An observational study in Churg-Strauss Syndrome and Eosinophilic Granulomatosis With Polyangiitis, sponsored by GlaxoSmithKline. Completed at 34 sites in Japan. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by GlaxoSmithKline · Observational
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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.
61 studies on the registry are indexed under Churg-Strauss Syndrome; 17 are open to participants now.
This study's enrollment of 118 is below the median of 239 across 30 observational studies indexed under Churg-Strauss Syndrome.
Browse Churg-Strauss Syndrome studies →GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
Counted across the registry records on this site, refreshed daily.
Adult participants with EGPA who have already received NUCALA treatment for 96 weeks after its market launch in Japan.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Participants have continuously used NUCALA for at least 96 weeks for the treatment of EGPA as mentioned in the current label in Japan.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Data will be collected of participants who have already received NUCALA for 96 weeks in routine clinical practice.
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.
Time frame: 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.
Time frame: Up to 96 weeks
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.
Time frame: At 96 weeks
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.
Time frame: Up to 96 weeks
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.
Time frame: Up to 96 weeks
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.
Time frame: Up to 96 weeks
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.
Time frame: 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
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.
Time frame: 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
This non-interventional study aims to assess the long-term safety and effectiveness of NUCALA in the real-world setting in participants with Eosinophilic granulomatosis with polyangiitis (EGPA) who have already used NUCALA for 96 weeks after its market launch in Japan and who completed the NUCALA Post marketing surveillance (PMS) study 208505 (NCT03557060).
| Milestone | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Started | 118 |
| Completed | 107 |
| Not completed | 11 |
| Withdrew: Adverse event | 4 |
| Withdrew: Protocol violation | 3 |
| Withdrew: Lost to follow-up | 1 |
| Withdrew: Physician decision | 3 |
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.
| Participants | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Any AE | 69 |
| Any SAE | 26 |
| Any AESI | 42 |
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.
| Participants | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | 0 |
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.
| Percentage of Participants | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Systemic; None | 90 |
| Systemic; Active disease | 10 |
| Systemic; Worsening | 0 |
| Systemic; Active disease + Worsening | 10 |
| Skin; None | 92 |
| Skin; Active disease | 7 |
| Skin; Worsening | 1 |
| Skin; Active disease + Worsening | 8 |
| Mucous Membrane and Eye; None | 100 |
| Mucous Membrane and Eye; Active disease | 0 |
| Mucous Membrane and Eye; Worsening | 0 |
| Mucous Membrane and Eye; Active disease + Worsening | 0 |
| Ear, nose, and throat; None | 85 |
| Ear, nose, and throat; Active disease | 14 |
| Ear, nose, and throat; Worsening | 1 |
| Ear, nose, and throat; Active disease + Worsening | 15 |
| Chest; None | 83 |
| Chest; Active disease | 15 |
| Chest; Worsening | 2 |
| Chest; Active disease + Worsening | 17 |
| Cardiovascular; None | 97 |
| Cardiovascular; Active disease | 3 |
| Cardiovascular; Worsening | 0 |
| Cardiovascular; Active disease + Worsening | 3 |
| Abdominal; None | 99 |
| Abdominal; Active disease | 1 |
| Abdominal; Worsening | 0 |
| Abdominal; Active disease + Worsening | 1 |
| Renal; None | 98 |
| Renal; Active disease | 2 |
| Renal; Worsening | 0 |
| Renal; Active disease + Worsening | 2 |
| Sensory Nervous System; None | 55 |
| Sensory Nervous System; Active disease | 45 |
| Sensory Nervous System; Worsening | 0 |
| Sensory Nervous System; Active disease + Worsening | 45 |
| Motor Nervous System; None | 70 |
| Motor Nervous System; Active disease | 30 |
| Motor Nervous System; Worsening | 0 |
| Motor Nervous System; Active disease + Worsening | 30 |
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.
| Percentage of Participants | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Percentage of Participants With Eosinophilic Granulomatosis With Polyangiitis (EGPA) Relapse | 10 |
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.
| Events per Person-year | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Annualized Rate of Hospitalization for EGPA-related Events | 0.02 (0.00 to 0.16) |
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.
| Events per Person-year | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Annualized Rate of Emergency Room/Unscheduled Visit for EGPA-related Events | 0.07 (0.01 to 0.53) |
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.
| Milligrams | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Week 0 | 3.00 (0.0 to 23.3) |
| Weeks 9-12 | 3.00 (0.0 to 38.4) |
| Weeks 21-24 | 2.50 (0.0 to 32.9) |
| Weeks 33-36 | 2.00 (0.0 to 25.0) |
| Weeks 45-48 | 2.00 (0.0 to 26.6) |
| Weeks 57-60 | 2.00 (0.0 to 25.5) |
| Weeks 69-72 | 2.00 (0.0 to 28.8) |
| Weeks 81-84 | 2.00 (0.0 to 21.4) |
| Weeks 93-96 | 2.00 (0.0 to 15.0) |
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.
| Participants | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Week 0; 0 mg/day | 37 |
| Week 0; >0 to <=4.0 mg/day | 45 |
| Week 0; >4.0 to <=7.5 mg/day | 23 |
| Week 0; >7.5 mg/day | 13 |
| Weeks 9-12; 0 mg/day | 36 |
| Weeks 9-12; >0 to <=4.0 mg/day | 46 |
| Weeks 9-12; >4.0 to <=7.5 mg/day | 20 |
| Weeks 9-12; >7.5 mg/day | 15 |
| Weeks 21-24; 0 mg/day | 39 |
| Weeks 21-24; >0 to <=4.0 mg/day | 46 |
| Weeks 21-24; >4.0 to <=7.5 mg/day | 15 |
| Weeks 21-24; >7.5 mg/day | 15 |
| Weeks 33-36; 0 mg/day | 41 |
| Weeks 33-36; >0 to <=4.0 mg/day | 42 |
| Weeks 33-36; >4.0 to <=7.5 mg/day | 17 |
| Weeks 33-36; >7.5 mg/day | 13 |
| Weeks 45-48; 0 mg/day | 42 |
| Weeks 45-48; >0 to <=4.0 mg/day | 40 |
| Weeks 45-48; >4.0 to <=7.5 mg/day | 18 |
| Weeks 45-48; >7.5 mg/day | 12 |
| Weeks 57-60; 0 mg/day | 41 |
| Weeks 57-60; >0 to <=4.0 mg/day | 39 |
| Weeks 57-60; >4.0 to <=7.5 mg/day | 18 |
| Weeks 57-60; >7.5 mg/day | 12 |
| Weeks 69-72; 0 mg/day | 42 |
| Weeks 69-72; >0 to <=4.0 mg/day | 38 |
| Weeks 69-72; >4.0 to <=7.5 mg/day | 16 |
| Weeks 69-72; >7.5 mg/day | 13 |
| Weeks 81-84; 0 mg/day | 41 |
| Weeks 81-84; >0 to <=4.0 mg/day | 40 |
| Weeks 81-84; >4.0 to <=7.5 mg/day | 12 |
| Weeks 81-84; >7.5 mg/day | 12 |
| Weeks 93-96; 0 mg/day | 43 |
| Weeks 93-96; >0 to <=4.0 mg/day | 37 |
| Weeks 93-96; >4.0 to <=7.5 mg/day | 14 |
| Weeks 93-96; >7.5 mg/day | 10 |
Collected over All-cause mortality, serious adverse events (SAEs) and non-serious adverse events (non-SAEs) were collected up to Week 96. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Participants With EGPA Who Have Received Mepolizumab 300 mg | 3/118 (2.5%) | 26/118 (22%) | 23/118 (19.5%) |
| Event | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| AsthmaRespiratory, thoracic and mediastinal disorders | 3/118 |
| COVID-19Infections and infestations | 2/118 |
| PneumoniaInfections and infestations | 2/118 |
| Spinal compression fractureInjury, poisoning and procedural complications | 2/118 |
| Subdural haematomaInjury, poisoning and procedural complications | 2/118 |
| Gastric cancerNeoplasms benign, malignant and unspecified (incl cysts and polyps) | 2/118 |
| BacteraemiaInfections and infestations | 1/118 |
| Enterocolitis viralInfections and infestations | 1/118 |
| Pneumonia aspirationInfections and infestations | 1/118 |
| Respiratory syncytial virus infectionInfections and infestations | 1/118 |
| Event | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| COVID-19Infections and infestations | 15/118 |
| AsthmaRespiratory, thoracic and mediastinal disorders | 9/118 |
| Age, Customized(Participants) | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| >=15 years to <65 years | 60 |
| >=65 years to <75 years | 38 |
| >=75 years | 20 |
| Sex: Female, Male(Participants) | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| Female | 65 |
| Male | 53 |
| Race/Ethnicity, Customized(Participants) | Participants With EGPA Who Have Received Mepolizumab 300 mg |
|---|---|
| ASIAN - JAPANESE HERITAGE | 118 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Dec 2020 to primary completion in Apr 2023, 28 months.
Results were first posted in Sep 2024, 1 year 4 months after primary completion.
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