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) - NA
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
入选标准
- •The subjects will be included in the study based on the following criteria:
- •1. Willing to provide voluntary written informed consent.
- •2. Male of Female subjects between 18 to 65 years of age (both inclusive)
- •3. Confirmed diagnosis of AS.
- •4. Has an inadequate response to or intolerance to one or more non steroidal anti inflammatory drugs (NSIDSs)as assessed by the investigator.
- •5. Willing and able to comply with the protocol
排除标准
- •The subjects will be excluded from the study based on the following
- •1. Has total spinal ankylosis (bamboo spine)
- •2. Has undergone spinal surgery or joint surgery involving joints
- •assessed within 2 months prior to screening
- •3. Has received intra-articular joint injection(s), spinal or paraspinal corticosteroid injection(s) within 28 days prior to Baseline
- •4. Has prior exposure to any anti-TNF (tumor necrosis factor)
- •therapy at any Time
- •5.Subjects with clinically active and latent TB
- •6. Subjects with underlying conditions that may predispose them to
- •7. 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
- •8. Known hypersensitivity to any component of the investigational
- •product and other medications used in this study
- •9. 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)
- •12. Subjects with congestive heart failure
- •13. Positive serology for human immunodeficiency virus (HIV),
- •hepatitis B
- •virus (HBV) and hepatitis C virus (HCV) at screening
- •14. Subjects of child bearing potential, who are not willing to use
- •Contraception during the study period.
- •15. Female subjects who are pregnant or nursing
- •16. Has any concurrent disease or condition, which in the opinion of
- •the investigator does not allow participation of the subject in this study
- •17. Has participated in any other clinical trial and received experimental medications within 4 weeks prior to screening
研究者
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