Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
RenJi Hospital
Age
18–70
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willingness of the subject to participate in the study, proven by signing the informed consent;
Systemic lupus erythematosus (SLE), as defined by meeting at least 4 of 11 classification criteria of American College of Rheumatology for the classification of systemic lupus erythematosus, either sequentially or coincidentally. The 4 criteria doesn't need to be present at the time of study enrollment;
The course of SLE longer than1 year; and there is a clear record of disease flares in the past 1 year with prednisone more than 20mg/day;
Patients with mild/moderate disease activity (score≤ 6 at screening on SLEDAI); no British Isles Lupus Assessment Group (BILAG) A or no more than one B;
A stable treatment regimen with fixed doses of prednisone (≤ 20mg/day), antimalarial, or immunosuppressive drugs (azathioprine/ mycophenolate mofetil/ methotrexate/ ciclosporin/ leflunomide/ thalidomide) for at least 30 days.
You may not be if
Patients who are unwilling to sign the inform consent;
Alanine aminotransferase (ALT)/ aspartate aminotransferase (AST) \> 2 times upper normal limits; creatinine clearance rate \< 60ml/min;
Patients who used cyclophosphamide 6-months before screening; used biological agents 12-months before screening;
Previous exposure of metformin within 30 days before screening; or previous history of intolerant to metformin;