Psoriasis
Conditions
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.
Interventions
DRUGRemsima
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.
Sponsors
Ghurki Trust and Teaching Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 59 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Psoriasis Area Severity Index Score | 24 weeks | Patients will be followed 4,8,14 and 24 weeks |
| Adverse Events | 24 weeks | Patients will be followed 4,8,14 and 24 weeks |
Countries
Pakistan
Outcome results
None listed