Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN (NCT06527872) | Clinical Trial Compass
RecruitingNot Applicable
Study to Assess Real-world Effectiveness of Belimumab for Treatment of Adults With LN
United States, Japan300 participantsStarted 2024-10-04
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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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 i…
What they're measuring
1
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