Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)

Exclusion Criteria

• •Inability to give their signed informed consent form,
• •Performans status \> 2
• •QTcorrected space before treatment \> 0.45 seconds
• •Hemoglobin less than 11g/dL
• •Neutrophils rate below 1 200 / mm3
• •Platelets rate below 100 Giga / mm3
• •Previous history of arrhythmia or heart rhythm disorder or other rhythm trouble by referring cardiologist
• •Heart disorder (progressive pericarditis, valvular disease, ...) according to cardiologist
• •Family previous history of arrhythmias
• •Taking drugs that potentially prolong the QT
• •Hypersensitivity to the active substance of Trisenox® or any of the excipients
• •Serum potassium ≤ 4 milliequivalent / L
• •Magnesemia ≤ 1,8 mg / dl
• •Increase corticosteroids beyond 20 mg / day within 15 days before inclusion
• •Immunosuppressive treatments, thalidomide introduced within the last 3 months
• •Biotherapy (rituximab, belimumab, ...) introduced within 6 months prior to inclusion
• •Pregnancy or lactation
• •For women of childbearing age, men and their partner : unless effective contraception for the duration of participation in the study that is 7 months
• •Creatinine clearance \<50 ml / min,
• •Hepatocellular insufficiency (TP \<50%), and / or AST (aspartate aminotransferase) / ALT (alanine aminotransferase) / ALP (alkaline phosphatase) \> 2N
• •HBsAg positive, DNA detectable HbS
• •Infection with HIV, HBV (hepatitis B virus) or HCV (hepatitis C virus)
• •Renal or progressive central neurological impairment with possible alternative therapeutic (to be discussed with the principal investigator and scientific board meeting)
• •Peripheral neuropathy
• •Unweaned alcoholism
• •Minor
• •Patients older than 65 years
• •Patient having been professionally exposed to arsenic (cleaning electronic circuits for example)
• •Guardianship patients