CTRI/2016/05/006899已完成3 期
A Comparative Study to Assess the Efficacy, Safety and Immunogenicityof YLB113 and Enbrel for the Treatment of Rheumatoid Arthritis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 26
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •Patients must meet the following criteria:
- •(1) Male or female adults more than or equal to 18 and less than or equal to 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 RA and are capable of providing written informed consent to participate in the study.
- •(3) Patients with more than or equal to 6 tender joints and more than or equal to 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
- •more than or equal to 3.2.
- •(4) Patients classified as Global Functional Assessment Class I, II, or III, according to the revised ACR criteria.
- •(5) Patients who have been treated with MTX for at least 3 months at an optimum dose (6 - 25 mg/week [15 â?? 25 mg/week for India], not exceeding the local approved dose) that
- •has remained stable for at least 6 weeks prior to screening.
- •(6) Patients who have discontinued treatment with disease-modifying anti-rheumatic drugs
- •(DMARDs), other than MTX and complete a washout period of at least 2 weeks or at least five half-lives prior to drug administration, whichever is longer.
- •(1) Patients who complete evaluations for Week 24 in Stage A and are willing to continue in Stage B.
- •(2) Patients without serious adverse events (SAEs) or unresolved Grade 3 or higher adverse
- •events related to the study drugs and who tolerated the study drugs administered in Stage A.
排除标准
- •Patients who meet any of the following criteria will be excluded from this clinical trial:
- •(1) Patients with known hypersensitivity to Etanercept or any other components of the YL Biologics Ltd.
- •(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 beta-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 (e.g. those who were in contact
- •with patients of active TB in the recent past prior to screening) 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
- •Sjogrenâ??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
- •(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 B surface
- •antibody [HBsAb] (except those with history of Hepatitis B vaccination, who will be
- •included, if positive for HBsAb but negative for HBsAg and HBcAb), hepatitis C
- •virus [HCV], or human immunodeficiency virus [HIV]).
- •(13) Patients with class III or IV congestive heart failure (as defined by the New York
- •Heart Association criteria) (New York Heart Association, 1994).
- •(14) Patients with clinically significant abnormal electrocardiogram (ECG) findings.
- •Other standard Exclusion criteria are as per Protocol.
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