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

RecruitingObservational study

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

Who can join

Ages 18 and older · All sexes

Full eligibility criteria
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.

About the study

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.

What is being tested

Sponsor: GlaxoSmithKline · Participants: 300 · Started: Oct 4, 2024

Contact the study team

Official record on ClinicalTrials.gov — NCT06527872

Locations in the U.S.

MarylandGSK Investigational Site, Baltimore
North CarolinaGSK Investigational Site, Charlotte
OhioGSK Investigational Site, Columbus
TennesseeGSK Investigational Site, Hixson

Conditions

From ClinicalTrials.gov, data retrieved Oct 3, 2026. Each study sets its own eligibility; the study team decides who can join.