A Phase 3 interventional study of Hydroxychloroquine and Placebo in Autoimmune Diseases, Sjogren's Syndrome and Dry Eye, sponsored by Seoul National University Hospital. Completed at 1 site in South Korea. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2013-10-17.
Sponsored by Seoul National University Hospital · Phase 3, Interventional, and Treatment
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).
672 studies on the registry are indexed under Autoimmune Diseases; 272 are open to participants now.
This study's enrollment of 39 is below the median of 44 across 433 interventional studies indexed under Autoimmune Diseases.
Browse Autoimmune Diseases studies →Seoul National University Hospital is the lead sponsor of 1,897 studies on the registry; 273 are open to participants now.
Of its 12 completed or terminated interventional studies of FDA-regulated products, 2 (17%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Hydroxychloroquine 300 mg once daily p.o.
Drug: Hydroxychloroquine
Placebo
Drug: Placebo
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)
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
The record gives a start of Jul 2011, a primary completion of Aug 2013 and a completion of Aug 2013. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Oct 2013. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Hydroxychloroquine
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