This is an open-label randomized controlled trial to compare the efficacy of Prednisone alone and combination therapy of Prednisone and Mycophenolate mofetil in IgG4RD patients.
Patients with IgG4-RD will be randomized in two therapeutic groups: Prednisone alone and combination therapy with Prednisone and Mycophenolate mofetil. These patients will be followed in 12 months. Treatment response and relapse will be recorded, as well as side effects.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
60
Prednisone: started with prednisone alone 0. 6-0. 8mg/kg.d for 1 month, decreased 5mg per 2 weeks, and maintained at 10mg/d to 12 months.
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. Immunosuppressive drugs: Mycophenolate mofetil 1g/d-1.5g/d for 6 months and 0.5/d-1.0g/d for 6 months.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGComplete and partial response rate at 3, 6, 9 and 12 months.
Complete and partial response are defined as resolution of clinical manifestations, biochemical tests (C-reactive Proteins and IgG or IgG4 levels), and imaging studies
Time frame: Up to 12 months
Disease response at 3, 6, 9 and 12 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.
Time frame: Up to 12 months
Number of participants with adverse effect
Treatment-related adverse effect, including glucocorticoid-induced diabetes mellitus and infections.
Time frame: Up to 12 months
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