The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 300
- 试验地点
- 7
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
This is a Phase 4 study and will involve both prospective and retrospective data collection from participants.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- •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.
研究组 & 干预措施
All Participants cohort
Participants with active LN who initiated belimumab as per local label alongside standard therapy/ies under routine care conditions.
干预措施: None (Observational study) (Other)
结局指标
主要结局
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
时间窗: At Month 24
Renal replacement therapy will involve participants requiring dialysis, kidney transplant, or those in end-stage kidney disease.
次要结局
- Time to Achieving eGFR 30% and 40% Reduction(Up to Month 60)
- 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)(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(At Month 24)
- Change in the Daily Dose of Steroid (in milligrams per day) from the Initiation of Belimumab(Baseline (Day 1) to Month 60)
- Estimated Glomerular Filtration Rate (eGFR) Slope over Time(Up to Month 60)
- Time to Initiating Renal Replacement Therapy(Up to Month 60)
- Number of Participants Maintaining Renal Function (<=30% Decline in eGFR from the Initiation of Belimumab) and Not Requiring Renal Replacement Therapy(At Month 60)