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

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.

Conditions

Lupus Nephritis

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Study Overview

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Study Details

Study overview

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.

The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study

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

Condition
Lupus Nephritis
Intervention / Treatment

-

Contacts and Locations

Charlotte

GSK Investigational Site, Charlotte, North Carolina, United States, 28207

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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 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 within the prior 24 months from belimumab initiation),
  • * Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation of belimumab
  • * Class III (focal LN) with or without Class V (membranous LN),
  • * Class IV (diffuse LN) with or without Class V,
  • * Class V.
  • * 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 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

GlaxoSmithKline,

Study Record Dates

2029-03-29