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CTRI Number  CTRI/2019/10/021694 [Registered on: 16/10/2019] Trial Registered Prospectively
Last Modified On: 03/08/2022
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Biological 
Study Design  Single Arm Study 
Public Title of Study   The purpose of this research study is to evaluate the safety and effectiveness profile of the medicine named as AdaliRel® in patients with moderate to severe plaque psoriasis which is a skin disease characterized by raised red patches covered with a silvery white buildup of dead skin cells or scale  
Scientific Title of Study   A prospective, multi-centre, open label, phase IV study to evaluate safety and efficacy profile of AdaliRel® in patients with moderate to severe plaque psoriasis 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
Protocol No.: RLS/PMS/2016/07 Version 4.0, Dated 06 Jul 2018  Protocol Number 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Sachin Singh 
Designation  Head - Clinical Operations 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  RLS Bio - Product Trials Group, Dhirubhai Ambani Life Sciences Centre (DALC) R-282, TTC Area of MIDC, Thane - Belapur Road, Rabale, Navi Mumbai - 400701,India

Thane
MAHARASHTRA
400701
India 
Phone  02235338269  
Fax  02235338299  
Email  Sachin2.Singh@relbio.com  
 
Details of Contact Person
Scientific Query

Modification(s)  
Name  Dr Supriya Sonowal  
Designation  Medical Monitor 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre (DALC), R-282, TTC Area of MIDC, Rabale, Navi Mumbai – 400701, Thane, Maharashtra, India

Thane
MAHARASHTRA
400701
India 
Phone  9427003728  
Fax  9427003728  
Email  Supriya.Sonowal@relbio.com  
 
Details of Contact Person
Public Query

Modification(s)  
Name  Chaitali Bornare  
Designation  Project Manager 
Affiliation  Reliance Life Sciences Pvt. Ltd. (RLS) 
Address  Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre (DALC), R-282, TTC Area of MIDC, Rabale, Navi Mumbai – 400701, Thane, Maharashtra, India

Thane
MAHARASHTRA
400701
India 
Phone  02235339148  
Fax  02235339148  
Email  chaitali.bornare@relbio.com  
 
Source of Monetary or Material Support  
Reliance Life Sciences Pvt. Ltd. (RLS), Dhirubhai Ambani Life Sciences Centre (DALC), R-282, TTC Area of MIDC, Rabale, Navi Mumbai – 400701, Maharashtra, India 
 
Primary Sponsor  
Name  Reliance Life Sciences Pvt Ltd RLS 
Address  Dhirubhai Ambani Life Sciences Centre (DALC), R-282, TTC Area of MIDC, Rabale, Navi Mumbai – 400701, Maharashtra, India 
Type of Sponsor  Pharmaceutical industry-Indian 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study
Modification(s)  
No of Sites = 17  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Chandra Sekhar Sirka   All India Institute of Medical Sciences  Department of Dermatology & Venerology Sijua, Patrapada, PO: Dumduma, Dist –Khurdha,Bhubaneswar

 
9438884055

csirka20006@gmail.com 
Dr sanjana S  BGS Global Institute of Medical Sciences and Hospital  BGS Global Institute of Medical Sciences and Hospital (“Institution”) both having their address at No. 67, BGS Health & Education City, Uttarahalli Main Road, Kengiri, Bengaluru, Karnataka 560060
Bangalore
KARNATAKA 
9880010325

sanjana629@gmail.com 
Dr Abhishek De  Calcutta National Medical College   Calcutta National Medical College
Kolkata
WEST BENGAL 
9903275551

dr_abhishek_de@yahoo.co.in 
Dr Ranjan Raval  CGS Medical College, Hospital and research Centre  CGS Medical College, Hospital and research Centre, Opp.DRM office, Nr Chamunda Bridge, Naroda road, Ahmedabad- 380025, Gujrat
Ahmadabad
GUJARAT 
9327022606

ranjancraval@gmail.com 
Dr Deepak Kotkar  Department of Dermatology, Shree Siddhivinayak Maternity and Nursing Home  Department of Dermatology, Shree Siddhivinayak Maternity and Nursing Home, Unity Campus, Second floor, Opposite KTHM College, Gangapur Road, Nashik- 422002, Maharashtra, India
Nashik
MAHARASHTRA 
9371580600

deepakkotkar@gmail.com 
Dr Sharmila Patil  Dr D Y Patil Hospital And Medical College  OPD 54, First Floor, Department Of Dermatology, Sector 5, Nerul, Navi Mumbai
Mumbai
MAHARASHTRA 
9821350217

drsharmilapatil@gmail.com 
Dr Vikrant Saoji  JN Medical College  Acharya Vinobha Bhave Rural Hospital, Sawangi Meghe (Wardha), 442004 Maharashtra, India
Wardha
MAHARASHTRA 
9822697892

vikrantsaoji@hotmail.com 
Dr Saurabh Kapadia  Kanoria Hospital and Research Centre,  Dr. Saurabh Kapadia
Ahmadabad
GUJARAT 
9824261031
7923969452
drgaudabhkapadia@yahoo.com 
Dr Konakachi Venkata   King George Hospital  Maharanipeta, Visakhapattanam- 530002, Andhra Pradesh, India
Visakhapatnam
ANDHRA PRADESH 
9848398923

drkvchalam99@yahoo.com 
Dr Neha Sharma  Lotus Multispeciality Hospital  Lotus Multispeciality Hospital,Block N, Krupa residency, Motera Stadium Road,Motera-Sabarmati,Ahmedabad-380005 Gujrat India.
Ahmadabad
GUJARAT 
0976614730

ns140786@gmail.com 
Dr Rachita Dhurat  LTMMC and LTMGH, Sion Hospital   LTMMC and LTMGH, Sion Hospital , Babasaheb Ambedkar Road, RB2 Central Railway Quarters, Sion (West), Mumbai-400022
Mumbai
MAHARASHTRA 
9870390057

rachitadhurat@yahoo.co.in 
Dr Sudhakarrao Grandhi   Medipoint Hospitals Pvt Ltd  241/1, New D.P.Road, Aundh, Pune- 411007
Pune
MAHARASHTRA 
9850082614

sudhakargrandhi@rediffmail.com 
Dr Monika Gawda  Medstar Speciality Hospital  Medstar Speciality Hospital (“Institution”) having its address at #614. 171/3, Kodigehalli Main Road, Opp. Chairman’s Club, Sanjeevani Nagar, Bengaluru, Karnataka-560092
Bangalore
KARNATAKA 
9538880387

medstarclinicalresearch@gamil.com 
Dr Dipak Patel  Nirmal Hospital Pvt Ltd  3rd floor, Department of Dermatology, A-Wing, Ring Road, Surat- 395002
Surat
GUJARAT 
9374711540

dr.dipak.patel@gmail.com 
Dr Yuvraj More  Pulse Multispeciality Hospital  Pulse Multispeciality Hospital, Vishwa Arcade, Near Bombay Bangalore Highway Pune-411041, Maharasthra
Pune
MAHARASHTRA 
9420482876

dryuvrajmore@yahoo.co.in 
Dr Hari Kishan Kumar   Rajarajaeswari Medical College and Hospital  Department of Dermatology, No.202, Kambipura, Mysore Road
Bangalore
KARNATAKA 
9002066568

drharikishankumar@gmail.com 
Dr Suneel Vartak  Sujata Birla Hospital & Medical Research Center  3rd Floor, Clinical Research Department, Opposite Bytco College, Nashik Pune Highway, Nashik Road
Nashik
MAHARASHTRA 
9373901829

suneel.vartak@gmail.com 
 
Details of Ethics Committee
Modification(s)  
No of Ethics Committees= 16  
Name of Committee  Approval Status 
BGS Global Institutinal Ethics Commitee  Approved 
Datta meghe Institute of medical SciencesInstitutinal Ethics comittee  Approved 
Ethics Committee of Pulse Multispecialty Hospital  Approved 
Institusinal Ethics Committee for Human Research ( IEC-HR)  Approved 
Institutinal ethics Committee  Approved 
Institutional Ethics committee All India Institute of Medical Sciences Bhubaneshwar  Approved 
Institutional Ethics Committee Padmashree Dr D Y Patil Hospital And Medical College  Approved 
Institutional Ethics Committee Rajarajaeswari Medical College and Hospital  Approved 
Institutional Ethics Committee, King George Hospital  Approved 
Kanoria Ethics Committee  Approved 
Lotus Ethics Committe  Approved 
Medstar speciality Hospital Ethics Committee  Approved 
Nirmal Hospital Pvt Ltd Ethics Committee  Approved 
Penta-Med Ethics committee  Approved 
Shree Sidhivinayak Hospital Ethics Comittee  Approved 
Yash Society Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Approved/Obtained 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L400||Psoriasis vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Adalimumab  Adalimumab for plaques psoriasis. Route of administration is subcutaneous injection. Dosing as per study schedule. 
Comparator Agent  N/A  N/A 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patients aged between 18 to 65 years (both inclusive)
2. Patients with confirmed diagnosis of plaque psoriasis since at least 6 months
3. Patients with moderate to severe plaque psoriasis with ≥10% BSA involvement and PASI ≥12
4. Physician’s Global Assessment (PGA) of at least moderate disease severity
5. Women of childbearing potential and men agreeing to use adequate contraception
6. Patients able to understand and willing to provide written informed consent 
 
ExclusionCriteria 
Details  1. Patients with hypersensitivity to Adalimumab or any of its components.
2. Pregnant or lactating females
3. Presence of serious or active infection due to bacteria, fungi, viruses or other opportunistic pathogens
4. History of serious infection, which caused hospitalization within 6 months prior to randomization or other severe or chronic infection (such as sepsis, abscess or opportunistic infections, invasive fungal infection such as histoplasmosis, or a history of recurrent herpes zoster or other chronic or recurrent infection) or a past diagnosis without sufficient documentation of complete resolution following treatment.
5. Infection requiring parenteral antibiotic treatment within 4 weeks of randomization.
6. Patients with history of any malignancy diagnosed within last 5 years or presence of any premalignant lesions
7. Patients with heart failure (New York Heart Association class III or IV)
8. Patients with known hematological disorders, demyelinating disease or lupus-like syndrome
9. Patients with known clinically significant liver disease
10. Known cases of HIV, Hepatitis B or Hepatitis C infection
11. Active TB. Also excluded are subjects who have evidence of latent TB [evidence of tuberculosis based on chest X rays, tuberculin skin (Mantoux) test, QuantiFERON®-TB Gold test or other tuberculosis test performed during screening] without adequate therapy for TB completed prior to first infusion of Study Medication. Also excluded are subjects with evidence of an old or latent TB infection without documented adequate therapy, if they will not be treated with antitubercular therapy during the study. Subjects with a current close contact with an individual with active TB will also be excluded. Additionally, subjects who have completed treatment for active TB within the previous 2 years are explicitly excluded from the study. Subjects with a household member who has a history of active pulmonary TB, which has been treated, should have had a thorough evaluation for TB prior to study enrolment as recommended by a local infectious disease specialist or published local guidelines of TB control agencies. Also excluded are subjects with opportunistic infections including, but not limited to, evidence of active cytomegalovirus, active pneumocystis carinii, aspergillosis, or atypical mycobacterial infection, etc., within the previous 6 months.
12. Patients with any condition that might make it difficult for patients to participate in the study or that might affect interpretation of results of the study, at the discretion of Investigator.
13. Participation in any clinical study of an investigational product within previous 3 months.
14. Current signs or symptoms of significant, progressive or uncontrolled renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, cardiac, neurologic or cerebral disease that renders the patient incapable of participating in the study. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Incidence of adverse events occurring during the study  throughout the study 
 
Secondary Outcome  
Outcome  TimePoints 
Percentage of patients achieving PASI 50/75/90/100 response from baseline to week 16  week 16 
Mean percentage PASI score improvement from baseline to week 16
 
Week 16 
Percentage of patient achieving Physician Global Assessment (PGA) score clear/clear or minimal from baseline to week 16  week 16 
 
Target Sample Size   Total Sample Size="216"
Sample Size from India="216" 
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)   21/10/2019 
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   None yet 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary
Modification(s)  

Psoriasis is an immune mediated genetically determined common dermatological disorder which affects skin, nails, joints and has various systemic associations. There is a growing number of population-based studies providing worldwide prevalence estimates of psoriasis. Prevalence of psoriasis varies in different parts of the world. According to published reports, prevalence in different populations varies from 0% to 11.8%. For most of the data given, the range extends from around 0.5% to close to 2.5%. In the USA, the prevalence of psoriasis was estimated to be around 4.6% while in Canada it was 4.7%. Data from Europe show little variation in countries with a range from 1.4% (Norway), 1.55% (Croatia) and 1.6% (UK). In East Africa, the figure was 0.7% and in the Henan district of China only 0.7% were found affected.

Adalimumab is the first fully human, high-affinity, recombinant immunoglobulin G1 (IgG1) anti-TNF monoclonal antibody. Adalimumab was created using phage display technology resulting in an antibody with human derived heavy and light chain variable regions and human IgG1:k constant regions. Adalimumab is produced by recombinant DNA technology in a mammalian cell expression system and is purified by a process that includes specific viral inactivation and removal steps. Because it is indistinguishable in structure and function from naturally occurring human IgG1, adalimumab has high selectivity and affinity for TNF; suitability for long-term chronic administration with a low degree of immunogenicity, with or without concomitant methotrexate (MTX) use; a low incidence of allergic reactions; and a half-life comparable to that of IgG1, allowing every-other-week dosing for patient convenience.

AdaliRel® is a similar biological medicinal product to the innovator product. AdaliRel® is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, Crohn’s disease, ulcerative colitis and plaque psoriasis.

This prospective, multi-centre, open label, phase IV study has been designed to evaluate the safety and efficacy of InfimabTM in patients with moderate to severe plaque psoriasis.

 
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