NCT04956484

Belimumab In Early Systemic Lupus Erythematosus

A Single Arm, 24 Weeks, Pilot Study of Belimumab In Treatment of Early Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Peking Union Medical College Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
BIOLOGICAL	Belimumab	Belimumab 10 mg/kg
DRUG	Standard of care	Steroid(≤1mg/kg/d) with or without proper immunosuppressants：CTX, MMF, AZA, CsA, FK 506, HCQ, MTX, LEF, SASP etc.

Timeline

• Start date: 2021-09-01
• Primary completion: 2022-04-08
• Completion: 2022-04-08
• First posted: 2021-07-09
• Last updated: 2022-07-08

Locations

1 site across 1 country: China

Regulatory

• FDA-regulated drug study