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To explore the clinical efficacy and safety of MTX in the treatment of moderate and severe psoriasis

To explore the clinical efficacy and safety of MTX in the treatment of moderate and severe psoriasis

Status
Active, not recruiting
Phases
Phase 1
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2200063752
Enrollment
Unknown
Registered
2022-09-15
Start date
2022-09-15
Completion date
Unknown
Last updated
2023-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

psoriasis

Interventions

Group 1 :7.5 mg/week
Group 2:10 mg/week
Group 3:15 mg/week

Sponsors

Shanghai Skin Disease Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. The age of the patient is 18-65 years old, and the gender is not limited; 2. Patients with confirmed moderate to severe psoriasis: disease duration >= 6 months, BSA >= 5% and PASI >= 5% at screening; 3. Have not received systemic treatment (Acitretin, cyclosporine, ultraviolet phototherapy, MTX, etc.) in the past 1 month, and have not received external drug treatment (vitamin D3 derivatives, retinoic acid, glucocorticoids, etc.) in the past 2 weeks hormones, calcineurin inhibitors, etc.), and the investigator believes that the patient is suitable for treatment; 4. Patients voluntarily sign informed consent and can be followed up on schedule.

Exclusion criteria

Exclusion criteria: 1. The patient has other active skin diseases that may affect the evaluation of the condition; 2. Patients who have received MTX treatment in the past and are clearly intolerant or ineffective to MTX; 3. Abnormal laboratory tests: at the time of screening, hemoglobin (Hb) was less than 80% of the lower limit of normal. The peripheral blood white blood cell count is less than 4.0 x 10^9/L, or greater than 12 x 10^9/L. The neutrophil count in peripheral blood was less than 1.5 x 10^9/L. Platelets are less than the lower limit of normal. Liver function (any one of ALT and TBIL) > 2 times the upper limit of normal value; if there is any abnormality, a re-examination is allowed. Renal function (serum creatinine Scr) > 2 times the upper limit of normal; 4. Suffering from serious, progressive, uncontrolled diseases of important organs and systems (including cardiovascular, liver, lung, and kidney), other autoimmune diseases, malignant tumors, and combined with other diseases that are considered inappropriate by the investigators Other diseases participating in this study; 5. Have a history of severe allergic reactions; 6. Received systemic treatment within 1 month before screening; received external drug treatment within 2 weeks before screening; 7. Women who are pregnant, breastfeeding and plan to become pregnant within one year.

Design outcomes

Primary

MeasureTime frame
Psoriatic lesion area;Psoriatic Lesion Severity Index;

Countries

China

Contacts

Public ContactJiajing Lu

Shanghai Skin Disease Hospital

bonnie166166@126.com+86 18017337916

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 4, 2026