NCT03257852已完成2 期
A Phase 2a, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Study to Evaluate the Efficacy and Safety of ASP5094 in Patients With Rheumatoid Arthritis on 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
- 66
- 试验地点
- 31
- 主要终点
- ACR50 response rate
研究概览
简要总结
The objective of this study is to evaluate the efficacy, safety and pharmacokinetics of ASP5094 in patients with rheumatoid arthritis (RA) treated with background methotrexate (MTX).
详细描述
The study drug will be intravenously administered.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has RA diagnosed according to the 1987 American College of Rheumatology (ACR) criteria or the 2010 ACR/European League Against Rheumatism (EULAR) criteria at least 6 months prior to screening.
- •Subject meets the 1991 ACR Revised Criteria for the Classification of Global Functional Status in RA Class I, II, or III at screening.
- •At screening and baseline, subject has active RA as evidenced by both of the following:
- •≥ 6 tender/painful joints (using 68-joint assessment)
- •≥ 6 swollen joints (using 66-joint assessment)
- •Subject meets the criterion for a CRP level (Latex Agglutination method) at screening.
- •Subject who has continuously received Methotrexate for at least 90 days prior to screening and who is able to continue a stable dose of Methotrexate from at least 28 days prior to screening throughout the study period.
排除标准
- •Subject has deviated from the criteria for previous and concomitant treatment before baseline.
- •Subject has an ongoing infection requiring antibiotics.
- •Subject is determined to be an inadequate responder to a prior biologic disease modifying antirheumatic drugs (DMARDs) or Janus kinase (JAK) inhibitors.
- •Subject has participated in previous ASP5094 clinical trial.
- •Subject has participated in a clinical trial or post-marketing clinical study of another ethical drug or medical device within 12 weeks (84 days).
- •Subject has another inflammatory arthritis than RA, or any other articular symptom which may affect on joint assessment.
- •Subject meets any of the criteria for laboratory values at screening.
- •Subject has a positive T-SPOT or QuantiFERON Gold test within 90 days prior to screening or at screening.
- •Subject has a history of or concurrent malignant tumor.
- •Subject has autoimmune disease except for RA or any severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, metabolic, endocrine, pulmonary, cardiac, neurological, or mental illness.
- •Subject has a history of clinically significant allergy.
- •Subject has clinically significant abnormalities on 12-lead electrocardiogram (ECG) at screening.
- •Subject has a history of Human Immunodeficiency Virus (HIV) infection.
- •Subject had surgery within 30 days prior to screening or has a planned elective surgery.
- •Subject has a wound that is currently healing at baseline.
研究组 & 干预措施
Placebo Group
Placebo Comparator
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
干预措施: Placebo (Drug)
ASP5094 Group
Experimental
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
干预措施: ASP5094 (Drug)
ASP5094 Group
Experimental
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
干预措施: Methotrexate therapy (Other)
Placebo Group
Placebo Comparator
To be intravenously administered ASP5094 in patients with rheumatoid arthritis (RA) treated with methotrexate.
干预措施: Methotrexate therapy (Other)
结局指标
主要结局
ACR50 response rate
时间窗: Week 12
To assess ACR (American College of Rheumatology) 50 for efficacy
次要结局
- ACR50 response rate(Up to Week 16)
- ACR20 response rate(Up to Week 16)
- ACR70 response rate(Up to Week 16)
- Percentage of subjects achieving SDAI score ≦ 3.3 (SDAI remission)(Up to Week 16)
- Change from baseline in DAS28-CRP score(Baseline and Up to Week 16)
- Change from baseline in Tender Joint Count (68 joints)(Baseline and Up to Week 16)
- Percentage of subjects achieving DAS28-ESR score for remission (<2.6)(Up to Week 16)
- Percentage of subjects achieving DAS28-CRP score for low disease activity (≦3.2)(Up to Week 16)
- Percentage of subjects achieving DAS28-ESR score for low disease activity (≦3.2)(Up to Week 16)
- Change from baseline in CRP(Baseline and Up to Week 16)
- Percentage of subjects achieving EULAR response criteria of "Good Response"(Up to Week 16)
- Percentage of subjects achieving ACR/EULAR score for remission(Up to Week 16)
- Percentage of subjects achieving DAS28-CRP score for remission (<2.6)(Up to Week 16)
- Percentage of subjects achieving EULAR response criteria of "Good Response" or "Moderate Response"(Up to Week 16)
- Change from baseline in DAS28-ESR score(Baseline and Up to Week 16)
- Change from baseline in Swollen Joint Count (66 joints)(Baseline and Up to Week 16)
- Change from baseline for the HAQ-DI(Baseline to Up to Week 16)
- Change from baseline in ESR(Baseline and Up to Week 16)
- Percentage of subjects achieving CDAI score ≦ 2.8 (CDAI remission)(Up to Week 16)
- Safety assessed by incidence of adverse events(Up to Week 16)
- Safety assessed by laboratory tests: Hematology(Up to Week 16)
- Safety assessed by laboratory tests: Biochemistry(Up to Week 16)
- Safety assessed by laboratory tests: Urinalysis(Up to Week 16)
- Safety assessed by vital signs: Body temperature(Up to Week 16)
- Safety assessed by vital signs: Sitting blood pressure(Up to Week 16)
- Safety assessed by vital signs: pulse rate(Up to Week 16)
- Safety assessed by weight(Up to Week 16)
- Safety assessed by standard 12-lead electrocardiogram(Up to Week 16)
- Serum concentration of ASP5094(Up to Week 16)
- Serum concentration of TNF-α(Up to Week 16)
- Serum concentration of MMP3(Up to Week 16)
- Serum concentration of IL-6(Up to Week 16)
- Anti-ASP5094 anti-bodies(Up to Week 16)
研究者
研究点 (31)
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