: 9.1Level: LLTClassification code 10026891EUCTR2008-000972-25-ITAB SCIENCE223
进行中（未招募）
1 期
Study to compare efficacy and safety of masitinib at 6 mg/kg/day toplacebo in treatment of patients with Systemic mastocytosis with severe handicapSmouldering Systemic or Indolent Systemic Mastocytosis with handicap.MedDRA version: 17.0Level: PTClassification code 10026891Term: MastocytosisSystem Organ Class: 10005329 - Blood and lymphatic system disordersEUCTR2008-000972-25-GRAB Science150