Clinical study to evaluate Safety and Efficacy of Adalimumab injection in patient with Ankylosing Spondylitis.
- Conditions
- Health Condition 1: M45- Ankylosing spondylitis
- Registration Number
- CTRI/2023/11/059396
- Lead Sponsor
- Enzene Biosciences Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Closed to Recruitment of Participants
- Sex
- Not specified
- Target Recruitment
- 0
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
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) <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
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
Study & Design
- Study Type
- PMS
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1. Treatment emergent serious and non-serious <br/ ><br>adverse events (AEs) and 2. Alteration in clinical <br/ ><br>laboratory parametersTimepoint: 1. Entire duration of the study and At week 6 and 12 (EOS)
- Secondary Outcome Measures
Name Time Method