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Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

NCT06043752 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 51

Last updated 2023-09-21

No results posted yet for this study

Summary

Psoriasis is a persistent condition which demands prolonged management, so it puts heavy financial as well as psychological burden on patients. Severe psoriasis makes work impossible for patients. If it affects exposed parts of the body, it may lead to decrease in self-esteem, social avoidance, and shame. Patients with even mild form of psoriasis have high stigma as compared to other cutaneous diseases. As a result, psoriasis affected individuals experience greater difficulty in social interactions and employment. Patients experience symptoms in psoriasis includes bleeding, itching and inflamed joints. Psoriatic patients develop psoriatic arthritis approximately at 40 years of age which contributes to fatigue in these individuals. Moreover, early age onset of psoriasis leads to more physical impairment. Hence, patients get trapped in a vicious cycle as stress leads to further aggravation of disease. The European Medicine Agency has given its approval regarding the usage of INFLIXIMAB bio similar REMSIMA for psoriasis after taking in consideration its effectiveness from other studies conducted on ankylosing spondylitis and rheumatoid arthritis. This study is being conducted as no data is present on REMSIMA SC in psoriasis patient in Pakistan.

Conditions

Interventions

DRUG

Remsima

The patient will be given one Injection of REMSIMA 120 mg subcutaneously at week 0, 1, 2, 3, 4 and then every 2 weeks i.e., at 6, 8, 10 and 14 weeks. If the weight of the patient is \>80 kg, 2 injections will be given.

Sponsors & Collaborators

  • Ghurki Trust and Teaching Hospital

    lead OTHER

Principal Investigators

  • Prof. Dr. Haroon Nabi · Professor Department of Dermatology LMDC

  • Dr. Nabigha Khalid · Department of Dermatology Ghurki Hospital

  • Dr. Saleha Batool · Assistant Professor Department of Dermatology, SIMS Hospital

  • Dr. Sumera Hanif · Senior Registrar Dermatology Department

  • Dr. Talat Masood Akbar · Associate Professor Dermatology LMDC GTTH

  • Dr. Faria Asad · Professor/ Head of Dermatology Department

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
59 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-03-10
Primary Completion
2023-07-15
Completion
2023-08-05

Countries

  • Pakistan

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06043752 on ClinicalTrials.gov