EUCTR2010-020992-21-DE进行中（未招募）不适用
A 24-week with possible extension, prospective, multicenter, randomised, double-blind, controlled, 3-parallel groups, Phase 2b/3 study to compare efficacy and safety of masitinib at 3 and 4.5 mg/kg/day to methotrexate, with a randomisation 1:1:1, in treatment of patients with active rheumatoid arthritis with inadequate response to 1. methotrexate or to 2. any DMARD including at least one biologic drug if patients previously failed methotrexate or to 3. methotrexate in combination with any DMARD including biologic drugs - AB1010 in treatement of patients with active rheumatoide arthritis.
AB Science0 个研究点目标入组 140 人开始时间: 2011年7月8日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 140
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 rheumatoid arthritis diagnosed according to ACR criteria
- •for at least 6 months.
- •2. Patient with ACR functional class I-III
- •3. Patient who have active RA consisting of
- •- = 6 swollen joints (over 66 swollen joints);- = 6 tender joints (over 68
- •tender joints);- and at least 2 out of 3 of the following:ESR/first hour =
- •20 mm; CRP = 10 mg/L;morning stiffness = 45 minutes at both
- •screening and baseline.
- •4. Patient who failed (defined as active RA with stable dose during 3
- •months) methotrexate at a dose = 15 mg/week or any DMARD including
- •biologics drugs if patients previously failed methotrexate at a dose = 15
- •mg/week or methotrexate at a dose = 15 mg/week in combination with
- •any DMARD including biologics drugs (Biologic drugs being defined as
- •any of the following therapies: anti-TNFa,Anti-CD20,Anti-IL1,Anti-
- •IL6,CTLA4)
- •5. Patient with a disease onset at > 16 years of age
- •6. Patient with an adequate organ function:ACN = 2 x 109/L;White blood
- •cells count = 4 x 109/L;Haemoglobin = 10 g/dL;PLT = 100 x
- •109/L;AST/ALT = 3 x ULN;Bilirubin = 1.5 x 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. No active infection (tuberculosis,HIV,hepatitis, ...)
- •9. 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: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 with a documented failure rate of <1% per
- •year;Abstinence
- •10. Male patients must use medically acceptable methods of
- •contraception if your female partner is pregnant from the time of the
- •first administration of the study drug until three months following
- •administration of the last dose of study drug.Acceptable methods
- •include:Condom;If you have undergone surgical sterilization (vasectomy
- •with documentation of azoospermia) a condom should also be used. Male
- •patients must 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. The
- 另有 7 项未显示
排除标准
- •1. Patient from whom the use of methotrexate is contraindicated as per
- •its SPC (i.e. patient with severe renal or liver failure, patient with preexisting
- •blood dyscrasia, patient with alcohol abuse, patient with acute
- •or chronic infection, patient with methotrexate intolerance, patient being
- •treated with live attenuated vaccine)
- •2. Patient with documented fibromyalgia
- •3. Patient who have had a major surgery within 2 weeks prior to study
- •4. Patient with lactose intolerance
- •5. 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 judgment of the
- •investigator, or symptomatic hypertension
- •6. Patient with history of primary malignancy < 5 years; except treated
- •basal cell skin cancer or cervical carcinoma in situ
- •7. Patient with a severe and/or uncontrolled medical condition
- •8. Pregnant or lactating woman
- •9. 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.
- •10. Patient who were treated with methotrexate >20 mg cannot be
- •included in the study
- •Previous treatments:
- •11. Administration of a DMARD (except methotrexate) within 4 weeks
- •(or 5 half-lives, whichever is longer) prior to baseline except for
- •leflunomide which requires a specific wash-out period of 12 weeks
- •before baseline and infliximab which requires a wash-out period of 8
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