Status:
UNKNOWN
To Evaluate the Clinical Efficacy of Iguratimod in the Treatment of IgG4 Related Disease (IgG4-RD) With Mild Symptom
Lead Sponsor:
Wen Zhang
Conditions:
IgG4-related Disease
Eligibility:
All Genders
18-70 years
Phase:
PHASE4
Brief Summary
30 untreated IgG4 related disease (IgG4-RD) patients with mild symptom are enrolled in this study, and will be treated with one dose of diprospan,then take Iguratimod 25mg, Bid orally. Patient's perip...
Detailed Description
Glucocorticoid is the recognized first-line medication for IgG4-RD, but it has many side effects. In order to avoid long time glucocorticoids intake, patients with mild disease will be treated with Ig...
Eligibility Criteria
Inclusion
- Mikulicz disease, with/without nasosinusitis or lymph node swelling.
- Without internal organs affected,
- With slow disease progression.
Exclusion
- Vital organs related:including autoimmune pancreatitis,retroperitoneal fibrosis, sclerosing cholangitis, lung related, kidney affected, IgG4 related castleman's disease and hypophysitis，
- Combined with other connective disease,
- With tumors,
- Pregnancy or to be pregnant,
- Active infection, including hepatitis B virus, hepatitis C virus, and tuberculosis.
- Leucocytopenia, impairment of liver and kidney function,
- Allergy of Iguratimod, or cannot tolerate Iguratimod.
Key Trial Info
Start Date :
September 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2018
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT03368274
Start Date
September 1 2017
End Date
June 1 2018
Last Update
April 11 2018
Active Locations (1)
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1
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100032