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Clinical Trials in the USA / NCT06527872
Recruiting Observational

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

NCT06527872 · tracked via the Priya Life Science USA tracker
Sponsor
GlaxoSmithKline
Phase
Observational
Started
2024-10-04
Last updated
2026-07-02

Condition(s) studied

Lupus Nephritis

Investigational drug(s) / intervention(s)

None (Observational study)

None (Observational study): Not Applicable since Observational Study

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * 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. Exclusion Criteria: * Participants receiving renal replacement therapy (i.e., dialysis, kidney transplant, or those in end-stage kidney disease) at initiation of belimumab, * Participant is concomitantly receiving another SLE targeted monoclonal antibody (MAb), or a MAb expected to compromise immune responses, at initiation of belimumab, * Participants in a clinical trial during the observation period (with the exception of allowing participation in other non-interventional studies), * Participant is pregnant at the initiation of belimumab, * Participant with a kidney transplant at the initiation of belimumab, * Participants will be excluded from the study if they are planning to become pregnant or are pregnant at study enrollment.

Primary outcome measure(s)

Trial sites (7)

FacilityCityRegionStatus
GSK Investigational Site Baltimore Maryland Recruiting
GSK Investigational Site Charlotte North Carolina Recruiting
GSK Investigational Site Columbus Ohio Recruiting
GSK Investigational Site Hixson Tennessee Recruiting
GSK Investigational Site Marseille France Recruiting
GSK Investigational Site Rozzano Milan Recruiting
GSK Investigational Site Fukuoka Japan Recruiting

More GlaxoSmithKline trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06527872 on ClinicalTrials.gov ↗ ← All trials in the USA