Last updated: 06/06/2025 11:20:07

Nucala Impact on Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome (HES) on Oral Corticosteroids (OCS) Use and Clinical Manifestations in a Large Network of Allergy Practices in the United States

GSK study ID
218960
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: Oral Corticosteroids (OCS) Sparing, Clinical Manifestations, and Clinical Outcomes Among Patients with Eosinophilic Granulomatosis with Polyangiitis (EGPA) and Hypereosinophilic Syndrome (HES) on Mepolizumab in a Large Network of Allergy Practices in the United States
Trial description: The primary purpose of the study is to evaluate change in proportion of participants prescribed Oral Corticosteroids (OCS) among participants with Eosinophilic Granulomatosis with Polyangiitis (EGPA) or Hypereosinophilic Syndrome (HES) treated within the Allergy Partners electronic medical record (AP EMR) database before and after mepolizumab initiation.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number and Percentage of Participants Receiving Oral Corticosteroids (OCS) Among Participants with EGPA and HES Before and After Mepolizumab Initiation

Timeframe: Up to 6 months

Secondary outcomes:

Percentage of Participants with Disease Characteristics and Comorbidities Among Participants with EGPA and HES Before Mepolizumab Initiation

Timeframe: Up to 6 months

Interventions:
Not applicable
Enrollment:
76
Primary completion date:
2024-30-08
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Hypereosinophilic Syndrome
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
November 2023 to August 2024
Type
Observational
Phase
Not applicable

Participation criteria

Sex
Female & Male
Age
12+ years
Accepts healthy volunteers
No
  • Initiated mepolizumab from 12 December 2017 to 17 August 2023 after Eosinophilic Granulomatosis with Polyangiitis (EGPA) diagnosis for EGPA cohort and from 25 September 2020 to 17 August 2023 after Hypereosinophilic Syndrome (HES) diagnosis for HES cohort (index date is defined as date of initiation of mepolizumab)
  • Aged greater than or equal to (>=) 18 years as of the index year for patients with EGPA; aged >= 12 years as of the index year for patients with HES
  • None
Inclusion and exclusion criteria
Inclusion criteria:

    Initiated mepolizumab from 12 December 2017 to 17 August 2023 after Eosinophilic Granulomatosis with Polyangiitis (EGPA) diagnosis for EGPA cohort and from 25 September 2020 to 17 August 2023 after Hypereosinophilic Syndrome (HES) diagnosis for HES cohort (index date is defined as date of initiation of mepolizumab)

    • Aged greater than or equal to (>=) 18 years as of the index year for patients with EGPA; aged >= 12 years as of the index year for patients with HES
    • >= 6 months of clinical activity prior to the index date, defined as the patient having at least one encounter information more than 6 months before the index date (timeframe may be re-evaluated based on the data)
    • >= 6 months of clinical activity after the index date, defined as the patient having at least one encounter information more than 6 months after the index date, unless the patient died (timeframe may be re-evaluated based on the data)
Exclusion criteria:
  • None

Trial location(s)

This study does not involve prospective enrollment of participants.

Study documents

Protocol
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
2024-30-08
Actual study completion date
2024-30-08

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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