RecruitingNCT06527872

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

The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study

Sponsor

GlaxoSmithKline

Enrollment

300 participants

Start Date

Oct 4, 2024

Study Type

OBSERVATIONAL

Conditions

Lupus Nephritis

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria9

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 Criteria6

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.

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