Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Wen Zhang
• Collaborators: Beijing Friendship Hospital; Tongji Hospital
• Treatments: Prednisolone

Criteria

Inclusion Criteria:

1. 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.

2. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)

3. The counts of peripheral blood eosinophil cells ≥0.75×109/L

Exclusion Criteria:

1. Patients who is not able to discontinue GC

2. Pregnancy or breastfeeding or planning to get pregnant within 2 years

3. Received glucocorticoids, immunosuppressants, biological agents or JAK inhibitors within 3 months

4. Allergic to Baricitinib

5. Concomitant other autoimmune diseases

6. Malignancy

7. Chronic HBV infection, latent tuberculosis, or active infection

8. Server liver or renal dysfunction, or heart failure.