Belimumab In Early Systemic Lupus Erythematosus
- Conditions
- Lupus Erythematosus, Systemic
- Interventions
- Biological: BelimumabDrug: Standard of care
- Registration Number
- NCT04956484
- Lead Sponsor
- Peking Union Medical College Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 16
- 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
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Belimumab 10 mg/kg plus standard of care Standard of care 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 Belimumab 10 mg/kg plus standard of care Belimumab 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Serologies week 12, week 24 Changes in titers of anti-DNA antibody levels
Dynamics of immune cell subsets week 12, week 24 T cell and B cell subsets
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
Complement levels week 12, week 24 Changes in measures of C3, C4
Glucocorticoid tapering week 12, week 24 A prednisone dose that was decreased≤ 7.5mg/d
Trial Locations
- Locations (1)
Peking Union Medical College hospital
🇨🇳Beijing, Dongcheng, China