Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

NCT07261306 | Recruiting Early Phase 1 DMC

• 1 other identifier: Derma LGH
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis

Keywords

MtX; Tofacitinib

Outcome Measures

Primary Outcomes (1)

• Efficacy Achievement

  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 Outcomes (1)

• Percentage Reduction in PASI Score

  From Baseline to Week 12

Study Arms (2)

Group mTX

ACTIVE COMPARATOR

Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase

Drug: Methotrexate

Tofacitinib

ACTIVE COMPARATOR

Tofacitinib is janus kinase inhibitor and had a role in treatment of psoriasis and psoriatic arthritis

Drug: Tofacitinib

Interventions

Methotrexate DRUG

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

Group mTX

Tofacitinib DRUG

Tofacitinib is janus kinase inhibitor and have role in psoriasis

Tofacitinib

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore general hospital

Lahore, Punjab Province, Pakistan

RECRUITING

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

Study Officials

• Maryam Fatima

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maryam Fatima, Mbbs

CONTACT

03361409014; maryamfatima726@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Randomized control trial

Study Record Dates

• First Submitted: July 23, 2025
• First Posted: December 3, 2025
• Study Start: August 29, 2025
• Primary Completion: December 10, 2025
• Study Completion: December 25, 2025
• Last Updated: December 3, 2025

Record last verified: 2025-08

Locations

PA (1)