Health Condition 1: M459- Ankylosing spondylitis of unspecified sites in spine
Conditions
Interventions
Intervention1: Biosimilar Adalimumab injection: 40 mg/0.4 mL, single-use glass vial, for subcutaneous use of Enzene Biosciences Ltd.
Control Intervention1: Innovator Adalimumab (HUMIRA�®): 40 mg/0.4
Sponsors
Enzene Biosciences Limited
Alkem Laboratories Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or Female subjects between 18 to 65 years of age 2. 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 4. Has inadequate response to or intolerance to one or more non-steroidal anti-inflammatory drugs (NSAIDs) as assessed by the Investigator 5. Willing and able to comply with the protocol. Willing and able to comply with the protocol.
Exclusion criteria
Exclusion criteria: 1. Has total spinal ankylosis 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 therapy at any time 5. Subjects with clinically active TB 6. Subjects with underlying conditions that may predispose them to infection 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 10. Subjectââ?¬•s having the following laboratory results at screening a. Absolute neutrophil count (ANC) c. Platelet count 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 11. 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 adequate 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To compare the efficacy of Biosimilar Adalimumab injection with HUMIRAÃ?® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteriaTimepoint: All subject completing till week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pharmacokinetics (PK) of Biosimilar versus HUMIRAÃ?® (adalimumab) injection 2. Immunogenicity of Biosimilar and HUMIRAÃ?® (adalimumab) injection by assessment of anti-Adalimumab antibody 3. Safety and tolerability of the investigational productTimepoint: 1. All subject completing till week 12 2. Subject completing pK assessment at baseline 3. Subject completing immunogenicity assessment at baseline, Week 6 and 12. | — |
Countries
India
Contacts
Public ContactDr Vinayaka Shahavi
Alkem Laboratoroes Limited
Outcome results
None listed