Glucocorticoids in Patients With IgG4-RD
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|ClinicalTrials.gov Identifier: NCT01758393|
Recruitment Status : Unknown
Verified December 2012 by Wen Zhang, Peking Union Medical College Hospital.
Recruitment status was: Recruiting
First Posted : January 1, 2013
Last Update Posted : January 1, 2013
|Condition or disease||Intervention/treatment||Phase|
|IgG4-related Disease||Drug: Prednisone||Phase 2 Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||40 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease|
|Study Start Date :||December 2012|
|Estimated Primary Completion Date :||January 2014|
|Estimated Study Completion Date :||April 2014|
Experimental: 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.
Experimental: 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.
- Complete Response [ Time Frame: 3 months ]Complete Response(CR) is defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies.
- Disease Response [ Time Frame: 3 months ]
Disease Response is measured by IgG4-RD Responder Index(IgG4-RD RI) and defined as:
- Improvement of > 2 points in the IgG4-RD RI over baseline
- No disease flares, as assessed by the IgG4-RD RI.
- Adverse Effect [ Time Frame: 3 months ]Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01758393
|Contact: Hua Chen, MDemail@example.com|
|Principal Investigator:||Wen Zhang, MD||Deptment of Rheumatology, Peking Union Medical College Hospital|
|Study Chair:||Fengchun Zhang||Deptment of Rheumatology, Peking Union Medical College Hospital|