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Comparison of short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease
This is a monocenter, 72-week prospective, randomized controlled study to compare short-term glucocorticoid monotherapy and short-term glucocorticoid combined with MMF in the treatment of IgG4 Related Disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| short-term glucocorticoid monotherapy | Placebo Comparator | Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. |
|
| short-term glucocorticoid combined with Mycophenolate mofetil | Experimental | Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 months. Oral Mycophenolate mofetil 0.75g bid for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| prednison | Drug | Oral prednison starts at 0.6-0.8mg/kg/d, then tapered and withdrawal in 6 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 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels. | 72 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| The time of recurrence | Clinical recurrence definition: any item of IgG4-RD Responder Index >=2 points; Recurrence of previously involved organs or involvement of new organs; With or without elevated serum IgG4 levels. | 0-72 weeks |
| The changes of IgG4-related disease Responder Index |
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Inclusion Criteria:
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 | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D000077733 | Immunoglobulin G4-Related Disease |
| ID | Term |
|---|---|
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D011241 | Prednisone |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D011244 | Pregnadienediols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| Mycophenolate mofetil | Drug | Oral Mycophenolate mofetil 0.75g bid for 6 months. |
|
According to international multispecialty validation study of IgG4-related disease Responder Index (November, 2018), Responder Index ≥ 0, and higher scores mean a worse outcome. |
| 72 weeks |
| The changes of serum IgG4 levels | Level of serum IgG4(mg/dL) | 72 weeks |
| The percentages of adverse events | Adverse effect of drugs | 72 weeks |
| The changes of PGA | Changes of patient global assessment from baseline, score (0-10, higher is worse) | 72 weeks |
| The difference of remission rate of IgG4-RD between the two groups | Including complete remission rate, partial remission rate and total response rate. | 72 weeks |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
| D005227 | Fatty Acids |
| D008055 | Lipids |