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

NCT ID: NCT04551989

Last Updated: 2024-09-19

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

118 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-11

Study Completion Date

2023-04-27

Brief Summary

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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.

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Association Corticosteroid/Azathioprine in Microscopic Polyangiitis/ Polyarteritis Nodosa or Eosinophilic Granulomatosis With Polyangiitis (Churg Strauss Syndrome)

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Detailed Description

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Conditions

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Churg-Strauss Syndrome Eosinophilic Granulomatosis With Polyangiitis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Participants with EGPA who have received NUCALA treatment

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

No interventions assigned to this group

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Aichi, , Japan

Site Status

GSK Investigational Site

Gunma, , Japan

Site Status

GSK Investigational Site

Hyōgo, , Japan

Site Status

GSK Investigational Site

Hyōgo, , Japan

Site Status

GSK Investigational Site

Hyōgo, , Japan

Site Status

GSK Investigational Site

Hyōgo, , Japan

Site Status

GSK Investigational Site

Ishikawa, , Japan

Site Status

GSK Investigational Site

Ishikawa, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kanagawa, , Japan

Site Status

GSK Investigational Site

Kochi, , Japan

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GSK Investigational Site

Mie, , Japan

Site Status

GSK Investigational Site

Mie, , Japan

Site Status

GSK Investigational Site

Miyagi, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Osaka, , Japan

Site Status

GSK Investigational Site

Saitama, , Japan

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GSK Investigational Site

Shiga, , Japan

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GSK Investigational Site

Shizuoka, , Japan

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GSK Investigational Site

Shizuoka, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tokyo, , Japan

Site Status

GSK Investigational Site

Tottori, , Japan

Site Status

GSK Investigational Site

Wakayama, , Japan

Site Status

GSK Investigational Site

Yamaguchi, , Japan

Site Status

Countries

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Japan

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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213684

Identifier Type: -

Identifier Source: org_study_id

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