A Multicenter, Randomized, Double-blind, PlacebO-controlled, Parallel-group Study to EValuate the Efficacy and Safety of JTE-051 Administered for 12 Weeks to Subjects With Active Rheumatoid Arthritis (MOVE-RA)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 260
- 主要终点
- Percentage of Subjects Achieving at Least 20% Improvement From Baseline in American College of Rheumatology (ACR) Core Set Measures (ACR20 Response Rate) Compared to Placebo at End-of-treatment (EOT)
研究概览
简要总结
This study will evaluate the efficacy, safety, tolerability and pharmacokinetics (PK) of JTE-051 administered for 12 weeks in subjects with active rheumatoid arthritis who are receiving background non-biologic disease-modifying anti-rheumatic drug therapy.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of RA prior to the Screening Visit.
- •Active disease despite ongoing therapy with up to two non-biologic disease-modifying anti-rheumatic drugs, including methotrexate at both the Screening and Baseline Visits.
- •Screening hs-CRP ≥1.2 x upper limit of normal (ULN).
排除标准
- •Prior/current exposure to biologic and/or kinase inhibitor therapy.
- •Known history or presence of polyneuropathy of any cause and no presence of clinically active compression neuropathy, radiculopathy or plexopathy at the Screening Visit.
- •Positive test results for human immunodeficiency (HIV) virus, hepatitis B virus or hepatitis C (HCV) virus at the Screening Visit.
- •Positive drug of abuse and alcohol test results.
- •History of a clinically-significant infection that required oral antimicrobial or antiviral therapy within 8 weeks prior to Day 1.
研究组 & 干预措施
JTE-051 Dose 2
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
JTE-051 Dose 3
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
JTE-051 Dose 1
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
JTE-051 Dose 4
One dose of study drug by mouth daily for 12 weeks
干预措施: JTE-051 (Drug)
Placebo
One dose of study drug by mouth daily for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Subjects Achieving at Least 20% Improvement From Baseline in American College of Rheumatology (ACR) Core Set Measures (ACR20 Response Rate) Compared to Placebo at End-of-treatment (EOT)
时间窗: Up to 12 Weeks
Percentage of subjects achieving at least 20% improvement from baseline (ACR20) in tender and swollen joint counts (ACR core set measures 1 and 2) and at least 20% improvement from baseline in the 3 of the 5 remaining ACR core set measures at EOT (up to Week 12) compared to placebo. The ACR core set measures are: 1. Tender joint count 2. Swollen joint count 3. Subject Assessment of arthritis pain 4. Subject's Global Assessment of disease activity (SGA) 5. Physician's Global Assessment of disease activity (PGA) 6. Health Assessment Questionnaire Disability Index (HAQ-DI) 7. Acute Phase Reactant (i.e., hs-CRP - high sensitivity C-reactive protein)
次要结局
- Percentage of Subjects Achieving ACR70 Response Rate Compared to Placebo at Week 12(Week 12)
- Change From Baseline in SDAI (Simplified Disease Activity Index) at Week 12(Week 12)
- Trough Concentrations (Ctrough) of JTE-051 in Plasma at Week 12(Week 12)
- Percentage of Subjects Achieving ACR20 Response Rate Compared to Placebo at Week 12(Week 12)
- Change From Baseline in CDAI (Clinical Disease Activity Index) at Week 12(Week 12)
- Percentage of Subjects Achieving ACR50 Response Rate Compared to Placebo at Week 12(Week 12)
- Change From Baseline in DAS28-CRP (Disease Activity Score [DAS] Based on High-sensitivity C-reactive Protein [Hs-CRP]) at Week 12(Week 12)
- Change From Baseline in HAQ-DI (Health Assessment Questionnaire Disability Index) at Week 12(Week 12)
- Number of Subjects With Treatment-related Adverse Events(Up to 16 Weeks)