CorEvitas 汎発性膿疱性乾癬 (GPP) 医薬品の安全性および有効性レジストリ
Prospective, observational registry for subjects with GPP under the care of a dermatology investigator.Approximately 200 subjects and 75 clinical sites in North America will be recruited to participate with no defined upper limit for either target
調査の概要
状態
条件
詳細な説明
The objective of the registry is to obtain information on the treatment patterns, disease activity progression, and the development of comorbidities and adverse events in a cohort of patients with GPP. Data collected will be used to better characterize the natural history and longitudinal trajectory of the disease. This will be done through the standardized data collection including validated patient-reported outcomes (PRO) and clinician-reported outcomes (ClinRO), the active evaluation of prevalent and incident comorbidities and adverse events, and the recording of medication utilization patterns. Personal information is also collected from each consenting registry subject allowing for linkages to other public or private clinical and administrative databases, as well as to databases maintained by organizations focused on the care and treatment of GPP for the purposes of clinical, market, or outcomes research.
This provides an opportunity to evaluate other aspects of the disease and its treatment, including but not limited to clinical and drug cost-effectiveness, health care resource utilization, and subject adherence.
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
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Massachusetts
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Waltham、Massachusetts、アメリカ、02451
- CorEvitas, LLC
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
Subjects are enrolled in the GPP Registry during regularly scheduled office visits. Selected dermatologists are invited to participate as investigators in the Registry.
説明
Inclusion Criteria:
-
A subject must meet all the following criteria to participate in the registry:
- Has been diagnosed with GPP by a dermatologist or a qualified dermatology practitioner.
- Is at least 18 years of age and has attained the legal age for consent to procedures involved in the research, under the applicable law of the jurisdiction in which the research is being conducted.
- Is willing to provide consent for participation in the registry.
- Is willing to provide Personal Information
Exclusion Criteria:
-
Any of the following would exclude the subject from participating in the registry:
- Is participating or planning to participate in a blinded clinical trial evaluating a systemic agent for the treatment or prevention of flares related to GPP.
- Is enrolled in another CorEvitas registry for a dermatological condition. Subjects enrolled in another CorEvitas registry must be exited to be eligible for enrollment into the GPP Registry
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
- 観測モデル：COHORT
- 時間の展望：PROSPECTIVE
コホートと介入
グループ/コホート |
|---|
|
Generalized Pustular Psoriasis (GPP)
Pts presenting to enrolling sites across the North America are invited to enroll if eligible |
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 |
|---|---|---|
|
Primary Outcome Measure:GPP epidemiology and Presentation
時間枠：Through study completion, an average of 10 years
|
The major clinical outcomes include an assessment of the epidemiology of GPP; to better understand the presentation and natural history. |
Through study completion, an average of 10 years
|
|
GPP management, and outcomes
時間枠：Through study completion, an average of 10 years
|
The major clinical outcome include an assessment of the epidemiology of GPP; to better understand the management and outcomes. |
Through study completion, an average of 10 years
|
協力者と研究者
スポンサー
出版物と役立つリンク
便利なリンク
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (実際)
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
- CorEvitas GPP-510
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
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。