Primary Sjögren's Syndrome
Conditions
Keywords
auto-immune diseases, hydroxychloroquine, primary Sjögren's syndrome, inflammatory arthritides, inflammatory rheumatic diseases, dryness, joint diseases
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 patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done. Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales.
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 patients. No treatment has proven effective in this disease. In open studies, some efficacy was observed with hydroxychloroquine but no RCT versus placebo has ever been done. Thus, the primary purpose of this study is to evaluate the efficacy and safety of hydroxychloroquine (400mg/ day) on dryness, pain, and fatigue, assessed by the patient using visual analogical scales (VAS). Response is defined by the improvement of 30% or more of at least 2 out of 3 of the following VAS : most disabling dryness, fatigue, and pain.
Interventions
DRUGHydroxychloroquine
Hydroxychloroquine : 200mg / day since 24 weeks
DRUGPlacebo
Placebo : 2cp/ day since 24 weeks
Sponsors
Sanofi
Assistance Publique - Hôpitaux de Paris
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of patients with an improvement of 30% or more of at least 2 out of the 3 following VAS: 1. the most disabling dryness 2. pain 3. fatigue | 6 months |
Secondary
| Measure | Time frame |
|---|---|
| SCHIRMER's test, van BIJSTERVELD score, salivary flow, disease systemic features, quality of life, interferon-inducible genes expression Association between clinical response and hydroxychloroquine blood level, interferon-inducible genes expression | 6 mois |
Countries
France
Outcome results
None listed