Health Condition 1: L400- Psoriasis vulgaris
Conditions
Interventions
Intervention1: Methotrexate and tofacitinib: Oral Methotrexate 0.3 mg/kg/week and oral Tofacitinib 5mg twice a day
Control Intervention1: Methotrexate and cyclosporine: Oral Methotrexate 0.3 mg/kg/wee
Sponsors
Banaras Hindu University
Eligibility
Inclusion criteria
Inclusion criteria: Patients of age 18-60 years Weight 50-75 kg Given their consent to participate in the study PASI more than 10 Cumulative methotrexate dose less than 1.5 gm Not taking systemic therapy for 1 month prior to enrolment Not applying topical therapy for 2 weeks prior to enrolment Not receiving phototherapy
Exclusion criteria
Exclusion criteria: Pregnancy or lactation History of alcoholism Taking hepatotoxic or nephrotoxic drugs Haemoglobin less than 8 gm per dL TLC less than 4000 cells per mm3 Platelet count less than 1 lakh per mm3 Lymphocytes less than 1500 per mm3 Raised SGPT or SGOT more than twice the normal limit at baseline or more than thrice the normal limit at follow up Raised Total bilirubin more than 1.2 or 30 percent increase from baseline during treatment period Serum creatinine values of more than 1.4 mg per dl at baseline or more than 30 percent increase in baseline at two consecutive visits. Any uncontrolled significant medical condition Peptic ulcers Any evidence of active or latent tuberculosis Long standing deep vein thrombosis Family or personal history of cancer or carcinoma in-situ
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI-100Timepoint: Baseline, Week 2, Week 4, Week 8, Week 12, Week 16 | — |
Secondary
| Measure | Time frame |
|---|---|
| PASI 75, PASI 90, Adverse effectsTimepoint: Baseline, Week 2, Week 4, Week 8, Week 12, Week16 | — |
Countries
India
Contacts
Public ContactDr Abisha
Institute of Medical Sciences, Banaras Hindu University
Outcome results
None listed