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

Lahore General Hospital

Status and phase: Enrolling; Early Phase 1

Conditions: Psoriasis

Treatments: Drug: Methotrexate; Drug: Tofacitinib

Study type: Interventional

Funder types: Other

Identifiers

NCT07261306

Derma LGH

Details and patient eligibility

About

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

Full description

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

Enrollment: 75 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 2 patient groups

Group mTX

Active Comparator group

Description:

Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase

Treatment:

Drug: Methotrexate

Tofacitinib

Active Comparator group

Description:

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

Treatment:

Drug: Tofacitinib