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| Name | Class |
|---|---|
| Tongji Hospital | OTHER |
| Beijing Friendship Hospital | OTHER |
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Evaluation of efficacy and safety of Baricitinib combined with glucocorticoid in patients of IgG4-related disease with eosinophilia.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Prednisolone monotherapy | Placebo Comparator | Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. |
|
| Prednisolone plus Baricitinib | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Prednisolone | Drug | Oral prednisolone 0.6-0.8mg/kg daily for 4 weeks, then tapered and withdrawal in 4 months. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The difference of recurrent rate of IgG4-RD between the two groups | 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. | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The time of recurrence | 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. | 0-52 weeks |
| The changes of IgG4-related disease Responder Index |
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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:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Linyi Peng, MD | Contact | +8615810395901 | drpenglinyi@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Wen Zhang, MD | Peking Union Medical College Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College Hospital | Recruiting | Beijing | Bejing | 100050 | China |
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| ID | Term |
|---|---|
| D000077733 | Immunoglobulin G4-Related Disease |
| D004802 | Eosinophilia |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D007960 | Leukocyte Disorders |
| D006402 | Hematologic Diseases |
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| ID | Term |
|---|---|
| D011239 | Prednisolone |
| C000596027 | baricitinib |
| ID | Term |
|---|---|
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
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| Baricitinib | Drug | Oral Baricitinib 2mg daily for 12 months. |
|
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. |
| 52 weeks |
| The changes of blood Eosinophil cells | Percentages (%) and counts (109) of peripheral eosinophil cells | 52 weeks |
| The changes of serum IgG levels | Level of serum IgG(g/L) | 52 weeks |
| The changes of serum IgG4 levels | Level of serum IgG4(mg/dL) | 52 weeks |
| The changes of serum hsCRP level | Level of serum high-sensitivity C-reactive protein level(mg/L) | 52 weeks |
| The changes of ESR | Serum erythrocyte sedimentation rate(mm/h) | 52 weeks |
| The percentages of adverse events | Adverse effect of drugs | 52 weeks |
| The changes of PGA | Changes of patient global assessment from baseline, score (0-10, higher is worse) | 52 weeks |
| The results of High-throughput analysis | The changes of results from baseline in High-throughput analysis, including GWAS, single cell sequencing of B cell receptor. | 52 weeks |
| D006425 |
| Hemic and Lymphatic Diseases |
| D000072473 |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |