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This study is a drug use investigation program of NUCALA. The objective of this study is to collect and assess information on the safety and effectiveness of the long-term use of NUCALA SC injection in daily clinical practice in subjects with Eosinophilic Granulomatosis with Polyangiitis (EGPA). All subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study. In addition, after the approval, subjects who had already received NUCALA for EGPA prior to the conclusion of the contract will also be included. Approximately 300 subjects will be included in the study. The observation period per subject is up to 96 weeks (2 years) from the start of NUCALA administration for EGPA at a maximum. If a subject has withdrawn from/terminated administration of NUCALA, it will be until the withdrawal/termination. Additionally, to consider the safety and effectiveness of NUCALA administration in subjects who had withdrawn from/terminated due to symptom improvement, 48 weeks (1 year) follow-up investigation should be conducted as much as possible. The total study duration will be approximately 3 years (2 years observation period and 1 year follow-up) from the approval of EGPA indication to the lifting of approval condition. NUCALA is a registered trademark of the GlaxoSmithKline [GSK] group of companies.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Participants with EGPA | Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nucala | Drug | NUCALA injections will be administered to eligible subjects with diagnosis of EGPA. Dose unit, daily dose frequency, date of administration will be at the investigator discretion. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | ADR is defined as adverse events for which a causal relationship with the drug was not ruled out. | Up to 96 Weeks |
| Response Rate Based on Global Assessment of Effectiveness | Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment*100. Percentage values are rounded-off. | Up to 96 Weeks |
| Time to EGPA Relapse | EGPA relapse was defined as conditions meeting any of the following 3 criteria in participants presenting with worsening of EGPA (newly developed symptoms or worsening of existing symptoms), and the presence or absence of relapse and the time to the first relapse were evaluated: 1. corticosteroid administration newly started or a corticosteroid dose increased; 2. immunosuppressant administration newly started or an immunosuppressant dose increased; 3. hospitalization for the treatment of EGPA. Participants were considered responder for EGPA relapse if they met with any one of the three criteria mentioned above. | Up to 96 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Subjects who administered NUCALA for the treatment of EGPA after its approval of indication will be included in the study.
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Tokyo | 107-0052 | Japan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Fujii T, Atsumi T, Okamoto N, Takahashi N, Tamura N, Nakajima A, Nakajima A, Matsuno H, Mukai I, Ishida A, Aizawa K, Kuwana M, Takagi M, Takeuchi T.Post-marketing surveillance of mepolizumab use in patients with eosinophilic granulomatosis with polyangiitis in Japan: Interim analysis.Ther Res.2021;42(6):403-422 |
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A total of 4115 participants were enrolled in the study; however, 836 participants were included in Safety Analysis Population. Safety Analysis Population consisted of the participants with locked case report form [CRF]. It includes participants that do not fall under the safety analysis exclusion criteria.
This non-interventional study aims to collect and assess the information on the safety and effectiveness of the long-term use of NUCALA in daily clinical practice in participants with Eosinophilic Granulomatosis with Polyangiitis (EGPA).
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| ID | Title | Description |
|---|---|---|
| FG000 | Participants With EGPA | Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Baseline characteristics were reported for Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria.
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| ID | Title | Description |
|---|---|---|
| BG000 | Participants With EGPA | Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Adverse Drug Reactions (ADRs) | ADR is defined as adverse events for which a causal relationship with the drug was not ruled out. | Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. | Posted | Count of Participants | Participants | Up to 96 Weeks |
|
|
All-cause mortality, serious and non-serious adverse drug reactions (ADRs) were collected up to Week 96
Safety Analysis Population which consisted of the participants with locked case report form (CRFs). It includes participants that do not fall under the safety analysis exclusion criteria. Only serious and non-serious ADRs were analyzed but not all adverse events as planned per Protocol.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With EGPA | Participants receiving NUCALA for the treatment of EGPA in clinical practice were enrolled in this study. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Condition aggravated | General disorders | MedDRA v27.1 | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Malaise | General disorders | MedDRA v27.1 | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 | GSKClinicalSupportHD@gsk.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 23, 2024 | Jan 30, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D015267 | Churg-Strauss Syndrome |
| ID | Term |
|---|---|
| D056648 | Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis |
| D056647 | Systemic Vasculitis |
| D014657 | Vasculitis |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C434107 | mepolizumab |
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| Financial reasons |
|
| Lack of Efficacy |
|
| Symptom improvement |
|
| Pregnancy |
|
| Discontinuation due to all Adverse Events |
|
| Participants only registered and whose CRF was not collected |
|
| Participants consent for publication was not obtained |
|
| Participants excluded from safety analysis |
|
| YEARS |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| Participants |
|
|
| Primary | Response Rate Based on Global Assessment of Effectiveness | Response rate is the percentage of participants assessed as "effective" based on the course of subjective symptoms and clinical symptoms. Response rate was calculated as number of participants showing response to the NUCALA treatment divided by total number of participants on treatment*100. Percentage values are rounded-off. | Effectiveness Analysis Population included participants in the safety analysis set who were not excluded from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Number | Percentage of Participants | Up to 96 Weeks |
|
|
|
| Primary | Time to EGPA Relapse | EGPA relapse was defined as conditions meeting any of the following 3 criteria in participants presenting with worsening of EGPA (newly developed symptoms or worsening of existing symptoms), and the presence or absence of relapse and the time to the first relapse were evaluated: 1. corticosteroid administration newly started or a corticosteroid dose increased; 2. immunosuppressant administration newly started or an immunosuppressant dose increased; 3. hospitalization for the treatment of EGPA. Participants were considered responder for EGPA relapse if they met with any one of the three criteria mentioned above. | Effectiveness Analysis Population included participants in the safety analysis set who were not excluded from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. | Posted | Mean | Standard Deviation | Days | Up to 96 Weeks |
|
|
|
| 1 |
| 836 |
| 15 |
| 836 |
| 46 |
| 836 |
| Death | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Pneumonia | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Pneumonia cytomegaloviral | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Haemorrhage subcutaneous | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Panniculitis | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Pustular psoriasis | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Neuropathy peripheral | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Autoimmune hepatitis | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
|
| Drug-induced liver injury | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
|
| Pulmonary embolism | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Eosinophilic granulomatosis with polyangiitis | Immune system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Osteonecrosis | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Alanine aminotransferase increased | Investigations | MedDRA v27.1 | Systematic Assessment |
|
| Renal impairment | Renal and urinary disorders | MedDRA v27.1 | Systematic Assessment |
|
| Condition aggravated | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Asthenia | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Injection site pain | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Injection site pruritus | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Injection site reaction | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Pyrexia | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Application site purpura | General disorders | MedDRA v27.1 | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Bronchitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Cystitis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Tinea pedis | Infections and infestations | MedDRA v27.1 | Systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Urticaria | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Acne | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Drug eruption | Skin and subcutaneous tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Dysaesthesia | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Peripheral sensory neuropathy | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Somnolence | Nervous system disorders | MedDRA v27.1 | Systematic Assessment |
|
| Hepatic function abnormal | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
|
| Liver disorder | Hepatobiliary disorders | MedDRA v27.1 | Systematic Assessment |
|
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Rhinitis hypertrophic | Respiratory, thoracic and mediastinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Enthesopathy | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Musculoskeletal stiffness | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
| Blood immunoglobulin G decreased | Investigations | MedDRA v27.1 | Systematic Assessment |
|
| Immunoglobulins decreased | Investigations | MedDRA v27.1 | Systematic Assessment |
|
| White blood cell count decreased | Investigations | MedDRA v27.1 | Systematic Assessment |
|
| Hot flush | Vascular disorders | MedDRA v27.1 | Systematic Assessment |
|
| Superficial vein prominence | Vascular disorders | MedDRA v27.1 | Systematic Assessment |
|
| Ocular hyperaemia | Eye disorders | MedDRA v27.1 | Systematic Assessment |
|
| Periorbital swelling | Eye disorders | MedDRA v27.1 | Systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA v27.1 | Systematic Assessment |
|
| Insomnia | Psychiatric disorders | MedDRA v27.1 | Systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA v27.1 | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single site data not precede the primary publication of the entire clinical trial.
| D002318 | Cardiovascular Diseases |
| D006099 | Granuloma |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D017445 | Skin Diseases, Vascular |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |