Last updated: 05/14/2025 13:40:08

Mepolizumab prospective Real World Study (RWS) in China

GSK study ID
220932
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: REAL world effectiveness of mepolizumab In paTIents with Asthma on medium- to high-dose inhaled corticosteroid in China (REALITI-A-China)
Trial description: This study is looking at participants in China who have asthma and are already on medium- to high-dose inhaled corticosteroids (ICS). These participants will be newly prescribed a medication called mepolizumab. The study will observe them without interfering with their usual medical care or affecting their treatment decisions. The decision to start mepolizumab will be made by each participant’s doctor. The "Index date" is when they first begin taking mepolizumab. The study will check in on these participants after 12 months and again after 24 months (follow up period). The researchers mainly want to find out whether the number of severe asthma attacks changes in the first year after starting mepolizumab compared to the year before they started it.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Change in Annualized Rate of Clinically Significant Exacerbation (CSE)

Timeframe: From 12 months pre-exposure to 12 months post first dose of mepolizumab

Secondary outcomes:

Change from Baseline in Asthma Control Test (ACT) Score to Week 1, Week 2 and Months 1, 3, 6, 12, 18, and 24 Post First Dose of Mepolizumab

Timeframe: From Baseline up to Week 1, Week 2 and Months 1, 3, 6, 12, 18, and 24 Post First Dose of Mepolizumab

Change in Annualized Rate of Clinically Significant Asthma Exacerbations

Timeframe: From 12 months pre-exposure to 12 months post first dose of mepolizumab

Change in Annualized Rate of Clinically Significant Asthma Exacerbations Between Pre-exposure Versus 24 months

Timeframe: From 12 months pre-exposure to 24 months post first dose of mepolizumab

Change in Annualized Rate of CSE Between Pre-exposure Versus 12-24 months

Timeframe: 12 months pre-exposure and Month 12 to Month 24 post first dose of mepolizumab

Change in Annualized Rate of CSE Between Pre-exposure Versus 24 months post first dose of mepolizumab

Timeframe: From 12 months pre-exposure to 24 months post first dose of mepolizumab

Change in Annualized Rate of CSE Between Pre-exposure versus 12-24 Months Post first Dose of Mepolizumab

Timeframe: 12 months pre-exposure and Month 12 to Month 24 post first dose of mepolizumab

Change in Annualized Rate of CSE Between Pre-exposure versus 12-24 Months Post first Dose of Mepolizumab

Timeframe: From month 12 to month 24 post first dose of mepolizumab

Change in Annualized Rate of CSE Requiring Emergency Department (ED) Visit and/or Hospitalization

Timeframe: From 12 months pre-exposure to 12 months post first dose of mepolizumab

Change in Annualized Rate of CSE Requiring ED visit and/or Hospitalization Between Pre- exposure versus 24 months Post First Dose of Mepolizumab

Timeframe: From 12 months pre-exposure to 24 months post first dose of mepolizumab

Change in Annualized Rate of CSE Requiring ED Visit and/or Hospitalization Between Pre- exposure Versus 12-24 Months Post First Dose of Mepolizumab

Timeframe: 12 months pre-exposure and Month 12 to Month 24 post first dose of mepolizumab

Number of Participants who Achieve/do not Achieve Clinical Remission at months 12 and 24

Timeframe: Month 12 and Month 24

Change from Baseline in Lung Function Measures to Month 12 and Month 24

Timeframe: From baseline to month 12 and month 24

Mean Change from Baseline in Work Productivity and Activity Impairment - General Health (WPAI-GH) score at Week 1, Week 2 and Months 1, 3, 6, 12, 18, and 24

Timeframe: From Baseline to Week 1, Week 2 and Months 1, 3, 6, 12, 18, and 24

Mean Change from Baseline in EQ-5D-5L at Week 1, Week 2 and Months 1, 3, 6, 12, 18, and 24

Timeframe: From baseline to week 1, week 2 and months 1, 3, 6, 12, 18, and 24

Mean Change from Baseline in EuroQol Visual Analogue Scale (EQ VAS) at Week 1, Week 2 and Months 1, 3, 6, 12, 18, and 24

Timeframe: From baseline to week 1, week 2 and months 1, 3, 6, 12, 18, and 24

Mean Change from Baseline in St. George’s Respiratory Questionnaire (SGRQ) at Week 1, Week 2 and Months 1, 3, 6, 12, 18, and 24

Timeframe: From baseline to week 1, week 2 and months 1, 3, 6, 12, 18, and 24

Mean Change from Baseline in Clinical Characteristics at Months 1, 3, 6, 12, 18, and 24

Timeframe: From baseline at months 1, 3, 6, 12, 18, and 24

Number of Participants with T2 Inflammation

Timeframe: Up to month 24 post first dose of mepolizumab

Mean Dose of Mepolizumab administered

Timeframe: Baseline up to Month 24

Number of Participants with Reason for initiation of Mepolizumab

Timeframe: Baseline up to Month 24

Number of Participants with Reason for Discontinuation of Mepolizumab

Timeframe: Baseline up to Month 24

Number of Participants with Change in Dosing and Frequency of Mepolizumab

Timeframe: Baseline up to Month 24

Number of Days Covered of Mepolizumab

Timeframe: Baseline up to Month 24

Number of Participants With Treatment Discontinuation

Timeframe: Baseline up to Month 24

Time to Treatment Discontinuation

Timeframe: Baseline up to Month 24

Number of Participants Still on Mepolizumab at months 12 and 24

Timeframe: Month 12 and 24

Number of Participants Taking Concomitant Medications at baseline, months 12 and 24

Timeframe: Baseline, month 12 and 24

Number of Participants who Stopped and Re-initiate Mepolizumab in the Post-exposure Period

Timeframe: Baseline, month 12 and 24

Mean Dose of Mepolizumab Prior Year Before Index, 1 Year and 2 Year after index

Timeframe: 1 year before Index date (Day 1), 1 year after Index date and 2 year after Index date

Number of Days Covered of Mepolizumab dosing Prior Year Before Index, 1 Year and 2 Year after index

Timeframe: 1 year before Index date (Day 1), 1 year after Index date and 2 year after Index date

Step up and down of Inhaled Corticosteroids (ICS) dosing in Prior Year Before Index, 1 Year and 2 Year after index

Timeframe: 1 year before Index date (Day 1), 1 year after Index date and 2 year after Index date

Change from Baseline in Number of Participants with a reduction in ICS / oral corticosteroids (OCS) dose utilization at months 12 and 24

Timeframe: Baseline, Month 12 and 24

Change from Baseline in Number of Participants with a reduction in Maintenance Oral Corticosteroid (mOCS) dose utilization at months 12 and 24

Timeframe: Baseline, Month 12 and 24

Change from Baseline in Number of Participants with a reduction in Systemin Corticosteroids (SCS) burst dose utilization at months 12 and 24

Timeframe: Baseline, Month 12 and 24

Change Cumulative ICS Dosing at Months 12 and 24 Compared to the Prior Year Before Index

Timeframe: Index Date, Month 12 and 24

Change Cumulative mOCS Dosing at Months 12 and 24 Compared to the Prior Year Before Index

Timeframe: Index Date, Month 12 and 24

Change Cumulative SCS burst Dosing at Months 12 and 24 Compared to the Prior Year Before Index

Timeframe: Index Date, Month 12 and 24

All Cause and Asthma-related Healthcare resource utilization (HCRU)

Timeframe: 12 months pre-exposure and 12 and 24 months post first dose of mepolizumab

Interventions:
Not applicable
Enrollment:
389
Primary completion date:
2028-26-12
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
May 2025 to December 2028
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Participant has provided informed consent for study participation
  • Participant has a confirmed clinical diagnosis of asthma as per physician’s assessment and is on medium- to high-dose inhaled corticosteroids (ICS)
  • Participant has received mepolizumab more than 30 days prior to the enrolment
  • Participation in an interventional clinical study 12 months prior to and at time of mepolizumab initiation
Inclusion and exclusion criteria
Inclusion criteria:

    Participant has provided informed consent for study participation

    • Participant has a confirmed clinical diagnosis of asthma as per physician’s assessment and is on medium- to high-dose inhaled corticosteroids (ICS)
    • Participant on medium- to high-dose ICS initiates mepolizumab treatment for asthma as per the physician’s decision in routine practice
    • Participant has relevant medical records available for greater than or equal to (>=)12 months prior to enrolment
Exclusion criteria:

    Participant has received mepolizumab more than 30 days prior to the enrolment

    • Participation in an interventional clinical study 12 months prior to and at time of mepolizumab initiation
    • Participant received biologics for any indication within 12 months prior to index date

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

No study documents available.

Results overview

No study documents available

Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable

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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