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

This trial does not accept healthy volunteers

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,

Trial population

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.

Trial design

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

None (Observational study)
Other intervention
Not Applicable since Observational Study

Treatment groups

300 Participants

are divided into 1 treatment group

Group A: All Participants cohort1 intervention

Trial outcomes

Primary outcomes

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.

Time frame

At Month 24

Secondary outcomes

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)

Time frame

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

Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.

Time frame

At Month 24

Change in the Daily Dose of Steroid (in milligrams per day) from the Initiation of Belimumab

Time frame

Baseline (Day 1) to Month 60

Estimated Glomerular Filtration Rate (eGFR) Slope over Time

Time frame

Up to Month 60