Last updated: 03/11/2025 05:40:23

Real-world study to evaluate effectiveness of Mepolizumab for treating asthma in Taiwan

GSK study ID
214665
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: A Real-world study to evaluate Effectiveness of Mepolizumab In treating severe asthma in Taiwan (REMIT)
Trial description: This study will assess the use of mepolizumab in treating severe eosinophilic asthma in a Chinese population with a heterogeneous disease condition, including a broader spectrum of co-morbidities and concomitant medications than would typically be allowed in Randomized controlled trials (RCTs). This study will extract data from structured medical records, including out-patient and in-hospital records, prescription records, results of relevant biometric measures (laboratory, radiology, lung function tests, etc.), and administrative records.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of clinically significant exacerbations 12-months after the index date (initiation of mepolizumab treatment) compared to the pre-exposure period

Timeframe: 12 months pre-dose to 12 months post-dose

Secondary outcomes:

Number of clinically significant asthma exacerbations requiring hospitalization and/or Emergency Department (ED) visit

Timeframe: 12 months pre-dose to 12 months post-dose

Number of participants with change in daily maintenance of Oral corticosteroids (OCS)

Timeframe: 12 months pre-dose to 12 months post-dose

Number of days OCS supplied

Timeframe: 12 months pre-dose to 12 months post-dose

Percent of participants discontinuing maintenance OCS therapy in the post-treatment period

Timeframe: 12 months pre-dose to 12 months post-dose

Interventions:
  • Drug: Mepolizumab
    • Enrollment:
    0
    Primary completion date:
    2023-31-03
    Observational study model:
    Cohort
    Time perspective:
    Retrospective
    Clinical publications:
    Shih-Lung Cheng, Shu-Min Lin, Chung-Kan Peng, Ming-Cheng Chan, Sheng-Yeh Shen, Ping-Hung Kuo, Chien-Hao Lai, Chou-Chin Lan, Chung-Yu Chen, Ching-Hsiung Lin, Kuang-Ming Liao, Po-Hao Feng, Jiin-Torng Wu, Yu-Feng Wei, Xiaomeng Xu, Rafael Alfonso-Christancho, Tina Lai, Aldo Navarro, Dominique Milea, Diahn-Warng Perng. A real-world study to evaluate effectiveness of mepolizumab in treating severe asthma in Taiwan (REMIT). Therapeutic advances in respiratory disease. 2025;19: 17534666241308406.  PMID: 39829048 DOI: 10.1177/17534666241308406
    Medical condition
    Asthma
    Product
    mepolizumab
    Collaborators
    Not applicable
    Study date(s)
    October 2022 to March 2023
    Type
    Observational
    Phase
    4

    Participation criteria

    Sex
    Female & Male
    Age
    18+ years
    Accepts healthy volunteers
    No
    • Treatment initiation with mepolizumab
    • Initiated treatment with mepolizumab at least 12 months prior to the data extraction date
    • Mepolizumab injection during the 12 months prior to index date.
    • Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months.
    Inclusion and exclusion criteria
    Inclusion criteria:
    • Treatment initiation with mepolizumab
    • Initiated treatment with mepolizumab at least 12 months prior to the data extraction date
    • Clinical diagnosis of asthma
    • Age greater than or equal to (≥)18 years at index date
    • At least 12 months of medical records available prior to initiation of mepolizumab
    Exclusion criteria:
    • Mepolizumab injection during the 12 months prior to index date.
    • Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12 months.
    • Missing data on date of first mepolizumab treatment (e.g. In case the treatment was initiated in another clinic)

    Trial location(s)

    This study does not involve prospective enrollment of participants.

    Study documents

    Study report synopsis
    Available language(s): English
    Download document(s)
    Protocol
    Available language(s): English
    Download document(s)
    Statistical analysis plan
    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
    2023-31-03
    Actual study completion date
    2023-31-03

    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