| CTRI Number |
CTRI/2021/07/034531 [Registered on: 02/07/2021] Trial Registered Prospectively |
| Last Modified On: |
08/08/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare the clinical efficacy and safety of shilpa adalimumab with Humaria in patients with active Rheumatoid arthritis. |
|
Scientific Title of Study
|
A Prospective, Randomized, Double Blind, Multidose, Multicenter, Parallel Group, Active Controlled Phase III Study to Compare Clinical Efficacy and Safety of Shilpa Adalimumab with Humira® (Adalimumab) in Patients with Active Rheumatoid Arthritis. |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| 20-134 Version No.02, Dated 10.10.2020 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Maheshwara Reddy |
| Designation |
Medical Monitor |
| Affiliation |
Jeevan Scientific Technology Ltd |
| Address |
Plot No 1 Sai Krupa Enclave Near Lanco Hills Golconda Post
Hyderabad
TELANGANA
500008
India |
| Phone |
04067364700 |
| Fax |
04067364707 |
| Email |
maheswara.mallu@jeevanscientific.com |
|
Details of Contact Person
Scientific Query
|
| Name |
P Veerendra Kumar |
| Designation |
Head Clinical Affairs Division |
| Affiliation |
Shilpa Medicare Limited |
| Address |
S 20 to S 26PharmaSEZTSIIC Green Industrial Park Polepally Village,
Jadcherla Mandal Mahaboobnagar District
Hyderabad
TELANGANA
509301
India |
| Phone |
04030492901 |
| Fax |
04027138562 |
| Email |
veerendrap.frd@shilpamedicare.com |
|
Details of Contact Person
Public Query
Modification(s)
|
| Name |
Dr Someswara Rao Korla |
| Designation |
Vice President |
| Affiliation |
Jeevan Scientific Technology Limited |
| Address |
Jeevan Scientific Technology Limited
Plot No. 1&2, Sai Krupa Enclave,
Golconda Post, Near Lanco Hills, Hyderabad.
Hyderabad
TELANGANA
500008
India |
| Phone |
9948591492 |
| Fax |
04067364707 |
| Email |
someswararao.korla@jeevanscientific.com |
|
|
Source of Monetary or Material Support
|
| Shilpa Biologicals Private Limited |
|
|
Primary Sponsor
|
| Name |
Shilpa Biologicals Private Limited |
| Address |
Plot No: 532 (A), KIADB, Belur Industrial Area,
Dharwad 580011 Karnataka, India |
| Type of Sponsor |
Pharmaceutical industry-Indian |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 26 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrGaurav Seth |
Aakash Healthcare Private Limited |
Aakash Healthcare Private Limited,Hospital Plot,Road No.201,Sector-3,Dwarka,New Delhi-110075
New Delhi
DELHI |
9151541428
gauravmarch18@gmail.com |
| Dr Khune Akash Anandrao |
Alexis Multi Speciality Hospital Private Limited |
Alexis Multi Speciality Hospital Private Limited,Manakapur Squre,Koradi Road,Nagpur-440030
Nagpur
MAHARASHTRA |
9404315602
7127120300
akashkhune@gmail.com |
| Dr Anupama |
All India Institute of Medical Sciences |
Sijua patrapada Bhubaneswar Odisha-751019
Khordha
ORISSA |
9437800568
anupama6799@gmail.com |
| Dr Tanmaya Kumar Sahu |
AMRI Hospitals Limited |
AMRI Hospitals Limited,Plot No.1
Near Satyasai Enclave,Khandagiri,Bhubaneswar -751030
Khordha
ORISSA |
8872504777
drtanmayacool@gmail.com |
| Dr Vishnu Sharma |
Avron Hospitals Pvt. Ltd |
Avron Hospitals Pvt Ltd 4 Shantiniketan park Near Sardar Patel Colony Ahmedabad 380013
Ahmadabad
GUJARAT |
8511555477
drvishnusharma@yahoo.co.in |
| Dr Diwakar |
BMCRI - Bangalore Medical College and Research Institute |
Victoria Hospital, K.R.Road Fort Bangalore-560002
Bangalore
KARNATAKA |
9844130534
dr.diwakartn@gmail.com |
| Dr Mohit Goyal |
Care Pain and Arthritis Centre |
Care Pain and Arthritis Centre,Goyal Hospital,328AB,Sector-5,Hiran Magri,Udaipur-313002
Udaipur
RAJASTHAN |
9887262726
dr.mohitgoyal@gmail.com |
| Dr Dinesh Jain |
Dayand Medical College and Hospital |
Tagore Nagar, Civil lines, Ludhiana Punjab 141001
Ludhiana
PUNJAB |
9815532533
drjaindinesh@yahoo.co.in |
| Dr Uppuluri Rama Krishna Rao |
Gleneagles Global Hospitals |
6-1-1070/1 Lakdikapool, Hyderabad, Telanagana-500004
Hyderabad
TELANGANA |
9849160640
urkrao@yahoo.com |
| Dr Sunil Naik |
Government Medical College and Government General Hospital |
Srikakulam, Andhra Pradesh-532001
Srikakulam
ANDHRA PRADESH |
9440828299
rimsresearch@gmail.com |
| Dr Mahendra Pal Singh |
GVSM Medical College |
Swaroop Nagar, Kanpur, Uttar Pradesh 208002
Kanpur Nagar
UTTAR PRADESH |
8765379671
mahendra.research01@gmail.com |
| Dr Parasar Ghosh |
Institute of Post Graduate, Medical Education and Research |
244 AJC, Bose Road, Kolkata, 700020, West Bengal
Kolkata
WEST BENGAL |
9433988317
drparasar15@yahoo.com |
| Dr Smruti Ramteke |
Jasleen Hospital |
Pansheel square, Old Big Bazar Dhantoli, Nagpur-440012
Nagpur
MAHARASHTRA |
9823514680
sramteke@rediffmail.com |
| Dr A Ramakrishnam Naidu |
King George Hospital |
Maharanipet
Visakhapatnam
ANDHRA PRADESH |
9885093386
rammky@yahoo.com |
| Dr Kaushik Basu |
Kolkata Medical College and Hospital |
88, College street Kolkata-700073
Kolkata
WEST BENGAL |
9038831211
phoenix.0013@gmail.com |
| Dr Dinesh Agarwal |
Marwari Hospitals |
S J Road Athgaon-781008
Kamrup
ASSAM |
9864061456
drdinesh944@gmail.com |
| Dr Swetha J |
Prakriya Hospitals |
Survey No 41, Rajareddy Layout,8TH MILE, Tumkur Road, NAGASANDRA, BENGALURU 560073
Bangalore
KARNATAKA |
9620488831
drswethaj31@gmail.com |
| Dr Sachin V Dhote |
Saraswati Kidney Care Centre |
13,New Sneh Nagar, Near Jaiprakash Nagar Metro Station, Jaitala Road, Nagpur-440015
Nagpur
MAHARASHTRA |
9823343626
drsachindhote123@gmail.com |
| Dr Reena Sharma |
Shalby Hospitals |
Shalby Hospitals,Opposite Karnavati Club,S G Highway,
Ahmedabad-380015
Ahmadabad
GUJARAT |
9978662400
reena141@gmail.com |
| Dr Ashish Pongde |
Shree Hospital and Critical Care Centre |
799, Om Nagar, Opp Tajshree Building,Sakkardara square,
Nagpur- 440009, Maharashtra
Nagpur
MAHARASHTRA |
9326118869
0712-2743071
drpongade@gmail.com |
| Dr Mayank Thakker |
Shri Giriraj Multispeciality Hospital |
27 Navjyot Park, 150 Ft Ring Road, Rajkot, Gujarat-360005
Rajkot
GUJARAT |
9909971118
drmayankthakker@gmail.com |
| Dr Avinash Agarwal |
Shri Nidaan Hospital & Hope Fertility Centre |
27-Vidhut Nagar-A, Ajmer Road, Jaipur-302021, Rajasthan
Jaipur
RAJASTHAN |
9829052451
dravitrial@gmail.com |
| Dr Neeraj Jain |
Sir Ganga Ram Hospital |
Sir Ganga Ram Hospital,Sir Ganga Ram Marg,Rajinder Nagar,
New Delhi-110060
New Delhi
DELHI |
9810130150
neerajrheumatology@gmail.com |
| Dr Firdaus Fatima |
St.Theresas Hospital |
Opp.Erragada Rythu Bazar Sanath Nagar -500038
Hyderabad
TELANGANA |
9177024456
ddrfirdusafatima@gmail.com |
| Dr Nilesh Nolkha |
Vijay Vallabh Hospital and Medical Research Centre |
Plot No.423, Tirupati Nagar, Phase 1, Bolinj, Virar(West), Distt- Palghar, Pin Code-401303
Mumbai
MAHARASHTRA |
9920355665
drnileshnolkha@yahoo.com |
| Dr Dhaiwat Shukla |
VS General Hospital |
VS General Hospital,Ellisbridge,
Ahmedabad-380006
Ahmadabad
GUJARAT |
8980024107
dr.dhaiwatshukla89@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 19 |
| Name of Committee |
Approval Status |
| AVRONHOSPITALS PvtLtd |
Approved |
| DayandMedicalCollegeandHospitalManagingSociety |
Approved |
| ECRCHECMarwariHopitals |
Approved |
| Ethics Committee GVSM Medical College |
Approved |
| Ethics Committee of BMCRI |
Approved |
| EthicscommitteeStTheresasHospital |
Approved |
| Institutional Ethics committee for Human Research |
Approved |
| Institutional Ethics committee Gleneagles Global Hospitals |
Approved |
| InstitutionalethicsCommitteeGovernmentmedicalcollegeGovernmentGeneralHospital |
Approved |
| InstitutionalethicsCommitteeKinggeorgehospital |
Approved |
| InstitutionalethicsCommitteevijayvallabahhospital |
Approved |
| IPGME&R Research Oversight Committee |
Approved |
| Meditrina Institute Ethics Committee |
Approved |
| Prakriya Hospitals Institutional Ethics Committee |
Approved |
| Sangini Hospital Ethics Committee |
Approved |
| Shree Giriraj Hospital Research Ethics Committee |
Approved |
| Shree Hospital Ethics Committee |
Approved |
| Swastic Ethics Committee |
Approved |
| Triveni Polyclinic Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M060||Rheumatoid arthritis without rheumatoid factor, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Adalimumab |
Injection 40 mg/0.4 ml
Route of administration : Subcutaneous
Frequency: Every other week
Duration of therapy: 24 weeks
|
| Comparator Agent |
HUMIRA® |
Injection 40 mg/0.4 ml
Route of administration : Subcutaneous
Frequency: Every other week
Duration of therapy: 24 weeks
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
1.Adult men and women patients with age ≥18 years and ≤ 65 years of age at the time of screening.
2.Patient should have been diagnosed with active Rheumatoid Arthritis as per 2010 American College of Rheumatology Criteria atleast 3 months prior to screening.
3.Patient with moderate to severe active disease defined as Disease Activity Score 28 (DAS 28) ≥ 3.2 despite standard anti-rheumatic DMARD treatment including atleast Methotrexate.
4.History of treatment with Methotrexate (MTX) 20-25 mg per week for atleast 12 weeks before screening, and being at stable dose for atleast 4 weeks before screening.
5.If the patients are on oral glucocorticoid (< 10 mg/day of prednisone or equivalent) then the dose must be stable for at least 4 weeks before screening. If they are not taking glucocorticoid currently then they must have not received glucocorticoid for atleast 4 weeks prior to screening.
6.If patients are using NSAIDs, they should have been on a stable dose for at least 4 weeks prior to screening.
7.Male or female patients of child-bearing potential must agree to use medically acceptable forms of contraception during the study.
8.Able to self-administer injection or with help of assistant.
9.Patients able to understand and voluntarily provide written informed consent before screening, following an explanation of the nature and purpose of this study.
10.Patient should be Negative for Tuberculosis with Mantoux test and Quantiferon test for latent Tuberculosis. |
|
| ExclusionCriteria |
| Details |
1.Known hypersensitivity to Adalimumab or any of its excipients or related group of drugs.
2.Prior treatment with other biological response modifiers (e.g. Adalimumab, infliximab and anakinra) within 3 months from screening.
3.Autoimmune disease other than RA or patients with significant systemic manifestations of RA.
4.Pregnant or Nursing female patients.
5.History of diagnosis of juvenile rheumatoid arthritis (JRA) and/or RA before age 16.
6.History of inflammatory arthritis other than RA (e.g., systemic lupus erythematosus (SLE), or psoriatic arthritis).
7.Any surgical procedure for the disease, including bone/joint surgery or planned surgery within 8 weeks prior to screening or during the study period.
8.History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks’ prior for Leflunomide).
9.History of use of disease-modifying anti-rheumatic drugs (DMARDs) other than MTX within 4 weeks prior to randomization (8 weeks’ prior for Leflunomide).
10.Use of intra-articular or parenteral corticosteroids within 4 weeks prior to screening visit. Inhaled corticosteroids for stable medical conditions are allowed.
11.Receipt of a live vaccine within 4 weeks prior to enrolment visit.
12.Patients with moderate to severe Heart Failure (NYHA grade III/IV).
13.Evidence of significant uncontrolled concomitant diseases such as cardiovascular disease, nervous system, renal, hepatic, endocrine, gastrointestinal, or pulmonary disease, including any pulmonary or other condition that would preclude subject participation.
14.Known active bacterial, viral, fungal, mycobacterial, or other infection (including tuberculosis or atypical mycobacterial disease, but excluding fungal infections of nail beds). |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The percentage of patients with an ACR20 response rate in both the treatment groups. |
week 24 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Percentage of patients with an ACR 20 response rate in both treatment groups
2.Percentage of patients with ACR20 ACR70 response rate in both treatment groups
3.Mean Change from baseline with respect to DAS28 Score C reactive protein Health asessment questionnaire score
4.Compare single dose pharmacokinetic profile between investigational products
5.compare pharmacodynamic and immunogenicity parameters prior to drug administration |
Week12 Week 24 Day 1 Day 15 day 85 Day 169 |
|
|
Target Sample Size
|
Total Sample Size="180"
Sample Size from India="180"
Final Enrollment numbers achieved (Total)= "201"
Final Enrollment numbers achieved (India)="201" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
07/07/2021 |
| Date of Study Completion (India) |
28/06/2022 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a prospective, randomized, double blind, multi dose, multicenter, parallel group, comparative clinical efficacy and safety study in patients with Active Rheumatoid Arthritis in between Shilpa Adalimumab (test) 40mg/0.4 ml prefilled Syringe from Shilpa Biologicals Private Limited and Humira® (Reference Adalimumab) 40mg/0.4 ml prefilled Syringe from AbbVie Deutschland GmbH & Co. KG administrated Subcutaneously till week 24 (12 doses, alternate week). Patients will be randomized in a ratio of 2:1 (120 in test arm and 60 reference arm). History of rheumatoid arthritis, as defined by the American College of Rheumatology (ACR) 2010 Criteria, for at least 3 months History of treatment with Methotrexate (MTX) 20-25 mg per week for atleast 12 weeks before screening, and being at stable dose for atleast 4 weeks before screening will be invited to participate in the study.
|