A Phase 2, Multi-center, Randomized, Double Blind, Placebo-controlled, Multiple-dose Study to Determine the Safety and Efficacy of Daily Orally Administered LX3305 in Subjects With Active Rheumatoid Arthritis (RA) on Stable Methotrexate (MTX) Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 208
- 试验地点
- 1
- 主要终点
- ACR20 Response at Week 12
研究概览
简要总结
The purpose of the study is to evaluate the safety, tolerability, and effectiveness of LX3305 versus a placebo control in subjects with active rheumatoid arthritis on stable methotrexate therapy.
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
- •Males and females aged 18-75 years old
- •Rheumatoid arthritis present for at least 6 months, functional class I, II, or III as defined by ACR criteria
- •Active disease as determined by the presence of ≥6 swollen joints, ≥6 tender joints, and serum C-reactive protein level > upper limit of normal
- •Receiving stable dose of MTX (≥10 mg/wk) and folate supplementation at least 8 weeks prior to Day 1
- •Ability to provide written informed consent
排除标准
- •RA diagnosis prior to 16 years of age (Juvenile RA)
- •Lack of response to >3 disease modifying anti-rheumatic drugs (DMARDs) or exposure to >1 biologic DMARD
- •Use of DMARDs other than MTX within 12 weeks prior to Day 1
- •Intra-articular and/or parenteral corticosteroids within 4 weeks prior to study Day 1
- •Blood donation or receipt of live vaccine within 4 weeks prior to Day 1
- •Major surgical procedure within 8 weeks prior to Day 1
- •Any systemic inflammatory condition, recurrent infection, or current infection other than onychomycosis
- •History of cancer within 5 years prior to Day 1
- •Presence of hepatic or biliary disease
- •History of tuberculosis
- •History of human immunodeficiency virus (HIV)
研究组 & 干预措施
Low Dose
A low dose of LX3305; daily oral intake for 12 weeks
干预措施: LX3305 low dose (Drug)
Mid Dose
A mid dose of LX3305; daily oral intake for 12 weeks
干预措施: LX3305 mid dose (Drug)
High Dose
A high dose of LX3305; daily oral intake for 12 weeks
干预措施: LX3305 high dose (Drug)
Placebo
Matching placebo dosing with daily oral intake for 12 weeks
干预措施: Placebo (Drug)
结局指标
主要结局
ACR20 Response at Week 12
时间窗: Baseline and 12 weeks
Evaluates the efficacy of LX3305 by utilizing the American College of Rheumatology 20% response criteria (ACR20) at 12 weeks in subjects with active RA also receiving stable doses of MTX. For a response of ACR20, there had to be ≥20% improvement in swollen joint count, ≥20% improvement in painful/tender joint count, and ≥20% improvement in at least 3 of the following: subject's assessment of pain, global assessment of disease activity, assessment of physical function, or acute phase reactant (C-reactive protein or erythrocyte sedimentation rate).
次要结局
- ACR50 Response at Week 12(Baseline and 12 weeks)
- ACR70 Response at Week 12(Baseline and 12 weeks)
- Hybrid ACR Response at Week 12(Baseline and 12 weeks)
- Change From Baseline in C-reactive Protein (mg/L) at Week 12(Baseline and 12 weeks)
- Change From Baseline in Erythrocyte Sedimentation Rate (mm) at Week 12(Baseline and 12 weeks)