Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

Phase 4

Completed

• Conditions: Psoriasis
• Interventions: Drug: Remsima

• Registration Number: NCT06043752
• Lead Sponsor: Ghurki Trust and Teaching Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-03-10
• Primary Completion: 2023-07-15
• Study Completion: 2023-08-05
• Status Verified: 2023-09
• Study First Submitted: 2023-09-12
• Study First Submitted QC: 2023-09-12
• Last Update Submitted: 2023-09-12
• Study First Posted: 2023-09-21
• Last Update Posted: 2023-09-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 51

Inclusion Criteria

• Age between 18-59 years
• Both genders
• Diagnosed patient of Psoriasis
• Moderate to severe psoriasis
• Not responding to topical treatment
• Not responding to conventional systemic treatments i.e., methotrexate, cyclosporine and phototherapy.
• PASI score >10.

Exclusion Criteria

Patient with active systemic lupus erythematosus or ANA positive patients.

• Patient with active tuberculosis.
• Extremely immunocompromised patient.
• Patient with cardiac disease.
• Patient with allergic reaction to REMSIMA.
• Pregnancy and Lactation.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Remsima	Remsima	-

Primary Outcome Measures

Name	Time	Method
Adverse Events	24 weeks	Patients will be followed 4,8,14 and 24 weeks
Psoriasis Area Severity Index Score	24 weeks	Patients will be followed 4,8,14 and 24 weeks

Trial Locations

Locations (1)

Ghurki Hospital; 🇵🇰 Lahore, Punjab, Pakistan