Mepolizumab Long-term Study to Assess Real World Safety and Effectiveness of Eosinophilic Granulomatosis With Polyangiitis (EGPA) in Japan (MARS)

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Eosinophilic Granulomatosis With Polyangiitis; Churg-Strauss Syndrome

Study type: Observational

Funder types: Industry

Identifiers

NCT04551989

213684

Details and patient eligibility

About

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.

Enrollment: 118 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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 have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan.

  • 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.

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 design

118 participants in 1 patient group

Participants with EGPA who have received NUCALA treatment

Description:

Data will be collected of participants who have already received NUCALA for 96 weeks in routine clinical practice.