Systemic lupus erythematosus
Conditions
Interventions
Observation group:None
Sponsors
Ningbo Medical Centre Lihuili Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) Age>=18 years old, male or female; (2) meet the 2019 EULAR/ACR SLE classification criteria (see Table 1); (3) Active disease: 5<=SLEDAI-2K score <15; (4) receiving a stable dose of hormonal therapy; (5) have not used iratimod in the past 30 days; (6) Agree to use effective contraception for the duration of the study and for 3 months after the end of the study; (7) Agree to sign the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Severe active lupus nephritis and severe lupus nephropathy (serum creatinine > 2.5mg/dL; need for hemodialysis due to lupus nephritis; The dose of hormones used> 1 mg/kg/day (prednisone dose or equivalent corticosteroid dose); (2) Severely active lupus encephalopathy: have had any of the following symptoms of lupus encephalopathy, regardless of whether the symptoms were present at the time of enrollment: seizures, mental confusion, organic brain syndrome, cerebrovascular lesions or encephalitis; (3) Accompanied by other autoimmune diseases, such as rheumatoid arthritis, Sjögren's syndrome, myositis, scleroderma, autoimmune liver disease, Hashimoto's thyroiditis, etc.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in SLEDAI-2K score at Week 24 of treatment; | — |
Countries
China
Contacts
Public ContactTingting Fu
Ningbo Medical Centre Lihuili Hospital
Outcome results
None listed