Belimumab In Treatment of Early Systemic Lupus Erythematosus

• Status: Not yet recruiting
• Trial end date: 2023-12-30
• Target enrollment: 0
• Participant gender: All

Summary

To investigate the efficacy and impact on B cell subsets of belimumab in early SLE patients(disease duration less than 3 months).

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Peking Union Medical College Hospital
• Treatments: Belimumab

Criteria

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 ≤ 3months

• SELENA-SLEDAI score ≥8 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;

• Physicians will decide whether to use drugs if routine blood test is abnormal WBC<2x109/L or HGB<60g/L or PLT<50x109/L;

• 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.