Status:
COMPLETED
Hydroxychloroquine Versus Placebo in Primary Sjögren's Syndrome
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Collaborating Sponsors:
Sanofi
Conditions:
Primary Sjögren's Syndrome
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of...
Detailed Description
Primary Sjögren's syndrome (SJp) affects 0.1% of the population. This systemic autoimmune disease systemic is characterized by disabling dryness, fatigue and pain, and systemic complications in 30% of...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2012
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT00632866
Start Date
March 1 2008
End Date
May 1 2012
Last Update
July 3 2012
Active Locations (1)
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1
Hopital Bicëtre
Le Kremlin-Bicêtre, France, 94275