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A study to compare the effectiveness of Methotrexate plus Apremilast combination therapy versus Tofacitinib single therapy in the treatment of both male and female patients presenting with psoriasis

A comparative study of effectiveness and safety of Methotrexate and Apremilast combination therapy versus Tofacitinib monotherapy in the treatment of moderate to severe plaque psoriasis. - Nil

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/04/109640
Enrollment
60
Registered
2026-04-28
Start date
Unknown
Completion date
Unknown
Last updated
2026-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L400- Psoriasis vulgaris

Interventions

Intervention1: Methotrexate plus Apremilast: Tablet Methotrexate at a dose of 0.4mg/kg/week , along with tablet Apremilast initiated with dose titration starting from 10mg on day 1 and gradually incre

Sponsors

Dr Vinayak Upadhyay
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: Diagnosed case of moderate to severe plaque psoriasis. Willingness to participate and provide written informed consent Ability to comply with treatment and follow up schedule

Exclusion criteria

Exclusion criteria: Patients below age of 18 years or above age of 60 years. Other forms of psoriasis (guttate, erythrodermic, pustular, palmoplantar) Abnormal laboratory parameters (CBC, LFT, renal function) Pregnancy or lactation History of alcohol abuse Chronic or recurrent infections (including tuberculosis) History of lymphoproliferative disorders Bleeding disorders

Design outcomes

Primary

MeasureTime frame
To compare effectiveness and safety of methotrexate and apremilast combination therapy versus tofacitinib monotherapy in the treatment of moderate to severe plaque psoriasis. To assess effectiveness and safety of methotrexate and apremilast combination therapy in the treatment of moderate to severe plaque psoriasis. To assess effectiveness and safety of tofacitinib monotherapy in the treatment of moderate to severe plaque psoriasis. Timepoint: Week 0 , week 4 , week 8 , week 12 , week 16

Secondary

MeasureTime frame
NILTimepoint: NIL

Countries

India

Contacts

Public ContactDr Vinayak Upadhyay

Baba Raghav Das Medical College

vinayakupadhyay1@gmail.com7351439071

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Jun 11, 2026