Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome

Inclusion criteria:

• Patients suffering from primary Sjögren's syndrome according to the European-Americanconsensus group criteria

• Male and female aged of 18 or more

• Conducting a clinical examination beforehand.

• Having undergone less than 6 months before an ophthalmological examination, which didnot counter-indicated hydroxychloroquine.

• Patient without heart conduction disturbance (PR>=0.2 sec and QRS>=0.08 sec).

• Patient with the ability to give informed, dated and signed consent before thebeginning of any proceedings related to the trial

• Patients treated with corticosteroids and / or NSAIDs, and / or cyclosporine, and / orpilocarpine must have received stable doses of these treatments during the monthpreceding inclusion.

Exclusion criteria:

• SJ associated with other autoimmune diseases

• Retinopathy /severe cataract/ monophthalmos

• Previous or ongoing treatment by hydroxychloroquine

• Treatment by another immunosuppressant not interrupted at least 4 weeks prior toinclusion, or 6 months prior to inclusion for cyclophosphamide or rituximab

• lymphoma or other severe SJp complications: vasculitis responsible for a documentedrenal, neurological, digestive or heart involvement, glomerular disease associatedwith hematuria and / or proteinuria > 0.5 g / d), CNS involvement, peripheralneurological involvement with motor deficiency scored at 3 or less on a scale of 5 ,interstitial pneumonitis, recent symptomatic cryoglobulinemia with neurological,renal, or other systemic involvement, myositis with motor deficiency (isolated purpurais not an exclusion criteria)

• Chronic Alcoholism

• Hepato-cellular insufficiency

• Creatinine clearance <60 ml / min

• Risk of lost follow-up

• People younger than 18, major trusteeship and guardianship, or deprived of liberty

• Pregnancy /Breastfeeding

• Hypersensitivity to chloroquine or to hydroxychloroquine or any of the otherconstituents of Plaquenil

• Psoriasis or intermittent porphyria.

• G6PD deficiency, congenital galactosemia, malabsorption syndrome, glucose andgalactose, or lactase deficiency.

• Non-membership in a social security system.