Last updated: 07/29/2020 03:50:14

Refresh Nucala 12 months pre/post

GSK study ID
209017
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: Update to Asthma Exacerbations and Healthcare Utilization in Patients Receiving Nucala in an Employer Claims Database
Trial description: Mepolizumab is a humanized interleukin-5 antagonist monoclonal antibody administered by subcutaneous injection by a health care professional via subcutaneous injection. Asthma is a common chronic respiratory disorder that effects millions of children and adults in the United States (US). Mepolizumab has been shown to reduce the frequency of asthma exacerbations in subjects with severe asthma in clinical trials. This is a retrospective cohort study which will compare rates of asthma exacerbations and costs associated with those exacerbations among subjects receiving mepolizumab. Medical or pharmacy claim between 1-November-2015 and 31-March-2017 with a Healthcare Common Procedure Coding System (HCPCS) or National Drug Code (NDC) code indicating administration of mepolizumab is part of the database. This study will try to analyze performance of mepolizumab in the market which will include effect on rate of asthma exacerbation and the associated costs. The data for the study will be derived from IBM Watson Health’s Research Databases.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Total number of asthma exacerbations per subjects

Timeframe: Up to 12 months post-dose of mepolizumab

Percentage of subjects with asthma exacerbations

Timeframe: Up to 12 months post-dose of mepolizumab

Percentage of subjects with exacerbation resulting in a hospitalization

Timeframe: Up to 12 months post-dose of mepolizumab

Total number of any exacerbation

Timeframe: Up to 12 months post-dose of mepolizumab

Total number of exacerbations result in hospitalization

Timeframe: Up to 12 months post-dose of mepolizumab

Rate of exacerbation

Timeframe: Up to 12 months post-dose of mepolizumab

Secondary outcomes:

Total cost related to asthma exacerbation post administration of mepolizumab

Timeframe: Up to 12 months post-dose of mepolizumab

Number of claims with asthma exacerbation related costs post administration of mepolizumab

Timeframe: Up to 12 months post-dose of mepolizumab

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2019-21-02
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Llanos JP, Ortega H, Bogart M, Packnett E, Manjelievskaia J, Bell C, Hahn B. Real-world effectiveness of mepolizumab in patients with severe asthma: an examination of exacerbations and costs. J Asthma Allergy. 2020;2020(13):77-87 DOI: 10.2147/JAA.S236609
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    IBM Watson Health
    Study date(s)
    December 2018 to February 2019
    Type
    Observational
    Phase
    Not applicable

    Participation criteria

    Sex
    Female & Male
    Age
    12+ years
    Accepts healthy volunteers
    No
    • Inclusion Criteria
    • Medical or pharmacy claim between November 1, 2015 and March 31, 2017 with a HCPCS or NDC code indicating administration of mepolizumab. The date of first mepolizumab administration (index date).
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Inclusion Criteria
    • Medical or pharmacy claim between November 1, 2015 and March 31, 2017 with a HCPCS or NDC code indicating administration of mepolizumab. The date of first mepolizumab administration (index date).
    • 12 months of continuous enrollment with medical and pharmacy benefits in the year prior to the index date (baseline period).
    • 12 months of continuous enrollment with medical and pharmacy benefits including and following the index date (follow-up period).
    • A diagnosis of asthma during the 12-month baseline period.
    • At least 12 years of age as of index.
    • A minimum of 2 doses of mepolizumab in the first 180 days of the 12-month follow-up period. Exclusion Criteria
    • Evidence of mepolizumab use during the 12-month baseline period.
    • Evidence of omalizumab use during the 12-month baseline or 12-month follow-up periods.
    • Evidence of reslizumab use during the 12-month baseline or 12-month follow-up periods.
    • Evidence of benralizumab use during the 12-month baseline or 12-month follow-up periods.
    • Evidence of dupilumab use during the 12-month baseline or 12-month follow-up periods.
    • Subjects with missing demographic information will be excluded from the study.

    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
    2019-21-02
    Actual study completion date
    2019-21-02

    Plain language summaries

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

    Additional information about the trial

    Not applicable
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