ClinicalTrials.gg
RecruitingNCT07261306MTXUpdated Dec 3, 2025

Comparison Between Oral Methotrexate and Tofacitinib in Chronic Plaque Psoriasis

An Early Phase 1 interventional study of Methotrexate and Tofacitinib in Psoriasis, sponsored by Lahore General Hospital. Recruiting at 1 site in Pakistan. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-03.

Sponsored by Lahore General Hospital · Early Phase 1, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by Dec 2025, 11 months ago, but the record still lists the study as recruiting.
  • Started Aug 2025; still recruiting 1 year 2 months later.
Phase
Early Phase 1
Study type
Interventional
Enrollment
75
Allocation
Randomized
Ages
18 Years to 70 Years
Sex
All
01

Study summary

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

Read the detailed description

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

02

Conditions studied

  • Psoriasis

Browse trials for

Keywords

  • MtX
  • Tofacitinib
03

In context

Psoriasis

2,028 studies on the registry are indexed under Psoriasis; 275 are open to participants now.

This study's planned enrollment of 75 is close to the median of 75 across 1,565 interventional studies indexed under Psoriasis.

Browse Psoriasis studies →

Lead sponsor

Lahore General Hospital is the lead sponsor of 32 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 70 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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 , biologics, or any other agents within 4 weeks prior to the start of the study will be excluded.
  • Known or 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 .
  • Pregnant or lactating women will not be eligible for the study.
Terms in these criteria, in plain language(5)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
75 participants (estimated)

Study arms

  • Active comparator
    Group mTX

    Methotrexate is a modified antirheumatic drug work by inhibiting dihydrofolate reductase

    Drug: Methotrexate

  • Active comparator
    Tofacitinib

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

    Drug: Tofacitinib

Interventions

  • Methotrexate is an antifolate drug work by inhibiting enzyme dihydrofolate reductase and inhibit cell proliferation and play a role in psoriasis treatment

  • Tofacitinib is janus kinase inhibitor and have role in psoriasis

06

What researchers measure

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 treatment

Secondary 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 12

07

Study locations

1 of 1 sites recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 3, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT07261306
Lead sponsor
Lahore General Hospital
Responsible party
Maryam Fatima (Principal Investigator, Lahore General Hospital) — Principal investigator
First posted
Dec 3, 2025
Start date
Aug 29, 2025
Primary completion
Dec 10, 2025 (estimated)
Completion
Dec 25, 2025 (estimated)
Last update
Dec 3, 2025

Study contacts

Maryam Fatima, Mbbs
Contact
maryamfatima726@yahoo.com
03361409014
Maryam Fatima
principal investigator · Lahore General Hospital, Lahore

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Interested in this study?

Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.

Contact study team

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Studies of the drugs tested here: Methotrexate · Tofacitinib

Start the discussion