Primary Sjögren syndrome is one of the most prevalent autoimmune diseases that present with dry eye and dry mouth. But there is no proven effective treatment for Sjögren syndrome patient. The relation between toll-like receptor (TLR) and the pathogenesis of Sjögren syndrome has been reported. Hydroxychloroquine is TLR7 and TLR9 antagonist. A few studies have been reported the effectiveness of Hydroxychloroquine for Sjögren syndrome but no randomized controlled study has been done. So the investigators evaluate the effectiveness and safeness of Hydroxychloroquine for primary Sjögren syndrome by randomized controlled study (Hydroxychloroquine 300 mg once daily p.o. group (N = 30) versus placebo group (N = 30).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
39
Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks)
2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks)
Seoul National Unversity Hospital
Seoul, Seoul, South Korea
Serum cytokine level
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Time frame: 16 weeks
Retinal exam
Macular exam for monitoring Hydroxychloroquine macular toxicity
Time frame: 16 weeks
Indicator of inflammation
Serum ESR
Time frame: 16 weeks
Tear production
Schirmer's test
Time frame: 16 weeks
Subjective clinical eye complaints
Ocular Surface Disease Index (OSDI)
Time frame: 16 weeks
Tear cytokine level
IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc.
Time frame: 16 weeks
Visual acuity
Best corrected visual acuity (Snellen)
Time frame: 16 weeks
Color test
HRR color vision test for monitoring hydroxychloroquine retinal toxicity
Time frame: 16 weeks
Tear breakup time
BUT (sec)
Time frame: 16 weeks
Corneal punctate fluorescein staining score
Corneal staining score (National Eye Institute Scale)
Time frame: 16 weeks
Changes in serum T-cell property
Serum T-cell property (FACS)
Time frame: 16 weeks
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