Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
ConditionPsoriasis
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorLahore General Hospital
About this trial
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
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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.
Trial design
Design model
Parallel
Treatments tested in this trial
Methotrexate
DrugMethotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment
Tofacitinib
DrugTofacitinib is janus kinase inhibitor and have role in psoriasis
Treatment groups
75 Participants
are divided into 2 treatment groupsGroup A: Group mTXActive comparator 1 intervention
Group B: TofacitinibActive comparator 1 intervention
Trial outcomes
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.
Time frame
Baseline to Week 12 of treatmentSecondary outcomes
1
Percentage Reduction in PASI Score
This outcome will quantify the degree of improvement by calculating the percentage reduction in PASI score from baseline to Week 12. Percentage reduction will be computed using the formula: \[(Baseline PASI - Week-12 PASI) ÷ Baseline PASI\] × 100.
Time frame
From Baseline to Week 12Sponsors and contacts
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Source ClinicalTrials.gov