NCT03605251已完成2 期
An Early Phase-II, Randomized, Double-blind, Study of TAS5315 in Rheumatoid Arthritis Patients With an Inadequate Response to Methotrexate
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 1
- 主要终点
- Proportion of participants achieving American College of Rheumatology 20% (ACR20) response
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.
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
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria
- •Have been treated with methotrexate (MTX) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening.
- •Have an inadequate response to MTX
- •Have a minimum of 6 swollen and 6 tender joints from 66/68 joint count
- •Have hsCRP of ≥ 0.6 mg/dL
排除标准
- •Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization
- •Have an inadequate response to biologic disease-modifying anti-rheumatic drug or Have been treated with 2 biologic treatment
- •Have been treated with Janus Kinase inhibitors or other Bruton's Tyrosine Kinase inhibitors
- •Have a positive result for hepatitis B surface antigen/antibody, hepatitis B core antibody, hepatitis C virus antibody or human immunodeficiency virus antigen/antibody at screening
- •Have been treated with Oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents
- •Have a diagnosis of Felty's syndrome
- •Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test or a T-spot ®-TB test at screening
- •Have a positive result of β-D-glucan at screening
研究组 & 干预措施
TAS5315 low dose group
Experimental
TAS5315 low dose and Methotrexate as specified
干预措施: TAS5315 low dose (Drug)
TAS5315 high dose group
Experimental
TAS5315 high dose and Methotrexate as specified
干预措施: TAS5315 high dose (Drug)
Placebo group
Placebo Comparator
Placebo and Methotrexate as specified
干预措施: Placebos (Drug)
结局指标
主要结局
Proportion of participants achieving American College of Rheumatology 20% (ACR20) response
时间窗: Week 12
次要结局
- Proportion of participants who achieve DAS28-hs C-ReactivePprotein (CRP) and DAS28-Erythrocyte Sedimentation Rate (ESR) for remission(Baseline, Week 12)
- Change from baseline in DAS28-CRP and DAS28-ESR score(Up to Week 36)
- Proportion of participants achieving American College of Rheumatology 50% (ACR50) and American College of Rheumatology 70% (ACR70) response(Up to Week 36)
- Proportion of participants who achieve ACR20 response(Up to Week 36, except for Week 12)
- Proportion of participants who achieve Clinical Disease Activity Index (CDAI) and Simplified Disease Activity Index (SDAI) for remission(Baseline, Week 12)
- Change from baseline in CDAI and SDAI score(Up to Week 36)
- Change from baseline in patient assessment score of arthritis pain(Up to Week 36)
- Change from baseline in patient global assessment score of arthritis(Up to Week 36)
- Change from baseline in physician's global assessment score of arthritis(Up to Week 36)
- Change from baseline in modified total sharp score(Baseline, Week 2, 4, 12)
- Change from baseline in Anti-cyclic Citrullinated Peptide antibody levels(Up to Week 36)
- Change from baseline in rheumatoid factor levels(Up to Week 36)
- Maximum observed plasma concentration for TAS5315(Baseline, Week 2, 4, 12)
- Time to reach the maximum plasma concentration for TAS5315(Baseline, Week 2, 4, 12)
- Area under the plasma concentration-time curve from time 0 to the time of the last quantifiable concentration for TAS5315(Baseline, Week 2, 4, 12)
- Incidence of adverse events and side effects as safety(Up to Week 36)
研究者
研究点 (1)
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