The purpose of this study is to evaluate the efficacy and safety of iguratimod compared to placebo in patients with active primary Sjogren's Syndrome.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
144
Iguratimod orally twice a day
Placebo orally twice a day
Change From Baseline in EULAR Sjogren's Syndrome Disease Activity Index (ESSDAI)
The EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) total score is calculated as the sum of scores for activity level for each domain. Overall score, which can range from 0 to 123, a higher score indicates more disease activity
Time frame: Week 12
Change From Baseline in EULAR Sjogren's Syndrome Patient Reported Index (ESSPRI)
The total score EULAR Sjögren's Syndrome Patient Reported Index (ESSPRI) is calculated as the mean of the 3 individual components. Total Score Range (0 = Best outcome and 10 = Worst Outcome) The scores for the ESSPRI individual components will be used as such reported by the participants and entered in the case report form (CRF), without any further calculations. It consists of 3 questions covering cardinal symptoms of Sjögren's syndrome: dryness, fatigue and pain. Each domain scored on scale of 0-10 (0 =no symptom at all and 10 = worst symptom imaginable), and overall score is calculated as the mean of 3 individual domains.
Time frame: Week 12
Change From Baseline in the Unstimulated Salivary Flow
The mean change from baseline in unstimulated whole salivary flow at all measured time points up to Week 12
Time frame: Week 12
Change From Baseline in Schirmer's Test
The Mean change from baseline in Schirmer's Test at all measured time points up to Week 12 The length in millimeters that the strip wets during the 5 minute test period for each eye. Collection is done separately for each eye.
Time frame: Week 12
Change From Baseline in the level of immunoglobulin (IgG, IgA, IgM)
The change from baseline in the level of immunoglobulin (IgG, IgA, IgM) at all measured time points up to Week 12
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Peking University People's Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe First Affiliated Hospital of Xiamen University
Xiamen, Fujian, China
RECRUITINGSouthern Medical University Nanfang Hospital
Guangzhou, Guangdong, China
RECRUITINGSun Yat-sen Memorial Hospital
Guangzhou, Guangdong, China
RECRUITINGthe Second Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
NOT_YET_RECRUITINGHebei General Hospital
Shijiazhuang, Hebei, China
NOT_YET_RECRUITINGthe Second Hospital of HeBei Medical University
Shijiazhuang, Hebei, China
RECRUITINGthe First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
RECRUITINGXinxiang Central Hospital
Xinxiang, Henan, China
NOT_YET_RECRUITINGThe First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
RECRUITING...and 20 more locations
Time frame: Week 12
Change From Baseline in the level of rheumatoid factor (RF)
The change from baseline in the level of RF at all measured time points up to Week 12
Time frame: Week 12
Change From Baseline in the level of B -cell activation factor (BAFF)
The change from baseline in the level of BAFF at all measured time points up to Week 12
Time frame: Week 12
Change From Baseline in the level of T/B/NK cell subsets
The change from baseline in the level of T/B/NK cell subsets at all measured time points up to Week 12
Time frame: Week 12
Change From Baseline in the level of erythrocyte sedimentation rate (ESR)
The change from baseline in the level of ESR at all measured time points up to Week 12
Time frame: Week 12
Change From Baseline in the level of serum complement (C3 and C4)
The change from baseline in the level of serum complement (C3 and C4) at all measured time points up to Week 12
Time frame: Week 12