Table 2

Inclusions and exclusion criteria

Inclusion criteria

Exclusion criteria

Age between 18 and 70 years

Chronic infection with HIV, Hepatitis B or Hepatitis C

Diagnosis of SLE according to the ACR criteria

Acute severe infection including fungal, viral, bacterial or protozoal diseases

Signs of active SLE nephritis: increasing urinary protein excretion of 1 g or more per 24 hours (if initially normal values) or a further increase of >50% over the baseline proteinuria and/or active urinary sediment and/or impaired renal function due to SLE nephritis (newly elevated serum creatinine

Signs of liver toxicity (WHO common toxicity criteria class 2 and higher)

If initially normal values - or >50% increase of serum creatinine levels if elevated before onset of renal flare), or signs of active LN in renal biopsy (any renal biopsy in the past two years)

Absence of adequate liver function (total bilirubin >25 μmol/L = 1.4 mg/dL unless otherwise explained (for example, inherited, hemolysis), ALT or AST >2.5 times upper limit of normal values)

Serum creatinine concentration of μ5.0 mg/dL

Anemia (hemoglobulin <8.0 g/dL)

Prior treatment with one or more immunosuppressive drugs (for example, CYC, AZA, methotrexate, cyclosporin A, MMF), or plasmapheresis

Leukopenia (leukocytes <4,000/µL unless attributable to SLE: leukocytes <2,000/µL in these cases)

Initial leukocyte count >4,000 cells/µL (unless leukopenia due to SLE disease activity: leukocyte count:/2,000/µL

Thrombocytopenia (platelets <50,000/µL),

Written informed consent

Neutrophil counts below 1,000/µL

Hypogammaglobulinemia (IgG below 400 mg/dl)

Pregnancy or lactation

Major and active SLE organ involvement other than the kidney, especially CNS involvement

History of malignancy

Participation in another clinical trial within six months before screening

2 = difference of baseline EGFR minus minimum EGFR during DSG trial from entry

ACR, American College of Rheumatology; AZA, azathioprin; CYC, cyclophosphamide; LN, lupus nephritis; MMF, mycophenolic acid; SLE, systemic lupus erythematosus.

Lorenz et al. Arthritis Research & Therapy 2011 13:R36   doi:10.1186/ar3268

Open Data