Comparison of Outcome Between Oral Methotrexate and Tofacitinib in Treatment of Chronic Plaque Psoriasis
| Registry | NCT07581418 |
|---|---|
| Status | Not yet recruiting |
| Phase | Not applicable |
| Study type | Interventional; randomized, parallel, masking: none, treatment |
| Enrollment | 88 (Estimated) |
| Sponsor | Pak Emirates Military Hospital (Other) |
| Conditions | Chronic Plaque Psoriasis |
| Interventions | Methotrexate, Tofacitinib (Drug) |
| Dates | start 2026-06-01 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-05-12, last updated 2026-05-12 |
Related Papers Related Patents Related Grants Related Experts
All trials for Chronic Plaque Psoriasis All trials of Methotrexate All trials of Tofacitinib
This randomized controlled trial aims to compare the efficacy and safety of oral methotrexate and tofacitinib in patients with chronic plaque psoriasis. Participants diagnosed with chronic plaque psoriasis will be randomly assigned to receive either methotrexate or tofacitinib and will be followed for six months. Clinical improvement, disease severity, treatment response, and adverse effects will be assessed and compared between the two treatment groups.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Methotrexate group | Active comparator | Drug: Methotrexate | Participants in this group will receive oral methotrexate according to standard treatment protocol for chronic plaque psoriasis for 8 weeks. |
| Tofacitinib Group | Active comparator | Drug: Tofacitinib | Participants in this group will receive oral tofacitinib according to standard treatment protocol for chronic plaque psoriasis for 8 weeks |
Sex: All, ages: 18 Years to 70 Years
Inclusion Criteria: * Eligible participants will comprise adults aged 18 to 70 years, of either gender, with moderate to severe plaque psoriasis defined by a Psoriasis Area and Severity Index (PASI) score greater than 10. A minimum disease duration of 6 months will be required. In addition, enrolment will be limited to patients whose psoriasis has shown inadequate response to at least one topical therapy despite a treatment duration of at least 4 weeks Exclusion Criteria: * Participants with non-plaque variants of psoriasis or any other clinically significant dermatological condition that could confound the assessment of psoriasis severity. Recent exposure to anti psoriatic therapy including systemic or biologic treatment within the preceding 4 weeks or topical treatment within the preceding 2 weeks. Individuals with known hypersensitivity to, or contraindications for, either methotrexate or tofacitinib. Patients with a history of significant hepatic, renal, hematologic, gastrointestinal, or immune system disorders. Pregnant or breastfeeding women. Patients unavoidable prolonged sun or ultraviolet exposure. Patients with a history of alcohol abuse, or other conditions that contraindicate methotrexate use..