Health Condition 1: L409- Psoriasis, unspecified
Conditions
Interventions
Intervention1: methotrexate: injection methotrexate 0.3mg/kg/week intramuscularly for 4 months
Control Intervention1: Tofacitinib: oral tofacitinib 5mg twice daily for 4 months
Control Intervention2:
Sponsors
Department of Dermatology
Eligibility
Inclusion criteria
Inclusion criteria: 1. All clinically diagnosed cases of psoriasis who give their consent to participate in study with BSA more than 10 percent and/or PASI more than 10. 2. Cumulative methotrexate dose less than 1.5g. 3. Not taking systemic therapy for 1 month and topical therapy for 2 weeks prior to enrolment.
Exclusion criteria
Exclusion criteria: 1. Pregnancy or lactation. 2. History of alcoholism. 3. Taking hepatotoxic or nephrotoxic drugs. 4. Haemoglobin less than 8 gm/dL. 5. TLC less than 4000 cells/mm3. 6. Platelet count less than 1 lakh/mm3. 7. Lymphocytes less than 1500/mm3. 8. Raised SGPT/OT more than or equal to twice the normal limit at baseline or more than equal to thrice the normal limit at follow up. 9. Raised Total bilirubin more than 1.2 or 30percent increase in baseline. 10. Serum creatinine values of more than 1.4 mg/dl at baseline or more than 30 percent increase in baseline at two consecutive visits. 11. Any evidence of active or latent tuberculosis.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Psoriasis Area and Severity Index (PASI) 75Timepoint: Psoriasis Area and Severity Index (PASI) 75 at baseline, 2 weekly for 4 weeks, 4 weekly for 12 weeks thereafter | — |
Secondary
| Measure | Time frame |
|---|---|
| PASI 90, PASI 100Timepoint: PASI 90, PASI 100 at baseline, 2 weekly for 4 weeks, 4 weekly for 12 weeks thereafter | — |
Countries
India
Contacts
Public ContactDr Soumya Bansal
Institute of Medical Sciences
Outcome results
None listed