Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
Key facts
- Where
- Rozzano, ItalySee the site
Where in Italy
- RozzanoRozzano, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- GlaxoSmithKline
- Trial code
- NCT06527872
- Record updated
- 2 July 2026
- Original description
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.Read full original descriptionShow less
The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN 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.
Inclusion: 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: 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,; Participant with a kidney transplant at the 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,; Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.