systemic lupus erythematosus
Conditions
Interventions
1:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day)
2:Hydroxychloroquine (5mg/kg/day) plus prednisone (0.5mg/kg/day) plus Mycophenolate Mofetil 500mg bid
Sponsors
Ruijin Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Aged between 18 and 65 years; 2. Diagnosed with SLE at the time of screening by fulfilling ACR 2019 classified criteria or its 2017 version ; 3. Have not received any prior SLE treatment; 4. Have a positive antinuclear antibody (HEp-2 titer >= 1:80); 5. Have a positive anti-dsDNA antibody (anti-dsDNA (ELISA) >= 300 IU/mL; anti-dsDNA (CLFT) >= 1:10 ); 6. Do not have major organ involvement (i.e., brain, heart, liver, kidney, lung, muscle, gastrointestinal tract). Participants were permitted to have rash, arthritis, alopecia, oral ulcer, and mild hematologic system involvement (white blood cell > 1.5*10^9/L and 90g/L and 60*10^9/L and < 100*10^9/L).
Exclusion criteria
Exclusion criteria: 1.SLE patients who had been treated; 2.Liver and kidney dysfunction (Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) > 2 times upper normal limits; creatinine clearance rate < 60ml/min); 3.Cancer; 4.Recent infection or hematologic diseases not caused by SLE; 5.Pregnancy or planned to be pregnant; 6.Patients who are not willing to join the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| the proportion of patients who have flares (mild to moderate flares and severe flares) defined by modified SELENA-SLEDAI Flare Index (SFI) at 96 weeks of follow-up; | — |
Secondary
| Measure | Time frame |
|---|---|
| The proportion of lupus low disease activity state (LLDAS) at week 96;Short form-36 (SF-36) score of before and after treatment in two groups;The proportion of adverse events of two groups in the follow-ups;Changes in SLEDAI-2000 score;Changes in prednisone dose; | — |
Countries
China
Contacts
Public ContactJunna Ye
Ruijin Hospital
Outcome results
None listed