NCT02167139已完成3 期
A Randomised, Double-blind, Parallel Group, Multicentre Clinical Study to Evaluate the Efficacy, Safety, Tolerability, Pharmacokinetics and Immunogenicity of SB5 Compared to Humira® in Subjects With Moderate to Severe Rheumatoid Arthritis
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
- 544
- 试验地点
- 2
- 主要终点
- American College of Rheumatology 20% Response Criteria (ACR20)
研究概览
简要总结
This is a randomised, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, tolerability, pharmacokinetics and immunogenicity of SB5 compared to Humira® in subjects with moderate to severe RA despite MTX therapy.
详细描述
Investigational product: SB5 40 mg (0.8 mL of 50 mg/mL) Indication studied: Rheumatoid arthritis
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
- •Are male or female aged 18-75 years at the time of signing the informed consent form.
- •Have been diagnosed as having RA according to the revised 1987 American College of Rheumatology (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:
- •More than or equal to six swollen joints and more than or equal to six tender joints (from the 66/68 joint count system) at Screening and Randomisation.
- •Either erythrocyte sedimentation rate (Westergren) ≥ 28 mm/h or serum C-reactive protein ≥ 10 mg/dL at Screening.
- •Must have been treated with MTX for a total of at least 6 months prior to Randomisation and must have been on both: a stable route of administration (oral or parenteral) and stable dose of MTX (10-25 mg/week) for at least 4 weeks prior to Screening.
- •Female subjects who are not pregnant or nursing at Screening and Randomisation and who are not planning to become pregnant from Screening until 5 months after the last dose of IP.
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 Humira or SB
- •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 (TB), have been recently exposed to a person with active TB, or are considered to have latent TB.
- •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 a history of chronic or recurrent infection.
- •Have any of the following conditions:
- •History of congestive heart failure (New York Heart Association Class III/IV).
- •History of acute myocardial infarction or unstable angina within the previous 12 months prior to Screening.
- •History of demyelinating disorders.
- •History of any malignancy within the previous 5 years prior to Screening.
- •History of lymphoproliferative disease including lymphoma.
- •Any other disease or disorder which, in the opinion of the Investigator, will put the subject at risk if they are enrolled.
- •Have physical incapacitation (ACR functional Class IV or wheelchair-/bed-bound).
研究组 & 干预措施
SB5 (proposed biosimilar to adalimumab)
Experimental
SB5 40 mg every other week via subcutaneous injection
干预措施: SB5 (proposed biosimilar to adalimumab) (Drug)
Humira (adalimumab)
Active Comparator
Humira 40 mg every other week via subcutaneous injection
干预措施: Humira (adalimumab) (Drug)
Humira (adalimumab)
Active Comparator
Humira 40 mg every other week via subcutaneous injection
干预措施: SB5 (proposed biosimilar to adalimumab) (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
- American College of Rheumatology 50% Response Criteria (ACR50)(Week 24, Week 52)
- Disease Activity Score Based on a 28 Joint Count (DAS28)(Week 24, Week 52)
- ACR20(Week 52)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
3 期
A Study Comparing SB4 to Enbrel® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisNCT01895309Samsung Bioepis Co., Ltd.596
已完成
3 期
A Study Comparing SB2 to Remicade® in Subjects With Moderate to Severe Rheumatoid Arthritis Despite Methotrexate TherapyRheumatoid ArthritisNCT01936181Samsung Bioepis Co., Ltd.584
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
Study to Assess the Efficacy and Safety of PT010 Relative to PT003 and PT009 in Subjects With Moderate to Very Severe COPD (Ethos)COPDNCT02465567Pearl Therapeutics, Inc.8,588
已完成
3 期
Efficacy and Safety Study of Benralizumab in Patients With Uncontrolled Asthma on Medium to High Dose Inhaled Corticosteroid Plus LABA (MIRACLE)AsthmaNCT03186209AstraZeneca695