Chronic Plaque PsoriasisNCT07581418
Comparison of Methotrexate and Tofacitinib in Chronic Plaque Psoriasis
A study testing Methotrexate and Tofacitinib in people with Chronic Plaque Psoriasis, run by Pak Emirates Military Hospital.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Plaque Psoriasis
- What is being tested?
- Methotrexate and Tofacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- No sites listed yet
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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..
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Outcome Between Oral Methotrexate and Tofacitinib in Treatment of Chronic Plaque Psoriasis
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.
- Conditions
- Chronic Plaque Psoriasis
- Being tested
- Methotrexate, Tofacitinib
- Keywords
- Psoriasis, Chronic Plaque Psoriasis, Methotrexate, Tofacitinib, Randomized Controlled Trial, Systemic Therapy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethotrexateDrug
Oral methotrexate administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks.
TofacitinibDrug
Oral tofacitinib administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| Methotrexate group | Active comparator | Participants in this group will receive oral methotrexate according to standard treatment protocol for chronic plaque psoriasis for 8 weeks. Receives: Drug: Methotrexate |
| Tofacitinib Group | Active comparator | Participants in this group will receive oral tofacitinib according to standard treatment protocol for chronic plaque psoriasis for 8 weeks Receives: Drug: Tofacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Psoriasis Area and Severity Index (PASI) score
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Plaque PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pak Emirates Military Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aimen Umar Luk, Pak Emirates Military Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581418
- Sponsor's protocol ID
- PEMH-PSO-2026-01
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 12 May 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Outcome Between Oral Methotrexate and Tofacitinib in Treatment of Chronic Plaque Psoriasis
- ClinicalTrials.gov ID
- NCT07581418
- Acronym / sponsor ID
- PEMH-PSO-2026-01
- Conditions
- Chronic Plaque Psoriasis
- Keywords
- Psoriasis, Chronic Plaque Psoriasis, Methotrexate, Tofacitinib, Randomized Controlled Trial, Systemic Therapy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Pak Emirates Military HospitalUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methotrexate group | Active comparator | Drug: MethotrexateParticipants in this group will receive oral methotrexate according to standard treatment protocol for chronic plaque psoriasis for 8 weeks. |
| Tofacitinib Group | Active comparator | Drug: TofacitinibParticipants in this group will receive oral tofacitinib according to standard treatment protocol for chronic plaque psoriasis for 8 weeks |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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..
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethotrexateOral methotrexate administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks. | Drug | Methotrexate group |
| TofacitinibOral tofacitinib administered according to standard treatment protocol for chronic plaque psoriasis for 8 weeks | Drug | Tofacitinib Group |
Primary outcome
Change in Psoriasis Area and Severity Index (PASI) score
Time frame: 8 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Methotrexate and Tofacitinib in people with Chronic Plaque Psoriasis, run by Pak Emirates Military Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Aimen Luk (+923215476167, aimanluk0915@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Psoriasis Area and Severity Index (PASI) score (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 May 2026.