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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.
This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| All Participants cohort | Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| None (Observational study) | Other | Not Applicable since Observational Study |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. | At Month 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants Achieving Modified Partial Renal Response (<=20% Decline in eGFR and <=0.7 Urine Protein-Creatinine Ratio [uPCR]) and Modified Complete Renal Response (<=10% Decline in eGFR and <=0.5 uPCR) | At Months 24 and 60 | |
| Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy (in Those that Remain Adherent to Belimumab) at Month 24 |
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Inclusion Criteria:
Exclusion Criteria:
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The study will include participants with lupus nephritis who initiated belimumab prescribed as per local label alongside standard therapy/ies under routine care conditions in the countries of interest.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| 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 |
| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Recruiting | Baltimore | Maryland | 21287 | United States |
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| ID | Term |
|---|---|
| D008181 | Lupus Nephritis |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D019370 | Observation |
| ID | Term |
|---|---|
| D008722 | Methods |
| D008919 | Investigative Techniques |
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Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. |
| At Month 24 |
| Change in the Daily Dose of Steroid (in milligrams per day) from the Initiation of Belimumab | Baseline (Day 1) to Month 60 |
| Estimated Glomerular Filtration Rate (eGFR) Slope over Time | Up to Month 60 |
| Time to Achieving eGFR 30% and 40% Reduction | Up to Month 60 |
| Time to Initiating Renal Replacement Therapy | Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. | Up to Month 60 |
| Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy | Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease. | At Month 60 |
| GSK Investigational Site | Recruiting | Charlotte | North Carolina | 28207 | United States |
|
| GSK Investigational Site | Recruiting | Columbus | Ohio | 43201 | United States |
|
| GSK Investigational Site | Recruiting | Hixson | Tennessee | 37343-7908 | United States |
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| GSK Investigational Site | Recruiting | Marseille | 13005 | France |
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| GSK Investigational Site | Recruiting | Rozzano | Milan | 20089 | Italy |
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| GSK Investigational Site | Recruiting | Fukuoka | 807-8556 | Japan |
|
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D008180 | Lupus Erythematosus, Systemic |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |