Last updated: 11/03/2018 21:30:46
PGx7530: Genetics of Mepolizumab (SB240563) Treatment Response in Severe Asthmatics in MEA115588
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: PGx7530: Genetics of Mepolizumab (SB240563) Treatment Response in Severe Asthmatics in MEA115588
Trial description: The objective of this study was to identify genetic variants predictive of patients least likely to show efficacy from mepolizumab treatment.Genetic markers and candidate genes that have previously been associated with asthma, asthma severity and/or map to candidate IL-5 and eosinophil pathway-related genes were prioritized into separate marker tiers and tested for association. All other common GWAS markers, measured or imputed, were explored for association with the primary and secondary outcome measures.Generalized linear regression assuming the Negative Binomial probability distribution (where the mean is related to covariate factors through a ‘log link’ function) was used to test for association between rates of asthma exacerbation and each genetic marker, assuming an additive genetic model. Cox proportional hazards model was used to assess the association between each genetic marker and `Time to first clinically significant asthma exacerbation’. For either regression, GWAS PCs and appropriate covariates were included in the model.Subject level data was analyzed separately for MEA112997 and MEA115588, and summary data meta-analyzed.For analysis within each marker tier, the false positive rate was controlled to 5%.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Clinically significant asthma exacerbation rate
Timeframe: Up to 52 weeks
Secondary outcomes:
Change in maximum on-treatment eosinophil count from baseline
Timeframe: Up to 52 weeks
Change in asthma exacerbation rate
Timeframe: Up to 52 weeks
Time to first clinically significant asthma exacerbation
Timeframe: Up to 52 weeks
Change in maximum on-treatment IgE levels from baseline
Timeframe: Up to 52 weeks
Interventions:
Drug: Placebo
Drug: Mepolizumab
Enrollment:
1
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
December 2013 to October 2014
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
12 - 81 Year
Accepts healthy volunteers
none
- Subjects who provided written informed consent and a DNA sample and had the clinical outcome data available were included in the study.
- Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.
Inclusion and exclusion criteria
Inclusion criteria:
- Subjects who provided written informed consent and a DNA sample and had the clinical outcome data available were included in the study.
Exclusion criteria:
- Subjects who did not provide written informed consent, a DNA sample, or did not have the clinical outcome data available were excluded from study.
Trial location(s)
No location data available.
Study documents
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
Not applicable
Actual study completion date
2014-31-10
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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