Last updated: 10/27/2021 04:40:15

Mepolizumab use and effectiveness in Real-World settings in Japan -Japan medical data center (JMDC)

GSK study ID
213221
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: Effectiveness of Nucala in Severe Eosinophilic Asthma in Japan using JMDC
Trial description: This is a retrospective observational study comparing incidence rates of and percentage of participants experiencing asthma exacerbations, treatments, and exacerbation-related healthcare costs (cost analysis will depend on feasibility of data recorded in database) before and after first mepolizumab use among participants with asthma. The primary objective will analyze participants who have 12 months of continuous enrolment prior to and following the date of first mepolizumab administration. Participant’s demographic and clinical characteristics will be collected in the 12-month Baseline period. This study will use the JMDC Claims Database, which contains claims from employment-based insurance plans throughout Japan whose population consists of employees and their family members.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change from Baseline in annual incidence rate of asthma exacerbation

Timeframe: Baseline and up to 12 months post-index

Secondary outcomes:

Percentage change from Baseline in asthma exacerbations

Timeframe: Baseline and up to 12 months post index

Change from Baseline in asthma-related exacerbations resulting in hospitalization

Timeframe: Baseline and up to 12 months post-index

Percentage change from Baseline in maintenance oral corticosteroids (OCS) therapy

Timeframe: Baseline and up to 12 months post-index

Change from Baseline in average daily dose of maintenance OCS

Timeframe: Baseline and up to 12 months post-index

Change from Baseline in asthma exacerbation-related healthcare resource use

Timeframe: Baseline and up to 12 months post-index

Asthma exacerChange from Baseline in asthma exacerbation-related healthcare resource costbation-related healthcare resource cost

Timeframe: Baseline and up to 12 months post-index

Interventions:
Not applicable
Enrollment:
0
Primary completion date:
2020-22-06
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Nagase H, Tamaoki J, Suzuki T, Nezu Y, Katsumata M, Komatsubara M, Mu G, Yang S, Cole A, Alfonso-Cristancho R. Effectiveness of mepolizumab in severe asthma in Japan: a real-world study using claims data. Clin Transl Allergy. 2021;11(8):e12063 DOI: https://doi.org/10.1002/clt2.12063 PMID: NULL
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2019 to June 2020
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Medical (inpatient/outpatient) or pharmacy claim between 07-Jun-2016 and 28-Feb-2018 (current data cut) or the most recent update at the time of analysis, with a medication code indicating administration of mepolizumab (JMDC Medication Code: 100000079813 and Code for Reimbursement Claims: 622489001).
  • 12 months of continuous enrolment in the year prior to the index date (Baseline period).
  • Evidence of mepolizumab use during the 12-month Baseline period.
  • Participants with inconsistent or missing information on age and sex.
Inclusion and exclusion criteria
Inclusion criteria:
  • Medical (inpatient/outpatient) or pharmacy claim between 07-Jun-2016 and 28-Feb-2018 (current data cut) or the most recent update at the time of analysis, with a medication code indicating administration of mepolizumab (JMDC Medication Code: 100000079813 and Code for Reimbursement Claims: 622489001).
  • 12 months of continuous enrolment in the year prior to the index date (Baseline period).
  • 12 months of continuous enrolment including and following the index date (Follow-up period).
  • A diagnosis of asthma (International Classification of Diseases [ICD]-10: J45 or J46) during the 12-month Baseline period.
  • At least 12 years of age as of index.
Exclusion criteria:
  • Evidence of mepolizumab use during the 12-month Baseline period.
  • Participants with inconsistent or missing information on age and sex.
  • Participants with eosinophilic granulomatosis with polyangiitis (EGPA) diagnosis

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
2020-22-06
Actual study completion date
2020-22-06

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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