Actively Recruiting
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
Led by Second Affiliated Hospital, School of Medicine, Zhejiang University · Updated on 2024-10-16
78
Participants Needed
1
Research Sites
180 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome
CONDITIONS
Official Title
The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with Primary Sj�f6gren's syndrome by meeting the 2016 ACR/EULAR Classification Criteria
- Complaint of dry mouth and eyes
- Positive anti-SSA/Ro-60 antibody at screening
- IgG level 16 g/L
- No hormone, immunosuppressant, biological agents, or other treatments received within 4 weeks before screening
- Negative pregnancy test and use of effective contraceptives during the trial (for female participants)
- No participation in any drug trial within 12 weeks before enrollment
You will not qualify if you...
- Pregnant, lactating, or planning to become pregnant during the study
- Complicated with other connective tissue diseases (CTD)
- Presence of malignancy
- Mental illness, history of alcohol abuse, immunodeficiency, uncontrolled infections, or drug/substance abuse
- Serious systemic damage requiring glucocorticoids, immunosuppressants, or biological agents for control, including heart, liver (transaminase/bilirubin >1.5 times upper normal limit), kidney (creatinine 133 mmol/L), lung (FVC % < 60%), or blood abnormalities (white blood cell <3�d7109/L, hemoglobin <80 g/L, platelets <80�d7109/L)
- Fundus or visual field lesions
- Allergy to any component of the study drugs (Iguratimod or Hydroxychloroquine)
- Investigator's judgment that the patient is unsuitable for the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Second affiliated hospital of zhejiang university，school of medical
Hangzhou, Zhejiang, China, 310000
Actively Recruiting
Research Team
J
Jing Xue
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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