Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

This randomized controlled trial aims to compare the efficacy and safety of oral methotrexate and tofacitinib in patients with chronic plaque psoriasis. Participants diagnosed with chronic plaque psoriasis will be randomly assigned to receive either methotrexate or tofacitinib and will be followed for six months. Clinical improvement, disease severity, treatment response, and adverse effects will be assessed and compared between the two treatment groups.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Chronic Plaque Psoriasis Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Eligible participants will comprise adults aged 18 to 70 years, of either gender, with moderate to severe plaque psoriasis defined by a Psoriasis Area and Severity Index (PASI) score greater than 10. A minimum disease duration of 6 months will be required. In addition, enrolment will be limited to patients whose psoriasis has shown inadequate response to at least one topical therapy despite a treatment duration of at least 4 weeks

Exclusion criteria

Participants with non-plaque variants of psoriasis or any other clinically significant dermatological condition that could confound the assessment of psoriasis severity. Recent exposure to anti psoriatic therapy including systemic or biologic treatment within the preceding 4 weeks or topical treatment within the preceding 2 weeks. Individuals with known hypersensitivity to, or contraindications for, either methotrexate or tofacitinib. Patients with a history of significant hepatic, renal, hematologic, gastrointestinal, or immune system disorders. Pregnant or breastfeeding women. Patients unavoidable prolonged sun or ultraviolet exposure. Patients with a history of alcohol abuse, or other conditions that contraindicate methotrexate use..

Treatment and study plan

methotrexate

Drug

Oral methotrexate administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks.

tofacitinib

Drug

Oral tofacitinib administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks

Primary outcomes

Change in Psoriasis Area and Severity Index (PASI) score

Time frame: 8 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Aimen Luk

CONTACT

[email protected]

+923215476167

Sponsors and collaborators

Lead sponsor

Pak Emirates Military Hospital

Other

Registry information

Official study title

Comparison of Outcome Between Oral Methotrexate and Tofacitinib in Treatment of Chronic Plaque Psoriasis

Important dates

Study start: 2026
Primary completion: 2026
Study completion: 2026
First posted: May 12, 2026
Registry last updated: May 12, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed