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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
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
- None (Observational study) (other)
Sponsor: GlaxoSmithKline · Participants: 300 · Started: Oct 4, 2024
Contact the study team
- US GSK Clinical Trials Call Center · Phone: 877-379-3718
- EU GSK Clinical Trials Call Center · Phone: +44 (0) 20 89904466
Official record on ClinicalTrials.gov — NCT06527872
Locations in the U.S.
| Maryland | GSK Investigational Site, Baltimore |
| North Carolina | GSK Investigational Site, Charlotte |
| Ohio | GSK Investigational Site, Columbus |
| Tennessee | GSK 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.