Clinical trial: Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome (NCT00632866)

Eligibility criteria:
Inclusion criteria:

          -  Patients suffering from primary Sjögren's syndrome according to the European-American
             consensus 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 did
             not 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 the
             beginning of any proceedings related to the trial

          -  Patients treated with corticosteroids and / or NSAIDs, and / or cyclosporine, and / or
             pilocarpine must have received stable doses of these treatments during the month
             preceding 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 to
             inclusion, or 6 months prior to inclusion for cyclophosphamide or rituximab

          -  lymphoma or other severe SJp complications: vasculitis responsible for a documented
             renal, neurological, digestive or heart involvement, glomerular disease associated
             with hematuria and / or proteinuria > 0.5 g / d), CNS involvement, peripheral
             neurological 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 purpura
             is 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 other
             constituents of Plaquenil

          -  Psoriasis or intermittent porphyria.

          -  G6PD deficiency, congenital galactosemia, malabsorption syndrome, glucose and
             galactose, or lactase deficiency.

          -  Non-membership in a social security system.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.


Patient description (medical language): A 40-year-old woman comes to the clinic complaining of gritty sensation in her eyes. She also has difficulty swallowing dry foods with no pain or heartburn.  The patient is a schoolteacher and must drink water frequently during lectures due to her mouth dryness.  She also reports occasional joint pain.  Medical history is not significant other than the confirmed Sjogren disease with no other rheumatologic disease.  She is sexually active with her husband and has 2 children both delivered by natural vaginal delivery. She has no history of any kind of surgery. Physical examination shows conjunctival erythema and cracking of the lips. The remainder of the examination and history is normal. Her lab result shows elevated ESR (50 mm/h)

Patient description (patient's own words): I went to the clinic because I had a terrible gritty sensation in my eyes. It was also hard to swallow dry food, but it didn't burn, and there was no pain. I'm a 40-year-old female school teacher and I should drink water for the lectures because otherwise, my mouth gets really dry. I also have joint pain from time to time. I have been diagnosed with Sjogren disease but no other rheumatologic disease. I have a husband, we're sexually active, and I also have two lovely children that I delivered both naturally. I never undergone any surgery. Physical examination when I came to the clinic, and it showed cracking on my lips and a pink eye. The rest was fine. I also did some lab tests, and they came back with high ESR.

Does the patient match the trial criteria? 1