CTRI/2014/09/005044Other2 期
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
AB SCIENCE0 个研究点目标入组 450 人开始时间: 待定最近更新:
试验速览
- 阶段
- 2 期
- 状态
- Other
- 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
入排标准
入选标准
- •1. Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months.
- •2. Patient with ACR functional class I-III.
- •3. Patient who have active RA.
- •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-TNFα, Anti-CD20, Anti-IL1, Anti-IL6, CTLA4).
- •5. Patient with a disease onset at > 16 years of age.
排除标准
- •A patient must not be enrolled if he/she fulfills one of the following exclusion criteria:
- •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 pre-existing 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 entry
- •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.
研究者
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