Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis (MTX)

November 21, 2025 updated by: Maryam Fatima, Lahore General Hospital
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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Pakistan
    • Punjab Province
      • Lahore, Punjab Province, Pakistan
        • Recruiting
        • Lahore General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Group mTX
Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase
Drug: Methotrexate
Methotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment
Active Comparator: Tofacitinib
Tofacitinib is janus kinase inhibitor and had a role in treatment of psoriasis and psoriatic arthritis
Drug: Tofacitinib
Tofacitinib is janus kinase inhibitor and have role in psoriasis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Baseline to Week 12 of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From Baseline to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lahore General Hospital

Investigators

  • Principal Investigator: Maryam Fatima, Lahore General Hospital, Lahore

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 29, 2025

Primary Completion (Estimated)

December 10, 2025

Study Completion (Estimated)

December 25, 2025

Study Registration Dates

First Submitted

July 23, 2025

First Submitted That Met QC Criteria

November 21, 2025

First Posted (Estimated)

December 3, 2025

Study Record Updates

Last Update Posted (Estimated)

December 3, 2025

Last Update Submitted That Met QC Criteria

November 21, 2025

Last Verified

August 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Derma LGH

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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