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

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
North Carolina
GSK Investigational Site
RECRUITING
Charlotte
Contact Information
Primary
US GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
877-379-3718
Backup
EU GSK Clinical Trials Call Center
GSKClinicalSupportHD@gsk.com
+44 (0) 20 89904466
Time Frame
Start Date: 2024-10-04
Estimated Completion Date: 2029-03-29
Participants
Target number of participants: 300
Treatments
All Participants cohort
Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.
Sponsors
Leads: GlaxoSmithKline

This content was sourced from clinicaltrials.gov