A randomized controlled trial comparing the efficacy and safety profile of oral versus subcutaneous route of methotrexate administration in moderate to severe psoriasis

This study is a prospective, doubleblinded, randomized, parallel group study to  compare the effectiveness and safety profileof oral versus subcutaneous route of administration of methotrexate inmanagement of patients with moderate to severe psoriasis. The recruitedpatients will be randomized into treatment arms. Randomization will be doneusing computer generated random number table.The patients in first treatmentarm will receive 0.3 mg/kg (upto a maximum of 25 mg/week )  of weekly oral  methotrexate for 12 weeks or achievement ofPASI 90 whichever is earlier while the patients in second treatment arm will receive subcutaneous methotrexateat 0.3 mg/kg/week  for the same duration.The patients will be followed at regular intervals and monitored adequately forhematological, hepatotoxic and other adverse effects both clinically andthrough laboratory investigations according to methotrexate consensusguidelines during the treatment period. PASI, Body surface area (BSA)involvement and DLQI will be assessed at each follow up visit and at the end of12 weeks. The treatment will be tapered at the rate of 5 mg/2 weeks and stoppedafter 12 weeks or achievement of PASI 90 whichever is earlier.. Follow ups willbe done at every  2weeks until treatmentcompletion (12 weeks) and at every 4 weeks till 24 weeks after completion oftreatment.

The primary outcome measures will beachievement of PASI 90 (90 % reduction in psoriasis area severity score (PASI)compared to baseline).The secondary outcomes will be improvement in DLQI(dermatology life quality index), relapse rate and adverse events if any.