Psoriasis
Conditions
Interventions
Subcutaneous methotrexate injection:The recommended starting dose in the instructions is 7.5 mg of methotrexate, once a week, subcutaneously. The dose should be gradually increased, but the weekly dos
Sponsors
The Fourth Affiliated Hospital of Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-75 years, regardless of gender; 2. Diagnosed with psoriasis according to the "Guidelines for the Diagnosis and Treatment of Psoriasis in China (2023)"; 3. Evaluated by clinicians, the expected benefits of using methotrexate injection to treat psoriasis outweigh the risks; 4. Agree to participate in this study, be able to cooperate with follow-up, and sign the informed consent form.
Exclusion criteria
Exclusion criteria: 1. Allergic to the components of methotrexate injection; 2. Pregnant or lactating women; 3. Those who plan to get pregnant during the study or within 6 months after the end of the study (including men); 4. Those with hematopoietic system damage: a. Hemoglobin 2 ULN; b. Aspartate aminotransferase >2 ULN; c. ?-glutamyl transferase >2 ULN; d. Total bilirubin>5mg/dL (85.5µmol/L); e. Albumin<35g/L (3.5g/dL); 6. Severe renal impairment: glomerular filtration rate calculated by CKD-EPIscr formula <60mL/min*1.73m^2; 7. Alcoholism or alcoholic liver disease; 8. Active hepatitis B or C; 9. Tuberculosis T-SPOT positive and chest X-ray indicates active pulmonary tuberculosis; 10. Severe acute or chronic infection; 11. Peptic ulcer disease or ulcerative colitis; 12. Patients with obvious or laboratory confirmed immunodeficiency syndrome; 13. Patients who have received attenuated live vaccine within 4 weeks or plan to receive it during the study; 14. Other conditions that the investigator considers unsuitable for participation in this clinical study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of PASI75 responses after 16 weeks of treatment; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of participants achieving PASI75 after 4, 8 and 12 weeks of medication;The proportion of participants reaching PASI50 after 4, 8, 12 and 16 weeks of medication;The proportion of participants achieving PASI90 after 4, 8, 12 and 16 weeks of medication;Changes in PASI scores compared to baseline after 4, 8, 12, and 16 weeks of medication;Changes in PGA, BSA and DLQI scores of participants after 4, 8, 12 and 16 weeks of medication; | — |
Countries
China
Contacts
Public ContactYang Sen
The Fourth Affiliated Hospital of Soochow University
Outcome results
None listed