A clinical trial to study the safety and efficacy of Biosimilar Adalimumab injection versus HUMIRA�® in subjects with active Ankylosing spondylitis .

Phase 3

• Conditions: Health Condition 1: M459- Ankylosing spondylitis of unspecified sites in spine

• Registration Number: CTRI/2020/09/028070
• Lead Sponsor: Enzene Biosciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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

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) < 1,500/mm3 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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified