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NCT06527872Recruiting

Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN

GlaxoSmithKline

Start Date

10/4/2024

Completion Date

3/29/2029

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. This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants.

Detailed Description

This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.

Eligibility Criteria

Age Range: 18 years to No maximum

Inclusion Criteria: * 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 Criteria: * 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.

Interventions

OTHER

None (Observational study)

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Conditions

Lupus Nephritis

Locations

GSK Investigational Site

Baltimore, Maryland 21287

United States

GSK Investigational Site

Charlotte, North Carolina 28207

United States

GSK Investigational Site

Columbus, Ohio 43201

United States

GSK Investigational Site

Hixson, Tennessee 37343-7908

United States

GSK Investigational Site

Marseille, 13005

France

GSK Investigational Site

Rozzano, Milan 20089

Italy

GSK Investigational Site

Fukuoka, 807-8556

Japan