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
PHASE2/PHASE3
40 participants
INTERVENTIONAL
2012-12-31
2014-04-30
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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Medium Dose
Patients are treated with prednisone or equivlent at doseage of 0.5-0.6 mg/kg/d (max 40mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
Prednisone
High Dose
Patients are treated with prednisone or equivlent at doseage of 0.8-1.0 mg/kg/d (max 60mg daily) for 3 weeks, then tapering gradually to 15mg/d in 3 months.
Prednisone
Interventions
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Prednisone
Eligibility Criteria
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Inclusion Criteria
* Age 18-70 years old with informed consent
* Patients with IgG4-RD:
1. swelling, sclerosing and inflammatory involvement of one or more organ, including sclerosing pancreatitis, sclerosing cholangitis, inflammatory pseudotumors, retroperitoneal or mediastinal fibrosis, interstitial nephritis, hypophysitis, sclerosing dacryoadenitis, sialadenitis, 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);
4. exclusion of other diseases.
Exclusion Criteria
* Pregnancy or lactating
* Concurrent severe and/or uncontrolled and/or unstable diseases
* Patient with malignancy
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
Principal Investigators
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Wen Zhang, MD
Role: PRINCIPAL_INVESTIGATOR
Deptment of Rheumatology, Peking Union Medical College Hospital
Fengchun Zhang
Role: STUDY_CHAIR
Deptment of Rheumatology, Peking Union Medical College Hospital
Locations
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Deptment of Rheumatology, Peking Union Medical College Hospital
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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PUMCH-GC-IgG4RD
Identifier Type: -
Identifier Source: org_study_id
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