Evaluation and prediction of relapse risk after glucocorticoid or immunosuppressant withdrawal in patients with stable IgG4 related disease: a prospective cohort study from china.
IgG4-related disease (IgG4-RD) is a chronic autoimmune disease with a relapsing-remitting course. For patients in remission, glucocorticoid (GC) and immunosuppressant are used to be maintained for a long time in fear of disease flare. Long-term GC and immunosuppressant could bring a lot of side-effects and economic burden. Whether and when patients with stable disease should withdraw GC or immunosuppressant? How about the relapse risk respectively? What are the risk factors for disease flare? All the above remain unclear. The aim of this study is to explore the relapse risk after GC or immunosuppressant withdrawal in IgG4-RD patients with stable disease and to establish a predictive model for risk stratification. Meanwhile the investigators aim to testify the effects of immunosuppressant in preventing IgG4-RD relapse. This study is a prospective cohort clinical trial.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
138
Follow-up intervals: Every 3 months (3th, 6th, 9th, 12th, 15th, 18th month).
Beijing Friendship Hospital
Beijing, Beijing Municipality, China
RECRUITINGThe difference of recurrent rate of IgG4-RD among three groups.
Clinical recurrence definition: any item of IgG4-RD Responder Index \>=2,new organ involvement; with or without elevated serum IgG4 levels. Serum recurrence definition: Serum IgG4 level was higher than baseline level, IgG4-RD Responder Index was higher than or equal to 1 point, without clinical symptom or imaging deterioration.
Time frame: One and half year
The changes of IgG4-RD Responder Index
According to IgG4-RD responder Index Validation Study (Version: 13, December, 2015)
Time frame: One and half year
The changes of serum IgG4 levels
Level of serum IgG4(mg/dL)
Time frame: One and half year
The changes of serum IgG level
Level of serum IgG(g/L)
Time frame: One and half year
The changes of serum hsCRP level
Level of serum high-sensitivity C-reactive protein level(mg/L)
Time frame: One and half year
The changes of ESR
Serum erythrocyte sedimentation rate(mm/h)
Time frame: One and half year
The percentages of adverse events
Adverse effect of drugs
Time frame: One and half year
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.