NCT01895309已完成3 期
A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB4 Compared to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate Therapy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 596
- 试验地点
- 1
- 主要终点
- American College of Rheumatology 20% Response Criteria (ACR20)
研究概览
简要总结
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will receive SB4 for an additional 48 weeks.
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
- •Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months but not exceeding 15 years prior to Screening
- •Have moderate to severe active disease despite MTX therapy defined as having more than or equal to six swollen joints and more than or equal to six tender joints and either erythrocyte sedimentation rate (ESR, Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 1.0 mg/dL
- •Must have been treated with MTX for at least 6 months prior to Randomisation and on a stable dose of MTX 10-25 mg/week given at least 4 weeks prior to Screening
- •Female subjects who are not pregnant or nursing at Screening and who are not planning to become pregnant from Screening until 2 months after the last dose of investigational product
排除标准
- •Have been treated previously with any biological agents including any tumour necrosis factor inhibitor
- •Have a known hypersensitivity to human immunoglobulin proteins or other components of Enbrel or SB4
- •Have a positive serological test for hepatitis B or hepatitis C or have a known history of infection with human immunodeficiency virus
- •Have a current diagnosis of active tuberculosis
- •Have had a serious infection or have been treated with intravenous antibiotics for an infection within 8 weeks or oral antibiotics within 2 weeks prior to Randomisation.
- •Have any of the following conditions
- •Other inflammatory or rheumatic diseases.
- •History of any malignancy within the previous 5 years prior to Screening
- •History of lymphoproliferative disease including lymphoma.
- •History of congestive heart failure
- •Physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
- •History of demyelinating disorders.
研究组 & 干预措施
Enbrel (etanercept)
Active Comparator
Enbrel 50 mg/week via subcutaneous injection
干预措施: Enbrel (etanercept) (Drug)
SB4 (proposed biosimilar to etanercept)
Experimental
SB4 50 mg/week via subcutaneous injection
干预措施: SB4 (proposed biosimilar to etanercept) (Drug)
结局指标
主要结局
American College of Rheumatology 20% Response Criteria (ACR20)
时间窗: Week 24
次要结局
- ACR20(Week 52)
- American College of Rheumatology 50% Response Criteria (ACR50)(Week 24, Week 52)
研究者
研究点 (1)
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