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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	No
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	18 Years and Over
Gender	All

More Inclusion & Exclusion Criteria

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 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 within the prior 24 months from belimumab initiation), - Biopsy-confirmed diagnosis of active LN in the two-years prior to the initiation of belimumab.

- 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 at initiation of belimumab, - Participant is concomitantly receiving another biologic 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.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT06527872
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	GlaxoSmithKline
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	N/A
Principal Investigator Affiliation	N/A
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	Industry
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Lupus Nephritis

Arms & Interventions

Arms

: All Participants cohort

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

Interventions

Other: - None (Observational study)

Not Applicable since Observational Study

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

GSK Investigational Site, Charlotte, North Carolina

Status

Recruiting

Address

GSK Investigational Site

Charlotte, North Carolina, 28207

Site Contact

US GSK Clinical Trials Call Center

[email protected]

877-379-3718

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