A Multicenter, Open Label, Randomized, Parallel-group Study to Evaluate the Efficacy of Oral AB1010 in Adult Patients With Active Rheumatoid Arthritis With Inadequate Response to at Least One Disease Modifying Anti Rheumatic Drugs (DMARD)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 43
- 主要终点
- rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks
研究概览
简要总结
The objective of this study is to evaluate the activity of 2 oral doses of AB1010 in subjects suffering from active RA who have shown an inadequate response to one DMARD including MTX or anti-TNF, after 3 months (12 weeks) of treatment.
The safety and efficacy will be evaluated on:
Rate of patients achieving ACR 20, 50, 70 and 90 DAS (disease activity score) after 3 months treatment ACRn after 3 months treatment Therapeutic maintenance of AB1010 at 3 months Quality of Life assessed by SF12 Health Assessment Questionnaire (HAQ) Clinical and biological safety Pharmacokinetic profile of AB1010
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
- None
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
- •Meet American College of Rheumatology (ACR) criteria for RA
- •Have active RA
- •ACR functional class I-III
- •Disease onset at > 16 years of age
- •Disease duration of at least 6 months
- •Failure to one DMARD including methotrexate and anti-TNF alpha
排除标准
- •Pregnant or breastfeeding women
- •Inadequate bone marrow function
- •Current use of a DMARD within 4 weeks (or 5 half-lives, whichever is longer) of screening except for leflunomide which requires a specific wash-out
- •Any previous use of recombinant IL1-Ra
- •Current use of more than 1 non steroidal anti-inflammatory drug (NSAID) or change of dose of the NSAID within 4 weeks of baseline or NSAID use greater than the maximum recommended dose
- •Within 4 weeks before baseline, use of more than 10 mg/day of prednisone or equivalent or change in the dose of prednisone or equivalent, or having intra-articular corticosteroid injection or bolus intramuscular or intravenous treatment with corticosteroids (>20 mg prednisone or equivalent
研究组 & 干预措施
1
masitinib (AB1010) 3 mg/kg/day
干预措施: masitinib (AB1010) (Drug)
2
masitinib (AB1010) 6 mg/kg/day
干预措施: masitinib (AB1010) (Drug)
结局指标
主要结局
rate of patients achieving ACR 20, 50, 70 and 90 at 12 weeks
时间窗: 12 weeks
次要结局
- DAS (disease activity score) at 12 weeks(12 weeks)
- ACRn at 12 weeks(12 weeks)
- improvement of quality of life assessed by SF12 at 12 weeks(12 weeks)