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CTRI Number  CTRI/2023/11/059396 [Registered on: 01/11/2023] Trial Registered Prospectively
Last Modified On: 19/03/2024
Post Graduate Thesis  No 
Type of Trial  PMS 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   Clinical study to evaluate Safety and Efficacy of Adalimumab injection in patient with Ankylosing Spondylitis. 
Scientific Title of Study   A prospective, multicenter, Open labelled, Phase IV study to evaluate safety & Efficacy of Biosimilar Adalimumab injection of Enzene Biosciences Ltd. in subjects with active Ankylosing spondylitis (AS) 
Trial Acronym  NA 
Secondary IDs if Any  
Secondary ID  Identifier 
ALK29/ENZ129-ADA2, Version 2.0, Dated 07 Aug 2023  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dinesh Kumar Garg 
Designation  Head - Clinical Trials 
Affiliation  Raptim Research Pvt. Ltd 
Address  A-242,A-226, TTC Industrial Area, Near Mahape Depot, Mahape MIDC, Navi Mumbai India Mumbai India

Mumbai
MAHARASHTRA
400710
India 
Phone  912227781889  
Fax    
Email  dinesh.garg@raptimresearch.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Amol Aiwale 
Designation  Sr. Medical Monitor 
Affiliation  Alkem Laboratories Limited, 
Address  Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel,

Mumbai
MAHARASHTRA
400013
India 
Phone  02239829999  
Fax    
Email  amol.aiwale@alkem.com  
 
Details of Contact Person
Public Query
Modification(s)  
Name  Mr Mukesh Jaiswal 
Designation  Project Manager 
Affiliation  Alkem Laboratories Limited, 
Address  Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel,

Mumbai
MAHARASHTRA
400013
India 
Phone  02239829999  
Fax    
Email  mukesh.jaiswal@alkem.com  
 
Source of Monetary or Material Support  
Alkem Laboratories Limited, Alkem House, Senapati Bapat Marg, Lower Parel, Mumbai –400013, Maharashtra  
Enzene Biosciences Limited, Plot No A 22, A/ 1/2 Chakan Industrial Area, Phase 2, Khalumbre, Chakan, Pune 410501, Maharashtra, India.  
 
Primary Sponsor  
Name  Enzene Biosciences Ltd. 
Address  Plot No A 22, A/ 1/ 2 Chakan Industrial Area, Phase 2, Khalumbre, Chakan, Pune 410501, Maharashtra, India. 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
Alkem Laboratories Ltd   ALKEM HOUSE, “Devashish”, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel, Mumbai – 400 013 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 7  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Nikunj Dadhaniya   Avron Hospital Pvt Ltd.   4, Shantiniketan Park Near Sardar patel statue Naranpura-380013, India
Ahmadabad
GUJARAT 		 9712999726

nikunjvdadhaniya@gmail.com 
Dr Rajendra Kumar Verma  GSVM medical college and hospital, Kanpur  GSVM medical college and hospital, Swaroop Nagar, 208002
Kanpur Nagar
UTTAR PRADESH 		 7839261937

drrkverma.research@gmail.com 
Dr Sarang Vyawahare  Ishwar Institute of Health Care  Ishwar Heights, 1st Floor, Plot Number – 7, Gut No. 6/1, Beside Punjabi Bhawan, Padegaon, 431002, India
Aurangabad
MAHARASHTRA 		 9822314268

ishwarhealthcare@gmail.com 
Dr Nilesh Patil  Life point Multi speciality Hospital  145/1, Mumbai Bangalore Highway, Near Hotel Sayaji, Wakad, Pune – 411057, India
Pune
MAHARASHTRA 		 9004009101

patilnj81@gmail.com 
Dr Girish Kakade  Medipoint Hospital Pvt. Ltd.,   241/1, New D. P. Road, Aundh, 411007, India
Pune
MAHARASHTRA 		 9529751970

drgirishk.medipoint@gmail.com 
Dr Jeet Patel  Parikh Multispeciality Healthcare Pvt. Ltd.  Parikh Multispeciality Healthcare Pvt. Ltd., Bhagwati Park Society, Opp. Tube Colony, Near Apollo Clinic, Old Padra Road, 390020
Vadodara
GUJARAT 		 9821808588

drjeetpatelnm@gmail.com 
Dr Dhaiwat Shukla  Sheth Vadilal Darabhai General Hospital and Sheth Chinai Maternity Hospital  Ellis Bridge-380006, India
Ahmadabad
GUJARAT 		 918980024107

dr.dhaiwatshukla89@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 7  
Name of Committee  Approval Status 
Avron Multi Speciality Hospitals, Ethics Committee  Approved 
Ethics committee of Ishwar Institue of healthcare  Approved 
Ethics committee, GSVM medical college , Kanpur   Approved 
Institutional Ethics Committee Aatman Hospital  Approved 
Lifepoint Research- ethics committee,  Approved 
Parikh Institutional Ethics Committee  Approved 
Penta-Med ethics committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: M45||Ankylosing spondylitis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adalimumab  Dose-40 mg, Route of Administration Subcutaneously Frequency-every other week Total duration-12 weeks 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  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 
 
ExclusionCriteria 
Details  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 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Treatment emergent serious and non-serious
adverse events (AEs) and 2. Alteration in clinical
laboratory parameters 		 1. Entire duration of the study and At week 6 and 12 (EOS) 
 
Secondary Outcome  
Outcome  TimePoints 
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) 		 At week 6 and 12 (EOS)

 
 
Target Sample Size   Total Sample Size="200"
Sample Size from India="200" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   Phase 4 
Date of First Enrollment (India)   10/10/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Adalimumab is a biosimilar which is an anti TNF medicine. TNF are found in the synovial fluid of subjects with AS and plays an important role in pathologic inflammation. Adalimumab binds specifically to TNF-alpha and blocks its interaction. This phase Iv study will be conducted to assess safety and efficacy of biosimilar adalimumab injection where primary endpoint is to assess safety and secondary endpoint is to assess efficacy through number of achievers improved on ASAS 20 criteria.  
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