Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Oral Methotrexate along with oral Apremilast: If patient fits in Inclusion criteria, Oral Methotrexate(15mg/kg) along with oral Apremilast( starting from 10 OD increasing upto 30mg BD)
Sponsors
GMERS Medical College and CIvil Hospital Sola
Eligibility
Inclusion criteria
Inclusion criteria: 1. Patients ready to be part of study and sign ICF. 2. Patient presenting with Moderate to Severe Chronic Plaque Psoriasis according to the Rule of Tens (PASI score >10)
Exclusion criteria
Exclusion criteria: 1. Patients who failed to give written consent. 2. In patients in which Methotrexate and/or Apremilast is contraindicated 3. Pregnant women and Lactating Mothers 4. Patients with mild disease (PASI 5. Erythrodermic or pustular psoriasis, predominant scalp or nail involvement 6. Patients who have taken methotrexate continuously or intermittently in more than 2.5gm total dose. 7. Patients with hepatic or renal impairment, cardiac dysfunction, blood dyscrasias or any other systemic comorbidity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. To study the efficacy of oral Methotrexate vs oral Methotrexate with Apremilast in patients with moderate to severe chronic plaque psoriasis 2. To access clinical improvement based on clinical photographs and PASI score 3. To assess the dose requirement of methotrexate in both groups.Timepoint: Baseline, then monthly upto 4 months | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. To compare the DLQI in both the study groups 2. To study the safety profile of study drugs. Timepoint: Baseline, then monthly upto 4 months | — |
Countries
India
Contacts
Public ContactDr Krina Patel
GMERS Medical College & Civil Hospital, Sola
Outcome results
None listed