CTRI/2019/09/021078 [Registered on: 05/09/2019] Trial Registered Prospectively
Last Modified On:
10/05/2021
Post Graduate Thesis
No
Type of Trial
PMS
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 Infimabâ„¢ 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 Infimabâ„¢ in patients with moderate to severe plaque psoriasis
Trial Acronym
Secondary IDs if Any
Secondary ID
Identifier
RLS/PMS/2016/08, Version 2.0 dated 24 Mar 2017
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study) Modification(s)
Name
Sachin Singh
Designation
Head - Clinical Operations
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
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
02235338287
Fax
02235338299
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
Address
Dhirubhai Ambani Life Sciences Centre (DALC), R-282, TTC Area of MIDC, Rabale, Navi Mumbai – 400701, Maharashtra, India
Acharya Vinoba Bhave Rural Hospital, Jawaharlal Nehru Medical College, Datta Meghe institute of Medical Sciences, Sawangi (Meghe) Wardha, 442004 Wardha MAHARASHTRA
9320885343
drbhushan81@gmail.com
Dr Amit Madan
Ajanta Hospiatl
Ajanta Research Centre
Ajanta Hospital & IVF Centre
765,ABC Complex, Kanpur Road, Lucknow-226005.
Lucknow UTTAR PRADESH
9838001239
amitmadan_2000@yahoo.com
Dr Ravindranath Chavan
B. J. Govt. Medical College & Sassoon General Hospital
Dept. of Skin & V. D., Pune Station Road,Pune-411001, Maharashtra, India Pune MAHARASHTRA
9421346016 02026126868 drrchavan1@gmail.com
Dr Dinesh Oswal
Baramati Hospital
Baramati Hospital, Behind kavivarya Moropant Natyamandir, Ring road, Baramati, Pune 413102, Maharashtra, India Amravati MAHARASHTRA
9822308147
dineshoswal1968@rediffmail.com
Dr Indrashis Podder
Department of Dermatology, College of Medicine & Sagore Dutta
Department of Dermatology, College of Medicine & Sagore Dutta hospital 578, B.T Road Kamarhati ,, Kolkata- 700058 Kolkata WEST BENGAL
900797761
ipodder88@gmail.com
Dr Madan Mohan
Dr B.R Ambedkar Medical College
Department of Dermatology,Gandhi Nagar, Kadugondanahalli, Bangalore - 560045, Karnataka , India. Bangalore KARNATAKA
9845074316
madanmohan1869@gmail.com
Dr V Revathi
Government Medical College and Government General Hospital (Old RIMSGGH)
Department of Dermatology
Srikakulam-532001, Andhra Pradesh, India Srikakulam ANDHRA PRADESH
9908066043
drrevathivggh@gmail.com
Dr Prashant Palawade
Ishwar Institute of Healthcare
Ishwar Institute of Healthcare, Ishwar Heights, Plot No 7, Gut no 6/1, besides Panjabi Bhavan, Padegaon, Aurangabad, Maharashtra Aurangabad MAHARASHTRA
9323707031
prashantpalawade@gmail.com
Dr Bangaru H
K R Hospital Mysore Medical College
K R Hospital Mysore Medical College, Mysore Mysore KARNATAKA
9886789231
drbangauskin@gmail.com
Dr Nandini A S
Kempegowda Institute of Medical Sciences (KIMS Hospital)
Department of Dermatology, B Block, OPD Building, Ground Floor,Room No 10, K.R. Road, V.V. Puram, Bangalore – 560004, Karnataka, India. Bangalore KARNATAKA
9886829579
drnandinias2002@yahoo.co.in
Dr Shendkar Sonal Mahadev
Lifepoint Multispeciality Hospital
145/1,Mumbai-Banglore Highway, near Hotel Sayaji, Wakad, Pune-411057, Maharashtra, India. Pune MAHARASHTRA
Institutional Ethics Committee Dr. B.R. Ambedkar Medical College, Gandhi Nagar, Kadugondanahalli, Bangalore - 560045, Karnataka, India
Submittted/Under Review
Datta Meghe Institute of medical Science institutinal Ethics Committee
Approved
Ethic Committee of Shree Hospital, Siddharth Mansion, Nagar Road, Pune – 411006,Maharashtra, India
Approved
Ethics Commitee S. P medical college Bikaner
Approved
Ethics Committee Ishwar Institute of Health care
Approved
IEC-MMC and RI and Associated Hospital, Mysore Medical College and Research Institute
Submittted/Under Review
Institutinal Ethics Committee College of Medicine and SagoreDatta Hospital-Kolkata 700058
Approved
Institutional Ethics Committee Ajanta Hospital and IVF centre
Approved
Institutional Ethics committee King george hospital
Approved
Institutional Ethics Committee of B. J. Govt. Medical College & Sassoon General Hospital, Department of Pharmacology, B. J. Govt. Medical College, Sassoon Road, Pune - 411001, Maharashtra,India
Approved
KIMS Institutional Ethics Committee, Kempegowda Institute of Medical Sciences (KIMS), Banshankari II Stage, Bangalore - 560070, Karnataka, India
Lokmanya Medical Research Centre Institutional Ethics Committee
Approved
MGM Ethics Committee for research on Human Subjects, MGM Medical college
Approved
Noble Hospital Institutional Ethics committee
Approved
Ojas Multispecialty Hospital Ethics Committee
Approved
Society for research welfare Independent 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
Infimabâ„¢ (Infliximab)
Infimabâ„¢ 5 mg/kg will be administered as intravenous
infusion over a period of not less than 2 hours at Day 0, Week 2/ Day 14 and Week 6/ Day 42.
Comparator Agent
Not Applicable
Not Applicable
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 having PASI score >10.
4. Women of childbearing potential agreeing to use adequate contraception.
5. Able to understand and willing to provide written informed consent.
ExclusionCriteria
Details
1. Patients with hypersensitivity to Infliximab 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. Patients with active or latent tuberculosis
5. Patients with history of any malignancy including lymphomas or presence of any
premalignant lesions
6. Patients with heart failure (New York Heart Association class III or IV)
7. Patients with known hematological disorders, demyelinating disease or lupus-like
syndrome
8. Patients with known clinically significant liver disease
9. Known cases of HIV, Hepatitis B or Hepatitis C infection
10. 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.
11. Participation in any clinical study of an investigational product within previous 3
months.
12. 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
Baseline to Week 14
Secondary Outcome
Outcome
TimePoints
Change in Psoriasis Area and Severity Index (PASI) score from baseline to week 14
From baseline to Week 14
Change in Physician Global Assessment (PGA) score from baseline to week 14
From baseline to Week 14
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"
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Brief Summary
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.
InfimabTM has been approved by the regulatory authority in India for the treatment of plaque psoriasis.