Baricitinib Plus Glucocorticoid for Eosinophilia in IgG4-RD
Study Details
Study Description
Brief Summary
Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| N/A |
Detailed Description
This is a multicenter, 52-week prospective, randomized controlled study to compare the efficacy and safety of Baricitinib combined with glucocorticoid and glucocorticoid monotherapy in proliferative IgG4-RD patients with eosinophilia.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Prednisolone monotherapy Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. |
Drug: Prednisolone
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
|
| Experimental: Prednisolone plus Baricitinib 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. |
Drug: Prednisolone
Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months.
Drug: Baricitinib
Oral Baricitinib 2mg daily for 12 months.
|
Outcome Measures
Primary Outcome Measures
- The difference of recurrent rate of IgG4-RD between the two groups [52 weeks]
Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.
Secondary Outcome Measures
- The time of recurrence [0-52 weeks]
Clinical recurrence definition: any item of IgG4-RD Responder Index ≥2 (without treatment), or ≥ 3 (with treatment) or new organ involvement; with or without elevated serum IgG4 levels.
- The changes of IgG4-related disease Responder Index [52 weeks]
According to international multispecialty validation study of IgG4-related disease Responder Index (Version: 13, December, 2015), Responder Index ≥ 0, and higher scores mean a worse outcome.
- The changes of blood Eosinophil cells [52 weeks]
Percentages (%) and counts (109) of peripheral eosinophil cells
- The changes of serum IgG levels [52 weeks]
Level of serum IgG(g/L)
- The changes of serum IgG4 levels [52 weeks]
Level of serum IgG4(mg/dL)
- The changes of serum hsCRP level [52 weeks]
Level of serum high-sensitivity C-reactive protein level(mg/L)
- The changes of ESR [52 weeks]
Serum erythrocyte sedimentation rate(mm/h)
- The percentages of adverse events [52 weeks]
Adverse effect of drugs
- The changes of PGA [52 weeks]
Changes of patient global assessment from baseline, score (0-10, higher is worse)
- The results of High-throughput analysis [52 weeks]
The changes of results from baseline in High-throughput analysis, including GWAS, single cell sequencing of B cell receptor.
Eligibility Criteria
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.
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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
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Concomitant other autoimmune diseases
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Malignancy
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Chronic HBV infection, latent tuberculosis, or active infection
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Server liver or renal dysfunction, or heart failure.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Peking Union Medical College Hospital | Beijing | Bejing | China | 100050 |
Sponsors and Collaborators
- Wen Zhang
- Tongji Hospital
- Beijing Friendship Hospital
Investigators
- Principal Investigator: Wen Zhang, MD, Peking Union Medical College Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Baricitinib for Eosinophilia