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Churg-Strauss SyndromeMARSNCT04551989

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

An observational study of Churg-Strauss Syndrome and Eosinophilic Granulomatosis With Polyangiitis, run by GlaxoSmithKline at 34 sites in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 years and older
How many people
118 participants
Where
34 sitesJapan
Study dates
11 Dec 2020to 27 Apr 2023
Phase
Observational
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

34 sites in 1 country.

34 sites in 1 country

Japan34 sites

  • GSK Investigational Site

    Aichi, 489-8642

  • GSK Investigational Site

    Gunma, 371-8511

  • GSK Investigational Site

    Hyōgo, 653-0013

  • GSK Investigational Site

    Hyōgo, 670-8520

  • GSK Investigational Site

    Hyōgo, 674-0063

  • GSK Investigational Site

    Hyōgo, 675-8611

  • GSK Investigational Site

    Ishikawa, 920-8530

  • GSK Investigational Site

    Ishikawa, 923-8560

  • GSK Investigational Site

    Kanagawa, 216-8511

  • GSK Investigational Site

    Kanagawa, 241-0801

  • GSK Investigational Site

    Kanagawa, 241-0811

  • GSK Investigational Site

    Kanagawa, 252-0392

  • GSK Investigational Site

    Kochi, 780-8522

  • GSK Investigational Site

    Mie, 510-8567

  • GSK Investigational Site

    Mie, 511-0061

  • GSK Investigational Site

    Miyagi, 980-8574

  • GSK Investigational Site

    Osaka, 533-0024

  • GSK Investigational Site

    Osaka, 534-0021

  • GSK Investigational Site

    Saitama, 350-8550

  • GSK Investigational Site

    Shiga, 520-2192

  • GSK Investigational Site

    Shizuoka, 430-8525

  • GSK Investigational Site

    Shizuoka, 436-8555

  • GSK Investigational Site

    Tokyo, 104-8560

  • GSK Investigational Site

    Tokyo, 113-8431

  • GSK Investigational Site

    Tokyo, 113-8603

  • GSK Investigational Site

    Tokyo, 113-8655

  • GSK Investigational Site

    Tokyo, 173-8606

  • GSK Investigational Site

    Tokyo, 183-8524

  • GSK Investigational Site

    Tokyo, 190-0014

  • GSK Investigational Site

    Tokyo, 194-0023

  • GSK Investigational Site

    Tokyo, 204-8585

  • GSK Investigational Site

    Tottori, 680-0833

  • GSK Investigational Site

    Wakayama, 640-8558

  • GSK Investigational Site

    Yamaguchi, 755-8505

Other trials in Japan

About this study

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

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.

Keywords
NUCALA, Eosinophilic granulomatosis with polyangiitis, Real world setting, Long term safety and efficacy
Medical subject headings
Churg-Strauss Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04551989
Study groupRoleWhat they receive
Participants with EGPA who have received NUCALA treatmentData will be collected of participants who have already received NUCALA for 96 weeks in routine clinical practice.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Up to 96 weeks

  2. 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.

    Measured: Up to 96 weeks

Secondary outcomes (6)

  1. Percentage of Participants With Clinical Symptoms

    Clinical symptoms as assessed by 9 organ-systems (i.e. systemic, skin, mucous membranes/eyes, ears/nose/throat, chest, cardiovascular, abdominal, renal, nervous system [motor and sensory]) relevant to EGPA in systemic vasculitis were assessed. Data were summarized for following categories; none, active, worsening, active + worsening. "None" is defined as absence of clinical symptoms. "Active disease" is defined as follows: The participant has clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as "None". "Worsening" is defined as follows: The participant has worsening clinical symptoms, or worsening of symptoms is noted as compared to those in the preceding observation period and the status in the preceding observation period was assessed as "Active disease" or "Worsening". Percentage values are rounded off.

    Measured: At 96 weeks

  2. Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse

    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. Percentage of participants with EGPA relapse were reported. Percentage values are rounded off.

    Measured: Up to 96 weeks

  3. Annualized Rate of Hospitalization for EGPA-related Events

    Annualized rate of hospitalization = (Number of corresponding hospital visits * 365)/ (number of days in the observation period). The annualized rate and associated 95 percent (%) confidence intervals (CIs) were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported.

    Measured: Up to 96 weeks

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

    Annualized rate of Emergency Room/Unscheduled Visit = (Number of corresponding Emergency Room/Unscheduled Visits * 365)/(number of days in the observation period). The annualized rate and associated 95% CIs were calculated using a negative binomial generalized linear model with logarithm of time as an offset variable, without covariate. Number (estimated event per person year) and 95% CI were reported.

    Measured: Up to 96 weeks

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

    Average daily dose of OCS for each participant was calculated by 12-weekly periods as: Total dosage of OCS (mg) / Total duration of administration of OCS (day). Total duration of administration is defined as: Last date of period minus later date of (first date of each period or start date of OCS) +1.

    Measured: 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

  6. Number of Participants by Dosing Categories Relative to Average Daily OCS (Prednisolone-equivalent)

    Number of participants by each category of average daily prednisolone-equivalent of OCS were assessed. The dosing categories included: zero, greater than (>)0 to less than or equal to (<=) 4.0 milligrams per day (mg/day), >4.0 to <=7.5 mg/day, >7.5 mg/day.

    Measured: 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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Sep 2020
  2. Study start11 Dec 2020
  3. Primary completion27 Apr 2023
  4. Study completion27 Apr 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
118 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04551989
Sponsor's protocol ID
213684
Acronym
MARS
Status last verified
Apr 2024
First submitted
11 Sep 2020
Last updated
19 Sep 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

An observational study of Churg-Strauss Syndrome and Eosinophilic Granulomatosis With Polyangiitis, run by GlaxoSmithKline at 34 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Any Adverse Events (AEs), Serious Adverse Events (SAEs) and Adverse Events of Special Interests (AESI) (time frame: Up to 96 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04551989.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.

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