Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease
This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
63
Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months.
Oral Mycophenolate mofetil 0.75g bid for 6 months.
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe difference of recurrent rate of IgG4-RD between the two groups
Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.
Time frame: 72 weeks
The time of recurrence
Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels.
Time frame: 0-72 weeks
The changes of IgG4-related disease Responder Index
According to international multispecialty validation study of IgG4-related disease Responder Index (November, 2018), Responder Index ≥ 0, and higher scores mean a worse outcome.
Time frame: 72 weeks
The changes of serum IgG4 levels
Level of serum IgG4(mg/dL)
Time frame: 72 weeks
The percentages of adverse events
Adverse effect of drugs
Time frame: 72 weeks
The changes of PGA
Changes of patient global assessment from baseline, score (0-10, higher is worse)
Time frame: 72 weeks
The difference of remission rate of IgG4-RD between the two groups
Including complete remission rate, partial remission rate and total response rate.
Time frame: 72 weeks
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