Phase II Study of Safety and Efficacy of Intravenous LY2127399 in Patients With Rheumatoid Arthritis Treated With Methotrexate
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 136
- 试验地点
- 1
- 主要终点
- Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale)
研究概览
简要总结
This study is a multicenter, double-blind, study to evaluate the safety and effectiveness of treatment with LY2127399 (in addition to the standard of care treatment, methotrexate) for participants with Rheumatoid Arthritis. Participants will receive three intravenous doses of LY2127399 or placebo. Participants will participate in 10 or more visits to the study site, over 6 months. Evaluation of safety and efficacy will be conducted throughout the study.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Male or female between the ages of 18 and 75 years
- •Have given written informed consent approval
- •Women must not be at risk to become pregnant during study participation
- •Diagnosis of Rheumatoid Arthritis according to the 1987 revised American Rheumatism Association (ARA) criteria for the classification of RA
- •Serum C-reactive protein (CRP) measurement greater than the upper limit of normal (ULN, 0.574 mg/dL), or erythrocyte sedimentation rate (ESR) ≥28 mm/hr
- •Current, regular use of Methotrexate, at a stable dose
- •Biologic DMARD naïve, and have had an insufficient response (in the opinion of the investigator) to an adequate therapeutic dose of at least 1 oral DMARD
排除标准
- •Use of excluded medications (reviewed by study doctor)
- •Surgical treatment of a joint with 2 months of study enrollment that is to be assessed in the study
- •Are unable to ambulate; that is, confined to bed or wheelchair bound
- •Have medical findings which, in the opinion of the study doctor, put participant at an unacceptable risk for participation in the study
- •Have had recent or ongoing infection which, in the opinion of the study doctor put participant at an unacceptable risk for participation.
研究组 & 干预措施
A
干预措施: LY2127399 (Drug)
B
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving American College of Rheumatology 20% Response (ACR20) (Effectiveness of LY2127399 in Treating Rheumatoid Arthritis Using the ACR20 Scale)
时间窗: Week 16
ACR Responder Index is a Composite of clinical, laboratory, and functional measures of rheumatoid arthritis (RA). ACR20 Responders: had ≥20% improvement from baseline in both tender and swollen joint counts and ≥20% improvement in at least 3 of 5 criteria: participant's and physician's global assessment of disease activity, Health Assessment Questionnaire-Disability Index (HAQ-DI) (which measured participants' perceived degree of difficulty performing daily activities), visual analog pain scale, and erythrocyte sedimentation rate (ESR) or C-reactive protein (CRP).
次要结局
- Change From Baseline in the Disease Activity Score 28 Joint Count (DAS28-CRP)(Baseline, Week 24)
- European League Against Rheumatism (EULAR28) Response: Percentage of Participants With Combined Good and Moderate Responses(Baseline, Week 24)
- Change From Baseline in CD20+ B Cell Number Count(Baseline, Week 24)
- Percentage of Participants Achieving ACR 50 and ACR70(Baseline through Week 24)
- Change From Baseline (CFB) in Serum Immunoglobulins IgG, IgA and IgM(Baseline, Week 24)
- Number of Participants With Treatment Emergent Adverse Events (TEAE) (Safety of Repeat Doses (3) of LY2127399 Through Evaluation of Laboratory Tests, Vital Signs and Electrocardiograms)(Baseline through Study Completion (Up to 19 Months))
- Evaluation of the Pharmacokinetics of LY2127399: Clearance(2 hours pre-dose, pre-dose, 1 hour and 4 hour(s) post dose)