RECRUITINGPhase 4INTERVENTIONAL
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study
About This Trial
A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome
Who May Be Eligible (Plain English)
Who May Qualify:
- 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
Who Should NOT Join This Trial:
- 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, weakened immune system, 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
Always talk to your doctor about whether this trial is right for you.
Original Eligibility Criteria
View original clinical language
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
Treatments Being Tested
DRUG
Iguratimod Tablets
Participants are treated with Iguratimod Tablets 25 mg Twice a day for 24 weeks.
DRUG
Hydroxychloroquine Sulfate Tablets
Participants are treated with Hydroxychloroquine Sulfate Tablets 200 mg Twice a day for 24 weeks.
Locations (1)
Second affiliated hospital of zhejiang university,school of medical
Hangzhou, Zhejiang, China