Actively Recruiting
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
Led by GlaxoSmithKline · Updated on 2026-03-27
300
Participants Needed
5
Research Sites
233 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The purpose of the OBSErve-LN study is to assess the real-world use and effectiveness of belimumab in routine practice for the treatment of adults with active LN in multiple countries of interest. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.
CONDITIONS
Official Title
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Provide signed informed consent at enrollment per protocol
- Male or female aged 18 years or older at initiation of belimumab
- Received belimumab (subcutaneous or intravenous) for active LN as per local label combined with standard immunosuppressive therapy at belimumab initiation
- Initiated belimumab 6 to 24 months prior to study enrollment
- Accessible medical records from belimumab initiation, including 12 months prior and confirmatory biopsy before belimumab initiation
- Biopsy-confirmed diagnosis of LN prior to belimumab initiation
- LN Class III with or without Class V, Class IV with or without Class V, or Class V
You will not qualify if you...
- Receiving renal replacement therapy (dialysis, kidney transplant, or end-stage kidney disease) at belimumab initiation
- Receiving another SLE targeted monoclonal antibody or one expected to compromise immune responses at belimumab initiation
- Participating in a clinical trial during the observation period (except other non-interventional studies allowed)
- Pregnant at belimumab initiation
- Had a kidney transplant at belimumab initiation
- Planning to become pregnant or pregnant at study enrollment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 5 locations
1
GSK Investigational Site
Baltimore, Maryland, United States, 21287
Actively Recruiting
2
GSK Investigational Site
Charlotte, North Carolina, United States, 28207
Actively Recruiting
3
GSK Investigational Site
Columbus, Ohio, United States, 43201
Actively Recruiting
4
GSK Investigational Site
Hixson, Tennessee, United States, 37343-7908
Actively Recruiting
5
GSK Investigational Site
Fukuoka, Japan, 807-8556
Actively Recruiting
Research Team
U
US GSK Clinical Trials Call Center
CONTACT
E
EU GSK Clinical Trials Call Center
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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