NCT06043752

Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 51 (actual)
• Sponsor: Ghurki Trust and Teaching Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Not accepted

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

• Psoriasis

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2022-03-10
• Primary completion: 2023-07-15
• Completion: 2023-08-05
• First posted: 2023-09-21
• Last updated: 2023-09-21

Locations

1 site across 1 country: Pakistan