Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Nantes University Hospital
With
Medsenic Company
Age
18–65
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Systemic Lupus meeting the ACR (American College of Rheumatology) criteria, progressive either SLEDAI activity score ≥ 4, despite a corticosteroid therapy ≥ 10 mg / d associated with hydroxychloroquine (in the absence of contraindication or intolerance) and / or an immunosuppressive treatment at a stable dose,
Insured,
Availability for hospitalization required by the protocol (conventional and daily hospitalizations).
You may not be if
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
Clareo Health | Phase 2a Study Evaluating the Arsenic Trioxide (ATO) in Systemic Lupus (SLE) (Protocol LUPSENIC)
