Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

NCT07581418 | Not Yet Recruiting

• 1 other identifier: PEMH-PSO-2026-01
• Study Type: interventional
• Target: 88
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Chronic Plaque Psoriasis

Keywords

Psoriasis; Chronic Plaque Psoriasis; Methotrexate; Tofacitinib; Randomized Controlled Trial; Systemic Therapy

Outcome Measures

Primary Outcomes (1)

• Change in Psoriasis Area and Severity Index (PASI) score

  8 weeks

Study Arms (2)

Methotrexate group

ACTIVE COMPARATOR

Participants in this group will receive oral methotrexate according to standard treatment protocol for chronic plaque psoriasis for 8 weeks.

Drug: Methotrexate

Tofacitinib Group

ACTIVE COMPARATOR

Participants in this group will receive oral tofacitinib according to standard treatment protocol for chronic plaque psoriasis for 8 weeks

Drug: Tofacitinib

Interventions

Methotrexate DRUG

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

Methotrexate group

Tofacitinib DRUG

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

Tofacitinib Group

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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..

Sponsors & Collaborators

• Pak Emirates Military Hospital: lead

MeSH Terms

Conditions

Psoriasis

Interventions

Methotrexate; tofacitinib

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Aminopterin; Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Aimen Luk

CONTACT

+923215476167; aimanluk0915@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident Dermatology

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 12, 2026

Record last verified: 2026-05