CTRI/2019/01/016851招募中3 期
Randomized, Controlled Open Label Clinical Study to Compare the Impact of Single Transition from Enbrel® Auto-Injector (AI) to YLB113 AI on Safety, PK and Compare Usability of Both AIs in Patients with Active Rheumatoid Arthritis (RA).
Lupin Limited Biotechnology Division19 个研究点 分布在 1 个国家目标入组 150 人开始时间: 2019年4月1日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 19
- 主要终点
- Comparative safety assessment in terms of incidence of TEAEs including abnormal changes in laboratory parameters, vital signs and ECG that are clinically significant.
研究概览
简要总结
This is a multicentre, open label, randomized, comparative, sequential study in 150 patients with Rheumatoid Arthritis (RA). The study will be conducted in approximately 25 sites in India. The objective of the study to evaluate the safety of Enbrel® (reference product) in RA patients switched to YLB113 (test product biosimilar) as compared to Enbrel® AI continuation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Patients must be able and willing to give written informed consent prior to any study related procedures 2.Patients diagnosed with RA according to the 2010 American College of Rheumatology (ACR)/ European League Against Rheumatism (EULAR) classification criteria for RA.
- •3.Patients who have moderate to severe disease activity with DAS28 score >3.2 and CDAI score ≥10.
- •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 (10-25 mg/week, not exceeding the local approved dose) that has remained stable for at least 4 weeks prior to screening, based on patient history.
- •6.Patients who have completed washout of minimum 7 days for Azathioprine, Sulfasalazine and Cyclosporine, 4 weeks for hydroxychloroquine and Auranofin (oral gold) prior to first dose of IP.
- •Transition Period: 7.Patients who complete 6 week Lead-in Period.
- •8.Patients without drug related serious adverse events (SAEs) or unresolved Grade 3 or higher adverse events in Lead-in Period.
排除标准
- •Patients who meet any of the following criteria should be disqualified from entering the study: 1.Patients with known hypersensitivity to Etanercept or any other components of the study drug 2.Patients allergic to latex (the needle cover within the needle cap of the Etanercept AI 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 within 3 months prior to screening 4.Patients with active tuberculosis (TB), prior history of unsuccessfully treated TB, latent TB, or patients who are positive for TB test viz.
- •QuantiFERON®-TB Gold 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 prosthetic joints 6.Patients diagnosed with other rheumatic diseases, autoimmune diseases, connective tissue diseases, or immune deficiencies (viz., 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 within 5 years prior to screening (except for successfully treated non-metastatic basal or squamous cell carcinoma of the skin and carcinoma in situ 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 who received leflunomide within 3 months of screening.
- •12.Patients previously treated with any other biologic response modifiers for any auto-immune indications (including but not limited to tocilizumab, adalimumab, anakinra, abatacept, infliximab, golimumab, etanercept, certolizumab and tofacitinib) within 6 months and patients treated with rituximab within 12 months prior to randomization.
- •13.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]) 14.Patients with class III or IV heart failure (as defined by the New York Heart Association criteria) (New York Heart Association, 1994) 15.Patients with clinically significant abnormal electrocardiogram (ECG) findings 16.Patients with abnormal screening laboratory values: •Hemoglobin ≤8 g/dL •Platelet count ≤125,000/mm3 •White blood cell (WBC) count ≤3500/mm3 •Lymphocyte count ≤1000 cells/mm3 •Aspartate aminotransferase (AST)/ Alanine aminotransferase (ALT)/ Alkaline phosphatase (ALP) ≥3 × the upper limit of normal (ULN), or serum total bilirubin ≥2 × ULN •Serum creatinine ≥2 mg/dL 17.Patients with active or prior history of clinically significant or uncontrolled respiratory, hepatic, renal, hematologic, gastrointestinal, endocrine, dermatologic, neurologic (including demyelinating disorders), metabolic, pulmonary, or cardiovascular diseases, or a history of any autoimmune disease or psychiatric illness, or any other condition which, in the opinion of the investigator, would jeopardize the safety of the patient or the validity of the study results 18.Patients who have participated in any other investigational study within 3 months prior to screening or are likely to simultaneously participate in another therapeutic clinical study 19.Pregnant females or nursing mothers 20.Females of childbearing potential and males who are not willing to use reliable and effective contraceptive measures during the course of the study 21.Patients receiving systemic/ intra-articular corticosteroids, excluding those receiving a ≤10 mg/day oral dose of prednisolone or equivalent corticosteroid, 2 weeks prior to screening 22.Patients who are receiving or who have received alkylating agents (e.g., cyclophosphamides) within 6 months prior to screening only if being received for conditions other than cancer (refer Exclusion criteria No. 7) or multiple sclerosis (prior history of either is a contraindication) 23.Patients who are using nonsteroidal anti-inflammatory drugs (NSAIDs) and are not on a stable dose within 2 weeks prior to screening 24.Patients determined by the investigator (or sub-investigator) to be ineligible for this study 25.Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator, could affect the patient’s participation in the study.
结局指标
主要结局
Comparative safety assessment in terms of incidence of TEAEs including abnormal changes in laboratory parameters, vital signs and ECG that are clinically significant.
时间窗: Up to 12 weeks
次要结局
- Serum trough concentrations (Ctrough) at selected time points following Etanercept administration(at Day 1, Day 22, Day 43, Day 64 and Day 78)
- Proportion of patients with anti-etanercept antibodies (binding & neutralizing) following Etanercept administration.(at Day 1, Day 43 and Day 84)
- Assessment of usability experience based on changes in SIAQ® scores over time during the study.(Day 1, Day 22, Day 43, Day 64 and Day 78)
研究者
研究点 (19)
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