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Recruiting NCT07261306

Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

Early Phase I Interventional Psoriasis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Methotrexate, Tofacitinib.
Who it may be relevant to
Registry conditions: Psoriasis. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Pakistan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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

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

Interventions

  • Drug Methotrexate
    Methotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment
  • Drug Tofacitinib
    Tofacitinib is janus kinase inhibitor and have role in psoriasis

Primary outcome measures

  • Efficacy Achievement [Time frame: Baseline to Week 12 of treatment]
Secondary outcome measures (1)
  • Percentage Reduction in PASI Score [Time frame: From Baseline to Week 12]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Pakistan · 1 center
  • Lahore general hospital — Lahore

Identifiers

NCT: NCT07261306 · Derma LGH

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗