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

Recruiting now

Conditions studied: Lupus Nephritis

In brief

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.

Key facts

Study ID

NCT06527872

Run by

GlaxoSmithKline

People needed

300

Starts

2024-10-04

Expected to finish

2029-03-29

Last updated by the study team

2026-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• GSK Investigational Site — Baltimore, Maryland, United States (enrolling)
• GSK Investigational Site — Charlotte, North Carolina, United States (enrolling)
• GSK Investigational Site — Columbus, Ohio, United States (enrolling)
• GSK Investigational Site — Hixson, Tennessee, United States (enrolling)
• GSK Investigational Site — Marseille, France (enrolling)
• GSK Investigational Site — Rozzano, Milan, Italy (enrolling)
• GSK Investigational Site — Fukuoka, Japan (enrolling)

Full record on ClinicalTrials.gov

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