Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN

Last updated: November 4, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Recruiting

Phase

N/A

Condition

Lupus Nephritis

Kidney Disease

Nephritis

Treatment

None (Observational study)

Clinical Study ID

NCT06527872
216147
  • Ages > 18
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Participants to provide a signed informed consent at the time of enrollment perprotocol,

  • Male or female aged 18 or over at initiation of belimumab,

  • Participants received belimumab for the treatment of active LN prescribed as perlocal label in combination with standard immunosuppressive therapy/ies at initiationof belimumab,

  • Participants initiated belimumab 6 to 24 months prior to study enrollment,

  • Accessibility of medical records starting at belimumab initiation (includingaccessibility of medical records for the prior 12 months and confirmatory biopsywithin the prior 24 months from belimumab initiation),

  • Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation ofbelimumab

  • Class III (focal LN) with or without Class V (membranous LN),

  • Class IV (diffuse LN) with or without Class V,

  • Class V.

Exclusion

Exclusion Criteria:

  • Participants receiving renal replacement therapy at initiation of belimumab,

  • Participant is concomitantly receiving another biologic at initiation of belimumab,

  • Participants in a clinical trial during the observation period (with the exceptionof 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 pregnantor are pregnant at study enrollment.

Study Design

Total Participants: 300
Treatment Group(s): 1
Primary Treatment: None (Observational study)
Phase:
Study Start date:
October 04, 2024
Estimated Completion Date:
March 29, 2029

Connect with a study center

  • GSK Investigational Site

    Charlotte, North Carolina 28207
    United States

    Active - Recruiting

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