Clinical trial NCT04981145: The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
Official title: The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Primary Sjögren's Syndrome
Keywords: Primary Sjögren's syndrome
Sjögren's syndrome
Iguratimod
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-07-28
Enrollment: 78
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome


Eligibility criteria: Inclusion Criteria:

* Diagnosed with pSS by meeting the 2016 ACR/EULAR Classification Criteria.
* The patient complained of dry mouth and eyes.
* Positive anti-SSA/Ro-60 antibody at screening.
* IgG≥16 g/L.
* No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;
* Pregnancy test of is negative. Use effective contraceptives during the trial (female)
* Those who did not participate in any drug trial within 12 weeks before enrollment

Exclusion Criteria:

* Pregnant or lactating or planning to get pregnant during the duration of the study.
* Complicated with other CTD
* Complicated with malignancy
* mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse
* serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase/bilirubin \>1.5 times the upper normal limit), kidney (Cr≥133mmol/L), lung (FVC % \< 60%), blood (white blood cell \<3×109/L, HGB\<80g/L, PLT\<80×109/L), etc.
* Fundus/visual field lesions;
* Allergic to any component of the study drug (IGU and/or HCQ);
* the investigator considers the patient to be unsuitable for entry into the study

Primary outcomes:
measure: The change of SSRI-30 between the two groups at 24 weeks
timeFrame: 24 weeks
Secondary outcomes:
measure: Change in The European League Against Rheumatism (EULAR) Sjogren's Syndrome Patient Reported Index (ESSPRI) score from Baseline to Week 24
timeFrame: 24 weeks
measure: Change in total score of the EULAR Sjogren's syndrome disease activity index (ESSDAI) from baseline to week 24
timeFrame: 24 weeks
measure: Change in Schimer's test
timeFrame: 24 weeks
measure: Change in Immunoglobulin G (IgG) concentration
timeFrame: 10 and 24 weeks
measure: Change in serum complements C3 and C4 concentration
timeFrame: 10 and 24 weeks
measure: Change in titer of Rheumatoid Factors
timeFrame: 10 and 24 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second affiliated hospital of zhejiang university，school of medical
state: Zhejiang
Study officials:
affiliation: Sir Run Run Shaw Hospital
name: Yongmei Han
role: PRINCIPAL_INVESTIGATOR
affiliation: Affiliated Hospital of Jiaxing University
name: Hongzhi Wang
role: PRINCIPAL_INVESTIGATOR
affiliation: Zhuji People's hospital
name: Ying Guan
role: PRINCIPAL_INVESTIGATOR
References: