Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD
IgG4-related Disease With Eosinophilia
About this trial
This is an interventional treatment trial for IgG4-related Disease With Eosinophilia focused on measuring IgG4-related disease, eosinophilia
Eligibility Criteria
Inclusion Criteria: All patients must meet the following diagnostic criteria of IgG4RD (2020): 1) and radiological features: One or more organs show diffuse or localized swelling or a mass or nodule characteristic of IgG4-RD. In single organ involvement, lymph node swelling is omitted. 2) serological diagnosis: Serum IgG4 levels greater than 135 mg/dl. 3) diagnosis diagnosis: Positivity for two of the following three criteria: a. Dense lymphocyte and plasma cell infiltration with fibrosis. b. Ratio of IgG4-positive plasma cells /IgG-positive cells greater than 40% and the number of IgG4-positive plasma cells greater than 10 per high powered field. c. Typical tissue fibrosis, particularly storiform fibrosis, or obliterative phlebitis. Patients fulfill (1) + (2) + (3) are diagnosed as definite IgD4RD; (1) + (2): possible IgG4RD; (1) + (3): probable IgG4RD. exclusion of other diseases. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ) The counts of peripheral blood eosinophil cells ≥0.75×109/L Exclusion Criteria: Patients who is not able to discontinue GC Pregnancy or breastfeeding or planning to get pregnant within 2 years Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months Allergic to Baricitinib Concomitant other autoimmune diseases Malignancy Chronic HBV infection, latent tuberculosis, or active infection Server liver or renal dysfunction, or heart failure.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Placebo Comparator
Experimental
Prednisolone monotherapy
Prednisolone plus Baricitinib
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. Oral Baricitinib 2mg daily for 12 months.