Last updated: 01/31/2023 13:00:26

Evaluation of use of belimumab in clinical practice settings

GSK study ID
117295
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2014-30-09
    Observational study model:
    Cohort
    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)

    This study does not involve prospective enrollment of participants.

    Study documents

    Protocol
    Available language(s): English
    Download document(s)
    Scientific result summary
    Available language(s): English
    Download document(s)

    If you wish to request for full study report, please contact - [email protected]

    Results overview

    Refer to study documents

    Recruitment status
    Study complete
    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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