Multiple-Dose, Dose-Escalation Study to Evaluate Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of LY2127399 in Japanese Patients With Rheumatoid Arthritis Treated With Methotrexate
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Number of Participants With Adverse Events (AEs) [Clinically Significant Effects]
研究概览
简要总结
This study will evaluate the safety and tolerability of multiple doses of LY2127399 (tabalumab) in Japanese participants with RA. The study consists of a 20-week treatment period. All participants will be followed for up to 12 weeks after the last study drug administration.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 20 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 pregnant, breastfeeding or be at risk to become pregnant during study participation
- •Diagnosis of RA
- •Active RA
- •Current, regular use of Methotrexate, at a stable dose
- •Body weight between 40 and 105 kilograms (kg), inclusive
排除标准
- •Use of excluded medications (reviewed by study doctor)
- •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
- •Evidence of tuberculosis
- •Have systemic inflammatory condition other than RA
研究组 & 干预措施
120 mg Tabalumab
120 mg tabalumab Q4W for 20 weeks (6 doses of study drug)
干预措施: LY2127399 (Tabalumab) (Drug)
60 mg Tabalumab
60 mg tabalumab Q4W for 20 weeks (6 doses of study drug)
干预措施: LY2127399 (Tabalumab) (Drug)
30 milligrams (mg) Tabalumab
30 mg tabalumab every 4 weeks (Q4W) for 20 weeks (6 doses of study drug)
干预措施: LY2127399 (Tabalumab) (Drug)
Placebo Q4W
Q4W for 20 weeks
干预措施: Placebo (Drug)
120 mg once every 2 weeks (Q2W) Tabalumab
Initial loading dose of 240 mg tabalumab followed by 120 mg Q2W for 20 weeks (10 doses of study drug)
干预措施: LY2127399 (Tabalumab) (Drug)
Placebo Q2W
Q2W for 20 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs) [Clinically Significant Effects]
时间窗: Baseline through study completion (up to Week 32 plus up to 12 weeks for B cell monitoring)
Clinically significant effects are defined as serious AEs (SAEs) and other non-serious AEs regardless of causality. A summary of SAEs and other non-serious AEs regardless of causality is located in the Reported Adverse Events module.
次要结局
- Percent Change From Baseline in Erythrocyte Sedimentation Rate (ESR)(Baseline, Weeks 4, 8, 16, and 24)
- Pharmacokinetics (PK) of Tabalumab: Area Under the Concentration Time Curve (AUC)(Week 0: Day 1 [predose and 1 hour (h), 3 h, and 6 h postdose], Days 2, 3, and 5, and Weeks 1, 2, 3, and 4 postdose)
- Change From Baseline in Rheumatoid Factor (RF)(Baseline, Week 24)
- Change From Baseline in Serum Immunoglobulins (IgG, IgM, IgA)(Baseline, Weeks 4, 16, 24, and 32)
- PK of Tabalumab: Maximum Observed Drug Concentration (Cmax)(Week 0: Day 1 Predose, 1 h, 3 h, and 6 h postdose)
- Percent Change From Baseline in B Cell [Cluster Designation 20+ (CD20+)] Counts(Baseline, Week 0 (Day 2), Weeks 1, 2, 3, 4, 6, 8, 12, 16, 20, 24, and 32)
- Change From Baseline in Anti-Cyclic Citrullinated Peptide (Anti-CCP) Antibody [Inova Enzyme-Linked Immunosorbent Assay (ELISA) Method](Baseline, Week 24)
- Change From Baseline in Anti-CCP Antibody (Roche Cobas 6000 Method)(Baseline, Week 24)
- Percent Change From Baseline in CRP(Baseline, Weeks 4, 8, 16, and 24)