Health Condition 1: M45- Ankylosing spondylitis
Conditions
Interventions
Intervention1: Adalimumab: Dose-40 mg,
Route of Administration Subcutaneously
Frequency-every
other week
Total duration-12 weeks
Control Intervention1: NA: NA
Sponsors
Enzene Biosciences Ltd.
Alkem Laboratories Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: The subjects will be excluded from the study based on the following criteria: 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 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 Subject’s having the following laboratory results at screening a. Absolute neutrophil count (ANC) b. Hemoglobin (Hb) 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 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 |
|---|---|
| 1. Treatment emergent serious and non-serious adverse events (AEs) and 2. Alteration in clinical laboratory parametersTimepoint: 1. Entire duration of the study and At week 6 and 12 (EOS) | — |
Secondary
| Measure | Time frame |
|---|---|
| Number of achievers in Assessment in Ankylosing spondylitis (ASAS20) response criteria at week 6 and week 12, where the achievers are defined as subjects experiencing at least 20 % improvement and an absolute improvement of at least one unit as compared to baseline in at least 3 out of four domains, with no deterioration (defined as a worsening of at least 20 % or an absolute increase of at least one unit from baseline) in the Remaining domain. The four domains of response criteria are 1. Subjects global assessment of disease activity during the previous week (assessed by 0-10cm VAS) 2. Subjects assessment of pain during the previous week, represented by total back pain score (assessed by 0-10cm VAS) 3. Function, represented by Bath Ankylosing Spondylitis Functional Index (BASFI) score, (assessed by 0-10cm VAS) 4. Inflammation represented by the mean of the severity and duration of morning stiffness (i.e question 5 and 6 of the BASDAI assessed by 0-10cm vas)Timepoint: At week 6 and 12 (EOS) | — |
Countries
India
Contacts
Public ContactMr Mukesh Jaiswal
Alkem Laboratories Limited,
Outcome results
None listed