Last updated: 11/16/2024 08:20:33
Mepolizumab long-term study to assess real world safety and effectiveness of Eosinophilic granulomatosis with polyangiitis (EGPA) in JapanMARS
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A single arm, multi-center study to assess the long-term real-world safety and effectiveness of Nucala in EGPA patients who have already used Nucala for at least 96 weeks in Japan
Trial description: Eosinophilic granulomatosis with polyangiitis (EGPA), formerly known as the Churg-Strauss syndrome, is a systemic necrotizing vasculitis that affects small and medium sized blood vessels. NUCALA® (mepolizumab 300 milligrams [mg], subcutaneous administration) was approved in Japan in 2018 for the treatment of EGPA in adult participants. This is a single-arm, multi-center, prospective, non-interventional study that aims to assess long-term (2 to 4 years) real-world safety and effectiveness of NUCALA. Approximately 120 participants who completed the NUCALA Post Marketing Surveillance (PMS) study (National Clinical Trial [NCT]03557060) will be enrolled in the study.NUCALA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interest (AESI)
Timeframe: Up to 96 weeks
Number of participants with Adverse drug reactions (ADRs)
Timeframe: Up to 96 weeks
Secondary outcomes:
Percentage of participants with clinical symptoms
Timeframe: Up to 96 weeks
Percentage of participants with EGPA relapse
Timeframe: Up to 96 weeks
Number of participants with hospitalization for EGPA-related events
Timeframe: Up to 96 weeks
Number of participants with emergency room/unscheduled visits for EGPA-related events
Timeframe: Up to 96 weeks
Number of participants receiving prednisolone-equivalent of OCS over 96 weeks
Timeframe: Up to 96 weeks
Percentage of participants in each category of average daily prednisolone-equivalent of OCS over 96 weeks
Timeframe: Up to 96 weeks
Interventions:
Not applicable
Enrollment:
118
Primary completion date:
2023-27-04
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Alfonso-Cristancho R, Hayashi E, Howarth P, Ishii T, Kobayashi T, Komatsubara M, et al. . Real-world safety and effectiveness of mepolizumab for patients with eosinophilic granulomatosis with polyangiitis in Japan: MARS study . Mod Rheumatol.
PMID: 39508562
DOI: 10.1093/mr/roae100
Medical condition
Churg-Strauss Syndrome, Eosinophilic Granulomatosis with Polyangiitis
Product
mepolizumab
Collaborators
NA
Study date(s)
December 2020 to April 2023
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
20 Years - NA
Accepts healthy volunteers
No
- Adult participants with EGPA of >=20 years of age inclusive, at the time of signing the informed consent.
- Participants must have a current clinical diagnosis of EGPA by physician.
- Participants who have previously discontinued NUCALA treatment for EGPA for more than 12 weeks.
- Participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product.
Inclusion and exclusion criteria
Inclusion criteria:
- Adult participants with EGPA of >=20 years of age inclusive, at the time of signing the informed consent.
- Participants must have a current clinical diagnosis of EGPA by physician.
- Participants thus were registered and completed the NUCALA PMS study (special drug use investigation; Protocol Number 208505, NCT03557060) prior to be enrolled in this study.
- Physician’s decision to continue treatment with NUCALA for the treatment of EGPA as mentioned in the current label in Japan.
- Prior to commencing any study related activities, participants must be able and willing to provide written informed consent.
Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan.
Exclusion criteria:
- Participants who have previously discontinued NUCALA treatment for EGPA for more than 12 weeks.
- Participating in another clinical trial within the past 12 months, in which the participant has been exposed to an investigational or non-investigational pharmaceutical product.
- Participants with any reasons that in physician’s opinion would place the participants at risk.
- Participants who are pregnant or breastfeeding.
Trial location(s)
Showing 1 - 6 of 34 Results
Study documents
Protocol
Available language(s): English
Statistical analysis plan
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
2023-27-04
Actual study completion date
2023-27-04
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