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Efficacy and Safety of Belimumab in SLE Patients

NCT04515719 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 231

Last updated 2025-05-14

No results posted yet for this study

Summary

Systemic lupus erythematosus (SLE) is a chronic inflammatory systemic autoimmune disease. Recurrent relapses of disease and development of long-term organ damage are two key unsolved clinical problems. Belimumab is the only FDA-approved biological agent for SLE. Data showed that treatment with belimumab on the background of standard therapy was effective in active SLE patients. However, the efficacy of low-dose belimumab for prevention of disease flares in SLE patients with low disease activity is to be explored.

Conditions

Interventions

BIOLOGICAL

Belimumab

Belimumab 2mg/kg intravenously

BIOLOGICAL

Placebo

Placebo intravenously

Sponsors & Collaborators

  • RenJi Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-03-10
Primary Completion
2022-04-10
Completion
2022-04-10

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04515719 on ClinicalTrials.gov