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

GlaxoSmithKline (GSK)

Status: Enrolling

Conditions: Lupus Nephritis

Treatments: Other: None (Observational study)

Study type: Observational

Funder types: Industry

Identifiers

NCT06527872

216147

Details and patient eligibility

About

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.

Full description

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

Enrollment: 300 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

300 participants in 1 patient group

All Participants cohort

Description:

Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.

Treatment:

Other: None (Observational study)