CTRI/2019/07/020274.

Study name	Comparative efficacy of methotrexate, apremilast and their combination in psoriasis vulgaris
Methods	Randomised, parallel‐group, multiple arm trial India
Participants	Randomised: 30 Inclusion criteria: > 18 year to 60 years Patients with psoriasis vulgaris requiring systemic therapy. (Body surface area > 10%) PASI score > 10 or non‐responsive to topical therapy) Exclusion criteria Patients suffering from any other significant systemic illness History of anti‐psoriatic treatment in the last 2 months Pregnant or lactating women
Interventions	Intervention 1: Apremilast 30 mg twice a day, starting at 10 mg/day with an increment of 10 mg/day over 5 days, for 8 weeks Intervention 2: Oral methotrexate 0.2 mg/kg/week, maximum 25 mg/week for 8 weeks Intervention 3: Oral methotrexate 0.2 mg/kg/week, maximum 25 mg/week along with oral apremilast 30 mg twice a day, starting at 10 mg/day with an increment of 10 mg/day over 5 days, for 8 weeks
Outcomes	Primary outcome: To compare the efficacy of apremilast and methotrexate and their combination in patients with psoriasis vulgaris by comparing the PASI score before and after start of the therapy. 0,2,4,6,8 weeks. Secondary outcome: To assess the safety of all the three treatment modalities by assessing the side effects. 0,2,4,6,8 weeks
Starting date	22 July 2019
Contact information	Dr Nainika Goel Government Medical College and Hospital, Chandigarh Address Department of dermatology, D block, 5th floor, GMCH, sector 32, Chandigarh Chandigarh CHANDIGARH 160030 dr.nainika1311@gmail.com
Notes	Last checked on 7 September 2020, not yet recruiting