What this study is
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.
What's being tested
- None (Observational study)
Intervention · OTHER
Not Applicable since Observational Study
Study details
- Official title
- The Evaluation Of Use of Belimumab in Routine Care SEttings in Lupus Nephritis (LN): the OBSErve-LN Study
- Sponsor
- GlaxoSmithKline
- Conditions
- Lupus Nephritis
- Enrolling
- 300 people
- Starts
- 2024-10-04
- Est. completion
- 2029-03-29
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- 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.
You can't join if
- 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.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (5)
5 openContact for every open site
- US GSK Clinical Trials Call Center · Contact877-379-3718GSKClinicalSupportHD@gsk.com
- EU GSK Clinical Trials Call Centre · Contact+44 (0) 20 8990 4466GSKClinicalSupportHD@gsk.com
GSK Investigational Site
Baltimore, Maryland, United States
- Michelle Petri · Principal investigator
RecruitingGSK Investigational Site
Charlotte, North Carolina, United States
- Gordon Lam · Principal investigator
RecruitingGSK Investigational Site
Columbus, Ohio, United States
- Isabelle Ayoub · Principal investigator
RecruitingGSK Investigational Site
Hixson, Tennessee, United States
- Joseph Huffstutter · Principal investigator
Recruiting
1 site outside the US
GSK Investigational Site
Fukuoka, Japan
- Shingo Nakayamada · Principal investigator
Recruiting
Study team
Sponsor
GlaxoSmithKline
Study ID 216147
Study director
GSK Clinical Trials
GlaxoSmithKline
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.