The Reduction of Systemic Lupus Erythematosus Flares :Study PLUS

Exclusion Criteria

• •Known retinopathy, present or passed
• •Severe cataract obstructing the ophthalmologic monitoring
• •MONOPHTALM patients
• •Past history of intolerance with HCQ (in particular gastro-intestinal, or retinal) during the possible former use of a higher dosage
• •Use of nivaquine during the 3 previous months
• •Treatment with biotherapy (for example Rituximab) during the 12 previous months
• •Calculated clearance of creatinin lower than 60 ml/min
• •Chronic alcoholism
• •Liver failure
• •Desire of pregnancy in the next 7 months
• •Known non compliance, and risks of random follow-up
• •Absence of social security cover
• •People profiting from a particular protection:
• •Pregnant women
• •Age under 18
• •Patient under supervision and TRUSTEESHIP
• •People who are hospitalized without their consent and not protected by the law
• •People who are private of freedom.
• •Criteria of inclusion at the visit of randomization (D0):
• •All the patients responding to the next criterions can be randomized:
• •Blood HCQ concentration ranging between 100 and 750 ng/ml at the time of the visit of preselection,
• •No increase in the steroids dosage since last visit
• •No modifications of a possible immunosuppressor since last visit
• •SELENA-SLEDAI \< or = 12 Activity of the lupus remaining stable (no increase of more than 2 points of the SELENA-SLEDAI),
• •Ophthalmologic examination in the 6 previous months with no contra-indication for the use of HCQ,
• •Absences of conductive disorders on the ECG
• •Use of an effective contraception,
• •Negative Beta-HCG.