EUCTR2015-002809-12-LV进行中（未招募）1 期
A comparative Study to Assess the Efficacy, Safety and Immunogenicity of YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •(1) Male or female adults = 18 and = 75 years of age at the time of
- •informed consent.
- •(2) Patients diagnosed with RA according to the 2010 American College
- •of Rheumatology (ACR)/ European League Against Rheumatism (EULAR)
- •classification criteria for RA1 and are capable of providing written
- •informed consent to participate in the study.
- •(3) Patients with = 6 tender joints and = 6 swollen joints (based on the
- •Swollen Joint Count [SJC] using 66 joints and Tender Joint Count [TJC]
- •using 68 joints) and a DAS28 score = 3.2.
- •(4) Patients classified as Global Functional Assessment Class I, II, or III,
- •according to the revised ACR criteria.
- •Please refer to protocol for remaining criteria
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 350
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 150
排除标准
- •(1) Patients with known hypersensitivity to Etanercept or any other
- •components of the study drug.
- •(2) Patients allergic to latex (the needle cap on the Etanercept prefilled
- •syringe contains latex, which may cause allergic reactions in individuals
- •sensitive to latex).
- •(3) Patients suffering from acute or chronic, localized or disseminated
- •infections (bacterial/fungal/viral) or sepsis, or patients with a history of
- •recurring infections, or those who are at an increased risk of developing
- •infections or sepsis (and those with positive test results for ß-D-glucan
- •only for Japan) within 3 months prior to screening.
- •(4) Patients with active tuberculosis (TB), prior history of unsuccessfully
- •treated TB, latent TB, or those who are at risk of developing TB and
- •patients who are not negative for TB tests (e.g., T-SPOT® TB or
- •QuantiFERON®-TB Gold test/ appropriate test).
- •(5) Patients with a history of septic arthritis of native joints within 12
- •months prior to screening, or any prior history of septic arthritis of a
- •prosthetic joint.
- •(6) Patients diagnosed with other rheumatic diseases, autoimmune
- •disease, connective tissue disease, or immune deficiencies (e.g.,
- •psoriasis, psoriatic arthritis, primary Sjogren's syndrome, systemic lupus
- •erythematosus, or demyelinating diseases such as multiple sclerosis).
- •(7) Patients with active or prior history of malignancies (except for
- •successfully treated non-metastatic basal or squamous cell carcinoma of
- •the skin and carcinoma insitu of the cervix).
- •(8) Patients with a prior history of blood dyscrasias.
- •(9) Patients with a history of alcohol, drug, or chemical abuse in the past
- •2 years prior to screening.
- •(10) Patients who received any live or attenuated vaccines within 4
- •weeks of screening.
- •(11) Patients previously treated with any other biologic response
- •modifiers for any auto-immune indication (including but not limited to
- •tocilizumab, adalimumab, anakinra, abatacept, infliximab, rituximab,
- •golimumab, etanercept, certolizumab and tofacitinib).
- •(12) Patients with serious systemic infections (e.g., patients who test
- •positive for hepatitis B surface antigen [HBsAg], hepatitis B core
- •antibody [HBcAb], hepatitis C virus [HCV], or human immunodeficiency
- •virus [HIV]).
- •Please refer to protocol for remaining criteria
研究者
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