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NCT Number: NCT07261306

Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

Psoriasis is a chronic inflammatory dermatoses which include well demarcated scaly erythematous plaques on whole body including scalp role of methotrexate vs tofacitinib is compared in this study

Recruiting

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Key information

Conditions

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

Early Phase 1

Primary location

Lahore general hospital

Lahore, Punjab Province, Pakistan

Location status: Recruiting

Location contact

Dr Ayesha Wahid, Fcps

CONTACT

[email protected]

+92 323 4822177

About this study

Comparison between safety and efficacy of oral methotrexate and tofacitinib in chronic plaque psoriasis is to be determined in this study

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Patients aged 18- 70 years of either gender.
  • Only patients with Psoriasis Area and Severity Index (PASI) score of 10 or above, and/or Body Surface Area (BSA) involvement of 10% or more, will be included.
  • Duration of plaque psoriasis for at least 6 months prior to the study.
  • Psoriasis that has not shown adequate response to topical therapies

Exclusion criteria

  • Individuals with other forms of psoriasis or other significant dermatological conditions that might interfere with the assessment of psoriasis.
  • Participants currently receiving systemic corticosteroids, biologics, or any other immunosuppressive agents within 4 weeks prior to the start of the study will be excluded.
  • Known hypersensitivity or contraindications to either methotrexate or tofacitinib.
  • History of significant liver, kidney, hematologic/bleeding disorder, gastrointestinal/acid peptic disease, or immune system disorders.and any history of tuberculosis and malignancy.
  • Pregnant or lactating women will not be eligible for the study.

Treatment and study plan

methotrexate

Drug

Methotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment

tofacitinib

Drug

Tofacitinib is janus kinase inhibitor and have role in psoriasis

Primary outcomes

  1. Efficacy Achievement

    Time frame: Baseline to Week 12 of treatment

    The primary outcome will be the proportion of participants who demonstrate a minimum 75 percent reduction in the Severity Index (PASI-75) from baseline to Week 12 of treatment. A participant will be classified as "Achieved" if the Week-12 PASI score reflects a reduction of 75 percent or greater from the baseline measurement, and "Not Achieved" if this threshold is not met.

Secondary outcomes

  1. Percentage Reduction in PASI Score

    Time frame: From Baseline to Week 12

    This outcome will quantify the degree of improvement by calculating the percentage reduction in PASI score from baseline to Week 12. Percentage reduction will be computed using the formula:

    [(Baseline PASI - Week-12 PASI) ÷ Baseline PASI] × 100.

Study contacts

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

Maryam Fatima, Mbbs

CONTACT

[email protected]

03361409014

Sponsors and collaborators

Lead sponsor

Lahore General Hospital

Other Gov

Registry information

Acronym: MTX

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Dec 3, 2025
Registry last updated
Dec 3, 2025

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.

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