Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
70 participants
INTERVENTIONAL
2018-07-01
2020-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Group 1
Patients treated with single glucocorticoid
Prednisone
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.
Prednisone and Leflunomide
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.
Group 2
Patients treated with Leflunomide and glucocorticoid
Prednisone
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.
Prednisone and Leflunomide
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.
Interventions
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Prednisone
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 7.5mg to 10mg/d to 12 months.
Prednisone and Leflunomide
Prednisone: started with prednisone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, maintained at 7.5mg to 10mg/d to 12 months.
Leflunomide: 20mg qd for 6 months and 10mg qd for 6 months.
Eligibility Criteria
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Inclusion Criteria
* Aged 18 to 70 years old with informed consent
* All patients must meet the following diagnostic criteria of IgG4RD (2011):
1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sialadenitis (Mikulicz disease), sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, inflammatory aortic aneurysm, lymphadenopathy, or other inflammatory conditions;
2. elevated serum IgG4 (\>1.35 g/L);
3. histopathologic features of fibrosis and/or lymphocytic and polyclonal plasma cell infiltration (and IgG4+ plasma cells on immunohistology when performed). Patients fulfill 1)+2)+3) are diagnosed as definite IgD4RD, 1)+2): possible IgG4RD; 1)+3): probable IgG4RD;
4. exclusion of other diseases.
Exclusion Criteria
1. Patients who were diagnosed as other autoimmune diseases;
2. Patients who were diagnosed as malignant diseases;
3. Pregnant and lactating women；
4. Active infection: HIV, HCV, HBV, TB；
5. Serious organ function failure, expected life time less than 6 months.
6. Presenting with Mikulicz disease without other manifestations.
18 Years
70 Years
ALL
No
Sponsors
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Peking Union Medical College Hospital
OTHER
Responsible Party
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Wen Zhang
Professor
Locations
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Yunyun Fei
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Treatment for IgG4-RD
Identifier Type: -
Identifier Source: org_study_id
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