NCT06527872Recruiting
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
Source: ClinicalTrials.gov · Last updated 2 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 300 (estimated)
- First submitted
- 26 Jul 2024
- Start date
- 4 Oct 2024
- Primary completion date
- 29 Mar 2029
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Lupus (SLE)
- NCT number
- NCT06527872
What you commit to
- Study type: Observational
- Planned participants: 300
- From 4 Oct 2024 to the primary completion date, 29 Mar 2029
- 7 sites in 4 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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,
Other
- 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.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (7)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Marseille | France | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Rozzano | Italy | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Fukuoka | Japan | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Baltimore | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Charlotte | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Columbus | United States | Recruiting |
| GSK Investigational Site Coordinator of this site? Confirm its status | Hixson | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.