Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis

Psoriasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06043752
• Other study ID #: D7
• Status: Completed
• Phase: Phase 4
• Start date: March 10, 2022
• Est. completion date: August 5, 2023

Study information

• Verified date: September 2023
• Source: Ghurki Trust and Teaching Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 51
• Est. completion date: August 5, 2023
• Est. primary completion date: July 15, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 59 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis

Intervention

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.

Locations

Country	Name	City	State
Pakistan	Ghurki Hospital	Lahore	Punjab

Sponsors (1)

Lead Sponsor	Collaborator
Ghurki Trust and Teaching Hospital

Country where clinical trial is conducted

Pakistan, 

References & Publications (3)

Arsiwala S. Infliximab: efficacy in psoriasis. Indian J Dermatol Venereol Leprol. 2013 Jul;79 Suppl 7:S25-34. doi: 10.4103/0378-6323.115525. — View Citation

Chaudhari U, Romano P, Mulcahy LD, Dooley LT, Baker DG, Gottlieb AB. Efficacy and safety of infliximab monotherapy for plaque-type psoriasis: a randomised trial. Lancet. 2001 Jun 9;357(9271):1842-7. doi: 10.1016/s0140-6736(00)04954-0. — View Citation

Gisondi P, Bianchi L, Conti A, Dapavo P, Malagoli P, Piaserico S, Savoia F, Prignano F, Girolomoni G. Infliximab biosimilar CT-P13 in the treatment of chronic plaque psoriasis: data from the Psobiosimilars registry. Br J Dermatol. 2017 Dec;177(6):e325-e326. doi: 10.1111/bjd.15659. Epub 2017 Nov 22. No abstract available. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis Area Severity Index Score	Patients will be followed 4,8,14 and 24 weeks	24 weeks
Primary	Adverse Events	Patients will be followed 4,8,14 and 24 weeks	24 weeks