A Randomized, Double-blind, Placebo Controlled, Dose Ranging Study to Evaluate the Efficacy and Safety of CDP6038 Administered Subcutaneously for 12 Weeks to Asian Subjects With Active Rheumatoid Arthritis Having Previously Failed TNF Blocker Therapy
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 39
- 主要终点
- Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy and safety of CDP6038 administered subcutaneous (sc) at various doses compared to placebo.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of adult-onset RA of at least 6 months' (24 weeks) duration as defined by the 1987 ACR classification criteria or a score of ≥6 as defined by the ACR/European League Against Rheumatism Classification and Diagnostic Criteria for RA
- •Must have moderately to severely active RA disease as defined by ≥6 tender joints (68-joint count) at Screening and Baseline, ≥6 swollen joints (66-joint count) at Screening and Baseline, CRP ≥1.2 times the upper limit of normal (ULN) or ESR >28mm/hour
- •Must be on an MTX dose of 6 to 16mg/week in Japan or 7.5 to 20mg/week in Korea and Taiwan, which has been stable for at least 6 weeks prior to Screening with a stable route of administration
- •Must have had intolerance or inadequate response to treatment with 1 or more TNF-blocker therapies within 2 years of Screening
- •Female subjects must be either postmenopausal for at least 1 year, surgically incapable of childbearing, or effectively practicing 2 acceptable methods of contraception
排除标准
- •Have a diagnosis of any other inflammatory arthritis
- •Female subjects who are breast-feeding, pregnant, or plan to become pregnant during the study or within 24 weeks
- •Disease modifying antirheumatic drug (DMARDs) other than methotrexate (MTX)
- •Subjects with known concurrent acute or chronic viral hepatitis B or C infection
- •Subject has known tuberculosis (TB) disease, high risk of acquiring TB infection, or latent TB infection
- •Subjects with known history of or current clinically active infection
- •Subjects at high risk of infection
- •Subjects with known human immunodeficiency virus (HIV) or human T cell lymphotropic virus type 1 (HTLV 1) infection
- •Have received vaccinations within 8 weeks prior to Screening or plan to receive vaccines during the study (with the exception of injectable influenza and pneumococcal vaccinations which are permitted)
- •Concurrent malignancy or a history of malignancy (with the exception of successfully treated carcinoma of the cervix more than 5 years prior to Screening or no more than 2 successfully treated basal cell carcinomas within 2 years prior to Screening
研究组 & 干预措施
Olokizumab 60 mg every 2 weeks
Olokizumab 60 mg injections administered at week 0, 2, 4, 6, 8 and 10
干预措施: Olokizumab 60 mg (Biological)
Olokizumab 60 mg every 4 weeks
Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
干预措施: Olokizumab 60 mg (Biological)
Olokizumab 120 mg every 2 weeks
Olokizumab 120 mg injections administered at week 0, 2, 4, 6, 8 and 10
干预措施: Olokizumab 120 mg (Biological)
Olokizumab 120 mg every 4 weeks
Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
干预措施: Olokizumab 120 mg (Biological)
Olokizumab 240 mg very 4 weeks
Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
干预措施: Olokizumab 240 mg (Biological)
Placebo every 2 weeks
Injections administered at week 0, 2, 4, 6, 8 and 10
干预措施: Placebo (Biological)
Olokizumab 60 mg every 4 weeks
Olokizumab 60 mg injection administered at week 0, 4, and 8 and Placebo injection administered at week 2, 6, and 10
干预措施: Placebo (Biological)
Olokizumab 120 mg every 4 weeks
Olokizumab 120 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
干预措施: Placebo (Biological)
Olokizumab 240 mg very 4 weeks
Olokizumab 240 mg injections administered at week 0, 4 and 8 and Placebo injections at week 2, 6 and 10
干预措施: Placebo (Biological)
结局指标
主要结局
Change from Baseline in the Disease Activity Score 28-joint count (C-reactive protein) (DAS28[CRP]) at Week 12
时间窗: From Week 0 (Baseline) to Week 12
次要结局
- Number of responders in American College of Rheumatology 20% Response Criteria (ACR20) at Week 12(From Week 0 (Baseline) to Week 12)
- Number of responders in American College of Rheumatology 50% Response Criteria (ACR50) at Week 12(From Week 0 (Baseline) to Week 12)
- Number of responders in American College of Rheumatology 70% Response Criteria (ACR70) at Week 12(From Week 0 (Baseline) to Week 12)