NCT01652937撤回2 期
A Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Evaluate the Safety and Efficacy of BIIB057 in Subjects With Rheumatoid Arthritis Who Have Had an Inadequate Response to Disease-Modifying Antirheumatic Drugs
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 发起方
- Biogen
- 试验地点
- 1
- 主要终点
- Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)
研究概览
简要总结
Phase II study designed to evaluate the safety and efficacy of BIIB057 in Subjects with Rheumatoid Arthritis who have experienced an Inadequate Response to Disease-Modifying Antirheumatic Drugs (DMARDs).
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 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Adult onset RA satisfying 2010 Revised ACR Criteria for the Classification of RA with a disease history of at least 6 months
- •Active RA as defined by: at least 4 swollen joints (based on 28-joint count), at least 4 tender joints (based on 28-joint count), and high-sensitivity CRP (hsCRP) 10mg/L or greater
- •No prior treatment with biologics
- •Receiving a DMARD therapy for at least 3 months, using a regimen that has been stable for at least 28 days prior to screening
排除标准
- •History of inflammatory joint disease other than RA
- •Abnormal chest X-ray consistent with tuberculosis, malignancy, or infection
- •History of malignancy, carcinoma in situ, or high-grade dysplasia
- •History of opportunistic infection, infection requiring treatment, serious local infection, recent fever, active herpes zoster or Epstein-Barr virus, or diagnosis or family history of Creutzfeldt-Jakob disease.
- •Clinically significant cardiac disease
- •Treatment with prednisone >10 mg orally daily
- •Intra-articular steroid injection within 28 days before screening
- •Clinically significant abnormality in hematology or blood chemistry values at screening
研究组 & 干预措施
Placebo + Background Therapy
Placebo Comparator
Background therapy including DMARD(s) approved by protocol
干预措施: Placebo (Drug)
BIIB057 Dose 1 + Background Therapy
Experimental
Background therapy including DMARD(s) approved by protocol
干预措施: BIIB057 (Drug)
BIIB057 Dose 2 + Background Therapy
Experimental
Background therapy including DMARD(s) approved by protocol
干预措施: BIIB057 (Drug)
BIIB057 Dose 3 + Background Therapy
Experimental
Background therapy including DMARD(s) approved by protocol
干预措施: BIIB057 (Drug)
结局指标
主要结局
Proportion of subjects achieving an ACR20 response (ACR20 = American College of Rheumatology 20% response criteria change from baseline)
时间窗: Week 12
次要结局
- Assess the safety and tolerability of BIIB057 by measuring the incidence of AEs, SAEs and changes in laboratory test results during the study(Up to 16 weeks)
- Proportion of subjects with 28-joint count Disease Activity Score with C-reactive protein (DAS28-CRP) <3.2, <2.6, and <2.32(Week 12)
- Proportion of subjects achieving ACR50 and ACR70 response(Week 12)
研究者
研究点 (1)
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