Last updated: 07/21/2020 18:50:06

HO-16-16593 - Treatment Patterns, Discontinuation and pre-post analysis of Belimumab in the real-world setting

GSK study ID
206345
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: HO-16-16593 - Treatment Patterns, Discontinuation and pre-post analysis of Belimumab in the real-world setting
Trial description: Belimumab is a human monoclonal antibody that was approved by the United states (US) Food and Drug Administration in March 2011 for use among Systemic Lupus Erythematosus (SLE) Subjects. While initiating treatment of Belimumab, the first three administrations are given every two weeks (i.e., days 0, 14 and 28), in a period of time is known as the “initiation period”. Following the initiation period, dosing is one belimumab administration every four weeks. Published literature to date has not investigated belimumab treatment patterns and discontinuation, and frequency and timing of belimumab administrations during the initiation period and post-initiation period. Therefore this retrospective study will use the database from the Truven Health MarketScan Commercial Database from 01 Sep 2010 to 31 Dec 2015 to assess the clinical and economic outcomes related to belimumab treatment.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of inpatient admission

Timeframe: Up to 5 years 4 months

Number of visits to physician's office

Timeframe: Up to 5 years 4 months

Number of emergency room visit

Timeframe: Up to 5 years 4 months

Number of hospital based out-patient visit

Timeframe: Up to 5 years 4 months

Number of Laboratory services required by subjects

Timeframe: Up to 5 years 4 months

Number of Outpatient pharmacy prescription

Timeframe: Up to 5 years 4 months

Total cost per subject

Timeframe: Up to 5 years 4 months

Cumulative overall Oral corticosteroid (OCS) dose per subject

Timeframe: Up to 5 years 4 months

Average daily OCS dose

Timeframe: Up to 5 years 4 months

Secondary outcomes:

Frequency of Belimumab administration during study period

Timeframe: Up to 5 years 4 months

Timing of Belimumab administration during study period

Timeframe: Up to 5 years 4 months

Concomitant medication used during the study period

Timeframe: Up to 5 years 4 months

Number of subject discontinuing belimumab treatment

Timeframe: Up to 5 years 4 months

Number of subject persisting belimumab treatment

Timeframe: Up to 5 years 4 months

Frequency of SLE flare episodes

Timeframe: Up to 5 years 4 months

Severity of SLE flare Episodes

Timeframe: Up to 5 years 4 months

Interventions:
  • Drug: Belimumab
    • Enrollment:
    0
    Primary completion date:
    2018-26-02
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Bell C, Priest J, Stott-Miller M, Kan H, Amelio J, Song X, Limone, B, Noxon V, Costenbader K.Real-world treatment patterns, healthcare resource utilisation and costs in patients with systemic lupus erythematosus treated with belimumab: a retrospective analysis of claims data in the United States.Lupus Sci Med.2020;7(1):e000357 DOI: 10.1136/lupus-2019-000357 PMID: 32341790
    Medical condition
    Systemic Lupus Erythematosus
    Product
    belimumab
    Collaborators
    Truven Health Analytics
    Study date(s)
    February 2017 to February 2018
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    18 - 64 Years
    Accepts healthy volunteers
    Not applicable
    • At least one inpatient claim or non-diagnostic outpatient claim with a diagnosis of SLE between 01 Sep 2010 to 31 Dec 2015
    • Evidence of belimumab treatment between 09 Mar 2011 and 31 Dec 2015 based on one of the criteria listed; An outpatient prescription claim with a National drug codes (NDC) for belimumab between 09 Mar 2011 and 31 Dec 2015 or An outpatient medical claim with a Healthcare Common Procedure Coding System (HCPCS) code for belimumab between 09 Mar 2011 and 31 Dec 2015 or An outpatient medical claim with a Current Procedural Terminology (CPT) code for monoclonal antibody/chemotherapy administration between 09 Mar 2011 and 01 Jul 2011. In order to ensure that the CPT code is for the administration of belimumab and not the administration of a chemotherapy agent, the subject must also have an inpatient or non-diagnostic outpatient claim with a diagnosis of SLE and no inpatient or non-diagnostic outpatient claims with diagnosis of cancer and no outpatient claims with a HCPCS code for rituximab administration on the same date of service
    • The >2 inpatient or non-diagnostic outpatient medical claims with a diagnosis of acute or chronic glomerulonephritis (including lupus glomerulonephritis), acute or chronic renal failure, nephritis or nephrotic syndrome (including lupus nephrotic syndrome), renal failure or proteinuria
    • The >2 inpatient or non-diagnostic outpatient medical claims where the service provider is a nephrologist
    Inclusion and exclusion criteria
    Inclusion criteria:
    • At least one inpatient claim or non-diagnostic outpatient claim with a diagnosis of SLE between 01 Sep 2010 to 31 Dec 2015
    • Evidence of belimumab treatment between 09 Mar 2011 and 31 Dec 2015 based on one of the criteria listed; An outpatient prescription claim with a National drug codes (NDC) for belimumab between 09 Mar 2011 and 31 Dec 2015 or An outpatient medical claim with a Healthcare Common Procedure Coding System (HCPCS) code for belimumab between 09 Mar 2011 and 31 Dec 2015 or An outpatient medical claim with a Current Procedural Terminology (CPT) code for monoclonal antibody/chemotherapy administration between 09 Mar 2011 and 01 Jul 2011. In order to ensure that the CPT code is for the administration of belimumab and not the administration of a chemotherapy agent, the subject must also have an inpatient or non-diagnostic outpatient claim with a diagnosis of SLE and no inpatient or non-diagnostic outpatient claims with diagnosis of cancer and no outpatient claims with a HCPCS code for rituximab administration on the same date of service
    • At least six months of continuous enrollment with medical and prescription drug coverage prior to the index date
    • At least three months of continuous enrollment with medical and prescription drug coverage following the index date (pre-index period)
    • Aged 18-64 years as of the index date
    Exclusion criteria:
    • The >2 inpatient or non-diagnostic outpatient medical claims with a diagnosis of acute or chronic glomerulonephritis (including lupus glomerulonephritis), acute or chronic renal failure, nephritis or nephrotic syndrome (including lupus nephrotic syndrome), renal failure or proteinuria
    • The >2 inpatient or non-diagnostic outpatient medical claims where the service provider is a nephrologist

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Clinical study report
    Available language(s): English
    Download document(s)
    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
    2018-26-02
    Actual study completion date
    2018-26-02

    Plain language summaries

    Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website