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
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
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
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 (“Institutionâ€) 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
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"
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.