Lupus Erythematosus, Systemic
Conditions
Keywords
SLE, Belimumab
Brief summary
To investigate the efficacy of belimumab in early SLE patients (disease duration less than 6 months).
Detailed description
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.
Interventions
BIOLOGICALBelimumab
Belimumab 10 mg/kg
DRUGStandard of care
Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.
Sponsors
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| LLDAS | week 24 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complement levels | week 12, week 24 | Changes in measures of C3, C4 |
| Dynamics of immune cell subsets | week 12, week 24 | T cell and B cell subsets |
| Serologies | week 12, week 24 | Changes in titers of anti-DNA antibody levels |
| Remission | week 12, week 24 | 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 |
| LLDAS | week 12 | 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 |
| Glucocorticoid tapering | week 12, week 24 | A prednisone dose that was decreased≤ 7.5mg/d |
Countries
China
Outcome results
None listed