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This is a randomized, open-label, single-center clinical trial to compare the efficacy and safety profile for medium-dose versus high dose glucocorticoid in patients with IgG4-related Disease. Patients will be followed for three months to measure the primary outcome and secondary outcomes.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Medium Dose | Experimental | 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. |
|
| High Dose | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisone | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete Response | Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Response | Disease Response is measured by IgG4-RD Responder Index(IgG4-RD RI) and defined as:
| 3 months |
| Adverse Effect |
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Inclusion Criteria:
Males and females
Age 18-70 years old with informed consent
Patients with IgG4-RD:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hua Chen, MD | Contact | +86-10-69158797 | chenhua@pumch.cn |
| Name | Affiliation | Role |
|---|---|---|
| Wen Zhang, MD | Deptment of Rheumatology, Peking Union Medical College Hospital | Principal Investigator |
| Fengchun Zhang | Deptment of Rheumatology, Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Deptment of Rheumatology, Peking Union Medical College Hospital | Recruiting | Beijing | Beijing Municipality | 100032 | China |
| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 7, 2017 | |
| Reset | Jun 23, 2017 | |
| Release | Jul 6, 2017 | |
| Reset | Jan 29, 2018 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 7, 2017 | Jun 23, 2017 | |||
| Jul 6, 2017 |
| ID | Term |
|---|---|
| D000077733 | Immunoglobulin G4-Related Disease |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
| 3 months |
| Jan 29, 2018 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |