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)

GSK study ID
204710
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 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
    Primary completion date:
    2021-25-01
    Observational study model:
    Cohort
    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
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Ancona, Marche, Italy, 60020
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Arcadia, California, United States, 91007
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Atlanta, Georgia, United States, 30322-1047
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Augsburg, Bayern, Germany, 86150
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Badalona, Spain, 08916
    Status
    Study Complete
    Contact us
    Location
    GSK Investigational Site
    Badalona, Catalonia, Spain, 08035
    Status
    Study Complete
    Contact us
    Showing 1 - 6 of 84 Results

    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
    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
    Participate in clinical trial
    Access to clinical trial data by researchers
    Visit website