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 6 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
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 324
- 试验地点
- 1
- 主要终点
- ACR50
研究概览
简要总结
The objective is to compare efficacy and safety of masitinib at 3 and 6 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.
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
- •Patient with rheumatoid arthritis diagnosed according to American College of Rheumatology (ACR) criteria for at least 6 months
- •Patient with ACR functional class I-III
- •Patient who have active RA
- •Patient who failed (defined as active RA with stable dose during 3 months) methotrexate or any DMARD including biologics drugs if patients previously failed methotrexate or methotrexate in combination with any DMARD including biologics drugs
- •Patient with a disease onset at > 16 years of age
排除标准
- •Patient for whom the use of methotrexate is contraindicated as per its SPC
- •Patient with documented fibromyalgia
- •Patient with lactose intolerance
- •Patient presenting with cardiac disorders
研究组 & 干预措施
masitinib 3 mg
masitinib 3 mg/kg/day, tablets, orally, twice a day
干预措施: masitinib 3 mg (Drug)
masitinib 3 mg
masitinib 3 mg/kg/day, tablets, orally, twice a day
干预措施: Placebo (methotrexate) (Drug)
masitinib 6.0 mg
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
干预措施: masitinib 6.0 mg (Drug)
masitinib 6.0 mg
masitinib 6.0 mg/kg/day, tablets, orally, twice a day
干预措施: Placebo (methotrexate) (Drug)
methotrexate
methotrexate at the dose of 15 or 20 mg per week
干预措施: methotrexate (Drug)
methotrexate
methotrexate at the dose of 15 or 20 mg per week
干预措施: Placebo (masitinib) (Drug)
结局指标
主要结局
ACR50
时间窗: week 24
次要结局
- ACR(week 12)