治療パターンを説明し、潰瘍性大腸炎集団に最新の治療流を作成する (EFFECT-1LAT)
潰瘍性大腸炎集団の処方パターンを説明し、更新された潰瘍性大腸炎治療パラダイムを生成する
Describing Treatment Patterns and Creating an Updated Treatment Flow in an Ulcerative Colitis Population
調査の概要
詳細な説明
Exploring the long-term outcomes of uncontrolled inflammation, and how does early switching to advanced treatments affect disease outcomes and inflammation control in patients with poorly controlled ulcerative colitis.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Tadworth、イギリス、KT207NS
- Pfizer
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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
The Lothian IBD registry (LIBDR) was compiled through a capture-recapture methodology, describes the observed prevalence of IBD in Lothian between 2008 and 2018, and has been maintained as a prospective registry since 1 August 2018 and thus the study period is up to 1st August 2025 (2008 - 2025). The study size is expected to be a defined population of approximately 4000 UC patients, with more than 600 having commenced an advanced therapy. The study period will be from 2008 - 2025.
説明
Patients must meet all of the following inclusion criteria to be eligible for inclusion in the study:
- Patient enrolled in IBD registry from 2009
- >18 years at time of diagnosis.
- Diagnosis of Ulcerative Colitis.
- Patient data entered during the study period.
- Minimum duration of data post UC diagnosis (Cohort A: 6 months, Cohort B-D 6 months)
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：RETROSPECTIVE
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Cohort A
Patients within the Lothian IBD registry, approximately 4000 patients, of which 3200 are on conventional therapy. |
As provided in real world practice
他の名前：
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Cohort B
Patients with uncontrolled inflammation defined as two or more episodes of raised CRP or faecal calprotectin recording 6-24 months post UC diagnosis. |
As provided in real world practice
他の名前：
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Cohort C
Patients with steroid dependent controlled inflammation defined as normal CRP and faecal calprotectin but the requirement of a dose of steroids between 6-24 months. |
As provided in real world practice
他の名前：
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Cohort D
Patients with controlled inflammation defined as the absence of steroid requirement or normal CRP or faecal calprotectin 6-24 months post UC diagnosis |
As provided in real world practice
他の名前：
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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 |
|---|---|---|
|
Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis.
時間枠：6-24 months from UC diagnosis.
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Proportion of patients that achieve early control of inflammation on conventional therapeutics within 6-24 months of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR). |
6-24 months from UC diagnosis.
|
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Difference in proportion of patients with inadequate control of inflammation (defined as two or more episodes of raised CRP or faecal calprotectin) treated with conventional therapeutics versus treatment escalation 24 months post UC diagnosis.
時間枠：24 months
|
Explore the differences in long term outcomes for patients with uncontrolled inflammation, treated with prolonged conventional therapeutics versus treatment escalation up to 24 months for patients with inadequate control of inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
24 months
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Characterise patient demography at the time of diagnosis and associated co-morbidities and extra-intestinal manifestations of interest.
時間枠：Baseline demography.
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Characterise patient demography at the time of UC diagnosis and associated co-morbidities and extra-intestinal manifestations of interest in the Lothian inflammatory bowel disease registry (LIBDR). |
Baseline demography.
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Map treatment use from conventional therapies to advanced therapies from time of UC diagnosis.
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
|
Map treatment use from from conventional therapies to advanced therapies from time of UC diagnosis in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from Baseline in Faecal Calprotectin (Fcal).
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
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Generate Faecal Calprotectin (Fcal) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from Baseline in C-Reactive Protein (CRP).
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
|
Generate C-Reactive Protein (CRP) profile and longitudinal inflammatory response models for patients on conventional therapy in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with colectomies from baseline.
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
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Assess colectomy rates of patients in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with hospitalisations from baseline.
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
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Assess hospitalisation rates in the Lothian inflammatory bowel disease registry (LIBDR) with a relevant UC diagnosis. |
Study period is up to 1st August 2025 (2008 - 2025).
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Proportion of patients with advanced therapy (AT) requirements with relevant UC diagnosis.
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
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Assess advanced therapy (AT) requirements in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Correlate duration of uncontrolled inflammation within first 6-24 months of treatment to long term outcomes as provided in real world evidence practice.
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
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Duration of uncontrolled inflammation in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Describe the effects of conventional treatment to AT's (etrasimod and tofacitinib) by change from baseline in steroid utilisation.
時間枠：Study period is up to 1st August 2025 (2008 - 2025).
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Effects of conventional treatment to advanced therapies (AT's) in steroid utilisation in the Lothian inflammatory bowel disease registry (LIBDR). |
Study period is up to 1st August 2025 (2008 - 2025).
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Change from baseline in control of inflammation (CRP or faecal calprotectin) in patients that are moved from conventional treatments to advanced treatments with a UC diagnosis.
時間枠：From baseline, study period is up to 1st August 2025 (2008 - 2025).
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Describe the effects of changing from conventional treatment to advanced treatments (etrasimod and tofacitinib) in control of inflammation (CRP or faecal calprotectin) in the Lothian inflammatory bowel disease registry (LIBDR). |
From baseline, study period is up to 1st August 2025 (2008 - 2025).
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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：Pfizer CT.gov Call Center、Pfizer
出版物と役立つリンク
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
- C5041058
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?
IPD プランの説明
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
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
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