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

ConditionLupus Nephritis

Trial statusRecruiting

Trial phaseNot listed

Trial typeObservational

Biological sexAll

Age18+

SponsorGlaxoSmithKline

About this trial

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 criteria

Qualifiers

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,

Disqualifiers

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,