Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:39 PM
Ignite Modification Date:
2025-12-24 @ 4:39 PM
NCT ID:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT00632866
Study Brief:
Protocol Section:
NCT00632866