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
- 500
- 试验地点
- 23
- 主要终点
- Stage A: ACR20 response rate at Week 24 of dosing.
研究概览
简要总结
This is Multicenter, double-blind, randomized, parallel-group, comparative study.
The objective of this study is to compare the efficacy and safety, at Week 24 of
treatment with YLB113 50 mg or Enbrel 50 mg given once a week as a
subcutaneous injection along with methotrexate (MTX) in patients with active
rheumatoid arthritis (RA) despite MTX therapy and to evaluate the long-term
safety and immunogenicity, of YLB113 administration.
Stage A: To compare the efficacy, safety and immunogenicity of YLB113 and
Enbrel
Stage B: To compare long-term safety and immunogenicity of YLB113 and
Enbrel
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •Stage A 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.
- •(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 (
- •25 mg/week [15 – 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. Stage B (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: Stage A: (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 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 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".
结局指标
主要结局
Stage A: ACR20 response rate at Week 24 of dosing.
时间窗: 24 weeks
次要结局
- Efficacy assessments:(- ACR20 response rate at Weeks4, 8 and 12 of dosing)
研究者
研究点 (23)
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