Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Hydroxychloroquine | Active Comparator | Hydroxychloroquine 300 mg once daily p.o. |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Hydroxychloroquine | Drug | Hydroxychloroquine 300 mg once daily p.o. for 12 weeks and go off medication for 4 weeks (total 16 weeks) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Serum cytokine level | IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc. | 16 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Retinal exam | Macular exam for monitoring Hydroxychloroquine macular toxicity | 16 weeks |
| Indicator of inflammation | Serum ESR | 16 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seoul National Unversity Hospital | Seoul | Seoul | 110-744 | South Korea |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27366013 | Derived | Yoon CH, Lee HJ, Lee EY, Lee EB, Lee WW, Kim MK, Wee WR. Effect of Hydroxychloroquine Treatment on Dry Eyes in Subjects with Primary Sjogren's Syndrome: a Double-Blind Randomized Control Study. J Korean Med Sci. 2016 Jul;31(7):1127-35. doi: 10.3346/jkms.2016.31.7.1127. Epub 2016 Apr 20. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D012859 | Sjogren's Syndrome |
| D015352 | Dry Eye Syndromes |
| ID | Term |
|---|---|
| D007154 | Immune System Diseases |
| D001172 | Arthritis, Rheumatoid |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D006886 | Hydroxychloroquine |
| ID | Term |
|---|---|
| D002738 | Chloroquine |
| D000634 | Aminoquinolines |
| D011804 | Quinolines |
| D006574 | Heterocyclic Compounds, 2-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Drug | 2cp/day for 12 weeks and go off medication for 4 weeks (total 16 weeks) |
|
| Tear production | Schirmer's test | 16 weeks |
| Subjective clinical eye complaints | Ocular Surface Disease Index (OSDI) | 16 weeks |
| Tear cytokine level | IL-6, IL-17, IL-1b, TNF-alpha, INF-alpha, BAFF, etc. | 16 weeks |
| Visual acuity | Best corrected visual acuity (Snellen) | 16 weeks |
| Color test | HRR color vision test for monitoring hydroxychloroquine retinal toxicity | 16 weeks |
| Tear breakup time | BUT (sec) | 16 weeks |
| Corneal punctate fluorescein staining score | Corneal staining score (National Eye Institute Scale) | 16 weeks |
| Changes in serum T-cell property | Serum T-cell property (FACS) | 16 weeks |
| D009140 |
| Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D014987 | Xerostomia |
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
| D007766 | Lacrimal Apparatus Diseases |
| D005128 | Eye Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D000072471 |
| Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |