Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Apremilast in treatment of moderate to severe Psoriasis.: From Baseline to end of treatment and follow-up 16 weeks
Control Intervention1: Methotrexate in the treatment of moderate to se
Sponsors
Government Institute of Medical Sciences (GIMS) Greater Noida
Eligibility
Inclusion criteria
Inclusion criteria: 1.Adults aged more than 18 years of either sex. 2.Clinically and histopathologically confirmed moderate to severe psoriasis based on the Psoriasis Area and Severity Index PASI more than and equal 10 or Body Surface Area BSA more than and equal 10 percent. 3.Candidates for systemic therapy due to inadequate response to topical treatments or phototherapy. 4.Patients who are either treatment-na ve or have not used Methotrexate or Apremilast in the past 6 months
Exclusion criteria
Exclusion criteria: 1.Pregnancy & Lactation 2.Severe Co morbidities Any contraindication of starting Methotrexate or Apremilast 3.Use of Methotrexate for indications other than psoriasis 4.Severe Infections: Active tuberculosis, HIV, hepatitis B or C, or other chronic infections
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in PASI (Psoriasis Area and Severity Index) Score o Difference in PASI score from baseline to 16 weeks. 2.Adverse Effects Profile o Incidence, severity, and type of adverse drug reactions in each treatment group. 3.Drug Tolerability o Number of patients who discontinue treatment due to side effects. 4.Laboratory Safety Parameters o Changes in liver enzymes, renal function, haematological profile during treatment.Timepoint: From baseline to end of treatment and follow up to week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| nilTimepoint: nil | — |
Countries
India
Contacts
Public ContactDr Saubhagya Gupta
Government Institute of Medical Sciences (GIMS)
Outcome results
None listed