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To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).
This is a single arm, 24 weeks, pilot trial. All patients will be treated with standard of care plus Belimumab (at a dose of 10 mg per kilogram of body weight) .
The primary endpoint is the proportion of LLDAS in week 24.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Belimumab 10 mg/kg plus standard of care | Experimental | Standard of care and Belimumab: 10 mg per kilogram of body weight,days 1 (baseline), 15, and 29 and every 28 days thereafter to week 24 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Belimumab | Biological | Belimumab 10 mg/kg |
|
| Measure | Description | Time Frame |
|---|---|---|
| LLDAS | Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Serologies | Changes in titers of anti-DNA antibody levels | week 12, week 24 |
| Complement levels | Changes in measures of C3, C4 | week 12, week 24 |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking Union Medical College hospital | Beijing | Dongcheng | 100730 | China |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C511911 | belimumab |
| D059039 | Standard of Care |
| ID | Term |
|---|---|
| D019984 | Quality Indicators, Health Care |
| D011787 | Quality of Health Care |
| D006298 | Health Services Administration |
| D017530 | Health Care Quality, Access, and Evaluation |
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| Standard of care | Drug | Steroid(≤1mg/kg/d) with or without proper immunosuppressants:CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc. |
|
| Dynamics of immune cell subsets | T cell and B cell subsets | week 12, week 24 |
| Glucocorticoid tapering | A prednisone dose that was decreased≤ 7.5mg/d | week 12, week 24 |
| Remission | a clinical SLEDAI-2K of 0 (disregarding the serology, including anti-dsDNA and complements), Physician Global Assessment <0.5 (0-3). The patient may be on antimalarials, low-dose glucocorticoids (prednisolone ≤5 mg/day), and/or stable immunosuppressives including biologics | week 12, week 24 |
| LLDAS | Lupus low disease activity status (LLDAS) was defined as SLEDAI-2K ≤4, no activity in any major organ, no new disease activity feature, PGA ≤1, prednisone ≤7.5 mg/day, and allowance for maintenance of IS and antimalarials | week 12 |