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 skincells or scale

Phase 4

Active, not recruiting

• Conditions: Psoriasis vulgaris,

• Registration Number: CTRI/2019/09/021078
• Lead Sponsor: Reliance Life Sciences Pvt Ltd

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-20
• Last Update Posted: 2021-10-05

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: All
• Target Recruitment: 200

Inclusion Criteria

• Patients aged between 18 to 65 years (both inclusive).
• Patients with confirmed diagnosis of plaque psoriasis since at least 6 months.
• Patients with moderate to severe plaque psoriasis having PASI score >10.
• Able to understand and willing to provide written informed consent.

Exclusion Criteria

• 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.
• 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.
• Participation in any clinical study of an investigational product within previous 3 months.
• 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.

Study & Design

• Study Type: PMS
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events occurring during the study	Baseline to Week 14

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (20)

Acharya Vinoba Bhave Rural Hospital,; 🇮🇳 Wardha, MAHARASHTRA, India

Ajanta Hospiatl; 🇮🇳 Lucknow, UTTAR PRADESH, India

B. J. Govt. Medical College & Sassoon General Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Baramati Hospital; 🇮🇳 Amravati, MAHARASHTRA, India

Department of Dermatology, College of Medicine & Sagore Dutta; 🇮🇳 Kolkata, WEST BENGAL, India

Dr B.R Ambedkar Medical College; 🇮🇳 Bangalore, KARNATAKA, India

Government Medical College and Government General Hospital (Old RIMSGGH); 🇮🇳 Srikakulam, ANDHRA PRADESH, India

Ishwar Institute of Healthcare; 🇮🇳 Aurangabad, MAHARASHTRA, India

K R Hospital Mysore Medical College; 🇮🇳 Mysore, KARNATAKA, India

Kempegowda Institute of Medical Sciences (KIMS Hospital); 🇮🇳 Bangalore, KARNATAKA, India

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Acharya Vinoba Bhave Rural Hospital,

🇮🇳Wardha, MAHARASHTRA, India

Dr Bhushan Madke

Principal investigator

9320885343

drbhushan81@gmail.com