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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Remsima | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Remsima | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Psoriasis Area Severity Index Score | Patients will be followed 4,8,14 and 24 weeks | 24 weeks |
| Adverse Events | Patients will be followed 4,8,14 and 24 weeks | 24 weeks |
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Inclusion Criteria:
Exclusion Criteria:
Patient with active systemic lupus erythematosus or ANA positive patients.
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| Name | Affiliation | Role |
|---|---|---|
| Prof. Dr. Haroon Nabi | Professor Department of Dermatology LMDC | Study Director |
| Dr. Nabigha Khalid | Department of Dermatology Ghurki Hospital | Principal Investigator |
| Dr. Saleha Batool | Assistant Professor Department of Dermatology, SIMS Hospital | Study Chair |
| Dr. Sumera Hanif | Senior Registrar Dermatology Department | Study Chair |
| Dr. Talat Masood Akbar | Associate Professor Dermatology LMDC GTTH | Study Chair |
| Dr. Faria Asad | Professor/ Head of Dermatology Department | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ghurki Hospital | Lahore | Punjab Province | Pakistan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23974692 | Background | Arsiwala S. Infliximab: efficacy in psoriasis. Indian J Dermatol Venereol Leprol. 2013 Jul;79 Suppl 7:S25-34. doi: 10.4103/0378-6323.115525. | |
| 11410193 | Background | 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. |
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| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| C000591237 | CT-P13 |
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| 28498543 | Background | 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. |