REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal… (NCT06041386) | Clinical Trial Compass
Active — Not RecruitingPhase 4
REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study
United States336 participantsStarted 2024-03-20
Plain-language summary
This is a prospective, real-world, single arm, global, multi-centre study to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult participants with severe asthma with an eosinophilic phenotype (SA-EP).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. NUCALA can be initiated up to 7 days prior to study enrollment.
* No NUCALA use in the 6 months prior to enrollment.
* Participants with greater than or equal to (≥)60 percentage (%) predicted forced expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per year, as confirmed by the physician.
* Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria).
* Written informed consent
Exclusion Criteria:
* Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)
* Participants currently on maintenance OCS or intramuscular corticosteroids.
* Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment
* Participants participating in an interventional study with a treatment intervention
What they're measuring
1
Percentage (%) of Participants Achieving 4-Component Clinical Remission