Glucocorticoids in Patients With IgG4-RD
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||A Randomized Trial of Glucocorticoids in Patients With IgG4-Related Disease|
- Complete Response [ Time Frame: 3 months ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||April 2014|
|Estimated Primary Completion Date:||January 2014 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01758393
|Contact: Hua Chen, MDfirstname.lastname@example.org|
|Deptment of Rheumatology, Peking Union Medical College Hospital||Recruiting|
|Beijing, Beijing, China, 100032|
|Contact: Wen Zhang, MD +86-10-69158795 email@example.com|
|Contact: Hua Chen, MD +86-10-69158797 firstname.lastname@example.org|
|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|