Clinical trial NCT06043752: Efficacy and Safety of Infliximab Biosimilar Remsima in Psoriasis
Official title: Efficacy and Safety of Infliximab Biosimilar Remsima in Treatment of Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis
Lead sponsor: Ghurki Trust and Teaching Hospital
Sponsor class: OTHER
First posted: 2023-09-21
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Maximum age (years): 59
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Psoriasis Area Severity Index Score
timeFrame: 24 weeks
measure: Adverse Events
timeFrame: 24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Lahore
country: Pakistan
facility: Ghurki Hospital
state: Punjab
Study officials:
affiliation: Professor Department of Dermatology LMDC
name: Prof. Dr. Haroon Nabi
role: STUDY_DIRECTOR
affiliation: Department of Dermatology Ghurki Hospital
name: Dr. Nabigha Khalid
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistant Professor Department of Dermatology, SIMS Hospital
name: Dr. Saleha Batool
role: STUDY_CHAIR
affiliation: Senior Registrar Dermatology Department
name: Dr. Sumera Hanif
role: STUDY_CHAIR
affiliation: Associate Professor Dermatology LMDC GTTH
name: Dr. Talat Masood Akbar
role: STUDY_CHAIR
affiliation: Professor/ Head of Dermatology Department
name: Dr. Faria Asad
role: STUDY_CHAIR
References:
citation: Arsiwala S. Infliximab: efficacy in psoriasis. Indian J Dermatol Venereol Leprol. 2013 Jul;79 Suppl 7:S25-34. doi: 10.4103/0378-6323.115525.
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.
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.