Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

NCT ID: NCT07261306

Last Updated: 2025-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

EARLY_PHASE1

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-29

Study Completion Date

2025-12-25

Brief Summary

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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

Detailed Description

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

Conditions

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Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized control trial
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group mTX

Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase

Group Type ACTIVE_COMPARATOR

Methotrexate

Intervention Type DRUG

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

Tofacitinib

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

Group Type ACTIVE_COMPARATOR

Tofacitinib

Intervention Type DRUG

Tofacitinib is janus kinase inhibitor and have role in psoriasis

Interventions

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Methotrexate

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

Intervention Type DRUG

Tofacitinib

Tofacitinib is janus kinase inhibitor and have role in psoriasis

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Lahore General Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Maryam Fatima

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Maryam Fatima

Role: PRINCIPAL_INVESTIGATOR

Lahore General Hospital, Lahore

Locations

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Lahore general hospital

Lahore, Punjab Province, Pakistan

Site Status RECRUITING

Countries

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Pakistan

Central Contacts

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Maryam Fatima, Mbbs

Role: CONTACT

03361409014

Facility Contacts

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Dr Ayesha Wahid, Fcps

Role: primary

+92 323 4822177

Other Identifiers

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Derma LGH

Identifier Type: -

Identifier Source: org_study_id

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