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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

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 5 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "This study aims to provide the first long-term (up to 5 years) assessment of renal function preservation in belimumab treated participants."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study looks at how well belimumab works in routine care for adults with active lupus nephritis (LN), kidney disease caused by lupus. It will track how well their kidneys keep working for up to 5 years.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Sign a consent form when joining the study.
  • Be age 18 or older when starting belimumab.
  • Have started belimumab 6 to 24 months before joining the study.
  • Have received belimumab as a shot under the skin or through a vein for active LN, following local prescribing rules.
  • Have used belimumab with standard medicines that lower immune system activity when treatment began.
  • Have medical records available from the 12 months before starting belimumab and from treatment onward, including a kidney biopsy report.
  • Have LN confirmed by a kidney biopsy (a test of a small tissue sample) before starting belimumab.
  • Have LN class III or IV, with or without class V, or class V alone. These are types of kidney damage caused by lupus.

Who can't join

  • Were on dialysis (treatment that filters the blood), had a kidney transplant, or had end-stage kidney disease when starting belimumab.
  • Were taking another antibody medicine that targets lupus or may weaken immune responses when starting belimumab.
  • Take part in a clinical trial during the study period. Other studies that only observe care are allowed.
  • Were pregnant when starting belimumab.
  • Are pregnant or planning to become pregnant when joining the study.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (4)

MD

NC

OH

TN