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

Status: Recruiting
Location: See all (5) locations...
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 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.

Locations
United States
Maryland
GSK Investigational Site
RECRUITING
Baltimore
North Carolina
GSK Investigational Site
RECRUITING
Charlotte
Ohio
GSK Investigational Site
RECRUITING
Columbus
Tennessee
GSK Investigational Site
RECRUITING
Hixson
Other Locations
Japan
GSK Investigational Site
RECRUITING
Fukuoka
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

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