Last updated: 01/11/2024 17:50:15
A Multinational, Single Arm, Observational Study to Evaluate the Real-world Effectiveness and Pattern of Use of Mepolizumab in Patients with Severe Eosinophilic Asthma (204710: the REALITI-A study)
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: A Multinational, Single Arm, Observational Study to Evaluate the Real-world Effectiveness and Pattern of Use of Mepolizumab in Patients with Severe Eosinophilic Asthma (204710: the REALITI-A study)
Trial description: Mepolizumab has recently been launched for severe eosinophilic asthma. The aim of this study is to evaluate effectiveness of mepolizumab and to describe the use of Mepolizumab in real life clinical practice to provide a more complete understanding of the value of mepolizumab for patients with severe eosinophilic asthma.This is a prospective, self-controlled cohort study conducted to collect observational data from participants with a clinical diagnosis of severe eosinophilic asthma, to reflect the real world nature of the study.
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: Up to 12 months
Secondary outcomes:
Medication possession ratio
Timeframe: Up to 24 months
Proportion of days covered
Timeframe: Up to 24 months
Reasons for treatment discontinuation
Timeframe: Up to 24 months
Number of clinically significant exacerbations 24-months after the index date (initiation of mepolizumab treatment) compared to the pre-exposure period
Timeframe: Up to 24 months
Number of exacerbations requiring ED visits and/or hospitalization (12- and 24-month post-exposure periods)
Timeframe: Up to 24 months
Number of participants experiencing 1 or more exacerbations requiring ED visits and/or hospitalization (12 and 24 month post-exposure periods)
Timeframe: Up to 24 months
Number of exacerbations requiring hospitalization (12- and 24-month post-exposure periods)
Timeframe: Up to 24 months
Number of participants experiencing 1 or more exacerbation requiring hospitalization (12 and 24-month post-exposure periods)
Timeframe: Up to 24 months
Change in daily maintenance OCS dose (12- and 24-month post exposure periods)
Timeframe: Up to 24 months
Change in total OCS dose (12- and 24-month post-exposure periods)
Timeframe: Up to 24 months
Number of asthma hospitalizations events pre- and post exposure
Timeframe: Up to 24 months
Number of asthma ED events pre- and post exposure
Timeframe: Up to 24 months
Number of outpatient events pre- and post exposure
Timeframe: Up to 24 months
Number of asthma pharmacy pre- and post exposure
Timeframe: Up to 24 months
Days of hospital stay pre- and post exposure
Timeframe: Up to 24 months
Number of hospital readmission pre- and post exposure
Timeframe: Up to 24 months
Mean change from treatment index date in ACQ-5 score (12- and 24 month post-exposure periods)
Timeframe: Up to 24 months
Mean change from treatment index date in WPAI score (12- and 24 month post-exposure periods)
Timeframe: Up to 24 months
Interventions:
Other: None
Enrollment:
950
Observational study model:
Cohort
Primary completion date:
2021-25-01
Time perspective:
Prospective
Clinical publications:
Harrison T, Canonica G, Chupp G, Lee J, Schleich F, Welte T, Valero A, Gemzoe K, Maxwell A, Joksaite S, Yang S, Howarth P, Van Dyke M.Real-world mepolizumab in the prospective severe asthma REALITI‑A study – initial analysis.Eur Respir J.2020
DOI: 10.1183/13993003.00151-2020
Pini L, Caruso C, Colantuono S, Bagnasco D, Maxwell A, Price R, Howarth P, Canonica W on behalf of the Italian investigators of REALITI-A.Prospective Italian real-world study of mepolizumab in severe eosinophilic asthma validates retrospective outcome reports.Clin Transl Allergy.2021;11(8):e12067 DOI: 10.1002/clt2.12067 PMID: PMC8517195
Pilette C, Canonica GW, Chaudhuri R, Chupp G, Lee F E-H, Lee J, Almonacid C, Welte T, Alfonso-Cristancho R, Jakes R, Maxwell A, Price R, Howarth P.REALITI-A study: Real-world oral corticosteroid-sparing effect of mepolizumab in severe asthma.J Allergy Clin Immunol Pract.2022;:S2213-2198(22)00629-8
DOI: 10.1016/j.jaip.2022.05.042 PMID: 35753668
Medical condition
Asthma
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
December 2016 to January 2022
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
Not applicable
- Inclusion Criteria
- Informed Consent: Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
Inclusion and exclusion criteria
Inclusion criteria:
- Inclusion Criteria
- Informed Consent: Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
- Participants must have a current clinical diagnosis of asthma.
- Physician decision to initiate treatment with mepolizumab.
- Relevant paper or electronic health record systems (HER)-based medical records available for at least 12 months prior to enrolment date.
- Adults aged 18 years or over. Exclusion Criteria
- Mepolizumab injection during the 12 months prior to enrolment (note: an injection up to 7 days prior to enrolment is permitted if required for logistical reasons).
- Participation in an interventional clinical trial in which the treatment regimen and/or monitoring is dictated by a protocol during the previous 12-months.
Trial location(s)
Location
GSK Investigational Site
Arcadia, California, United States, 91007
Status
Study Complete
Location
GSK Investigational Site
Atlanta, Georgia, United States, 30322-1047
Status
Study Complete
Location
GSK Investigational Site
Baltimore, Maryland, United States, 21224
Status
Study Complete
Location
GSK Investigational Site
Bodelwyddan, Rhyl, United Kingdom, LL18 5UJ
Status
Study Complete
Location
GSK Investigational Site
Charlottesville, Virginia, United States, 22911
Status
Study Complete
Location
GSK Investigational Site
Cincinnati, Ohio, United States, 45231
Status
Study Complete
Location
GSK Investigational Site
Colorado Springs, Colorado, United States, 80909
Status
Study Complete
Location
GSK Investigational Site
Essen, Nordrhein-Westfalen, Germany, 45127
Status
Study Complete
Location
GSK Investigational Site
Fort Mitchell, Kentucky, United States, 41017
Status
Study Complete
Location
GSK Investigational Site
Freiburg, Baden-Wuerttemberg, Germany, 79106
Status
Study Complete
Location
GSK Investigational Site
Granada Hills, California, United States, 91344
Status
Study Complete
Location
GSK Investigational Site
Greenfield, Wisconsin, United States, 53228
Status
Study Complete
Location
GSK Investigational Site
Hannover, Niedersachsen, Germany, 30625
Status
Study Complete
Location
GSK Investigational Site
Kissimmee, Florida, United States, 34741
Status
Study Complete
Location
GSK Investigational Site
Louisville, Kentucky, United States, 40215
Status
Study Complete
Location
GSK Investigational Site
Midlothian, Virginia, United States, 23113
Status
Study Complete
Location
GSK Investigational Site
New Haven, Connecticut, United States, 6520
Status
Study Complete
Location
GSK Investigational Site
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Status
Study Complete
Location
GSK Investigational Site
Pozuelo de Alarcón/Madrid, Spain, 28223
Status
Study Complete
Location
GSK Investigational Site
Redwood City, California, United States, 94063
Status
Study Complete
Location
GSK Investigational Site
Roanoke, Virginia, United States, 24016
Status
Study Complete
Location
GSK Investigational Site
South Portland, Maine, United States, 4106
Status
Study Complete
Location
GSK Investigational Site
St. Charles-Borromee, Québec, Canada, J6E 2B4
Status
Study Complete
Location
GSK Investigational Site
Ulm, Baden-Wuerttemberg, Germany, 89073
Status
Study Complete
Location
GSK Investigational Site
Vancouver, British Columbia, Canada, V5Z 4E1
Status
Study Complete
Location
GSK Investigational Site
Virginia Beach, Virginia, United States, 23454
Status
Study Complete
Location
GSK Investigational Site
Waterbury, Connecticut, United States, 06708
Status
Study Complete
Location
GSK Investigational Site
Williamsburg, Virginia, United States, 23188
Status
Study Complete
Location
GSK Investigational Site
Wishaw, Lanarkshire, United Kingdom, ML2 0DP
Status
Study Complete
Location
GSK Investigational Site
Pittsburgh, Pennsylvania, United States, 15212
Status
Study Complete
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
2021-25-01
Actual study completion date
2022-05-01
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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Access to clinical trial data by researchers
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