Oral methotrexate versus tofacitinib for chronic plaque psoriasis
Official title: Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
Run by Lahore General Hospital · NCT07261306 · Data updated 2026-11-12
This trial will test whether oral methotrexate or tofacitinib works better for adults with moderate-to-severe chronic plaque psoriasis.
Quick facts
| Phase | Early Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Enrollment | 75 (estimated) |
| Sponsor | Lahore General Hospital Government |
| Drugs / interventions | tofacitinib, methotrexate |
| Locations | 1 site (Lahore, Punjab Province) |
| Status | Recruiting |
| Started | August 29, 2025 |
| Main results expected | December 10, 2025 |
| Study ends | December 25, 2025 |
| Registry record updated | December 3, 2025 |
| Trial ID | NCT07261306 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults 18–70 with chronic plaque psoriasis for at least six months, a PASI score ≥10 or BSA ≥10%, inadequate response to topical therapy, and no contraindications to methotrexate or tofacitinib.
✕Probably not a fit
Patients with other psoriasis types, active infection or recent use of systemic immunosuppressants/biologics, pregnancy, significant liver/kidney or hematologic disorders, history of tuberculosis or malignancy, or known hypersensitivity to either drug are unlikely to be eligible or to benefit.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
Adults aged 18–70 with chronic plaque psoriasis (PASI ≥10 or BSA ≥10% and disease duration ≥6 months) who have not responded to topical therapies will be enrolled. Participants will receive either oral methotrexate or oral tofacitinib and be monitored for skin improvement and side effects. The study compares safety and efficacy of the two oral treatments in a clinical setting. Findings aim to inform which medication offers better disease control and tolerability for this patient group.
Why it matters
Potential benefit: If successful, this trial could clarify which oral medicine provides better skin clearance with acceptable side effects, helping doctors choose the best option for patients.
How similar studies have gone: Methotrexate has long-established effectiveness for plaque psoriasis, and oral tofacitinib has shown efficacy in prior trials though safety signals have limited its routine use.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
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Lahore general hospital
Lahore, Punjab Province, Pakistan Recruiting
Study contacts
- Principal investigator: Maryam Fatima — Lahore General Hospital, Lahore
- Study coordinator: Maryam Fatima, Mbbs
- Email: maryamfatima726@yahoo.com
- Phone: 03361409014
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.