Last updated: 12/19/2025 08:30:17
Spanish Real World Eosinophilic Granulomatosis with Polyangiitis (EGPA) Evidence of Mepolizumab
GSK study ID
223358
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Will be recruiting
Will be recruiting
Trial overview
Official title: SREM Study_Spanish Real World EGPA Evidence of Mepolizumab. Mepolizumab for Eosinophilic Granulomatosis with Polyangiitis: an Observational, Multicentre and Retrospective Study
Trial description: The study aims to evaluate the impact of mepolizumab on adult participants with EGPA in real clinical setting across Spain. The study will utilize data collected from medical records and assess real-life clinical outcomes by comparing data from the 12 months before and after treatment with mepolizumab initiation. The date when the healthcare provider first prescribes mepolizumab to the participants will be defined as Baseline visit.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Description of Participant Baseline Demographics, Clinical Characteristics, and Treatment Regimens
Timeframe: At Baseline visit
Secondary outcomes:
Percentage of Participants with EGPA Relapse
Timeframe: 12 months before and after mepolizumab initiation
Percentage of Participants with Reduction in Oral Corticosteroid (OCS) Daily Dose
Timeframe: 12 months before and after mepolizumab initiation
Time to EGPA Relapse
Timeframe: Up to 60 months after mepolizumab initiation
Percentage of Participants Receiving OCS Doses of 0, Greater than (>) 0 to Less than or Equal to (<=) 4.0, >4.0 to <=7.5, or >7.5 milligrams per day (mg/day)
Timeframe: 12 months before and after mepolizumab initiation
Interventions:
Not applicable
Enrollment:
Not applicable
Primary completion date:
2026-31-03
Observational study model:
Cohort
Time perspective:
Retrospective
Clinical publications:
Not applicable
Medical condition
Autoimmune Diseases
Product
mepolizumab
Collaborators
Not applicable
Study date(s)
January 2026 to March 2026
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
- Participants greater than or equal to (>=) 18 years old.
- Participant with a diagnosis of EGPA according to the American College of Rheumatology (ACR) 1990 and ACR/European Alliance of Associations for Rheumatology (EULAR) 2022 classification established at least 12 months prior to date of first administration of mepolizumab (index date).
- Participants diagnosed with granulomatosis with polyangiitis (Wegener’s), microscopic polyangiitis or hypereosinophilic syndrome (HES).
Inclusion and exclusion criteria
Inclusion criteria:
- Participants greater than or equal to (>=) 18 years old.
- Participant with a diagnosis of EGPA according to the American College of Rheumatology (ACR) 1990 and ACR/European Alliance of Associations for Rheumatology (EULAR) 2022 classification established at least 12 months prior to date of first administration of mepolizumab (index date).
- Participants currently undergoing treatment with mepolizumab or who have received treatment with mepolizumab in the past and in both cases, have completed, at least, a minimum of 12 months of follow-up after index date.
- Participants with data available in medical records >= 12 months prior to initiation of mepolizumab treatment.
Exclusion criteria:
- Participants diagnosed with granulomatosis with polyangiitis (Wegener’s), microscopic polyangiitis or hypereosinophilic syndrome (HES).
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Will be recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
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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