Actively Recruiting
Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement
Led by Peking Union Medical College Hospital · Updated on 2024-05-28
60
Participants Needed
1
Research Sites
130 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study has been designed as a 18-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of two treatment strategies in active IgG4-RD patients with internal organ involvement during maintenance remission period: low dose mycophenolate mofetil group and leflunomide group.
CONDITIONS
Official Title
Treatment Strategies for IgG4-RD Patients With Internal Organ Involvement
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Fulfillment of the 2019 American College of Rheumatology/European League Against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria
- Newly-onset or relapsed patients who require initiation or continuation of glucocorticoids treatment
- Age between 18 and 75 years
You will not qualify if you...
- Diagnosis of other autoimmune diseases
- Diagnosis of malignant diseases
- Pregnant or lactating women
- Active infection with HIV, hepatitis C virus, hepatitis B virus, or tuberculosis
- Severe irreversible damage of organ function
- Receipt of any biologic therapy or immunosuppressive agent other than glucocorticoids
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Peking Union Medical College Hospital
Beijing, China
Actively Recruiting
Research Team
Y
Yunyun Fei, MD
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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