Belimumab In Early Systemic Lupus Erythematosus

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase

Completed

Phase 4

Conditions

Lupus Erythematosus, Systemic

Treatments

Biological: Belimumab

Drug: Standard of care

Study type

Interventional

Funder types

Other

Identifiers

NCT04956484

LXM-210622

Details and patient eligibility

About

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

Full 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.

Enrollment

16 patients

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

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.