Belimumab In Early Systemic Lupus Erythematosus

NCT ID: NCT04956484

Last Updated: 2022-07-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-09-01
• Study Completion Date: 2022-04-08

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.

Conditions

Lupus Erythematosus, Systemic

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Belimumab 10 mg/kg plus 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

Group Type: EXPERIMENTAL

Belimumab

Intervention Type: BIOLOGICAL

Belimumab 10 mg/kg

Standard of care

Intervention Type: DRUG

Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Interventions

Belimumab

Belimumab 10 mg/kg

Intervention Type: BIOLOGICAL

Standard of care

Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Intervention Type: DRUG

Other Intervention Names

BENLYSTA™

Eligibility 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 ≤ 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Peking Union Medical College hospital

Beijing, Dongcheng, China

Countries

China

Other Identifiers

LXM-210622

Identifier Type: -

Identifier Source: org_study_id