Last updated: 03/11/2025 05:40:23
Real-world study to evaluate effectiveness of Mepolizumab for treating asthma in Taiwan
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
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
Observational study model:
Cohort
Primary completion date:
2023-31-03
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)
No location data available.
Study documents
Study report synopsis
Available language(s): English
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
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
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