NCT00785928已完成2 期
Phase 2, Dose-Ranging Study of Multiple Subcutaneous Doses of LY2127399 in Patients With Active Rheumatoid Arthritis Despite Ongoing Methotrexate Therapy
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
- 158
- 试验地点
- 1
- 主要终点
- Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks
研究概览
简要总结
To assess the efficacy of LY2127399 versus placebo using American College of Rheumatology (ACR)50 response scale at 24 weeks
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
- •Have given written informed consent
- •Women must not be at risk to become pregnant during study participation
- •Diagnosis of Rheumatoid Arthritis (RA)
- •Current, regular use of Methotrexate, at a stable dose
- •Other criteria to be reviewed by study doctor
排除标准
- •Use of excluded medications(reviewed by study doctor)
- •Have not failed biologic tumor necrosis factor-alpha (TNF-α) inhibitor therapy
- •Have had recent or ongoing infection which, in the opinion of the study doctor put patient at an unacceptable risk for participation in the study
- •Evidence of tuberculosis
- •Have systemic inflammatory condition other than RA, such as juvenile RA, Crohn's disease, ulcerative colitis, psoriatic arthritis or seronegative spondyloarthropathy
- •Other criteria to be reviewed by study doctor
研究组 & 干预措施
3 mg LY2127399
Experimental
干预措施: LY2127399 (Biological)
10 mg LY2127399
Experimental
干预措施: LY2127399 (Biological)
Placebo
Experimental
干预措施: Placebo (Drug)
1 mg LY2127399
Experimental
干预措施: LY2127399 (Biological)
30 mg LY2127399
Experimental
干预措施: LY2127399 (Biological)
60 mg LY2127399
Experimental
干预措施: LY2127399 (Biological)
120 mg LY2127399
Experimental
干预措施: LY2127399 (Biological)
结局指标
主要结局
Percentage of Participants Who Achieved American College of Rheumatology (ACR) 50 Response up to 24 Weeks
时间窗: Up to week 24
ACR50 Responder Index is a composite of clinical, laboratory, and functional measures in rheumatoid arthritis. An ACR50 Responder is defined as a participant with \>50% improvement from baseline in both tender and swollen joint counts and in at least 3 of the following 5 criteria: physician global assessment, participant global assessment, functional ability measure (Health Assessment Questionnaire-Disability Index which measures participants' perceived degree of difficulty when performing various daily activities), visual analog pain scale, and erythrocyte sedimentation rate or C-reactive protein.
次要结局
- Percentage of Participants With A European League Against Rheumatism Responder Index Based on the 28 Joint Count (EULAR28) up to 24 Weeks(Up to 24 weeks)
- Percentage of Participants Achieving The American College of Rheumatology (ACR)20 Response up to 24 Weeks(Up to 24 weeks)
- Change From Baseline in the Tender Joint Count up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in the Disease Activity Score (DAS) up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in Swollen Joint Count up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in the Physician's Assessment of Disease Activity up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in the Participant's Assessment of Joint Pain up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI) up to 24 Weeks(Baseline, up to 24 weeks)
- Percent Change From Baseline in C-Reactive Protein (CRP) up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in the Short Form Health Survey (SF-36) up to 24 Weeks(Baseline, up to 24 weeks)
- Pharmacokinetics of LY2127399: C-Trough Steady State Concentration at 24 Weeks(24 weeks)
- Number of Participants Experiencing An Adverse Event(Baseline up to 24 weeks)
- Change From Baseline in the Participant's Assessment of Disease Activity up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in the Functional Assessment of Chronic Illness (FACIT) Fatigue Scale up to 24 Weeks(Baseline, up to 24 weeks)
- Pharmacokinetics of LY2127399: T-Half Life (t1/2, Tau) at 24 Weeks(24 weeks)
- Change From Baseline in the Absolute Total B Cell (CD20+CD3- Cells) Count up to 24 Weeks(Baseline, up to 24 weeks)
- Change From Baseline in Serum Immunoglobulin up to 24 Weeks(Baseline, up to 24 weeks)
研究者
研究点 (1)
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