潰瘍性大腸炎患者におけるエトラシモドの有効性について学ぶための研究 (EFFECT-UC)
潰瘍性大腸炎における疾患活動性および患者報告の転帰に対するエトラシモドの有効性 - EFFECT-UC
The purpose of this real world non-interventional study is to learn about the effects of etrasimod as treatment for patients with moderate to severe ulcerative colitis.
Patients will be treated according to standard of care and will only be included in the study if etrasimod is the best treatment choice according to the treating physician. Additionally, patients have to be between 18 and 65 years of age and should not have taken etrasimod in the past.
All patients will be prescribed etrasimod according to standard of care. Assessments will be conducted according to standard of care with the exception of health questionnaires which will be completed by the patients online on their own device.
The study duration is 52 weeks with 28 days of safety follow-up. Patients will visit their treating physician as they would if they were not enrolled in the study. During the study duration, patients will be asked to complete health questionnaires on a regular basis either on their mobile phone, tablet or computer.
The effects of etrasimod will be analyzed for each patient comparing to their disease activity prior to the start of etrasimod.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究場所
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Crumpsall、イギリス、M8 5RB
- Northern Care Alliance NHS Foundation Trust, Greater Manchester
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Kent、イギリス、TN2 4QJ
- Tunbridge Wells Hospital
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London、イギリス、SE59RS
- Kings College Hospital
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London、イギリス、NW1 2PG
- University College London Hospital
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London、イギリス、E1 1BB
- Barts Health NHS Trust, The Royal London Hospital
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London、イギリス、HA1 3UJ
- St. Mark's Hospital
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London、イギリス、SE1 7EH
- St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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London、イギリス、SW17 0QT
- St George's Hospital - St George's Healthcare Nhs Trust
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London、イギリス、W2 1PG
- Imperial College Healthcare NHS
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Newport、イギリス、NP20 2UB
- Royal Gwent Hospital
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Southampton、イギリス、SO16 6YD
- Southampton University Hospitals NHS Trust
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Lanarkshire
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Glasgow、Lanarkshire、イギリス、G4 0SF
- NHS Greater Glasgow and Clyde
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Nottinghamshire
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Nottingham、Nottinghamshire、イギリス、NG7 2UH
- Nottingham University Hospitals NHS Trust, Queens Medical Centre
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Oxfordshire
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Oxford、Oxfordshire、イギリス、OX3 9DU
- Oxford University Hospitals NHS Foundation Trust
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Scotland
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Edinburgh、Scotland、イギリス、EH4 2XU
- Western General Hospital
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British Columbia
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Kelowna、British Columbia、カナダ、V1Y 6J6
- Kelowna Gastroenterology Associates
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New Westminster、British Columbia、カナダ、V3L 3E3
- Columbia Medical Building
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Richmond、British Columbia、カナダ、V7C 5L9
- Richmond Hospital
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Vancouver、British Columbia、カナダ、V5Z 1M9
- Vancouver Coastal Health
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Vancouver、British Columbia、カナダ、V6Z 2K5
- Providence Health Care (PHC)
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Ontario
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London、Ontario、カナダ、N6A5A5
- London Health Sciences Centre
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Ottawa、Ontario、カナダ、K1H8L6
- Ottawa Hospital
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Quebec
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Montreal、Quebec、カナダ、H3G 1A4
- Montreal General Hospital
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Montreal、Quebec、カナダ、H2X 3E4
- CHUM
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Montreal、Quebec、カナダ、H4J 1C4
- Hôpital du Sacré-Cœur de Montréal
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Aachen、ドイツ、52064
- MVZ Gastroenterologie Aachen
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Andernach、ドイツ、56626
- Praxis Heil und Müller
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Berlin、ドイツ、10825
- MVZ für Gastroenterologie am Bayerischen Platz
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Cologne、ドイツ、51103
- Evangelisches Krankenhaus Kalk
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Dachau、ドイツ、85221
- MVZ Dachau
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Frankfurt am Main、ドイツ、60594
- Interdisziplinares Crohn Colitis Centrum
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Grevenbroich、ドイツ、41515
- Facharztpraxis für Gastroenterologie
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Halle、ドイツ、06108
- Studiengesellschaft BSF UG.
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Heidelberg、ドイツ、69115
- Praxis für Gasteroenterologie
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Lübeck、ドイツ、23560
- Praxis für Gasteroenterologie Lübeck
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Lüneburg、ドイツ、21339
- Klinikum Lüneburg
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Oldenburg、ドイツ、10115
- Internistische Praxengemeinschaft Oldenburg
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Remscheid、ドイツ、42859
- Magen-Darm-Zentrum Remscheid
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Wesseling、ドイツ、50389
- CED am Rhein
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Breisgau
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Freiburg im Breisgau、Breisgau、ドイツ、79102
- Gastrofreiburg
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Hesse
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Kassel、Hesse、ドイツ、34117
- Gastroenterologie OpernstraBe
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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
Eligible patients can be included in this study if their physician makes a clinical decision to treat them with etrasimod, as defined by the local approved label and independent from the decision to enroll the patient in this study.
説明
Inclusion Criteria:
- Male and female patients ≥18 and <65 years of age at baseline
- Patients with confirmed diagnosis of ulcerative colitis and who are prescribed etrasimod for moderately to severely active ulcerative colitis as per the product label independently of the decision to enroll a patient in this study.
- Evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the study.
Exclusion Criteria:
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Presence of clinical findings suggestive of Crohn's disease.
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Severe extensive colitis evidenced by:
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Physician judgement that the patient is likely to require hospitalization for medical or surgical intervention of any kind for UC (eg, colectomy) within 12 weeks.
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Current evidence of acute severe UC, fulminant colitis, or toxic megacolon 3. Patients with a stoma or planned UC surgical intervention requiring hospitalization.
4. Prior/Concomitant Therapy:
- any previous exposure to etrasimod including participation in the etrasimod clinical program.
- any co-medication with one of the following conventional therapies: methotrexate or a thiopurine (azathioprine, mercaptopurine or tioguanine) or with any of the following advanced therapies for UC: biologics (a TNF, integrin or cytokine antagonist); JAK inhibitors (filgotinib, tofacitinib or upadacitinib) or with any other S1P receptor modulator.
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Not owning a digital device with internet connection and/or not willing to complete health questionnaires on this device or not capable of using the health questionnaire collection tool.
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Investigator site staff or Pfizer employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family.
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 |
介入・治療 |
|---|---|
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潰瘍性大腸炎に対してエトラシモドを受けている患者
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As provided in real world practice |
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 with symptomatic remission
時間枠：Week 12
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Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease. |
Week 12
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Proportion of patients with symptomatic remission
時間枠：Week 52
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Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease. |
Week 52
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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 |
|---|---|---|
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Proportion of patients with clinical response
時間枠：Week 12
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Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission. |
Week 12
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Proportion of patients with clinical response.
時間枠：Week 52
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Clinical response was defined as decrease of at least 20% in Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2) from baseline or achievement of symptomatic remission. |
Week 52
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Proportion of corticosteroid-free patients with symptomatic remission
時間枠：Week 52
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Symptomatic remission was defined as stool frequency sub score (SFS)= 0 (or = 1 with a ≥ 1-point decrease from baseline) and rectal bleeding sub score (RBS) =0.. Stool frequency score and rectal bleeding score are components of the Patient-Reported Outcome-2 score derived based on components of Mayo score (PRO2): instrument designed to measure disease activity of ulcerative colitis. Total score range: stool frequency 0 to 3 and rectal bleeding 0 to 3; higher score=more severe disease. Patients have to be corticosteroid-free for at least 12 weeks prior to the visit. |
Week 52
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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 (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
その他の研究ID番号
- C5041041
- EFFECT-UC (その他の識別子：Alias Study Number)
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
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。