Last updated: 01/31/2023 13:00:26
Evaluation of use of belimumab in clinical practice settings
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Evaluation of use of belimumab in clinical practice settings
Trial description: Systemic lupus erythematosus (SLE) is a complex and severe rheumatic disease with diverse clinical manifestations. Belimumab is a B-lymphocyte stimulator (BLyS)-specific inhibitor that is indicated for the treatment of patients with active, autoantibody-positive SLE who are receiving standard therapy including corticosteroids, antimalarials, immunomodulatory agents, and non steroidal anti-inflammatory drugs. Understanding the utilization patterns and outcomes associated with belimumab may help inform future research.The objective of this study is to examine data from clinical practices in the United States, to describe the characteristics of patients receiving belimumab, and to describe the overall patterns of SLE care for belimumab users in clinical practice during the first 6 months of its usage. As a secondary objective, the study will describe healthcare resource utilization among users of belimumab in clinical practice. The study design is a retrospective, multi-center, observational cohort study. The data source will be blinded medical records data from a nationally representative, stratified random sample of 150 rheumatologists who have prescribed belimumab.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change in SLE disease manifestations
Timeframe: 6 months prior to index date and 6 months post-index date
Secondary outcomes:
Healthcare Resource Utilization
Timeframe: 6 months prior to index date and 6 months post-index date
Interventions:
Drug: Belimumab-treated subjects
Enrollment:
501
Observational study model:
Cohort
Primary completion date:
2014-30-09
Time perspective:
Retrospective
Clinical publications:
C E Collins, M Dall'Era, H Kan, C Macahilig, C Molta, V Koscielny and D J Chang.Response to belimumab among patients with systemic lupus erythematosus in clinical practice settings: 24-month results from the OBSErve study in the USA.Lupus Sci Med.2016;3:e000118
Christopher F Bell, Jake Chung, Bernard Rubin.Real-world clinical outcomes in belimumab-treated US African American and Hispanic patients with systemic lupus erythematosus: a retrospective, observational study.Rheumatol Ther.2023;
DOI: https://doi.org/10.1007/s40744-022-00524-y
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
August 2012 to September 2014
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
none
- Diagnosed with SLE
- Adults at least 18 years old
- Subjects enrolled in an SLE-related clinical trial
Inclusion and exclusion criteria
Inclusion criteria:
- Diagnosed with SLE
- Adults at least 18 years old
- Prescribed belimumab by treating physician as part of usual care
- Received at least 8 belimumab infusions
- Reason for belimumab initiation can be identified
- Medical history must be available for chart abstraction as defined by the study period
Exclusion criteria:
- Subjects enrolled in an SLE-related clinical trial
Trial location(s)
No location data available.
Study documents
Protocol
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
2014-30-09
Actual study completion date
2014-30-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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