Primary Sjögren's Syndrome Clinical Trial
Official title:
Randomized, Double-blind, Placebo-controlled Trial of Hydroxychloroquine in Primary Sjögren's Syndrome
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.
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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