CTRI/2023/11/059396进行中（未招募）4 期
A prospective, multicenter, Open labelled, Phase IV study to evaluate safety & Efficacy of BiosimilarAdalimumab injection of Enzene Biosciences Ltd. in subjects with active Ankylosing spondylitis(AS)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
- 试验地点
- 7
- 主要终点
- 1. Treatment emergent serious and non-serious
研究概览
简要总结
Adalimumab is a biosimilar which is an anti TNF medicine. TNF are found in thesynovial fluid of subjects with AS and plays an important role in pathologicinflammation. Adalimumab binds specifically to TNF-alpha and blocks its interaction. This phase Iv study will be conducted to assess safety and efficacy ofbiosimilar adalimumab injection where primary endpoint is to assess safety andsecondary endpoint is to assess efficacy through number of achievers improvedon ASAS 20 criteria.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •The subjects will be included in the study based on the following criteria:
- •Willing to provide voluntary written informed consent.
- •Male of Female subjects between 18 to 65 years of age (both inclusive)
- •Confirmed diagnosis of AS.
- •Has an inadequate response to or intolerance to one or more non steroidal anti inflammatory drugs (NSIDSs)as assessed by the investigator.
- •Willing and able to comply with the protocol.
排除标准
- •The subjects will be excluded from the study based on the following criteria:
- •Has total spinal ankylosis (bamboo spine)
- •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 (tumor necrosis factor) therapy at any Time 5.Subjects with clinically active and latent 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) 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)
- •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
1. Treatment emergent serious and non-serious
时间窗: 1. Entire duration of the study and At week 6 and 12 (EOS)
adverse events (AEs) and 2. Alteration in clinical
时间窗: 1. Entire duration of the study and At week 6 and 12 (EOS)
laboratory parameters
时间窗: 1. Entire duration of the study and At week 6 and 12 (EOS)
次要结局
- Number of achievers in Assessment in(Ankylosing spondylitis (ASAS20))
研究者
研究点 (7)
Loading locations...
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