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

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04551989
• Collaborator: (none)
• Enrollment: 120
• Locations: 34
• Anticipated Duration (Months): 27.7
• Patients Per Site: 3.5
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Churg-Strauss Syndrome

Study Design

• Study Type: Observational
• Anticipated Enrollment: 120 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Dec 11, 2020
• Anticipated Primary Completion Date: Apr 3, 2023
• Anticipated Study Completion Date: Apr 3, 2023

Arms and Interventions

Arm	Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

1. Number of participants with Adverse events (AEs), Serious adverse events (SAEs) and Adverse events of special interest (AESI) [Up to 96 weeks]

   AEs, SAEs, and AESIs will be collected.

2. Number of participants with Adverse drug reactions (ADRs) [Up to 96 weeks]

   ADRs related to NUCALA will be collected.

Secondary Outcome Measures

1. Percentage of participants with clinical symptoms [Up to 96 weeks]

   Clinical symptoms relevant to EGPA in systemic vasculitis will be assessed.

2. Percentage of participants with EGPA relapse [Up to 96 weeks]

   EGPA relapse is defined as any of the following with worsening EGPA: increased dose of oral corticosteroids (OCS), initiation/increased dose of immuno-suppressive agents or EGPA treatment with hospitalization.

3. Number of participants with hospitalization for EGPA-related events [Up to 96 weeks]

   Participants with hospitalization for EGPA-related events will be assessed.

4. Number of participants with emergency room/unscheduled visits for EGPA-related events [Up to 96 weeks]

   Participants with emergency room/unscheduled visits for EGPA-related events will be assessed.

5. Number of participants receiving prednisolone-equivalent of OCS over 96 weeks [Up to 96 weeks]

   Number of participants receiving prednisolone-equivalent of OCS over 96 weeks will be assessed.

6. Percentage of participants in each category of average daily prednisolone-equivalent of OCS over 96 weeks [Up to 96 weeks]

   Percentage of participants in each category of average daily prednisolone-equivalent of OCS over 96 weeks will be assessed. The dosing categories will include: zero, greater than (>)0 to less than or equal to (<=)4.0 mg/day, >4.0 to <=7.5 mg/day, >7.5 mg/day.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 20 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Aichi		Japan	489-8642
2	GSK Investigational Site	Gunma		Japan	371-8511
3	GSK Investigational Site	Hyogo		Japan	653-0013
4	GSK Investigational Site	Hyogo		Japan	670-8520
5	GSK Investigational Site	Hyogo		Japan	674-0063
6	GSK Investigational Site	Hyogo		Japan	675-8611
7	GSK Investigational Site	Ishikawa		Japan	920-8530
8	GSK Investigational Site	Ishikawa		Japan	923-8560
9	GSK Investigational Site	Kanagawa		Japan	216-8511
10	GSK Investigational Site	Kanagawa		Japan	241-0801
11	GSK Investigational Site	Kanagawa		Japan	241-0811
12	GSK Investigational Site	Kanagawa		Japan	252-0392
13	GSK Investigational Site	Kochi		Japan	780-8522
14	GSK Investigational Site	Mie		Japan	510-8567
15	GSK Investigational Site	Mie		Japan	511-0061
16	GSK Investigational Site	Miyagi		Japan	980-8574
17	GSK Investigational Site	Osaka		Japan	533-0024
18	GSK Investigational Site	Osaka		Japan	534-0021
19	GSK Investigational Site	Saitama		Japan	350-8550
20	GSK Investigational Site	Shiga		Japan	520-2192
21	GSK Investigational Site	Shizuoka		Japan	430-8525
22	GSK Investigational Site	Shizuoka		Japan	436-8555
23	GSK Investigational Site	Tokyo		Japan	104-8560
24	GSK Investigational Site	Tokyo		Japan	113-8431
25	GSK Investigational Site	Tokyo		Japan	113-8603
26	GSK Investigational Site	Tokyo		Japan	113-8655
27	GSK Investigational Site	Tokyo		Japan	173-8606
28	GSK Investigational Site	Tokyo		Japan	183-8524
29	GSK Investigational Site	Tokyo		Japan	190-0014
30	GSK Investigational Site	Tokyo		Japan	194-0023
31	GSK Investigational Site	Tokyo		Japan	204-8585
32	GSK Investigational Site	Tottori		Japan	680-0833
33	GSK Investigational Site	Wakayama		Japan	640-8558
34	GSK Investigational Site	Yamaguchi		Japan	755-8505

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT04551989
• Other Study ID Numbers: 213684
• First Posted: Sep 16, 2020
• Last Update Posted: Jul 27, 2021
• Last Verified: Jul 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by GlaxoSmithKline: NUCALA; Eosinophilic granulomatosis with polyangiitis; Real world setting; Long term safety and efficacy
• Additional relevant MeSH terms: Granulomatosis with Polyangiitis; Churg-Strauss Syndrome

Study Results

No Results Posted as of Jul 27, 2021