궤양성 대장염 환자에 대한 에트라시모드의 효과를 알아보기 위한 연구 (EFFECT-UC)
궤양성 대장염의 질병 활동 및 환자 보고 결과에 대한 에트라시모드의 효과 - 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.
연구 개요
상태
상태
정황
정황
개입 / 치료
개입 / 치료
연구 유형
연구 유형
등록 (추정된)
등록
연락처 및 위치
연구 장소
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Aachen, 독일, 52064
- MVZ Gastroenterologie Aachen
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Andernach, 독일, 56626
- Praxis Heil und Müller
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Berlin, 독일, 10825
- MVZ für Gastroenterologie am Bayerischen Platz
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Cologne, 독일, 51103
- Evangelisches Krankenhaus Kalk
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Dachau, 독일, 85221
- MVZ Dachau
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Frankfurt am Main, 독일, 60594
- Interdisziplinares Crohn Colitis Centrum
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Grevenbroich, 독일, 41515
- Facharztpraxis für Gastroenterologie
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Halle, 독일, 06108
- Studiengesellschaft BSF UG.
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Heidelberg, 독일, 69115
- Praxis für Gasteroenterologie
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Lübeck, 독일, 23560
- Praxis für Gasteroenterologie Lübeck
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Lüneburg, 독일, 21339
- Klinikum Lüneburg
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Oldenburg, 독일, 10115
- Internistische Praxengemeinschaft Oldenburg
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Remscheid, 독일, 42859
- Magen-Darm-Zentrum Remscheid
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Wesseling, 독일, 50389
- CED am Rhein
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Breisgau
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Freiburg im Breisgau, Breisgau, 독일, 79102
- Gastrofreiburg
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Hesse
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Kassel, Hesse, 독일, 34117
- Gastroenterologie OpernstraBe
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Crumpsall, 영국, M8 5RB
- Northern Care Alliance NHS Foundation Trust, Greater Manchester
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Kent, 영국, TN2 4QJ
- Tunbridge Wells Hospital
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London, 영국, SE59RS
- Kings College Hospital
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London, 영국, NW1 2PG
- University College London Hospital
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London, 영국, E1 1BB
- Barts Health NHS Trust, The Royal London Hospital
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London, 영국, HA1 3UJ
- St. Mark's Hospital
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London, 영국, SE1 7EH
- St Thomas' Hospital - Guy's & St Thomas' NHS Foundation Trust
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London, 영국, SW17 0QT
- St George's Hospital - St George's Healthcare Nhs Trust
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London, 영국, W2 1PG
- Imperial College Healthcare NHS
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Newport, 영국, NP20 2UB
- Royal Gwent Hospital
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Southampton, 영국, SO16 6YD
- Southampton University Hospitals NHS Trust
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Lanarkshire
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Glasgow, Lanarkshire, 영국, G4 0SF
- NHS Greater Glasgow and Clyde
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Nottinghamshire
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Nottingham, Nottinghamshire, 영국, NG7 2UH
- Nottingham University Hospitals NHS Trust, Queens Medical Centre
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Oxfordshire
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Oxford, Oxfordshire, 영국, OX3 9DU
- Oxford University Hospitals NHS Foundation Trust
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Scotland
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Edinburgh, Scotland, 영국, EH4 2XU
- Western General Hospital
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British Columbia
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Kelowna, British Columbia, 캐나다, V1Y 6J6
- Kelowna Gastroenterology Associates
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New Westminster, British Columbia, 캐나다, V3L 3E3
- Columbia Medical Building
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Richmond, British Columbia, 캐나다, V7C 5L9
- Richmond Hospital
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Vancouver, British Columbia, 캐나다, V5Z 1M9
- Vancouver Coastal Health
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Vancouver, British Columbia, 캐나다, V6Z 2K5
- Providence Health Care (PHC)
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Ontario
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London, Ontario, 캐나다, N6A5A5
- London Health Sciences Centre
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Ottawa, Ontario, 캐나다, K1H8L6
- Ottawa Hospital
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Quebec
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Montreal, Quebec, 캐나다, H3G 1A4
- Montreal General Hospital
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Montreal, Quebec, 캐나다, H2X 3E4
- CHUM
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Montreal, Quebec, 캐나다, H4J 1C4
- Hôpital du Sacré-Cœur de Montréal
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참여기준
자격 기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
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.
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: PROSPECTIVE
그룹/코호트 수
코호트 및 개입
그룹/코호트그룹/코호트 |
개입 / 치료개입 / 치료 |
|---|---|
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궤양성 대장염으로 에트라시모드를 투여받는 환자
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As provided in real world practice |
연구는 무엇을 측정합니까?
주요 결과 측정
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients with symptomatic remission
기간: Week 12
|
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
기간: Week 52
|
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
|
2차 결과 측정
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients with clinical response
기간: Week 12
|
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.
기간: Week 52
|
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
기간: Week 52
|
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
|
공동 작업자 및 조사자
수사관
수사관
- 연구 책임자: Pfizer CT.gov Call Center, Pfizer
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
연구 시작
기본 완료 (추정된)
기본 완료
연구 완료 (추정된)
연구 완료
연구 등록 날짜
최초 제출
최초 제출
QC 기준을 충족하는 최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
처음 게시됨
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
마지막 업데이트 게시됨
QC 기준을 충족하는 마지막 업데이트 제출
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
기타 연구 ID 번호
기타 연구 ID 번호
- C5041041
- EFFECT-UC (기타 식별자: Alias Study Number)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
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.
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .