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治験 NCT07221890（対象：自己免疫疾患、関節リウマチ (RA)、炎症性腸疾患（IBD）、Psoriasis (PsO)）は実施中／登録終了です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
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ブリガム・アンド・ウィメンズ病院A Trial of Academic Detailing to Promote Prescribing of Biosimilars 1,325 生物学的製剤 アカデミア主導 バーチャル
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07221890 は 介入研究 臨床試験 で、自己免疫疾患、関節リウマチ (RA)、炎症性腸疾患（IBD）、Psoriasis (PsO) に関するものです。現在は 実施中／登録終了 で、2025年11月6日 から開始しています。1,325 名の参加者 の募集が計画されています。この試験は ブリガム・アンド・ウィメンズ病院 によって主導され、2027年3月31日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2025年12月8日 です。
概要
The goal of this trial is to learn if an interactive evidence-based educational outreach visits to clinicians who prescribe biologics change prescribing of biosimilar medications. The main questions it aims to answer are:
- Do educational outreach visits lead to a higher number of prescriptions for biosimilar versions of adalimumab?
- Do in-person or virtual visits work better?
Researchers will compare clinicians...
もっと見る詳細説明
This is a parallel, cluster randomized controlled trial in which medical practices with clinicians who prescribed adalimumab (Humira) to patients in a Humana Medicare Prescription Drug Plan (PDP) will be randomized to have eligible clinicians within the practice invited to participate in the educational module about biosimilars (the intervention group). Practices with eligible physicians that are not offered the educ...もっと見る
公式タイトル
A Trial of Academic Detailing to Promote Prescribing of Biosimilars
疾患名
自己免疫疾患関節リウマチ (RA)炎症性腸疾患（IBD）Psoriasis (PsO)その他の研究識別子
- 2025P002143
NCT番号
開始日
2025-11-06
最終更新日
2025-12-08
終了予定日
2027-03-31
目標参加者数
1,325
試験の種類
介入研究
治験の相・段階
該当なし
状況
実施中／登録終了
キーワード
biosimilar
biologic
academic detailing
clinician education
prescribing
Medicare Part D
biologic
academic detailing
clinician education
prescribing
Medicare Part D
主目的
医療サービス研究
割付方法
無作為化
介入モデル
並行割当
盲検化
なし（非盲検）
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Intervention Offered an academic detailing session either in-person or virtually (depending on assigned geographic region), plus standard-of-care outreach from the insurance plan. | Offered an academic detailing session Clinicians will be offered an academic detailing session that will be delivered by a specially trained pharmacist, nurse, or physician (i.e., detailer). These academic detailers will be provided and trained by an independent non-profit organization. After a clinician agrees to participate in an academic detailing session, the detailer will schedule a 1-on-1 meeting lasting 15-20 minutes during which the detailer will...もっと見る Standard-of-care outreach from the insurance plan Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars. |
実薬対照薬Control Not offered an academic detailing session. Standard-of-care outreach from the insurance plan. | Standard-of-care outreach from the insurance plan Clinicians will receive formulary information from Humana to provide information about coverage of adalimumab (Humira) and its biosimilars. |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of biosimilar adalimumab prescriptions per clinician | 12 months | |
Number of originator adalimumab (Humira) prescriptions per clinician | 12 months | |
Total spending (payer + patient) on adalimumab | 12 months | |
Patient out-of-pocket spending on adalimumab | 12 months |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
Number of participants in the intervention arm who participated in an educational meeting with an academic detailer | 6 months | |
Number of filled biosimilar prescriptions for other medications with biosimilar versions available, including ustekinumab, tocilizumab, and infliximab | 12 months | |
Number of filled prescriptions for other brand-name disease-modifying medications that are FDA approved to treat 1 or more of the same indications as adalimumab, such as TNF-alpha inhibitors and interleukin inhibitors | 12 months | |
Number of patients who fill 1 or more prescriptions for biosimilar adalimumab who subsequently switch back to originator biologic | 12 months |
参加アシスタント
適格基準
対象年齢
小児, 成人, 高齢者
対象性別
全て
- Wrote 7 or more adalimumab prescriptions that were filled by patients enrolled in research-eligible Humana Medicare Part D plans in the calendar year 2025
- Retired
- Not able to identify active clinical practice in the US (50 states plus Washington DC)
ブリガム・アンド・ウィメンズ病院Humana Healthcare Research, Inc.責任者
Benjamin Rome, 主任研究者, Assistant Professor of Medicine, Brigham and Women's Hospital
連絡先情報がありません。
2 1カ国の場所
Kentucky
Humana Healthcare Research, Inc., Louisville, Kentucky, 40202, United States
Massachusetts
Brigham and Women's Hospital, Boston, Massachusetts, 02115, United States