Benralizumab Effectiveness in EGPA (BELONG-EGPA)
2026年9月8日 更新者：European EGPA Study Group
Benralizumab Effectiveness in the LONG-term Real-life Setting in EGPA: The BELONG-EGPA Study
This is a multicenter, retro-prospective observational study evaluating the effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting.
The study will include patients treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group.
Clinical, laboratory, lung function, treatment, relapse, and safety data will be collected from medical charts at baseline and during follow-up up to 24 months.
調査の概要
詳細な説明
BELONG-EGPA is a multicenter, retro-prospective observational study conducted within centers belonging to the European EGPA Study Group. The study is designed to evaluate the long-term real-world effectiveness and safety of benralizumab in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA).
The study population will include adult patients with EGPA who meet the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria for EGPA or the criteria proposed in the MIRRA trial, and who receive benralizumab 30 mg every 4 weeks. Only patients with at least 3 months of available follow-up after starting benralizumab will be included.
Demographic, clinical, biological, lung function, and treatment-related data will be collected from medical charts through a standardized electronic case report form. Data will be collected at the start of benralizumab treatment and at 3, 6, 12, and 24 months of follow-up.
The primary effectiveness outcomes include achievement of complete response and partial response, changes in lung function measured by pre-bronchodilator FEV1, and disease relapses. Complete response is defined as no disease activity, with Birmingham Vasculitis Activity Score equal to 0, and an oral corticosteroid dose of 4.0 mg/day or less of prednisone, prednisolone, or equivalent. Partial response is defined as no disease activity with an oral corticosteroid dose greater than 4.0 mg/day.
Secondary outcomes include treatment persistence, oral corticosteroid tapering and discontinuation, effectiveness and safety in first-line patients compared with patients previously exposed to mepolizumab, outcomes after benralizumab dosage switching, and adverse events and serious adverse events during treatment.
Additional outcomes include changes in organ manifestations, discontinuation of disease-modifying antirheumatic drugs, changes in ANCA status, and variation in eosinophil count. All data will be anonymized and stored in a centralized database.
研究の種類
観察的
入学 (推定)
100
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究連絡先
- 名前：Giacomo Emmi, MD/PhD
- 電話番号：+393286852815
- メール：giacomo.emmi0105@gmail.com
研究連絡先のバックアップ
- 名前：Irene Mattioli, PharmD/PhD
- メール：irene.mattioli@unifi.it
研究場所
-
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Italy
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Florence、Italy、イタリア、50134
- 募集
- Edoardo Biancalana
-
コンタクト：
- Edoardo Biancalana, MD
- 電話番号：+393287394992
- メール：edoardo.biancalana@unifi.it
-
-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
非確率サンプル
調査対象母集団
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) treated with benralizumab 30 mg every 4 weeks at EGPA referral centers participating in the European EGPA Study Group.
Patients may be newly diagnosed or have relapsing or refractory EGPA, and will be included if at least 3 months of follow-up data after benralizumab initiation are available.
説明
Inclusion Criteria:
- Age 18 years or older.
- Diagnosis of eosinophilic granulomatosis with polyangiitis (EGPA) according to the 2022 American College of Rheumatology/European Alliance of Associations for Rheumatology classification criteria or the criteria proposed in the MIRRA trial.
- Treatment with benralizumab 30 mg every 4 weeks.
- At least 3 months of available follow-up data after starting benralizumab.
- Written informed consent for study participation and data collection.
Exclusion Criteria:
- Age younger than 18 years.
- No available follow-up data after starting benralizumab.
- Follow-up after benralizumab initiation shorter than 3 months.
- Lack of written informed consent, where required by local regulations.
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
Patients with EGPA treated with benralizumab
Adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) receiving benralizumab 30 mg every 4 weeks in a real-world setting.
Patients may be newly diagnosed or have relapsing or refractory EGPA and must have at least 3 months of available follow-up after starting benralizumab.
|
Benralizumab administered at a dose of 30 mg every 4 weeks in adult patients with eosinophilic granulomatosis with polyangiitis (EGPA) in a real-world setting.
Patients may receive benralizumab as first-line biologic therapy or after previous exposure to mepolizumab.
Treatment use, persistence, dosage changes, effectiveness outcomes, and safety events will be assessed during follow-up.
|
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Complete Response
時間枠：Baseline and up to 24 months (at 3, 6, 12, 24 months)
|
Proportion of patients achieving complete response during follow-up.
Complete response is defined as no disease activity (BVAS=0) and oral corticosteroid dose ≤4.0 mg/day.
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Baseline and up to 24 months (at 3, 6, 12, 24 months)
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Change in Lung Function
時間枠：Baseline, 3, 6, 12, and 24 months
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Change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) from baseline to each follow-up time point. Unit of Measure: Milliliters |
Baseline, 3, 6, 12, and 24 months
|
|
Disease relapse
時間枠：3, 6, 12, and 24 months
|
Proportion of patients experiencing disease relapse after achieving complete response.
Relapse is defined as active vasculitis, BVAS >0, and/or worsening asthma or ear-nose-throat manifestations leading to an increase in oral corticosteroid dose to >4.0 mg/day, initiation of a new immunosuppressive therapy, or hospitalization.
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3, 6, 12, and 24 months
|
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Partial response
時間枠：Baseline and up to 24 months (at 3, 6, 12, 24 months)
|
Proportion of patients achieving complete response during follow-up.
Partial response is defined as no disease activity (BVAS=0) and oral corticosteroid dose >4.0 mg/day.
|
Baseline and up to 24 months (at 3, 6, 12, 24 months)
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Treatment persistence
時間枠：3, 6, 12, and 24 months
|
Proportion of patients who continue benralizumab treatment, switch benralizumab dosage, or discontinue benralizumab for any reason.
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3, 6, 12, and 24 months
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Change in oral corticosteroid dose expressed as prednisone-equivalent dose
時間枠：Baseline, 3, 6, 12, and 24 months
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The daily dose of each oral corticosteroid will be converted to prednisone-equivalent mg/day using standardized glucocorticoid equivalence factors. Unit of Measure: mg/day of prednisone equivalent |
Baseline, 3, 6, 12, and 24 months
|
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Oral corticosteroid discontinuation
時間枠：3, 6, 12, and 24 months
|
Proportion of patients who discontinue oral corticosteroid therapy during follow-up.
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3, 6, 12, and 24 months
|
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Overall clinical benefit in first-line versus post-mepolizumab patients
時間枠：Baseline, 3, 6, 12, and 24 months
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A comparison of the overall clinical benefit in patients treated with benralizumab as first-line therapy versus patients switching to benralizumab following prior exposure to mepolizumab. Unit of Measure: Percentage of participants |
Baseline, 3, 6, 12, and 24 months
|
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Effectiveness after benralizumab dosage switching
時間枠：3 months after dosage switch
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Assessment of complete response, partial response, and changes in lung function in patients switching benralizumab dosage from 30 mg every 4 weeks to 30 mg every 8 weeks or from 30 mg every 8 weeks to 30 mg every 4 weeks.
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3 months after dosage switch
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Adverse event rate
時間枠：3, 6, 12, and 24 months
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Proportion of patients experiencing at least one adverse event during benralizumab treatment, regardless of causal association with treatment.
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3, 6, 12, and 24 months
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その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Changes in organ manifestations
時間枠：Baseline, 3, 6, 12, and 24 months
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Change in the proportion of patients with active EGPA-related organ manifestations assessed separately from Birmingham Vasculitis Activity Score items.
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Baseline, 3, 6, 12, and 24 months
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DMARD discontinuation rate
時間枠：3, 6, 12, and 24 months
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Proportion of patients discontinuing disease-modifying antirheumatic drug treatment that was ongoing or newly started at baseline.
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3, 6, 12, and 24 months
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Change in ANCA positivity
時間枠：Baseline, 3, 6, 12, and 24 months
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Change in the proportion of patients with positive ANCA testing and proportion of patients with ANCA negativization among those who were ANCA-positive at baseline.
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Baseline, 3, 6, 12, and 24 months
|
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Change in eosinophil count
時間枠：Baseline, 3, 6, 12, and 24 months
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Change in blood eosinophil count from baseline to each follow-up time point.
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Baseline, 3, 6, 12, and 24 months
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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Giacomo Emmi, MD/PhD、University of Trieste, Italy
出版物と役立つリンク
研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。
一般刊行物
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便利なリンク
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2026年2月11日
一次修了 (推定)
2027年2月11日
研究の完了 (推定)
2028年2月11日
試験登録日
最初に提出
2026年5月27日
QC基準を満たした最初の提出物
2026年9月8日
最初の投稿 (実際)
2026年9月11日
学習記録の更新
投稿された最後の更新 (実際)
2026年9月11日
QC基準を満たした最後の更新が送信されました
2026年9月8日
最終確認日
2026年9月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- BENRA_22336_oss
- 22336_oss (レジストリ識別子：Ethics Committee of the Tuscany Region - Central Area (CEAVC))
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
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