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

NCT04551989 | Completed Results

• 1 other identifier: 213684
• Study Type: observational
• Target: 118
• Locations: 1 country
• Sites: 34

Brief Summary

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.

Conditions

Churg-Strauss Syndrome; Eosinophilic Granulomatosis With Polyangiitis

Keywords

NUCALA; Eosinophilic granulomatosis with polyangiitis; Real world setting; Long term safety and efficacy

Outcome Measures

Primary Outcomes (2)

• Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI)

  An AE is any untoward medical occurrence in a clinical study participant, temporally associated with study participation, whether or not considered related to study participation. An SAE is defined as any untoward medical occurrence that, at any dose: results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect, and other situations which involve medical or scientific judgment. An AESI may be of scientific and medical concern related to the treatment, monitored, and rapidly communicated by investigator to sponsor. AESIs included Hypersensitivity (including anaphylaxis), Infections and Malignant tumors.

  Up to 96 weeks

• Number of Participants With Adverse Drug Reactions (ADRs)

  An ADR is defined as an AE for which the investigator classifies the possible relationship to study intervention as "Yes". ADRs related to NUCALA were collected.

  Up to 96 weeks

Secondary Outcomes (6)

• Percentage of Participants With Clinical Symptoms

  At 96 weeks

• Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse

  Up to 96 weeks

• Annualized Rate of Hospitalization for EGPA-related Events

  Up to 96 weeks

• Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events

  Up to 96 weeks

• Average Daily Dose (Prednisolone-equivalent) of Oral Corticosteroid (OCS)

  Week 0, Weeks 9-12, Weeks 21-24, Weeks 33-36, Weeks 45-48, Weeks 57-60, Weeks 69-72, Weeks 81-84, Weeks 93-96

Study Arms (1)

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.

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult participants with EGPA who have already received NUCALA treatment for 96 weeks after its market launch in Japan.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (34)

GSK Investigational Site

Aichi, 489-8642, Japan

Location

GSK Investigational Site

Gunma, 371-8511, Japan

Location

GSK Investigational Site

Hyōgo, 653-0013, Japan

Location

GSK Investigational Site

Hyōgo, 670-8520, Japan

Location

GSK Investigational Site

Hyōgo, 674-0063, Japan

Location

GSK Investigational Site

Hyōgo, 675-8611, Japan

Location

GSK Investigational Site

Ishikawa, 920-8530, Japan

Location

GSK Investigational Site

Ishikawa, 923-8560, Japan

Location

GSK Investigational Site

Kanagawa, 216-8511, Japan

Location

GSK Investigational Site

Kanagawa, 241-0801, Japan

Location

GSK Investigational Site

Kanagawa, 241-0811, Japan

Location

GSK Investigational Site

Kanagawa, 252-0392, Japan

Location

GSK Investigational Site

Kochi, 780-8522, Japan

Location

GSK Investigational Site

Mie, 510-8567, Japan

Location

GSK Investigational Site

Mie, 511-0061, Japan

Location

GSK Investigational Site

Miyagi, 980-8574, Japan

Location

GSK Investigational Site

Osaka, 533-0024, Japan

Location

GSK Investigational Site

Osaka, 534-0021, Japan

Location

GSK Investigational Site

Saitama, 350-8550, Japan

Location

GSK Investigational Site

Shiga, 520-2192, Japan

Location

GSK Investigational Site

Shizuoka, 430-8525, Japan

Location

GSK Investigational Site

Shizuoka, 436-8555, Japan

Location

GSK Investigational Site

Tokyo, 104-8560, Japan

Location

GSK Investigational Site

Tokyo, 113-8431, Japan

Location

GSK Investigational Site

Tokyo, 113-8603, Japan

Location

GSK Investigational Site

Tokyo, 113-8655, Japan

Location

GSK Investigational Site

Tokyo, 173-8606, Japan

Location

GSK Investigational Site

Tokyo, 183-8524, Japan

Location

GSK Investigational Site

Tokyo, 190-0014, Japan

Location

GSK Investigational Site

Tokyo, 194-0023, Japan

Location

GSK Investigational Site

Tokyo, 204-8585, Japan

Location

GSK Investigational Site

Tottori, 680-0833, Japan

Location

GSK Investigational Site

Wakayama, 640-8558, Japan

Location

GSK Investigational Site

Yamaguchi, 755-8505, Japan

Location

MeSH Terms

Conditions

Churg-Strauss Syndrome

Condition Hierarchy (Ancestors)

Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis; Systemic Vasculitis; Vasculitis; Vascular Diseases; Cardiovascular Diseases; Granuloma; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 11, 2020
• First Posted: September 16, 2020
• Study Start: December 11, 2020
• Primary Completion: April 27, 2023
• Study Completion: April 27, 2023
• Last Updated: September 19, 2024
• Results First Posted: September 19, 2024

Record last verified: 2024-04

Data Sharing

• IPD Sharing: Will not share

Locations

JP (34)