A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
78
Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.
Second affiliated hospital of zhejiang university,school of medical
Hangzhou, Zhejiang, China
RECRUITINGThe change of SSRI-30 between the two groups at 24 weeks
SS Responder Index (SSRI) is a composite endpoint, investigators defined an SSRI-30 response as a ≥30% improvement in at least two of five outcome measures (patient-assessed visual analogue scale scores for fatigue, oral dryness and ocular dryness, unstimulated whole salivary flow and ESR at 24 weeks
Time frame: 24 weeks
Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24
The ESSPRI is composed of 3 scales - dryness, fatigue, and pain. Each scale is measured 0 - 10, 0 being no symptoms, 10 being maximal imaginable dryness, fatigue or pain. The total score is the mean score of the three scales. Baseline ESSPRI total score will be compared to week 24, end of treatment, ESSPRI total score.
Time frame: 24 weeks
Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24
The ESSDAI is a disease activity measurement that has 12 domains. The score of each domain is the product of the weight of the domain by the level of activity. Activity levels are 0 - 3, 0 being no activity, 3 being high activity. The total score is the sum of the score of all domains. Change in total score from BL to week 24 will be measured.
Time frame: 24 weeks
Change in Schimer's test
The change from baseline in Schimer's test at 24 weeks. The Schirmer's test assesses tear secretion.
Time frame: 24 weeks
Change in Immunoglobulin G (IgG) concentration
The change from baseline in IgG concentration at 10 and 24 weeks.
Time frame: 10 and 24 weeks
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Change in serum complements C3 and C4 concentration
The change from baseline in serum complements C3 and C4 concentrationat 10 and 24 weeks.
Time frame: 10 and 24 weeks
Change in titer of Rheumatoid Factors
The change from baseline in titer of rheumatoid factors at 10 and 24 weeks.
Time frame: 10 and 24 weeks