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

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
GlaxoSmithKline
Study ID
NCT06527872
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • None (Observational study) — OTHER
    Not Applicable since Observational Study

Study Details

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.

Key Dates

Start date
Oct 4, 2024
Status verified
Mar 2026
Primary completion
Mar 29, 2029
Completion
Mar 29, 2029

Study Design

Enrollment
300 participants (estimated)

Arms

  • Arm: All Participants cohort
    Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.

Primary Outcome Measure

Number of Participants Maintaining Renal Function (Less than Equal to [<=] 30 Percentage [%] Decline in Estimated Glomerular Filtration Rate [eGFR] from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy [ Time Frame: At Month 24 ]

Central Contacts

Locations (4)

FacilityCityStateZIPSite coordinators
GSK Investigational SiteBaltimoreMaryland21287
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Michelle Petri (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteCharlotteNorth Carolina28207
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Gordon Lam (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteColumbusOhio43201
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Isabelle Ayoub (PRINCIPAL_INVESTIGATOR)
GSK Investigational SiteHixsonTennessee37343-7908
US GSK Clinical Trials Call Center
[email protected]
877-379-3718
EU GSK Clinical Trials Call Centre
[email protected]
+44 (0) 20 8990 4466
Joseph Huffstutter (PRINCIPAL_INVESTIGATOR)

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