CTRI/2020/09/028070 [Registered on: 28/09/2020] Trial Registered Prospectively
Last Modified On:
20/12/2021
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Biological
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical trial to study the safety and efficacy of Biosimilar Adalimumab injection versus HUMIRA® in subjects with active Ankylosing spondylitis .
Scientific Title of Study
A prospective, multicenter, randomized, double blind, Phase III study to compare the efficacy and safety of Biosimilar Adalimumab injection of Enzene Biosciences Ltd. with HUMIRA® (adalimumab) injection in subjects with active Ankylosing spondylitis (AS).
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
ALK20/ENZ129-ADA1 Version 2.0, 27/Jan/2020
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Akhilesh Sharma
Designation
President & CMO
Affiliation
Alkem Laboratoroes Limited
Address
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel
Mumbai MAHARASHTRA 400013 India
Phone
Fax
Email
akhilesh.sharma@alkem.com
Details of Contact Person Scientific Query
Name
Dr Vinayaka Shahavi
Designation
Associate General Manager - Clinical Research
Affiliation
Alkem Laboratoroes Limited
Address
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel
Mumbai MAHARASHTRA 400013 India
Phone
Fax
Email
vinayaka.shahavi@alkem.com
Details of Contact Person Public Query
Name
Dr Vinayaka Shahavi
Designation
Associate General Manager - Clinical Research
Affiliation
Alkem Laboratoroes Limited
Address
Alkem Laboratories Limited, Alkem House, Devashish, Adjacent to Matulya centre, Senapati Bapat Marg, Lower Parel
Department of clinical research, Block no. 1, Akash Healthcare Super Specilaity Hospital, Hospital Road, Road No. 201, Dwarka Sector- 3, New Delhi- 110075 New Delhi DELHI
9871446609
gauravmarch18@gmail.com
Dr Sujit Kumar Tripathy
All India Institute of Medical Sciences Bhubaneswar
Department of Orthopedics, All India Institute of Medical Sciences, Sijua, Patrapada, Bhubaneswar, Odisha 751019 Khordha ORISSA
9438884155
ortho_sujit@aiimsbhubaneswar.edu.in
Dr Uma Kumar
All India Institute of Medical Sciences, Delhi
Room No 4076, 4th Floor, Teaching Block, All India Medical Sciences, New Delhi New Delhi DELHI
9868217040
umaakumar@yahoo.co.in
Dr Mithun C B
Amrita Institue of Medical Science and Resrach Centre
Room no.1, Department of Rheumatology and Clinical Immunology, Amrita Institute of Medical Sciences, AIMS Ponekkara, Kochi- 682041, Kerala Ernakulam KERALA
9442361893
mithuncb21886@aims.amrita.edu
Dr A Ramakrishnam Naidu
Andhra Medical College, King George Hospital, Visakhapatnam
Department of Medicine, Andhra Medical College, King George Hospital, Maharanipeta, Visakhapatnam Visakhapatnam ANDHRA PRADESH
9885093386
rammky@yahoo.com
Dr Vishnu Sharma
Avron Hospital
Clinical Research Room, Department of Clinical Research, Avron Hospitals Pvt. Ltd., 4, Shantiniketan Park, Near Sardar Patel Colony, Ahmedabad, Gujarat 380013 Ahmadabad GUJARAT
8511555477
drvishnusharma@yahoo.co.in
Dr Piyush Joshi
B J Medical College and Civil Hospital
B J Medical College and Civil Hospital, 2nd floor, Department Orthopedic, Asarwa, Ahmedabad- 380016 Ahmadabad GUJARAT
8879102056
pnjoshi2005@gmail.com
Dr Chandrashekara Srikantiah
Chanre Rheumatology and Immunology Centre and Research
Chanre Rheumatology
and Immunology Centre
and Research, No. 65 (414), 20th Main, 1st Block, West of Chord Road, Rajaji Nagar, Bengaluru, Karnataka 560010 Bangalore KARNATAKA
08042516635
chanrericr@yahoo.co.in
Dr John Mathew
Christian Medical College
Room no. 900A, Department of Clinical Immunology and Rheumatology, West block building, Christian Medical College, VELLORE, Tamil Nadu- 632004 Vellore TAMIL NADU
041-62283537
johnmathew@cmcvellore.ac.in
Dr Sajal Mitra
Government Medical College and Hospital
Ward No. 17, Department Of Orthopedics, Government Medical College and Hospital, Medical College Square, Nagpur- 440003 Nagpur MAHARASHTRA
9373114929
sajalmitra2007@yahoo.co.in
Dr Jyoti Ranjan Parida
Institute of Medical Science and SUM Hospital
Institute of Medical Science and SUM Hospital, Room no. 71 (OPD), Department of Immunology and Rheumatology, New Extension Building,Super speciality Division, K8 Lane 1, Kalinga Nagar, Bhubaneswar, Odisha 751003 Khordha ORISSA
9556980101
drjrparida@gmail.com
Dr Saurabh Singh
Institute of Medical Sciences, Banaras Hindu University
4th floor, Department of Orthopaedic, Institute of Medical Sciences, Banaras Hindu University, Varanasi- 221005 Varanasi UTTAR PRADESH
9838759998
saurabhrpsingh@gmail.com
Dr Chengappa K G
Jawaharlal Institute of Postgraduate Medical Education, Puducherry
Department of Clinical Immunology, Jawaharlal Institute of Postgraduate Medical Education, Jipmer Campus Rd, Gorimedu, Dhanvantari Nagar, Puducherry, 605006 Pondicherry PONDICHERRY
04132297356
doc.chengappa@gmail.com
Dr Rajeshwar Nath Srivastava
King Georges Medical University
Department of Orthopedic surgery, King Georges Medical University, 9-Nabiullah Road, Lucknow 226003 Lucknow UTTAR PRADESH
9415054330
drrnsrivastava@gmail.com
Dr Kaushik Basu
Medical College and Hospital, Kolkata
OPD, Department of Medicine, Medical College and Hospital, 88 College street, Kolkata- 700073 Kolkata WEST BENGAL
9038831211
phoenix.0013@gmail.com
Dr Girish Bhatia
Medipoint Hospitals Pvt. Ltd.
Medipoint Hospitals Pvt. Ltd., 241/1, New D P Road, Aundh, Pune- 411007 Pune MAHARASHTRA
7387003636
drbhatia.pentagon@gmail.com
Dr Chethana Dharmapalaiah
Medstar Speciality Hospital,
Medstar Speciality Hospital,
Research Department,
5th Floor, 641/17/1/3, Kodigehalli Main Road, Sahakarnagar, Bangalore-560092, Karnataka, India Bangalore KARNATAKA
966334422
drchethanamedstar@gmail.com
Dr Susheel Kumar
Nehru Hospital, Postgraduate Institute of Medical Education & Research
Department of Internal Medicine, Nehru Hospital, Postgraduate Institute of Medical Education & Research, Sector 12, Chandigarh 160012 Chandigarh CHANDIGARH
7087008184
susheelbhutungru@gmail.com
Dr Bankim Desai
Nirmal Hospital
Nirmal Hospital, Ring Road, Surat- 395002, Gujarat Surat GUJARAT
9825136077
drbankimd@gmail.com
Dr Girish Kakade
Sahyadri Superspeciality hospital
Sahyadri Superspeciality Hospital, Room no. 21, Department of Orthopedic, 30-C, Erandwane, Karve Road, Pune- 411004 Pune MAHARASHTRA
020-67213000
drgirishkakade@gmail.com
Dr Ajit Nalawade
Sancheti Institute for Orthopaedics and Rehabilitation
Department of Rheumatology, Sancheti Institute for Orthopaedics and Rehabilitation, 16,Shivajinagar, Pune 411005, Maharashtra Pune MAHARASHTRA
02041236660
dr.ajitnalawade@gmail.com
Dr Archana Sonawale
Seth G.S. Medical College and KEM Hospital
Seth G.S. Medical College and KEM Hospital, 1st floor, Department of pharmacology and Therapeutics, College Building, Acharya Donde Marg, Parel East, Parel, Mumbai, Maharashtra 400012 Mumbai MAHARASHTRA
9892639939
archanasonawale@kem.edu
Dr Reena Sharma
Shalby Hospitals
Shalby Hospitals, Opp. Karnavati Club, S G Highway, Ahmedabad 380015 Ahmadabad GUJARAT
9924957400
reena141@gmail.com
Dr Neeraj Jain
Sir Ganga Ram Hospital
Clinical research room, Department of clinical research, 1 floor , near HDU, Department of Rheumatology and Clinical Immunology, Sir Ganga Ram Hospital, SGRH marg, Rajinder Nagar, New Delhi- 110060 New Delhi DELHI
9810130150
neerajrheumatology@gmail.com
Dr Raman Sharma
SMS Medical College and Hospital
Main Building Second floor, Department of Medicine, Division of general medicine, SMS Medical College & Attached Hospital’s, J.L.N. Marg, Jaipur- 302001, Rajasthan Jaipur RAJASTHAN
9414044488
sharmarm@gmail.com
Dr Sankaralingam Rajeshwari
Sri Ramachandra Institute of Higher Education and Research
Department of rheumatology, Sri Ramachandra Institute of Higher Education and Research, No.1, Ramachandra Nagar, Porur, Chennai, Tamil Nadu 600116 Chennai TAMIL NADU
9444174759
calling_raji@yahoo.com
Dr Firdusa Fatima
St Theresa’s Multi Specialty Hospital
Department of Clinical Research, 1st floor, Krupa Ward, St Theresa’s Multi Specialty Hospital, Erragadda Main Rd, opposite Erragadda Rythu Bazar, Jet Colony, Sanath Nagar, Hyderabad, Telangana 500018 Hyderabad TELANGANA
4023704411
drfirdusafatima@gmail.com
Dr Vikram Haridas
Sushruta Multispeciality Hospital & Research Centre Private Limited
Sushruta Multispeciality Hospital & Research Centre Private Limited., #313, 314, Old delux ward, Sushrutha Hospital, P B Road, Vidyanagar, Hubali- 580021, Karnataka Dharwad KARNATAKA
09379542888
haridasvikram@yahoo.co.in
Dr Romi Shah
Tristar Hospital
Tristar Hospital, opp. T & TV High School, Athwa Gate, Surat, Gujarat 395001 Surat GUJARAT
Office of Research Institutional Review Board, Christian Medical College
Approved
Office of the ethics committee, SMS Medical College & Attached Hospitals
Submittted/Under Review
Penta-Med Ethics Committee
Approved
Sahyadri Hospital Ltd., Ethics Committee
Approved
Sushrutha Hospital Ethics Committee, Huballi
Approved
The Shalby Limited, Ahmedabad
Approved
Tristar Hospital EThics Committee, Surat
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: M459||Ankylosing spondylitis of unspecified sites in spine,
Intervention / Comparator Agent
Type
Name
Details
Intervention
Biosimilar Adalimumab injection
40 mg/0.4 mL, single-use glass vial, for subcutaneous use of Enzene Biosciences Ltd.
Comparator Agent
Innovator Adalimumab (HUMIRA®)
40 mg/0.4 mL, single-use glass vial, for subcutaneous use of AbbVie Inc
Inclusion Criteria
Age From
18.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
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.
ExclusionCriteria
Details
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. Subject’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
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Centralized
Blinding/Masking
Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
Primary Outcome
Outcome
TimePoints
To compare the efficacy of Biosimilar Adalimumab injection with HUMIRA® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteria
All subject completing till week 12
Secondary Outcome
Outcome
TimePoints
1. Pharmacokinetics (PK) of Biosimilar versus HUMIRA® (adalimumab) injection
2. Immunogenicity of Biosimilar and HUMIRA® (adalimumab) injection by assessment of anti-Adalimumab antibody
3. Safety and tolerability of the investigational product
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.
Target Sample Size
Total Sample Size="192" Sample Size from India="192" Final Enrollment numbers achieved (Total)= "0" Final Enrollment numbers achieved (India)="0"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
A prospective, multicenter, randomized, double blind, Phase III study to compare the efficacy and safety of Biosimilar Adalimumab injection of Enzene Biosciences Ltd. with HUMIRA® (adalimumab) injection in subjects with active Ankylosing spondylitis (AS).
Primary Objective: To compare the efficacy of Biosimilar Adalimumab injection with HUMIRA® (adalimumab) injection, in subjects with active Ankylosing spondylitis (AS) by assessment of ASAS20 response criteria
Secondary Objective(s):
To evaluate the following: 1. Pharmacokinetics (PK) of Biosimilar versus HUMIRA® (adalimumab) injection
2. Immunogenicity of Biosimilar and HUMIRA® (adalimumab) injection by assessment of anti-Adalimumab antibody
3. Safety and tolerability of the investigational product