Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

May 6, 2026 updated by: Aimen Umar Luk, Pak Emirates Military Hospital

Comparison of Outcome Between Oral Methotrexate and Tofacitinib in Treatment of 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

88

Phase

  • Not Applicable

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

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

No

Description

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..

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: Methotrexate group
Participants in this group will receive oral methotrexate according to standard treatment protocol for chronic plaque psoriasis for 8 weeks.
Drug: Methotrexate
Oral methotrexate administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks.
Active Comparator: Tofacitinib Group
Participants in this group will receive oral tofacitinib according to standard treatment protocol for chronic plaque psoriasis for 8 weeks
Drug: Tofacitinib
Oral tofacitinib administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in Psoriasis Area and Severity Index (PASI) score
Time Frame: 8 weeks
8 weeks

Collaborators and Investigators

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

Sponsor

Pak Emirates Military Hospital

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 (Estimated)

June 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 6, 2026

First Posted (Actual)

May 12, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 6, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PEMH-PSO-2026-01

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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