NCT01936181已完成3 期
A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Pharmacokinetics and Immunogenicity of SB2 Compared to Remicade® 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
- 584
- 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 SB2 compared to Remicade in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) 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
- •Diagnosed as having RA according to the revised 1987 ACR criteria for at least 6 months
- •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 6 months after the last dose of investigational product
- •Inclusion Criteria for Transition-Extension Period:
- •Have been enrolled and completed the scheduled Week 54 visit of the randomised, double-blind period of the SB2-G31-RA study
- •In the opinion of the Investigator, subjects who may benefit from continuing IP treatment (either SB2 or Remicade), understand the implications of taking part in the study and willing to participate in the transition-extension period
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 Remicade or SB2
- •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.
- •Exclusion Criteria for Transition-Extension Period:
- •Have been withdrawn from the SB2-G31-RA study for any reason
- •Have had any significant medical conditions, such as an occurrence of a serious AE (SAE) or intolerance of SB2 or Remicade during the randomised, double-blind period of the SB2-G31-RA study which may render the subject unsuitable to participate in the transition-extension period, at the discretion of the Investigator
研究组 & 干预措施
SB2 (proposed biosimilar to inflixmab)
Experimental
SB2 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 70
干预措施: SB2 (proposed biosimilar to infliximab) (Drug)
Remicade (infliximab)
Active Comparator
Remicade 3 mg/kg at week 0, 2, 6 then every 8 weeks thereafter via intravenous infusion up to Week 46
干预措施: Remicade (infliximab) (Drug)
Remicade (infliximab), switch to SB2
Experimental
SB2 3mg/kg at week 54, 62, 70
干预措施: SB2 (proposed biosimilar to infliximab) (Drug)
Remicade (infliximab), continue as Remicade
Active Comparator
Remicade 3mg/kg at week 54, 62, 70
干预措施: Remicade (infliximab) (Drug)
结局指标
主要结局
American College of Rheumatology 20% Response Criteria (ACR20)
时间窗: Week 30
次要结局
- ACR20(Week 54, Week 78)
- American College of Rheumatology 50% Response Criteria (ACR50)(Week 30, Week 54, Week 78)
- Disease Activity Score Based on a 28 Joint Count (DAS28)(Week 30, Week 54, Week 78)
研究者
研究点 (1)
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