A Phase 1b/2 Multiple-Dose Safety Study and Pharmacokinetic/ Pharmacodynamic Study of LY2189102 in Patients With Rheumatoid Arthritis
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 121
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
The purpose of this study is to examine the safety and efficacy of this antibody in participants with rheumatoid arthritis.
Part A of the study is an initial dose escalation phase
Part B of the study is a randomized allocation of the entire dosing group to parallel treatment assignments
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
- •diagnosis of rheumatoid arthritis
- •regular use of methotrexate
- •active rheumatoid arthritis
排除标准
- •Juvenile Rheumatoid Arthritis
- •evidence of tuberculosis
- •women who are pregnant or become pregnant during study, or are breast-feeding
研究组 & 干预措施
Part A LY2189102 0.1 mg/kg/wk
Part A: 2 times (x) 0.1 milligrams/kilogram/week (mg/kg/wk) Loading dose, then 0.1 mg/kg/wk) X 4 weeks (wks), intravenous (IV)
Part B: 2 x 0.02 mg/kg/wk Loading dose, then 0.02 mg/kg/wk X 4 wks, IV
干预措施: LY2189102 (Drug)
Part A LY2189102 0.3 mg/kg/wk
Part A: 2 x 0.3 mg/kg/wk Loading dose, then 0.3 mg/kg/wk X 4 wks, IV
Part B: 2 x 0.15 mg/kg/wk Loading dose, then 0.15 mg/kg/wk X 4 wks, IV
干预措施: LY2189102 (Drug)
Part A LY2189102 1.0 mg/kg/wk
Part A: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV
Part B: 2 x 1.0 mg/kg/wk Loading dose, then 1.0 mg/kg/wk X 4 wks, IV
干预措施: LY2189102 (Drug)
Part A LY2189102 2.5 mg/kg/wk
Part A: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV
Part B: 2 x 2.5 mg/kg/wk Loading dose, then 2.5 mg/kg/wk X 4 wks, IV
干预措施: LY2189102 (Drug)
Placebo
IV, once weekly x 4 wks
干预措施: placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Baseline up to Day 98
Clinically significant events were defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of s SAEs and other non-serious AEs, regardless of causality, is located in the Reported Adverse Events module.
次要结局
- Pharmacokinetics (PK): Area Under the Concentration Time Curve at Steady State for One Dosing Interval Time 0 to 168 Hours (AUC0-168 hr,ss) of LY2189102(Part A: Day 1 predose and IAI, 2days post infusion, Day 14 and Day 28 predose and IAI, Day 35, 63 (convenient time))
- Change From Baseline in Simple Disease Activity Index Score (SDAI)(Baseline, Days 7, 21, 35, 63, and 98)
- Change From Baseline in Disease Activity Score 28-Joint Count (DAS28)(Baseline, Days 7, 21, 35, 63, and 98)
- Change From Baseline in C-Reactive Protein (CRP)(Baseline, Days 7, 14, 21, 28, 35, 63, and 98)
- Change From Baseline in Health Assessment Questionnaire (HAQ) Score(Baseline, Days 35, 63, and 98)