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).
upin Limited Biotechnology Division0 个研究点目标入组 0 人开始时间: 待定最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
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
- •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 >=10.1.
- •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 Sjogrenâ??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 Ã? the upper limit of normal (ULN), or serum total bilirubin >=2 Ã? 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 diso
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