Plaque psoriasis
Conditions
Interventions
experimental group:half dose Secukinumab + methotrexate
Sponsors
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Must be able to communicate well with the researcher and comply with the requirements of the study, and sign the informed consent. 2. Men and women aged 18-70 at the time of screening. 3. Patients with chronic plaque psoriasis for at least 6 months and diagnosed before screening visit. 4. Patients with moderate to severe psoriasis at baseline who met the following three conditions: (1) PASI score >= 12; (2) IgA mod 2011 score >= 3 (according to 0-4 subscale); and (3) body surface area (BSA) affected by plaque psoriasis >= 10%. 5. Candidates for systemic treatment. Defined as subjects with moderate to severe chronic plaque psoriasis poorly controlled by local therapy and / or phototherapy and / or previous systemic therapy.
Exclusion criteria
Exclusion criteria: 1. Patients with psoriasis other than chronic plaque type (e.g., pustular, erythrodermic, and guttate psoriasis) at screening or baseline. 2. Patients with drug-induced psoriasis at baseline (i.e. new onset psoriasis or psoriasis exacerbation caused by beta blockers, calcium channel inhibitors or lithium). 3. Patients who are using prohibited psoriasis treatment. The elution period of prohibited drugs should be in accordance with the table of prohibited drugs (see Table 3). People who are reluctant to limit their UV exposure (e.g., sunbathing and / or tanning devices) during the study period. 4. Subjects who used live vaccine within 6 weeks before randomization or planned to use live vaccine during the study. 5. Subjects who have been exposed to secukinumab or any other biological agents directly targeting IL-17 or IL-17 receptor. 6. Subjects who were using other experimental drugs or were in the 5-fold half-life period or within 30 days of the experimental drugs at the time of enrollment, whichever is longer. 7. Pregnant or lactating women who are unwilling to cooperate with contraceptive requirements during the trial. 8. Patients with active inflammatory diseases other than psoriasis that may confuse the evaluation of drug treatment. Currently, he has a serious progressive or uncontrolled disease that is not suitable for the trial or puts him at high risk. Uncontrolled hypertension (systolic blood pressure >= 160mmhg and / or diastolic blood pressure >= 95mmhg), congestive heart failure (New York Heart Association status class III or IV). Subjects with serum creatinine levels above 2.0 mg / dl (176.8 µ mol / L). The total white blood cell (WBC) count was less than 2500 / µ L, or platelet count was less than 100000 / µ L, neutrophil count was less than 1500 / µ L, or hemoglobin count was less than 8.5 g / dl. Liver function ALT or ast > 2uln; 9. Patients with progressive infection or malignant disease can provide chest X-ray, computed tomography (CT) or MRI evidence within 12 weeks before screening, which is evaluated and confirmed by qualified doctors. 10. Active systemic infections (except colds) or any other infections that recur regularly within the two weeks prior to baseline. 11. Patients with a history of chronic or recurrent infectious diseases, or TB infection evidence determined by T-SPOT test at screening. Subjects with positive or uncertain results can participate in the study if they have received a comprehensive TB examination (according to local practice / guidelines) within 12 weeks before baseline and have finally confirmed that there is no evidence of active TB. If latent tuberculosis is confirmed, treatment must be initiated and maintained before baseline in accordance with Chinese guidelines. 12. Patients with human immunodeficiency virus (HIV), hepatitis B or hepatitis C infection or corresponding history. 13. Patients with a history of lymphoproliferative disease, or any known malignancy, or any history of organ system malignancy in the past 5 years. 14. Patients who are unable or unwilling to receive repeated venipuncture. 15. Patients with a history of alcohol or drug abuse or evidence of abuse within 6 months before baseline. 16. Subjects with allergic history of drug components.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| PASI; | — |
Secondary
| Measure | Time frame |
|---|---|
| IGAmod2011;BSA;DLQI;rate of AE;cost; | — |
Countries
China
Contacts
Public ContactYanfang Han
Sun Yat-sen Memorial Hospital of Sun Yat-sen University
Outcome results
None listed