REIMAGINE - Real World EvaluatIon of Mepolizumab in Severe Asthma achievinG on Treatment clinIcal remissioN, a prospEctive Study (REIMAGINE)
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ClinicalTrials.gov Identifier: NCT06041386 |
Recruitment Status :
Not yet recruiting
First Posted : September 18, 2023
Last Update Posted : September 18, 2023
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Asthma | Drug: Mepolizumab Other: Spirometry | Phase 4 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 336 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Masking Description: | There will be no masking in this study. |
Primary Purpose: | Other |
Official Title: | A Prospective, Real-World, Interventional Study To Evaluate The Effect Of Mepolizumab On Achieving Clinical Remission In Participants With Severe Asthma |
Estimated Study Start Date : | November 16, 2023 |
Estimated Primary Completion Date : | July 27, 2026 |
Estimated Study Completion Date : | July 27, 2026 |
Arm | Intervention/treatment |
---|---|
All Participants
All participants with clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care.
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Drug: Mepolizumab
Mepolizumab will be prescribed based on physician decision.
Other Name: NUCALA Other: Spirometry Lung function via spirometry will be collected. |
- Percentage (%) of Participants Achieving 4-Component Clinical Remission [ Time Frame: At month 12 ]4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function.
- Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits [ Time Frame: At month 12 ]CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission.
- Percentage of Participants Achieving Oral corticosteroids (OCS) Sparing Remission [ Time Frame: At month 12 ]OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest.
- Percentage of Participants Achieving 3-Component Clinical Remission [ Time Frame: At month 12 ]3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT.
- Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score [ Time Frame: Baseline and at month 12 ]The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability.
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06041386
Contact: US GSK Clinical Trials Call Center | 877-379-3718 | GSKClinicalSupportHD@gsk.com | |
Contact: EU GSK Clinical Trials Call Center | +44 (0) 20 89904466 | GSKClinicalSupportHD@gsk.com |
Study Director: | GSK Clinical Trials | GlaxoSmithKline |
Responsible Party: | GlaxoSmithKline |
ClinicalTrials.gov Identifier: | NCT06041386 |
Other Study ID Numbers: |
219871 |
First Posted: | September 18, 2023 Key Record Dates |
Last Update Posted: | September 18, 2023 |
Last Verified: | September 2023 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/ |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Informed Consent Form (ICF) Clinical Study Report (CSR) |
Time Frame: | Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications. |
Access Criteria: | Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months. |
URL: | https://www.gsk.com/en-gb/innovation/trials/data-transparency/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Product Manufactured in and Exported from the U.S.: | Yes |
Severe asthma Eosinophilic phenotype Oral corticosteroids (OCS) Asthma exacerbations |
Clinical remission NUCALA Mepolizumab |
Asthma Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases |
Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |