Effectiveness of Upadacitinib and Biologics for the Achievement of Minimal Disease Activity in Adults With Moderate-to-Severe Atopic Dermatitis (RAMpUp) (RAMpUp)
A Prospective, Observational Study to Evaluate the Effectiveness of Upadacitinib and Biologics on the Achievement of Minimal Disease Activity in Patients With Moderate-to-severe Atopic Dermatitis (RAMpUp)
Atopic dermatitis (AD) is a common, chronic, inflammatory skin disease with a significant impact on patients' health-related quality of life. In addition to skin lesions, patients often experience pruritis, often at night, which can result in scratching and frequent sleep disturbances. These impacts can subsequently contribute to mental health problems and diminished quality of life. This study aims to evaluate the real-world effectiveness of upadacitinib for the achievement of minimal disease activity and optimal treatment targets in relation to biological treatments in adults with moderate-to-severe atopic dermatitis.
This is a prospective, observational, cohort study to evaluate the effectiveness of upadacitinib and biologics in participants with moderate-to-severe atopic dermatitis. Upadacitinib is an approved selective and reversible JAK inhibitor for the treatment of atopic dermatitis. This study is non-interventional and observational in design. Participants will be prescribed either upadacitinib or an approved biologic treatment for AD as per local country label and prescribing guidelines by their physician independent of study participation. Adult participants with moderate-to-severe AD who are biologic-naive or biologic-experienced will be enrolled. Around 900 participants will be enrolled in the study at multiple sites worldwide.
The study will follow participants for 48 weeks with recommended assessments. The treatment regimen, including route, form, and frequency, will be determined by the physician's usual clinical practice and local prescribing guidelines.
There will be no additional burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the course of the study at a hospital or clinic and will be asked to provide additional information by questionnaire at each visit.
調査の概要
状態
条件
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前:Meerat Oza
- 電話番号:844-663-3742
- メール:meerat.oza@abbvie.com
研究連絡先のバックアップ
- 名前:Meerat Oza
- メール:meerat.oza@abbvie.com
参加基準
適格基準
就学可能な年齢
- 大人
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Physician confirmed diagnosis of moderate-to-severe AD validated Investigator's Global Assessment (vIGA-AD ≥ 3) with onset of symptoms ≥ 1 year prior to baseline
- Biologic-naive or biologic-experienced (use of a biologic treatment for AD within 2 years prior to the baseline visit)
- Participants initiating upadacitinib or an approved biologic treatment for AD per local label and local prescription guidelines
- Participants who are willing and able to complete the patient reported questionnaires
- Participants must voluntarily sign and date an informed consent form approved by an IEC/IRB prior to inclusion in this study (as per local regulations).
Exclusion Criteria:
- Participation in any interventional trial or observational study (not restricted to AD). Participation in a registry is permitted.
- Prior use of the AD treatment being evaluated in the study.
研究計画
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 |
|---|
|
Upadacitinib
Participants initiating upadacitinib for the management of moderate-to-severe atopic dermatitis per local country label and physician decision.
Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.
|
|
Biologics
Participants initiating approved biologic treatments for moderate-to-severe atopic dermatitis per local country label and physician decision.
Treatment prescribed in accordance with the terms of local country authorization and professional and reimbursement guidelines.
|
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 |
|---|---|---|
|
Percentage of Participants Achieving Minimal Disease Activity (MDA)
時間枠:At Week 16
|
Achievement of MDA defined as Eczema Area and Severity Index (EASI ≤ 3) and Worst Pruritus Numerical Rating Scale (WP-NRS) 0/1. The EASI is a validated measure used in clinical practice and clinical trials to assess the severity and extent of AD: Clear=0, Almost clear=0.1-1.0, Mild=1.1-7.0, Moderate=7.1-21.0, Severe=21.1-50.0, Very severe=50.1-72.0 Worst Pruritus NRS (WP-NRS) is a validated single self-reported measure where patients rate the worst level of itching they have experienced over the past 24 hours on a scale from 0 (no itching) to 10 (worst itching imaginable) |
At Week 16
|
協力者と研究者
スポンサー
捜査官
- スタディディレクター:ABBVIE INC.、AbbVie
研究記録日
主要日程の研究
研究開始 (推定)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
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
- P26-178
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?
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
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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