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Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD

China74 participantsStarted 2023-01-20

Plain-language summary

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

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)
✕. The counts of peripheral blood eosinophil cells ≥0.75×109/L
✕. 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

The difference of recurrent rate of IgG4-RD between the two groups

Timeframe: 52 weeks

NCT IDNCT05781516

SponsorWen Zhang

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-06

Linyi Peng, MD

Who can participate

Age range18 Years – 70 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. 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.

✕. Active IgG4-RD (Responder Index ≥ 2 points for each involved organ)
✕. The counts of peripheral blood eosinophil cells ≥0.75×109/L
✕. 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