NCT02357069Unknown3 期
Multi-center (in Korea and Japan), Double-blind, Randomized, Parallel-group Study to Evaluate Similarity of Efficacy and Safety of LBEC0101 50mg Subcutaneous Weekly Injection to Enbrel® 50mg Subcutaneous Weekly Injection, as Adjunctive Therapy to Methotrexate (MTX), in Patients With Active Rheumatoid Arthritis Who Had an Inadequate Response to MTX
LG Life Sciences2 个研究点 分布在 2 个国家目标入组 372 人开始时间: 2015年2月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 发起方
- 入组人数
- 372
- 试验地点
- 2
- 主要终点
- Disease activity score based on a 28 joint count (DAS28)
研究概览
简要总结
This is a randomized, double-blind, parallel group, multicenter clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of LBEC0101 compared to Enbrel in subjects with active Rheumatoid Arthritis despite 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
- 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
- •Male or Female patients from 20 years to 75 years of age when signing Informed Consent.
- •Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months prior to screening
- •Patients who have inadequate response to MTX administered for at least 12 weeks before the beginning of screening period and on a stable dose.
排除标准
- •patients with active tuberculosis or latent tuberculosis based on current clinical symptoms, chest X-ray test and IFN-γ release assay at screening
- •patients with any of the following concomitant diseases and/or history within 24 weeks before the first administration of investigational products in this study; Serious infectious disease, Opportunistic infection, Chronic or recurrent infectious disease
- •patients with any seropositive result for hepatitis B or hepatitis C or HIV
- •patients who have any of the following diseases; Sepsis, Demyelinating disorders, Lymphoproliferative disease, Infection with prosthetic joint, Autoimmune diseases other than rheumatoid arthritis
研究组 & 干预措施
LBEC0101
Experimental
Etanercept
干预措施: LBEC0101 (Drug)
Enbrel
Active Comparator
Etanercept
干预措施: Enbrel (Drug)
结局指标
主要结局
Disease activity score based on a 28 joint count (DAS28)
时间窗: Week 24
次要结局
未报告次要终点
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
A Study Comparing LBAL to Humira® in Subjects With Active Rheumatoid Arthritis Despite Methotrexate TherapyArthritis, RheumatoidNCT02746380LG Life Sciences383
已完成
3 期
Phase 3 Trial to Evaluate the Efficacy and Safety of LC15-0444 in Patients With Type 2 DiabetesType 2 Diabetes MellitusNCT01601990LG Life Sciences189
已完成
3 期
An Efficacy and Safety Study of Subcutaneous Tocilizumab in Combination With Methotrexate (MTX) and as Monotherapy Versus MTX in Participants With Moderate to Severe Rheumatoid Arthritis With Inadequate Response to Current Disease-Modifying Antirheumatic Drug (DMARD) TherapyRheumatoid ArthritisNCT03155347Hoffmann-La Roche340
已完成
3 期
A Study to Compare Efficacy, PK, PD, Safety and IMM of MB09 to Prolia® [EU-sourced] in Postmenopausal Osteoporosis.Postmenopausal Women With OsteoporosisNCT05338086mAbxience Research S.L.558
已完成
3 期
A Study Comparing SB5 to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisNCT02167139Samsung Bioepis Co., Ltd.544