CTRI/2020/09/028070已完成3 期
A prospective, multicenter, randomized, double blind, Phase III study to compare the efficacy and safety of Biosimilar Adalimumab injection of Enzene Biosciences Ltd. with HUMIRA® (adalimumab) injection in subjects with active Ankylosing spondylitis (AS).
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 192
- 试验地点
- 29
- 主要终点
- To compare the efficacy of Biosimilar Adalimumab injection with HUMIRA® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteria
研究概览
简要总结
A prospective, multicenter, randomized, double blind, Phase III study to compare the efficacy and safety of Biosimilar Adalimumab injection of Enzene Biosciences Ltd. with HUMIRA® (adalimumab) injection in subjects with active Ankylosing spondylitis (AS).
Primary Objective: To compare the efficacy of Biosimilar Adalimumab injection with HUMIRA® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteria
Secondary Objective(s):
To evaluate the following: 1. Pharmacokinetics (PK) of Biosimilar versus HUMIRA® (adalimumab) injection
-
Immunogenicity of Biosimilar and HUMIRA® (adalimumab) injection by assessment of anti-Adalimumab antibody
-
Safety and tolerability of the investigational product
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Male or Female subjects between 18 to 65 years of age
- •Subjects with diagnosis of Axial Ankylosing spondylitis based on the 1984 modified New York classification criteria, has active AS, as defined by fulfillment of at least 2 of the following 3 conditions at both Screening and Baseline visits: a.
- •BASDAI score ≥ 4 b.
- •Total back pain on a visual analog scale ≥ 4 c.
- •Morning stiffness ≥ 1 hour
- •Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as assessed by the Investigator
- •Willing and able to comply with the protocol.
排除标准
- •Has total spinal ankylosis
- •Has undergone spinal surgery or joint surgery involving joints assessed within 2 months prior to screening
- •Has received intra-articular joint injection(s), spinal or paraspinal corticosteroid injection(s) within 28 days prior to Baseline
- •Has prior exposure to any anti-TNF therapy at any time
- •Subjects with clinically active TB
- •Subjects with underlying conditions that may predispose them to infection
- •Subjects with history or presence of cardiac, renal, neurologic, psychiatric, endocrinologic, metabolic, or hepatic disease which in the opinion of the investigator does not allow participation of the subject in this study
- •Known hypersensitivity to any component of the investigational product and other medications used in this study
- •Subjects with a non-healed fracture
- •Subject’s having the following laboratory results at screening a.
- •Absolute neutrophil count (ANC) < 1,500/mm3 b.
- •Hemoglobin (Hb) <10 g/dL c.
- •Platelet count < 100,000/mm3 d.
- •Total bilirubin level > 1.5 times the upper limit of the normal laboratory range (ULN) e.
- •AST and ALT >3 x ULN f.
- •Alkaline phosphatase >3 x ULN g.
- •Serum Creatinine level > 1.25 xULN
- •Subjects suffering from acute or chronic infection(s)
- •Subjects with congestive heart failure
- •Positive serology for human immunodeficiency virus (HIV), hepatitis B virus (HBV) and hepatitis C virus (HCV) at screening
- •Subjects of child bearing potential, who are not willing to use adequate contraception during the study period.
- •Female subjects who are pregnant or nursing
- •Has any concurrent disease or condition, which in the opinion of the investigator does not allow participation of the subject in this study
- •Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening.
结局指标
主要结局
To compare the efficacy of Biosimilar Adalimumab injection with HUMIRA® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteria
时间窗: All subject completing till week 12
次要结局
- 1. Pharmacokinetics (PK) of Biosimilar versus HUMIRA® (adalimumab) injection(2. Immunogenicity of Biosimilar and HUMIRA® (adalimumab) injection by assessment of anti-Adalimumab antibody)
研究者
研究点 (29)
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