systemic lupus erythematosus
Conditions
Interventions
1:Background treatment( - hydroxychloroquine )
2:Background treatment( + hydroxychloroquine )
3:Background treatment + hydroxychloroquine + Metformin
Sponsors
Renji Hospital, Shanghai JiaoTong University School of Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Willingness of the subject to participate in the study, proven by signing the informed consent; 2. Men or woman, of at least 18 years of age; 3. SLE, as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of Systemic Lupus Erytematous, either sequeantiallysequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment; 4. Patients with active disease (score>=6 at screening on SELENA- SLEDAI); no more than one BILAG B score in all organ system; 5. Patients with quiescent disease - mild or moderate form (BILAG C score or better in all organ system); 6. Patients with a stable treatment regimen, with fixed doses of prednisone (0-40mg30mg/day), or common immunosupresiveimmunosuppressive agents (Hyidroxyicloqiune, /Cloroquine, Azathiporine,MMF, CyA, Leflunomide, Methotrexate), for at least 30 days before the first study dose (Metformin or placebo).
Exclusion criteria
Exclusion criteria: 1. Patients with non-quiescent form of SLE (BILAG A or more than two B in at least one organ system); 2. Patients with current symptoms of severe, progressive, or uncontrolled SLE/non-SLE related -related CNCS, renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, involvement; 3. Patients with liver, cardiac or renal failure (SLE/non-SLE related); 4. Patients with current symptoms of severe, progresive, or uncontroled non-SLE related LFT> 1.5 times upper normal limits; serum creatinine > upper normal limitsrenal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine, or cerebral disease; 5. Patients that used 30 days before screening Cyicoolophfosfphomide, MMF, Cyclosporine, Tacrolimus or 6-months0 days before screening; ever used biological agents before (concomitant use of biologics or cycolphosphomide are also not allowed); 6. Previous exposure of Metformin within 30 days before screening; or previous history of intolerant to metformin.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Systemic Lupus Erythematosus Disease Activity Index; | — |
Secondary
| Measure | Time frame |
|---|---|
| dose of Corticosteroids;carotid intima-media thickness; | — |
Countries
China
Contacts
Public ContactYe Shuang
Outcome results
None listed