Status:
RECRUITING
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
Lead Sponsor:
GlaxoSmithKline
Conditions:
Lupus Nephritis
Eligibility:
All Genders
18+ years
Brief Summary
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. Thi...
Detailed Description
This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.
Eligibility Criteria
Inclusion
- Participants to provide a signed informed consent at the time of enrollment per protocol,
- Male or female aged 18 or over at initiation of belimumab,
- Participants received belimumab in any formulation (subcutaneous or intravenous) for the treatment of active LN prescribed as per local label in combination with standard immunosuppressive therapy/ies at initiation of belimumab,
- Participants initiated belimumab 6 to 24 months prior to study enrollment,
- Accessibility of medical records starting at belimumab initiation (including accessibility of medical records for the prior 12 months and confirmatory biopsy at any time prior to belimumab initiation),
- Biopsy-confirmed LN diagnosis at any time prior to belimumab initiation for treatment of LN
- Class III (focal LN) with or without Class V (membranous LN),
- Class IV (diffuse LN) with or without Class V,
- Class V.
Exclusion
- Participants receiving renal replacement therapy (i.e., dialysis, kidney transplant, or those in end-stage kidney disease) at initiation of belimumab,
- Participant is concomitantly receiving another SLE targeted monoclonal antibody (MAb), or a MAb expected to compromise immune responses, at initiation of belimumab,
- Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),
- Participant is pregnant at the initiation of belimumab,
- Participant with a kidney transplant at the initiation of belimumab,
- Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.
Key Trial Info
Start Date :
October 4 2024
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
March 29 2029
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT06527872
Start Date
October 4 2024
End Date
March 29 2029
Last Update
November 10 2025
Active Locations (1)
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1
GSK Investigational Site
Charlotte, North Carolina, United States, 28207