RECRUITING

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

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Conditions

Lupus NephritisBelimumabOBSErve-LNRenal functionReal world data

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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

Quick Facts

Study Start:2024-10-04
Study Completion:2029-03-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06527872

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants to provide a signed informed consent at the time of enrollment per protocol,
  2. * Male or female aged 18 or over at initiation of belimumab,
  3. * 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,
  4. * Participants initiated belimumab 6 to 24 months prior to study enrollment,
  5. * 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),
  6. * Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation of belimumab
  7. * Class III (focal LN) with or without Class V (membranous LN),
  8. * Class IV (diffuse LN) with or without Class V,
  9. * Class V.
  1. * Participants receiving renal replacement therapy at initiation of belimumab,
  2. * Participant is concomitantly receiving another biologic at initiation of belimumab,
  3. * Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies),
  4. * Participant is pregnant at the initiation of belimumab,
  5. * Participant with a kidney transplant at the initiation of belimumab,
  6. * Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.

Contacts and Locations

Study Contact

US GSK Clinical Trials Call Center
CONTACT
877-379-3718
GSKClinicalSupportHD@gsk.com
EU GSK Clinical Trials Call Center
CONTACT
+44 (0) 20 89904466
GSKClinicalSupportHD@gsk.com

Study Locations (Sites)

GSK Investigational Site
Charlotte, North Carolina, 28207
United States

Collaborators and Investigators

Sponsor: GlaxoSmithKline

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-10-04
Study Completion Date2029-03-29

Study Record Updates

Study Start Date2024-10-04
Study Completion Date2029-03-29

Terms related to this study

Keywords Provided by Researchers

  • Belimumab
  • Lupus nephritis
  • OBSErve-LN
  • Renal function
  • Real world data

Additional Relevant MeSH Terms

  • Lupus Nephritis