The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome

Zhejiang University

Status and phase

Enrolling

Phase 4

Conditions

Primary Sjögren's Syndrome

Treatments

Drug: Hydroxychloroquine Sulfate Tablets

Drug: Iguratimod Tablets

Study type

Interventional

Funder types

Other

Identifiers

2021-0391

Details and patient eligibility

About

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

Enrollment

78 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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