Belimumab In Early Systemic Lupus Erythematosus

Study Overview
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Brief Summary
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To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).

Detailed Description
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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.

Official Title
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A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus

Conditions
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Lupus Erythematosus, Systemic

Intervention / Treatment
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* Biological: Belimumab
* Drug: Standard of care


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of SLE according to the 1997 American College of Rheumatology (ACR) classification criteria or 2019 EULAR/ACR classification criteria within three months, which is autoantibody-positive (antinuclear antibody titers ≥1:80, anti-double-stranded DNA antibodies, or both) 18-75 years of age body weight 45-80kg Disease duration of SLE ≤ 6months SELENA-2K score ≥6 scores Negative pregnancy test for child-bearing women at screening and baseline Provide written informed consent Exclusion Criteria: Known to be allergic to Prednisone Acetate, Meprednisone, Hydroxychloroquine, and Immunosuppressants including Mycophenolate Mofetil, Cyclophosphamide,et al Active serious neuropsychiatric systemic lupus erythematosus or other severe situations of SLE who need pulse steroid treatment Abnormal liver function (ALT or AST is 2 times higher than normal) Pregnancy or breastfeeding women; Have a history of malignant tumors; Have any serious acute, chronic or recurrent infectious disease (such as pneumonia or active stage of pyelitis, recurrent pneumonia, chronic bronchiectasis and tuberculosis) Chronic infections, such as Hepatitis B virus or hepatitis B and C and HIV; Previous visual obstruction, monocular dysfunction and cataract; Cardiac insufficiency with metabolic imbalance or severe high blood pressure (systolic pressure > 160mmHg or diastolic pressure > 100mmHg) or diabetics; Active hemorrhage or peptic ulcer; With other concommitant autoimmune disease; Receipt of B-cell-targeted therapy (including belimumab) within 1 year before randomization. Participated in other drugs clinical trials within 4 weeks.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belimumab 10 mg/kg plus standard of care<br>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 | Biological: Belimumab<br>* Belimumab 10 mg/kg<br>* Other names: BENLYSTA™;Drug: Standard of care<br>* Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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SLE, Belimumab