Systemic Lupus Erythematosus
Conditions
Interventions
Withdrawal group:withdraw low dose prednisone within 12 months and maintain the other therapies for SLE
maintanence group:maintain low dose prednisone and other therapies of SLE for 2 years
Sponsors
Peking University First Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18-80 years; 2. Meet the SLE classification criteria of the 1997 ACR and/or the 2012 SLICC; 3. The disease has reached the DORIS drug remission standard for at least 6 months: (1) Clinical SLEDAI = 0; (2) PGA < 0.5; (3) BILAG 2004 D/E(C in hematological system caused by leukopenia or isolated Coombs positive without hemolytic anemia was tolerated); (4) oral prednisone dosage <= 5mg; (5) The dosage of hydroxychloroquine sulfate and the type and dosage of immunosuppressants and biological agents (except B cell depleting therapy) are stable for at least 3 months.
Exclusion criteria
Exclusion criteria: 1. Patients with severe organ involvement in the course of the disease, such as severe neuropsychiatric lupus (such as disturbance of consciousness, seizures, mental symptoms), acute alveolar hemorrhage, refractory thrombocytopenia, and rapidly progressive glomerulonephritis; 2. Patients who are pregnant or planning to become pregnant; 3. Patients who have not used hydroxychloroquine sulfate and immunosuppressive agents in the past 1 year; 4. Patients who have used B cell depleting therapies in the past 6 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| disease flare rate (defined by revised SFI) within 2 years; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of patients with increased dosage of oral glucocorticoids within 2 years;Organ damage (defined by SDI) increase;disease flare rate (defined by BILAG) within 2 years;proportion of different flare severity defined by revised SFI;proportion of different flare severity defined by BILAG;change of social functional scores within 2 years (SF-36, SDSS);cumulative glucocoticoid dosage within 2 years; | — |
Countries
China
Contacts
Public ContactZhang Zhuoli
Peking University First Hospital
Outcome results
None listed