NCT06527872 · GlaxoSmithKline
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
(OBSErve-LN)
What this study is 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.
View original scientific 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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,
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.
Where
- Baltimore, Maryland
- Charlotte, North Carolina
- Columbus, Ohio
- Hixson, Tennessee
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 2, 2026 · Source of record for eligibility and locations