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

NCT ID: NCT06527872

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-10-04

Study Completion Date

2029-03-29

Brief Summary

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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.

Detailed Description

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This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.

Conditions

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Lupus Nephritis

Keywords

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Belimumab Lupus nephritis OBSErve-LN Renal function Real world data

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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All Participants cohort

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

None (Observational study)

Intervention Type OTHER

Not Applicable since Observational Study

Interventions

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None (Observational study)

Not Applicable since Observational Study

Intervention Type OTHER

Other Intervention Names

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Observational Study

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Charlotte, North Carolina, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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US GSK Clinical Trials Call Center

Role: CONTACT

Phone: 877-379-3718

Email: [email protected]

EU GSK Clinical Trials Call Center

Role: CONTACT

Phone: +44 (0) 20 89904466

Email: [email protected]

Facility Contacts

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US GSK Clinical Trials Call Center

Role: primary

EU GSK Clinical Trials Call Centre

Role: backup

Other Identifiers

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216147

Identifier Type: -

Identifier Source: org_study_id