- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT04173273
중등도 내지 중증 활동성 크론병 성인 참가자의 치료에서 경구용 에트라시모드의 효능 및 안전성을 평가하는 연구 (CULTIVATE)
중등도에서 중증 활동성 크론병에 대한 유도 및 유지 요법으로서 경구용 에트라시모드의 효능 및 안전성을 평가하기 위한 다기관, 무작위, 이중맹검, 병렬 그룹 연구
연구 개요
상세 설명
이 연구는 5개의 하위 연구를 포함합니다.
하위 연구 A - 2상: 유도 및 유지 용량 선택을 지원하는 중등도에서 중증 CD 환자의 경구용 에트라시모드 요법의 안전성, 내약성 및 효능을 평가하기 위한 2상, 무작위, 이중 맹검, 하위 연구 하위 연구 A는 현재 등록이 마감되었습니다.
하위 연구 1 - 2상: 에트라시모드를 유도 요법으로 평가하고 3상에서 지속적인 평가를 위한 유도 및 유지 용량을 선택하기 위한 2b상 무작위, 이중 맹검, 위약 대조, 용량 범위 유도 하위 연구. 하위 연구 1은 현재 참가자를 등록하고 있습니다.
하위 연구 2 - 유도: 에트라시모드를 유도 요법으로 평가하기 위한 3상 무작위, 이중 맹검, 위약 대조 하위 연구.
하위 연구 3 - 유지: 에트라시모드를 유지 요법으로 평가하기 위한 3상 무작위, 이중 맹검, 위약 대조 하위 연구. 하위 연구 1 및 하위 연구 2의 참가자는 하위 연구 3에 등록됩니다.
하위 연구 4 - 장기 연장: 최소 52주의 치료를 완료한 참가자를 위한 장기 연장 하위 연구. 하위 연구 3 및 하위 연구 A의 참가자는 하위 연구 4에 등록할 예정입니다.
연구 유형
등록 (실제)
단계
- 2 단계
- 3단계
연락처 및 위치
연구 장소
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Tbilisi, 그루지야, 0160
- LTD Aversi Clinic
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Tbilisi, 그루지야, 0159
- LTD Institute of Clinical Cardiology
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Tbilisi, 그루지야, 0160
- JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
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Tbilisi, 그루지야, 0160
- LTD Academician Nikoloz Kipshidze Central University Clinic
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Tbilisi, 그루지야, 0172
- Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD
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Tbilisi, 그루지야, 0179
- LTD Medical Center "CITO"
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Alexandroupoli, 그리스, 681 00
- University General Hospital of Alexandroupoli
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Athens, 그리스, 10676
- General Hospital of Athens "Evangelismos"
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Crete
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Heraklion, Crete, 그리스, 71500
- Univerisity General Hospital of Heraklion
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Free State
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Bloemfontein, Free State, 남아프리카, 9301
- Dr W Simmonds (Gastroenterology Department)
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Gauteng
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Benoni, Gauteng, 남아프리카, 1501
- Worthwhile Clinical Trials
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Benoni, Gauteng, 남아프리카, 1500
- Dr K Rahman (OTC and Opthalmoscopy)
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Benoni, Gauteng, 남아프리카, 1500
- Lakeview Hospital radiology (Radiology)
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Benoni, Gauteng, 남아프리카, 1500
- Worthwhile Clinical trials (PFT)
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Centurion, Gauteng, 남아프리카, 0157
- Dr E Meyer & Partners, Centurion Eye Hospital (OTC and Opthalmoscopy)
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Centurion, Gauteng, 남아프리카, 0157
- Dr Jorg Reichenberger (Endoscopy)
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Centurion, Gauteng, 남아프리카, 0157
- Drs Burger Radiologists Inc (X-ray/CT)
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Centurion, Gauteng, 남아프리카, 0157
- Johese Clinical Research, Unitas Hospital
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Johannesburg, Gauteng, 남아프리카, 2193
- Wits Clinical Research
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Kempton Park, Gauteng, 남아프리카, 1619
- Clinresco Centres (Pty) Ltd
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Kempton Park, Gauteng, 남아프리카, 1619
- Burger Radiology (Radiology)
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Kempton Park, Gauteng, 남아프리카, 1619
- Dr KJP Lubuya (OCT and Opthalmology)
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Kempton Park, Gauteng, 남아프리카, 1619
- Prof O Mwantembe (Endoscopy)
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Pretoria, Gauteng, 남아프리카, 0002
- Emmed Research
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Springs, Gauteng, 남아프리카, 1559
- Dr K Rahman(OTC and Opthalmoscopy)
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Sunninghill, Gauteng, 남아프리카, 2196
- Dr I Moola (Endoscopy)
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Western Cape
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Cape Town, Western Cape, 남아프리카, 7405
- Dr Peter Chapman (PFT + DLCO)
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Cape Town, Western Cape, 남아프리카, 7441
- Dr Chris Stander (OCT)
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Cape Town, Western Cape, 남아프리카, 7441
- Morton & Partners Radiologists (Radiology)
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Cape Town, Western Cape, 남아프리카, 7441
- Spoke Research Inc. Room 109
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Amsterdam, 네덜란드, 1105 AZ
- Academic Medical Centre
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Utrecht, 네덜란드, 3584 CX
- UMC Utrecht
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Daegu, 대한민국, 41404
- Kyungpook National University Chilgok Hospital
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Daegu, 대한민국, 41944
- Kyungpook National University Hospital
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Daegu, 대한민국, 41944
- Endoscopy Facility in kyungpook National University Hospital
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Daegu, 대한민국, 41944
- OCT Facility In kyungpook National University Hospital
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Daegu, 대한민국, 41944
- PFT Facility in Kyungpook National University Hospital
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Daejeon, 대한민국, 34943
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
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Incheon, 대한민국, 21565
- Gachon University Gil Medical Center
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Seongnam-si, 대한민국, 13496
- CHA University Bundang CHA Hospital
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Seoul, 대한민국, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, 대한민국, 06973
- Chung-Ang University Hospital
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Seoul, 대한민국, 02447
- Kyunghee University Medical Center
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, 대한민국, 10326
- Dongguk University Ilsan Hospital
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Aalborg, 덴마크, 9000
- Aalborg University Hospital, Department of Medical Gastroenterology, Medicinerhuset
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Hvidovre, 덴마크, 2650
- Hvidovre University Hospital
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Augsburg, 독일, 86156
- Universitaetsklinikum Augsburg
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Brandenburg an der Havel, 독일, 14770
- Staedtisches Klinikum Brandenburg
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Frankfurt, 독일, 60431
- Prof. Dr. med. Dr. med. Habil. Jens Buhren, FEBO
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Frankfurt am Main, 독일, 60431
- Agaplesion Markus Krankenhaus
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Hamburg, 독일, 20251
- HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
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Jena, 독일, 07747
- Universitaetsklinikum Jena
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Jena, 독일, 07747
- OCT/Ophtalmoscopy address: Universitaetsklinikum Jena
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Jena, 독일, 07747
- PFT address: Universitaetsklinikum Jena
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Kassel, 독일, 34121
- PFT address: Praxis fur Pneumologie und Allergologie
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Kassel, 독일, 34177
- OCT/Ophtalmoscopy address: Augenarztpraxis Dr. Karola Hassan
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Kiel, 독일, 24105
- Nordblick Augenklinik
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Kiel, 독일, 24105
- Universitatsklinikum Schleswig-Holstein- Campus Kiel
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Nürtingen, 독일, 72622
- Dr. Irina Hasewinkel
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Nürtingen, 독일, 72622
- Medius Klinik Nuertingen
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Hassen
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Kassel, Hassen, 독일, 34117
- Gastroenterologie Opernstraβe
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Kemerovo, 러시아 제국, 650066
- SAIH "Kemerovo Regional Clinical Hospital"
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Novosibirsk, 러시아 제국, 630005
- LLC "SibNovoMed"
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Novosibirsk, 러시아 제국, 630007
- Gastrocenter
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Novosibirsk, 러시아 제국, 630007
- LLC "Novosibirskiy Gastrocentr''
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Novosibirsk, 러시아 제국, 630084
- Hospital #12
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Novosibirsk, 러시아 제국, 630091
- LLC "Siberian Center for Prevention and Treatment of Myopia Eye"
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Novosibirsk, 러시아 제국, 630099
- Joint Stock Company Medical Center "AVICENNA"
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Omsk, 러시아 제국, 644013
- BHI of Omsk region "Clinical Oncology Dispensary"
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Omsk, 러시아 제국, 644024
- Clinicodiagnostic Center "Ultramed"
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Omsk, 러시아 제국, 644070
- Medical center "Intervzglyad"
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Saint Petersburg, 러시아 제국, 191015
- FSBI of Higher Education " North-Western Medical University n.a.I.I. Mechnikov '' of MoH RF
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Saint Petersburg, 러시아 제국, 195067
- FSBI of Higher Education "North-Western Medical University n.a.I.I. Mechnikov'' of MoH RF
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Stavropol, 러시아 제국, 355017
- Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical
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Stavropol Kray
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Pyatigorsk, Stavropol Kray, 러시아 제국, 357502
- LLC "Polyclinic of ultrasonography 4D"
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Beirut, 레바논, 166830
- Hotel Dieu de France Hospital
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Beirut, 레바논, 1100 2807
- Saint George University Hospital Medical Center
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Beirut, 레바논, 113-6044
- Rafik Hariri University Hospital
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Saida, 레바논
- Hammoud Hospital University Medical Center
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Tripoli, 레바논
- Nini Hospital s.a:l
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Bucharest, 루마니아, 012015
- SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
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Bucharest, 루마니아, 022328
- Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
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JUD. CLUJ
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Cluj-Napoca, JUD. CLUJ, 루마니아, 400006
- Spitalul Clinic Judetean de Urgenta Cluj Napoca
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Jud.constanta
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Constanța, Jud.constanta, 루마니아, 900591
- Centrul de Diagnostic si Tratament Affidea, Specialitatea Medicina Interna
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Vilnius, 리투아니아, LT-08661
- Vilnius University Hospital Santaros Klinikos
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Kuala Lumpur, 말레이시아, 59100
- University Malaya Medical Centre
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Chihuahua City, 멕시코, 31203
- Scientia Investigacion Clinica S.C.
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Chihuahua City, 멕시코, 31020
- Sanatorio Palmore A.C.
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Chihuahua City, 멕시코, 31203
- Vista Lasser de Chihuahua S.C.
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Chihuahua City, 멕시코, 31283
- Servicios Hospitalarios de México, S.A. de C.V.
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Veracruz, 멕시코, 91900
- FAICIC S. de R.L. de C.V.
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Veracruz, 멕시코, 91910
- Gabinete de Diagnostico COVADONGA
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Veracruz, 멕시코, 91918
- Alberto Collado Solorzano (Clinica Vision)
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Jalisco
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Guadalajara, Jalisco, 멕시코, 44130
- Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.
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Guadalajara, Jalisco, 멕시코, 44600
- Global Glaucoma Institute
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Guadalajara, Jalisco, 멕시코, 44600
- Video Endoscopia Americas
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Guadalajara, Jalisco, 멕시코, 44670
- Comercializadora Winco S.A. de C.V.
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Veracruz
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Boca del Rio, Veracruz, 멕시코, 94299
- Cirugia y Gastro de Veracruz S.A. de C.V. (Progastro)
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Chisinau, 몰도바, 2005
- "Sf. Arhanghel Mihail" Municipal Clinical Hospital, Department of Gastroenterology
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Chisinau, 몰도바, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery
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Chisinau, 몰도바, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Gastroenterology
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Chisinau, 몰도바, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department
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Alabama
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Dothan, Alabama, 미국, 36301
- Digestive Health Specialists
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Dothan, Alabama, 미국, 36301
- Dothan Eyecare-Dr. Brent McKinley (OCT Location)
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Dothan, Alabama, 미국, 36301
- Center for Digestive Health (Endoscopy Location)
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Dothan, Alabama, 미국, 36301
- Pulmonary Associates (PFT Location)
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Dothan, Alabama, 미국, 36305
- Flowers Hospital (Imaging Location)
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Mobile, Alabama, 미국, 36608
- Digestive Health Specialists (Satellite Clinic Location)
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Mobile, Alabama, 미국, 36608
- Premier Medical Group East (Opthalmology & Optometry Facility)
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Mobile, Alabama, 미국, 36608
- Pulmonary Associates (Chest X-Ray & PFT Facility)
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Mobile, Alabama, 미국, 36608
- Surgicare of Mobile (Endoscopy & Biopsy Facility)
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Arizona
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Peoria, Arizona, 미국, 85381
- Arizona Retina Institute/ Phoenix Retina Associates(OCT)
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Peoria, Arizona, 미국, 85381
- SimonMed Imaging (Imaging)
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Sun City, Arizona, 미국, 85351
- Sun City Endoscopy Center (Endoscopy)
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California
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Apple Valley, California, 미국, 92307
- OM Research LLC
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Apple Valley, California, 미국, 92307
- Victor Valley Advanced Imaging
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La Jolla, California, 미국, 92037
- UCSD lnvestigational Drug Service Pharmacy
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La Jolla, California, 미국, 92093
- Shiley Eye Institute (OCT)
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La Jolla, California, 미국, 92037
- Koman Family Outpatient Pavilion (ENDO)
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La Jolla, California, 미국, 92037
- Perlman Medical Offices
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La Jolla, California, 미국, 92037
- UCSD Clinical and Translational Research Institute
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La Jolla, California, 미국, 92037
- UCSD Health System (Endo/PFT/DLCO)
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Lancaster, California, 미국, 93534
- OM Research LLC
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Lancaster, California, 미국, 93534
- A V Pediatrics, Allergy and Family Medicine - PFT
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Lancaster, California, 미국, 93534
- Advanced Endoscopy and Pain Center - Colonoscopy
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Lancaster, California, 미국, 93534
- Advanced Imaging Center - Chest X-Ray
-
Lancaster, California, 미국, 93534
- Antelope Valley Eye Care - Ophthalmologist
-
Lancaster, California, 미국, 93534
- AV Pediatrics Allergy and Family Medicine
-
Lancaster, California, 미국, 93534
- Jatinder S. Pruthi, MD FACG CPI
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Murrieta, California, 미국, 92563
- United Medical Doctors
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Victorville, California, 미국, 92392
- Retina Consultants of Southern California
-
Victorville, California, 미국, 92395
- Physicians Surgery Center
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Colorado
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Colorado Springs, Colorado, 미국, 80907
- Peak Gastroenterology Associates
-
Colorado Springs, Colorado, 미국, 80903
- Front Range Endoscopy Center
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Colorado Springs, Colorado, 미국, 80909
- Colorado Springs Pulmonary Consultants, PC
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Colorado Springs, Colorado, 미국, 80909
- The Wright Eye Center (OCT Facility)
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Colorado Springs, Colorado, 미국, 80919
- Colorado Springs Imaging (Ultrasound and MRE Location)
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Florida
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Boca Raton, Florida, 미국, 33487
- Xera Med Research
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Boynton Beach, Florida, 미국, 33472
- RecioMed Clinical Research Network, Inc
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Brandon, Florida, 미국, 33511
- Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
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Clearwater, Florida, 미국, 33756
- West Coast Endoscopy Center (Endoscopy Procedures)
-
Clearwater, Florida, 미국, 33756
- Bay Area Chest Physicians, P.A. (Pulmonary Function Test)
-
Clearwater, Florida, 미국, 33761
- Northwood Vision (Optical Coherence Tomography)
-
Clearwater, Florida, 미국, 33761
- Safety Harbor Surgery (Endoscopy Procedures)
-
Clearwater, Florida, 미국, 33762
- Gastro Florida (Regulatory Administrative Duties)
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Coral Gables, Florida, 미국, 33134
- Beraja Medical Institute (OCT)
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Hialeah, Florida, 미국, 33012
- Advanced Eye Center
-
Jacksonville, Florida, 미국, 32256
- Encore Borland-Groover Clinical Research
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Jacksonville, Florida, 미국, 32207
- UF Health Imaging Center-Emerson (chest x-rays)
-
Jacksonville, Florida, 미국, 32207
- UF Health Laboratory Emerson (blood draws)
-
Jacksonville, Florida, 미국, 32209
- UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
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Jacksonville, Florida, 미국, 32209
- UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)
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Jacksonville, Florida, 미국, 32209
- UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)
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Jacksonville, Florida, 미국, 32209
- UF Health Radiology-Jacksonville (chest x-rays)
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Jacksonville, Florida, 미국, 32216
- Cisca Pulmonary & Critical Care (PFT Facility)
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Jacksonville, Florida, 미국, 32216
- Nicolitz Eye Consultants (OCT Facility)
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Jacksonville, Florida, 미국, 32256
- Borland-Groover Clinic (Endoscopy Facility)
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Jupiter, Florida, 미국, 33458
- Jupiter Outpatient Surgery Center
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Kissimmee, Florida, 미국, 34741
- IHS Health, LLC
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Largo, Florida, 미국, 33773
- Lee Shettle Eye & Hearing (Ophthalmoscopy Only)
-
Miami, Florida, 미국, 33133
- Infinite Clinical Research
-
Miami, Florida, 미국, 33156
- Research Associates of South Florida
-
Miami, Florida, 미국, 33176
- Anchor Medical Research, LLC
-
Miami, Florida, 미국, 33134
- The Endoscopy Center (Endoscopy Procedure)
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Miami, Florida, 미국, 33173
- Juan Barrio, MD (PFT when needed)
-
Miami, Florida, 미국, 33133
- Pulmonology Physicians of South Florida
-
Miami, Florida, 미국, 33133
- Reina Eye Care P.A.
-
Miami, Florida, 미국, 33155
- La Salud Research Clinic Inc.
-
Miami, Florida, 미국, 33156
- South Florida Center for Endoscopy and Digestive Disease, LLC
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Naples, Florida, 미국, 34102
- Gastroenterology Group Of Naples
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Naples, Florida, 미국, 34102
- Gulfshore Endoscopy Center
-
Naples, Florida, 미국, 34103
- Retina Consultants of Southwest Florida OCT only
-
Naples, Florida, 미국, 34109
- Lisette Delgado Sanchez, MD PFT only
-
Orlando, Florida, 미국, 32825
- Pediatric & Adult Research Center
-
Palmetto Bay, Florida, 미국, 33157
- IMIC Inc.
-
Palmetto Bay, Florida, 미국, 33157
- IMIC Inc
-
Port Orange, Florida, 미국, 32127
- Advanced Medical Research Center
-
Seminole, Florida, 미국, 33777
- Bardmoor GastroEnterology
-
South Miami, Florida, 미국, 33143
- Larkin Community Hospital (Endoscopy Procedure)
-
St. Petersburg, Florida, 미국, 33705
- St. Petersburg Endoscopy Center (Endoscopy Procedures)
-
St. Petersburg, Florida, 미국, 33707
- Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)
-
St. Petersburg, Florida, 미국, 33709
- Bay Area Endoscopy and Surgery Center (Endoscopy only)
-
St. Petersburg, Florida, 미국, 33709
- Theia Clinical Research, LLC
-
St. Petersburg, Florida, 미국, 33710
- Advanced Research Institute Inc.(IP and PFT)
-
Sun City Center, Florida, 미국, 33573
- Absolute Surgical Specialist - Craig Amshel, MD
-
Tampa, Florida, 미국, 33612
- USF Health Morsani Center for Advanced Healthcare
-
Tampa, Florida, 미국, 33606
- USF Health South Tampa Center for Advanced Healthcare
-
Tampa, Florida, 미국, 33609
- GCP Clinical Research,LLC
-
Tampa, Florida, 미국, 33609
- South Tampa Surgery Center
-
Tampa, Florida, 미국, 33609
- Newsome Eye Specialist (OCT Procedures Only)
-
Tampa, Florida, 미국, 33606
- Lab - Processing/ Storage
-
Tampa, Florida, 미국, 33609
- LoCicero Medical Group
-
-
Georgia
-
Atlanta, Georgia, 미국, 30342
- Atlanta Gastroenterology Associates
-
Atlanta, Georgia, 미국, 30309
- Digestive Healthcare of Georgia
-
Atlanta, Georgia, 미국, 30324
- Ross Eyecare - Opthalmoscopy and OCT
-
Atlanta, Georgia, 미국, 30342
- Atlanta Gastroenterology Associates (endoscopy only)
-
Atlanta, Georgia, 미국, 30342
- Atlanta Gastroenterology Associates(IP only)
-
Atlanta, Georgia, 미국, 30309
- Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs
-
-
Illinois
-
Arlington Heights, Illinois, 미국, 60005
- GI Alliance
-
Arlington Heights, Illinois, 미국, 60005
- Northwest Endoscopy Center (Endoscopy)
-
Gurnee, Illinois, 미국, 60031
- GI Alliance (PFT)
-
Gurnee, Illinois, 미국, 60031
- Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
-
Gurnee, Illinois, 미국, 60031
- Medical Eye Services LTD (Ophthalmoscopy with OCT)
-
Lake Bluff, Illinois, 미국, 60044
- North Shore Endoscopy Center (Endoscopy)
-
Libertyville, Illinois, 미국, 60048
- Libertyville Imaging Center (Diagnostic Imaging)
-
Morton Grove, Illinois, 미국, 60053
- 3T Imaging of Morton Grove (Diagnostic Imaging)
-
-
Maryland
-
Columbia, Maryland, 미국, 21045
- Cascades Endoscopy Center
-
Columbia, Maryland, 미국, 21044
- Charter Radiology
-
Columbia, Maryland, 미국, 21045
- Gastro Center of Maryland, LLC
-
Hanover, Maryland, 미국, 21076
- Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
-
Laurel, Maryland, 미국, 20707
- Lung Center (Pulmonary Function Test only)
-
-
Mississippi
-
Jackson, Mississippi, 미국, 39216
- Southern Therapy and Advanced Research, LLC
-
Jackson, Mississippi, 미국, 39216
- A Terrell Williams, MD, PLLC (OCT)
-
Jackson, Mississippi, 미국, 39216
- Jackson Pulmonary Associates (PFT)
-
Jackson, Mississippi, 미국, 39216
- St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)
-
-
Missouri
-
Creve Coeur, Missouri, 미국, 63141
- Barnes-Jewish West County Hospital (Additional Endoscopy Location)
-
St Louis, Missouri, 미국, 63110
- Barnes-Jewish Hospital
-
St Louis, Missouri, 미국, 63110
- Washington University School of Medicine
-
St Louis, Missouri, 미국, 63108
- Washington University School of Medicine
-
-
New Jersey
-
Freehold, New Jersey, 미국, 07728
- Allied Health Clinical Research Organization, LLC
-
Freehold, New Jersey, 미국, 07728
- Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County
-
Freehold, New Jersey, 미국, 07728
- Freehold Ophthalmology
-
Freehold, New Jersey, 미국, 07728
- Monmouth Ocean Pulmonary Medicine
-
Freehold, New Jersey, 미국, 07728
- Princeton Radiology
-
-
New York
-
New York, New York, 미국, 10016
- NYU Langone Health
-
New York, New York, 미국, 10016
- NYU Langone Inflammatory Bowel Disease Center
-
New York, New York, 미국, 10016
- NYU Langone Eye Center (Ophthalmology)
-
New York, New York, 미국, 10016
- NYU Langone Health - Ambulatory Care Center
-
New York, New York, 미국, 10016
- NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center
-
New York, New York, 미국, 10016
- NYU Pulmonary and Critical Care Associates (Pulmonary)
-
-
North Carolina
-
Charlotte, North Carolina, 미국, 28215
- Carolinas Research Center
-
Charlotte, North Carolina, 미국, 28204
- Queen City Gastroenterology and Hepatology (Endoscopy)
-
Charlotte, North Carolina, 미국, 28211
- Greenman Eye Associates (OCT)
-
Charlotte, North Carolina, 미국, 28273
- Cornerstone Medical (Imaging & PFT)
-
-
Ohio
-
Chardon, Ohio, 미국, 44024
- Geauga Sleep Center(PFT only)
-
Cincinnati, Ohio, 미국, 45219
- UC Health Physicians Office
-
Cincinnati, Ohio, 미국, 45229
- UC Health (Pulmonary Function Testing)
-
Cincinnati, Ohio, 미국, 45219
- UC Health Hoxworth (OCT only)
-
Cincinnati, Ohio, 미국, 45219
- University of Cincinnati Medical Center (PFT and Endoscopy location)
-
Mentor, Ohio, 미국, 44060
- Great Lakes Gastroenterology Research, LLC
-
Mentor, Ohio, 미국, 44060
- The Endoscopy Center of Lake County
-
Mentor, Ohio, 미국, 44060
- Ophthalmic Physicians Incorporated (OCT Only)
-
Mentor, Ohio, 미국, 44060
- Vitreo Retinal Consultants(OCT only)
-
Willoughby, Ohio, 미국, 44094
- Lake Pulmonary Associates (PFT only)
-
Willoughby Hills, Ohio, 미국, 44094
- Retina Specialists of Ohio(OCT only)
-
-
Oklahoma
-
Norman, Oklahoma, 미국, 73071
- Norman Endoscopy Center
-
Norman, Oklahoma, 미국, 73071
- Physicians and Surgeons X-Ray
-
Oklahoma City, Oklahoma, 미국, 73118
- Central Sooner Research
-
Oklahoma City, Oklahoma, 미국, 73102
- Hightower Clinical
-
Oklahoma City, Oklahoma, 미국, 73102
- Saint Anthony Endoscopy Center
-
Oklahoma City, Oklahoma, 미국, 73102
- SSM Health, Saint Anthony Hospital
-
Oklahoma City, Oklahoma, 미국, 73120
- Johnston Opthalmology
-
-
Pennsylvania
-
Hershey, Pennsylvania, 미국, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Texas
-
Austin, Texas, 미국, 78705
- Central Texas Clinical Research
-
Cypress, Texas, 미국, 77429
- Houston Pulmonary Sleep and Allergy Associates (PFT)
-
Houston, Texas, 미국, 77030
- The University of Texas Health Science Center at Houston
-
Houston, Texas, 미국, 77030
- Baylor St. Luke's Medical Center
-
Houston, Texas, 미국, 77047
- Pearland Surgery Center
-
Houston, Texas, 미국, 77030
- Alkek Eye Center Jamail Specialty Care Center (OCT)
-
Houston, Texas, 미국, 77024
- Houston Eye Associates (For Eye Examination)
-
Houston, Texas, 미국, 77030
- Baylor College of Medicine - Baylor St. Luke's Medical Center
-
Houston, Texas, 미국, 77030
- Baylor St. Luke's Medical Center - McNair Campus (pharmacy)
-
Houston, Texas, 미국, 77030
- Baylor St. Luke's Medical Center - McNair Campus
-
Houston, Texas, 미국, 77030
- Baylor St. Luke's Medical Center Endoscopy - McNair Campus
-
Houston, Texas, 미국, 77030
- Mann Eye Institute
-
Houston, Texas, 미국, 77030
- Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)
-
Houston, Texas, 미국, 77034
- Bay Area Endoscopy Center, LLC
-
Houston, Texas, 미국, 77055
- Memorial Endoscopy Center (For Colonoscopy)
-
Houston, Texas, 미국, 77065
- Eye Specialists of Texas
-
Houston, Texas, 미국, 77065
- Northside Gastroenterology Associates PA
-
Houston, Texas, 미국, 77079
- Memorial Pulmonology(For PFT)
-
Houston, Texas, 미국, 77204
- Digestive Health Associates
-
Houston, Texas, 미국, 77204
- Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)
-
Pearland, Texas, 미국, 77584
- LinQ Research, LLC
-
Tyler, Texas, 미국, 75701
- Tyler Research Institute, LLC
-
Tyler, Texas, 미국, 75701
- UT Health East Texas Physicians (pulmonary functions only)
-
Tyler, Texas, 미국, 75701
- Christus Trinity Mother Frances Endoscopy Center (endoscopies only)
-
Tyler, Texas, 미국, 75701
- Heaton Eye Associates (OCT only)
-
Victoria, Texas, 미국, 77904
- Victoria Gastroenterology
-
Victoria, Texas, 미국, 77904
- Citizens Healthplex (for PFT only)
-
Victoria, Texas, 미국, 77904
- Surgery Center (For endoscopy only)
-
Victoria, Texas, 미국, 77904
- Victoria Eye Center (For OCT only)
-
Webster, Texas, 미국, 77598
- GI Alliance Webster
-
-
Virginia
-
Forest, Virginia, 미국, 24551
- Harman Eye Center (OCT only)
-
Lynchburg, Virginia, 미국, 24502
- Blue Ridge Medical Research
-
Lynchburg, Virginia, 미국, 24501
- Lynchburg Pulmonary Associates, Inc. (PFT only)
-
-
Washington
-
Issaquah, Washington, 미국, 98029
- Swedish Endoscopy Center - Issaquah
-
Seattle, Washington, 미국, 98122
- Swedish Medical Center
-
Seattle, Washington, 미국, 98104
- Swedish Gastroenterology
-
Seattle, Washington, 미국, 98104
- Pacific Northwest Retina
-
Seattle, Washington, 미국, 98104
- Richard Bensinger, MD
-
Seattle, Washington, 미국, 98122
- First Hill Endoscopy Center
-
Seattle, Washington, 미국, 98122
- Pulmonary Function Lab
-
-
Wisconsin
-
Milwaukee, Wisconsin, 미국, 53226
- Froedtert Memorial Lutheran Hospital
-
-
-
-
-
Ghent, 벨기에, 9000
- Universitair Ziekenhuis Gent
-
Ghent, 벨기에, 9000
- AZ Maria-Middelares
-
Leuven, 벨기에, 3000
- Universitaire Ziekenhuizen Leuven
-
Roeselare, 벨기에, 8800
- Campus Brugsesteenweg
-
Roeselare, 벨기에, 8800
- Campus Rumbeke
-
Torhout, 벨기에, 8820
- Campus Rembert Torhout
-
Yvoir, 벨기에, 5530
- Centre Hospitalier Universitaire UCL Namur - Site Godinne
-
-
-
-
-
Homyel, 벨라루스, 246029
- Institution "Gomel Regional Clinical Hospital"
-
Minsk, 벨라루스, 220096
- Health care Institution "10th City Clinical Hospital"
-
Mogilev, 벨라루스, 212018
- Health Care Institution "Mogilev Hospital #1"
-
Vitebsk, 벨라루스, 210037
- Health Care Institution "Vitebsk Regional Clinical Hospital"
-
Vitebsk, 벨라루스, 210604
- Healthcare Institution "Vitebsk Regional Clinical Specialized Center"
-
-
-
-
-
Sofia, 불가리아, 1527
- UMHAT "Tsaritsa Yoanna-ISUL" EAD
-
Sofia, 불가리아, 1431
- "DCC Alexandrovska", EOOD
-
Sofia, 불가리아, 1606
- ,,University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov" EAD
-
-
-
-
-
Belgrade, 세르비아, 11000
- Clinical Center Zvezdara
-
-
-
-
-
Bern, 스위스, 3010
- Inselspital Bern
-
Bern, 스위스, 3012
- OCT/Ophtalmoscopy: Berner Augenklinik am Lindenhofspital
-
-
-
-
-
Las Palmas de Gran Canaria, 스페인, 35010
- Hospital Universitario de Gran Canaria Dr. Negrin
-
Madrid, 스페인, 28046
- Hospital Universitario La Paz
-
-
Ciudad REAL
-
Tomellso, Ciudad REAL, 스페인, 13700
- Hospital General de Tomelloso
-
-
-
-
-
Banská Bystrica, 슬로바키아, 975 17
- Fakultna nemocnica s poliklinikou F.D.Roosevelta
-
Bardejov, 슬로바키아, 08501
- ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva
-
Košice, 슬로바키아, 040 13
- ENDOMED, s.r.o. Gastroenterologicka ambulancia
-
Lipany, 슬로바키아, 082 71
- Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.
-
Nitra, 슬로바키아, 949 01
- KM Management spol.s.r.o. Gastroenterologicke a hepatologicke centrum
-
Prešov, 슬로바키아, 080 01
- GASTRO LM s.r.o., Gastroenterologicka ambulancia
-
Prešov, 슬로바키아, 080 01
- Pneumology: PULMO, s.r.o.
-
-
-
-
Prov. de Buenos Aires
-
Ciudadela, Prov. de Buenos Aires, 아르헨티나, 1702
- Instituto Medico Elsa Perez(I.M.E.P)
-
Ciudadela, Prov. de Buenos Aires, 아르헨티나, B1702GIK
- Instituto Medico Elsa Perez (I.M.E.P.) (Local Lab)
-
Ciudadela, Prov. de Buenos Aires, 아르헨티나, B1702GIK
- Instituto Medico Elsa Perez (I.M.E.P.) (Pharmacy)
-
Hurlingham, Prov. de Buenos Aires, 아르헨티나, B1686NCI
- Estudio de La Vision (OCT, Ophthalmoscopy)
-
-
Santa Fe Province
-
Rosario, Santa Fe Province, 아르헨티나, S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
-
Rosario, Santa Fe Province, 아르헨티나, S2000AUC
- Gastroenterologia Rosario (Endoscopy)
-
Rosario, Santa Fe Province, 아르헨티나, S2000CTC
- Microcirugia Ocular SA (OCT, Ophthalmoscopy)
-
Rosario, Santa Fe Province, 아르헨티나, S2000KZD
- Consultorios extemos de Sanatorio Parque (PFT with DLCO, Pulmonar Functional Test with DLCO)
-
-
Tucumán Province
-
San Miguel de Tucumán, Tucumán Province, 아르헨티나, T4000AXL
- Centro de Investigaciones Médicas Tucuman
-
-
-
-
-
Liverpool, 영국, L7 8XP
- Royal Liverpool University Hospital
-
London, 영국, SE1 9RT
- Guys & St Thomas Hospital
-
Norwich, 영국, NR4 7UQ
- Quadram Institute Clinical Research Facility
-
-
-
-
-
Graz, 오스트리아, 8036
- LKH Universitats-Klinikum Graz
-
Innsbruck, 오스트리아, A-6020
- Medical University Innsbruck, Internal Medicine Ⅰ
-
Vienna, 오스트리아, 1090
- AKH Wien- Universitatsklinik fiir Innere Medizin III
-
Vienna, 오스트리아, 1090
- Univ.-Professor Dr. Mehrdad Baghestanian
-
Vienna, 오스트리아, 1090
- AKH Wien- Universitatsklinik fur Innere Medizin III
-
-
-
-
-
Kharkiv, 우크라이나, 61124
- Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
-
Kharkiv, 우크라이나, 61024
- LLC "EyeQClinic"
-
Kharkiv, 우크라이나, 61022
- Llc "Ldts Skaymed'
-
Kharkiv, 우크라이나, 61037
- Communal Non-commercial Enterprise Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv
-
Kharkiv, 우크라이나, 61045
- Llc "Medical Center Oftalmika"
-
Kharkiv, 우크라이나, 61103
- Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care
-
Kyiv, 우크라이나, 01135
- Medical Center of Limited Liability Company Harmoniia Krasy
-
Kyiv, 우크라이나, 02091
- Med Center 'Ok!Clinic+' of Comp with limited liability "Int Inst of Clin Research", Unit of Gastro
-
Kyiv, 우크라이나, 04210
- Private Enterprise "Clinic Medicom"
-
Lutsk, 우크라이나, 43005
- CE Volyn Reg Clinical Hospital ofVolyn Reg Council, Surgical (Endocrine and Abdominal Pathology)
-
Vinnytsia, 우크라이나, 21000
- Private Enterprise Diagnostic Center "Mediscan"
-
Vinnytsia, 우크라이나, 21009
- Medical Center of LLC Health Clinic, Medical Clinical Research Center, Unit of Gastroenterology,
-
Vinnytsia, 우크라이나, 21018
- CNE of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Reg
-
Vinnytsia, 우크라이나, 21029
- Scientific and Research Institute of Invalid Rehabilitation (Educational, Scientific and Treatment
-
-
-
-
-
Afula, 이스라엘, 1834111
- Haemek Medical Center
-
Jerusalem, 이스라엘, 9103102
- Shaare Zedek Medical Center
-
Ramat Gan, 이스라엘, 5262000
- Chaim Sheba Medical Center
-
Tel Aviv, 이스라엘, 6423906
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Alexandria, 이집트, 21131
- Alexandria Clinical Research Center , Faculty of Medicine , Alexandria University
-
Cairo, 이집트
- National Hepatology and Tropical Medicine Research Institute
-
Cairo, 이집트, 11556
- Ain Shams University Hospital
-
Cairo, 이집트
- Air Force Specialized Hospital(AFSH)
-
Cairo, 이집트
- Cairo University , Kasr Al Aini Hospital
-
Dakahlia, 이집트
- Egyptian Liver Research Institute and Hospital ( ELRIAH)
-
Giza, 이집트
- Theodor Bilharz Research Institute Research Ethics Committee
-
Menofeya, 이집트, 32511
- National liver institute
-
-
-
-
-
Catania, 이탈리아, 829-95126
- Azienda Ospedaliera Ospedale Cannizzaro
-
Catanzaro, 이탈리아, 88100
- A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente Campus Universitario "Salvatore Venuta"
-
Catanzaro, 이탈리아, 88100
- A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente
-
Catanzaro, 이탈리아, 88100
- CAMPUS GERMANETO Magazzino farmaci e dispositivi medici, uffici
-
Pavia, 이탈리아, 27100
- Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
-
Rome, 이탈리아, 00189
- PFT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Pneumologia
-
Verona, 이탈리아, 37024
- IRCCS Ospedale Sacro Cuore Don Calabria
-
Verona, 이탈리아, 37134
- OCT/PFT/Endoscopy address: CRC - Cenro Ricerche Cliniche di Verona
-
-
Foggia
-
San Giovanni Rotondo, Foggia, 이탈리아, 71013
- IRCCS Ospedale Casa Sollievo della Sofferenza
-
San Giovanni Rotondo, Foggia, 이탈리아, 71013
- OCT/ PFT/ Endoscopy address: IRCCS Ospedale Casa Sollievo della Sofferenza
-
-
MI
-
Milan, MI, 이탈리아, 20132
- Ospedale San Raffaele
-
-
Milan
-
Garbagnate Milanese, Milan, 이탈리아, 20024
- ASST Rhodense - Pneumology Unit
-
Milan, Milan, 이탈리아, 20017 Rho
- ASST Rhodense, U.O.C. Gastroenterologia ed Endoscopia Digestiva
-
Rho, Milan, 이탈리아, 20017
- ASST Rhodense - Ophthalmology Unit
-
-
Milano
-
Rozzano, Milano, 이탈리아, 20089
- IRCCS Humanitas Research Hospital
-
-
Verona
-
Negrar, Verona, 이탈리아, 37024
- OCT/ PFT/ Endoscopy address: IRCCS Ospedale Sacro Cuore Don Calabria
-
-
-
-
-
Kochi, 인도, 682027
- Aster Medcity, Aster DM Healthcare Ltd.
-
-
Gujarat
-
Surat, Gujarat, 인도, 395002
- Surat Institute of Digestive Sciences
-
-
Haryana
-
Gurugram, Haryana, 인도, 122002
- Fortis Memorial Research Institute
-
-
Maharashtra
-
Nagpur, Maharashtra, 인도, 440010
- Midas Multispeciality Hospital Pvt. Ltd
-
-
Rajasthan
-
Jaipur, Rajasthan, 인도, 302001
- S. R. Kalla Memorial Gastro & General Hospital
-
-
-
-
Chiba
-
Kashiwa-shi, Chiba, 일본, 277-0871
- Kokikai Tsujinaka Hospital Kashiwanoha
-
Nagareyama-shi, Chiba, 일본, 270-0116
- Ishii Eye Clinic
-
-
Fukuoka
-
Kitakyushu-shi, Fukuoka, 일본, 807-8555
- Hospital of the University of Occupational and Environmental Health
-
Kitakyusyu-shi, Fukuoka, 일본, 802-8561
- Kitakyushu Municipal Medical Center
-
-
Ibaraki
-
Toride-shi, Ibaraki, 일본, 302-0014
- Matsumoto Eye Clinic
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, 일본, 892-0846
- Sameshima Hospital
-
Kagoshima, Kagoshima-ken, 일본, 892-0824
- Jiaikai Idzuro Imamura Hospital
-
Kagoshima, Kagoshima-ken, 일본, 890-0062
- Kagoshima Kouseiren Hospital
-
Kagoshima, Kagoshima-ken, 일본, 892-0825
- Sameshima Eye Clinic
-
-
Kumamoto
-
Kumamoto, Kumamoto, 일본, 861-8520
- Japanese Red Cross Kumamoto Hospital
-
-
Saga-ken
-
Saga, Saga-ken, 일본, 849-8501
- Saga University Hospital
-
-
Tokyo
-
Shinjuku-ku, Tokyo, 일본, 169-0073
- Japan Community Health care Organization Tokyo Yamate Medical Center
-
-
-
-
-
Horažďovice, 체코, 341 01
- MUDr. Jaroslava Skalova
-
Hradec Králové, 체코, 500 12
- Hepato-gastroenterologie HK, s.r.o.
-
Hradec Králové, 체코, 500 12
- VISUS, spol s.r.o.
-
Klatovy, 체코, 339 01
- GASTRO JeKa, s.r.o.
-
Klatovy, 체코, 339 01
- Klatovska nemocnice a.s.
-
Olomouc, 체코, 779 00
- PreventaMed s.r.o.
-
Olomouc, 체코, 779 00
- Ocni ordinace Olomouc
-
Olomouc, 체코, 779 00
- MUDr. Pavlina Kazinotova s.r.o.
-
-
-
-
RM
-
Santiago, RM, 칠레, 8330034
- Centro de Investigaciones Clinicas de la Universidad Catolica
-
-
Santiago Metropolitan
-
Santiago, Santiago Metropolitan, 칠레, 7620157
- Clínica Universidad de los Andes
-
Santiago, Santiago Metropolitan, 칠레, 8330336
- CeCim Biocinetic
-
-
-
-
Quebec
-
Montreal, Quebec, 캐나다, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Electrocardiogram Clinic)
-
Montreal, Quebec, 캐나다, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Endoscopy Clinic)
-
Montreal, Quebec, 캐나다, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Pharmacy)
-
Montreal, Quebec, 캐나다, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Radiology)
-
Montreal, Quebec, 캐나다, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Research Site)
-
Montreal, Quebec, 캐나다, H4A 3J1
- Centre for Innovative Medicine - Research Institute of the McGill University Health Centre(Pulmonary
-
Montreal, Quebec, 캐나다, H4P 2S4
- Eye Health MD (Ophthalmology)
-
-
-
-
Quindío Department
-
Armenia, Quindío Department, 콜롬비아, 630004
- IPS Fundacion Cardiomet CEQUIN
-
-
Valle del Cauca Department
-
Cali, Valle del Cauca Department, 콜롬비아, 760035
- Centro de lnvestigaciones Clinicas S.A.S
-
-
-
-
-
Zagreb, 크로아티아, 10000
- University Hospital Center Zagreb
-
-
-
-
-
Ankara, 터키 (Türkiye), 06500
- Gazi University Medical Faculty
-
Ankara, 터키 (Türkiye), 06100
- Hacettepe University Medical Faculty
-
Ankara, 터키 (Türkiye), 06800
- T.C. Saglik Bakanligi Ankara Sehir Hastanesi
-
Antalya, 터키 (Türkiye), 07100
- Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
-
Izmir, 터키 (Türkiye), 35100
- Ege Universitesi Tip Fakultesi Hastanesi
-
Kocaeli, 터키 (Türkiye), 41380
- Kocaeli University Research and Training Hospital
-
Yenişehir, 터키 (Türkiye), 33343
- Mersin University Faculty of Medicine
-
-
-
-
-
Bystra, 폴란드, 43-360
- Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
-
Karkow, 폴란드, 31-156
- Specjalistyczne Gabinety Lekarskie LANDA
-
Krakow, 폴란드, 30-033
- Centre De La Vision Centrum Okulistyczne(OCT, Ophthalmoscopy)
-
Krakow, 폴란드, 30-307
- Medicina (Endoscopy)
-
Krakow, 폴란드, 31-153
- Centrum Medyczne EVITA(Endoscopy)
-
Lodz, 폴란드, 90-752
- IP Clinic Sp. z o.o.
-
Lodz, 폴란드, 90-338
- Centrum Medyczne "Ksiezy Mlyn" (OCT, Ophtalmoscopy)
-
Lodz, 폴란드, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatolog i im. M. Kopernika w Lodzi
-
Lodz, 폴란드, 90-338
- (Centrum Medyczne Ksiezy Mlyn (OCT and Ophthalmoscopy)
-
Lodz, 폴란드, 90-644
- AMICARE Sp. z o.o. sp.k
-
Lodz, 폴란드, 91-053
- Centra Medyczne Medyceusz (DLCO)
-
Lodz, 폴란드, 92-551
- Salve Health Care Sp. o.o., (PFT and Endoscopy)
-
Nowy Targ, 폴란드, 34-400
- Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
-
Oświęcim, 폴란드, 32-600
- Medicome Sp. Z O.O
-
Piotrkow Trybunalski, 폴란드, 97-300
- Przychodnia Okulistyczna "Oculus" Barbara Cybulska (OCT, Ophtalmoscopy)
-
Piotrkow Trybunalski, 폴란드, 97-300
- Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika (Endoscopy)
-
Piotrokow Trybunalski, 폴란드, 97-300
- Trialmed CRS
-
Poznan, 폴란드, 60-529
- Solurmed Centrum Medyczne
-
Poznan, 폴란드, 60-538
- OCU Service Mikolaj Meller Sp.j.(OCT, Ophtalmoscopy)
-
Rzeszów, 폴란드, 35-326
- Centrum Medyczne Medyk
-
Rzeszów, 폴란드, 35-055
- Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie (Ophthalmpscopy)
-
Rzeszów, 폴란드, 35-241
- Podkarpackie Centrum Chorob Plue w Rzeszowie (DLCO)
-
Strzegom, 폴란드, 58-150
- Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)
-
Swidnica, 폴란드, 58-100
- DC-MED
-
Swidnica, 폴란드, 58-100
- Centrum Medyczne EZ-MEDICA (OCT, Ophtalmoscopy)
-
Swidnica, 폴란드, 58-100
- Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)
-
Warsaw, 폴란드, 00-635
- Centrum Zdrowia MDM
-
Warsaw, 폴란드, 00-631
- Centrum Zdrowia MDM (OCT,opthalmoscopy)
-
Warsaw, 폴란드, 01-138
- Instytut Gruzlicy i Chorob Pluc(DLCO)
-
Warsaw, 폴란드, 02-653
- Endoterapia PFG (Endoscopy)
-
Warsaw, 폴란드, 02-653
- Instytut Oka (OCT, Ophtalmoscopy)
-
Warsaw, 폴란드, 03-712
- Specjalistyczne Gabinety Lekarskie Body Clinic
-
Warsaw, 폴란드, 03-731
- Centrum Okulistyczne JASKRA (OCT, Ophthalmoscopy)
-
Warsaw, 폴란드, 04-141
- Wojskowy lnstytut Medyczny (PFT)
-
Wroclaw, 폴란드, 60-681
- EuroMediCare Szpital Specjalistyczny z Przychodniit (Endoscopy)
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, 폴란드, 60-681
- NSZOZ Termedica
-
-
-
-
-
Amiens, 프랑스, 80054
- CHU Amiens Picardie
-
Clermont-Ferrand, 프랑스, 63000
- Chu Gabriel Montpied
-
Clermont-Ferrand, 프랑스, 63000
- CHU De Clermont Ferrand - Hopital Estaing
-
Grenoble, 프랑스, 38043
- CHU Grenoble Alpes - Hopital Michallon
-
Grenoble, 프랑스, 38043
- Endoscopy: CHU Grenoble Alpes- Hopital Michallon
-
La Roche-sur-Yon, 프랑스, 85925
- CHD Vendee, Unite de Recherche Clinique
-
Lille, 프랑스, 59037
- CHU de Lille - Hopital Claude Huriez
-
Lille, 프랑스, 59037
- Optical Coherence Tomography and Ophthalmology CHU de Lille Hopital Roger Salengro
-
Lille, 프랑스, 59037
- Pulmonary Function Test CHU Lille, Institut Coeur Poumon
-
Montpellier, 프랑스, 34295
- CHU Saint-Eloi
-
Montpellier, 프랑스, 34295
- Hopital Saint-Eloi - Pole Digestif - Hgea Recherche Clinique - Rdc
-
Nice, 프랑스, 06202
- CHU de Nice, Hopital 1'Archet 2
-
Reims, 프랑스, 51100
- Hopital Maison Blanche, CHU DE REIMS
-
Reims, 프랑스, 51092
- Hôpital Robert Debré
-
Reims, 프랑스, 51100
- Hopital Robert Debre CHU DE REIMS
-
Saint-Etienne, 프랑스, 42055
- CHU Saint Etienne - Hôpital Nord
-
Saint-Priest-en-Jarez, 프랑스, 42270
- Optical Coherence Tomography and Ophthalmology
-
Saint-Priest-en-Jarez, 프랑스, 42270
- Pulmonary Function Test
-
Toulouse, 프랑스, 31059
- Hôpital Rangueil
-
Toulouse, 프랑스, 31300
- Hopital Purpan PPR pole cephalique
-
Vandœuvre-lès-Nancy, 프랑스, 54511
- CHRU Nancy Brabois
-
-
-
-
-
Budapest, 헝가리, 1136
- Pannónia Magánorvosi Centrum
-
Budapest, 헝가리, 1033
- Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. (abbreviated name: Clinexpert Kft.)
-
Budapest, 헝가리, 1062
- Ophthalmology procedures: Magyar Honvedseg Egeszsegugyi Kozpont
-
Budapest, 헝가리, 1062
- Pulmonary procedures: Vasutegeszsegugyi Nonprofit Kozhasznu K ft.
-
Budapest, 헝가리, 1134
- Ophthalmology, OCT: Medicover Zrt.
-
Budapest, 헝가리, 1139
- Chest X-ray: XIII. keruleti Egeszsegugyi Szolgalat Kozhasznu Nonprofit Kft.
-
Békéscsaba, 헝가리, 5600
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
-
-
Heves County
-
Gyöngyös, Heves County, 헝가리, 3200
- Bugat Pal Korhaz, Gasztroenterologia
-
-
Komárom-Esztergom
-
Tatabánya, Komárom-Esztergom, 헝가리, 2800
- Szent Borbala Korhaz
-
Tatabánya, Komárom-Esztergom, 헝가리, 2800
- DLCO and ophthalmology tests: Szent Borbala Korhaz
-
-
-
-
New South Wales
-
Macquarie University, New South Wales, 호주, 2109
- Macquarie University Hospital
-
Macquarie University, New South Wales, 호주, 2109
- Macquarie University Hospital Pharmacy
-
Macquarie University, New South Wales, 호주, 2109
- Macquarie Respiratory Services
-
Macquarie University, New South Wales, 호주, 2109
- Macquarie University Hospital Clinical Trials
-
Macquarie University, New South Wales, 호주, 2109
- MQ Health Ophthalmology
-
-
Queensland
-
Brisbane, Queensland, 호주, 4029
- Royal Brisbane & Women's Hospital
-
North Mackay, Queensland, 호주, 4740
- Coral Sea Clinical Research Institute
-
-
Victoria
-
Bellfield, Victoria, 호주, 3081
- MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons
-
Epping, Victoria, 호주, 3076
- The Northern Hospital
-
Heidelberg, Victoria, 호주, 3084
- Austin Hospital
-
Melbourne, Victoria, 호주, 3011
- Vision Eye Institute
-
Melbourne, Victoria, 호주, 3011
- Footscray Hospital
-
Parkville, Victoria, 호주, 3050
- The Royal Melbourne Hospital
-
Rosanna, Victoria, 호주, 3084
- Heidelberg Eye Clinic
-
-
Western Australia
-
Murdoch, Western Australia, 호주, 6150
- Fiona Stanley Hospital
-
Nedlands, Western Australia, 호주, 6009
- Lions Eye Institute Limited
-
O'Connor, Western Australia, 호주, 6163
- The trustee for The RTS Unit Trust trading as Respiratory Testing Services
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
설명
모든 하위 연구에 적용되는 자격 기준:
포함 기준:
- 18세에서 80세 사이의 남성 또는 여성,
- 서면 동의 또는 동의를 제공하고 프로토콜 평가 일정을 준수할 수 있는 능력
- 크론병(CD) 진단 ≥ 3개월
- 스크리닝 시 중등도 내지 중증 활성 CD를 가짐
CD 치료를 위한 다음 요법 중 1개 이상에 대한 부적절한 반응(즉, 1차 무반응), 반응 상실 또는 과민증이 입증됨:
- 경구 코르티코스테로이드(예: 프레드니손 또는 이에 상응하는 부데소니드)
- 면역억제제(예: 아자티오프린[AZA], 6 메르캅토퓨린[6-MP] 또는 메토트렉세이트[MTX])
- 종양 괴사 인자 알파(TNFα) 길항제(예: 인플릭시맙, 아달리무맙, 세르톨리주맙 페골 또는 바이오시밀러)
- 인테그린 수용체 길항제(예: 베돌리주맙)
- 인터루킨 -12/-23 길항제(예: 우스테키누맙)
- 가임 여성은 임신하지 않아야 합니다.
- 가임기 여성과 남성은 피임법을 사용해야 합니다.
제외 기준:
- CD 치료용으로 시판되는 2개 이상의 생물학적 제제(즉, TNFα 길항제, 인터루킨 12/23 길항제 및 인테그린 수용체 길항제)의 제제에 대한 부적절한 반응(즉, 1차 무반응)의 이력.
- 궤양성 대장염, 불확실성 대장염, 현미경적 대장염, 허혈성 대장염, 방사선 대장염, 게실 질환 관련 대장염, 독성 거대결장 또는 활동성 감염성 대장염이 있거나 스크리닝 시 클로스트리디오이데스 디피실 독소에 대해 양성 반응이 나타납니다.
- 기능적 또는 수술 후 단장 증후군 또는 수술이 필요하거나 효능 평가를 방해할 수 있는 관련 합병증이 있는 경우
- 무작위 배정 전 ≤ 8주 전에 복부 내 농양에 대한 외과적 치료 또는 무작위 배정 전 ≤ 4주 전에 항문주위 농양에 대한 외과적 치료를 받았습니다.
- 무작위화 ≤ 24주 전에 장 절제술을 받았거나 무작위화 ≤ 12주 전에 다른 복부 수술을 받았습니다.
- ileostomy 또는 colostomy가 있습니다.
하위 연구 3에 대한 포함 기준:
- Substudy 1 및 Substudy 2의 연장된 유도 기간에 진입한 참가자는 연장된 유도 - 6주차 방문을 완료해야 합니다.
하위 연구 4에 대한 포함 기준:
- 참가자는 하위 연구 3의 52주차 방문 또는 하위 연구 A의 66주차 방문을 완료해야 합니다.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 더블
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
위약 비교기: 위약
|
에트라시모드 매칭 플라시보 정제를 매일 1회 경구 복용합니다.
|
|
실험적: 에트라시모드 복용량 A
|
용량 A는 1일 1회 경구 복용합니다.
다른 이름들:
1일 1회 입으로 복용하는 복용량 B.
다른 이름들:
|
|
실험적: 에트라시모드 복용량 B
|
용량 A는 1일 1회 경구 복용합니다.
다른 이름들:
1일 1회 입으로 복용하는 복용량 B.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
기간: Week 14 of SSA
|
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from study baseline in SES-CD.
SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple, can be passed, 3= cannot be passed.
Total SES-CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score indicated more severe disease.
|
Week 14 of SSA
|
|
Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1
기간: Week 14 of SS1
|
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from study baseline in SES-CD.
SES-CD consisted of composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple can be passed, 3= cannot be passed.
Total SES CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
Multiple imputation (MI) method used; percentage calculated based on average response rate from MI datasets.
|
Week 14 of SS1
|
|
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort
기간: Week 52 of study
|
Clinical remission was considered as CDAI score <150.
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); hematocrit (HCT): 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
|
Week 52 of study
|
|
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort
기간: Week 52 of study
|
Clinical remission was considered as CDAI score <150.
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
|
Week 52 of study
|
|
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Responder Cohort
기간: Week 52 of study
|
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD.
SES-CD consisted of composite score based on size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon; rectum.
Size of ulcers score: 0=none, 1=aphthous ulcers,2=large ulcers,3=very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30%, 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%,2= 50%-75%,3= >75%.
Presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed,3=cannot be passed.
Total SES CD=sum of each domain score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score= more severe disease.
|
Week 52 of study
|
|
Percentage of Participants With Endoscopic Response by SES-CD at Week 52: SS3 Non-Responder Cohort
기간: Week 52 of study
|
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD.
SES-CD consisted of composite score based on size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right, transverse; left colon; rectum.
Size of ulcers score: 0=none, 1=aphthous ulcers,2=large ulcers,3=very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30%, 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%,2= 50%-75%,3= >75%.
Presence of narrowing score: 0=none,1=single, can be passed, 2=multiple, can be passed,3=cannot be passed.
Total SES CD=sum of each domain score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score= more severe disease.
|
Week 52 of study
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
기간: Week 14 of SSA
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Clinical remission was considered as CDAI score <150.
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
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Week 14 of SSA
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Change From Baseline in SES-CD Score at Week 14: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple, can be passed, 3= cannot be passed.
Total SES-CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score indicated more severe disease.
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Change From Baseline in CDAI Score at Week 14: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Plasma Concentration of Etrasimod at 4 Hours Post-dose: SSA
기간: 4 hours post-dose on Day 1
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The plasma concentration of etrasimod at 4 hours post-dose has been reported in this outcome measure.
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4 hours post-dose on Day 1
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Steady State Trough Concentration (Ctrough,ss) of Etrasimod From Week 2 to Week 14: SSA
기간: From Week 2 to Week 14
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The average steady-state Ctrough for Week 2 through 14 was calculated based on individual Ctrough data from Week 2, Week 6 and Week 14.
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From Week 2 to Week 14
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Change From Baseline in Absolute Lymphocyte Count (ALC) at Week 14 in Induction Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Percent Change From Baseline in ALC at Week 14 in Induction Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Change From Baseline in ALC at Week 66 in Extension Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Percent Change From Baseline in ALC at Week 66 in Extension Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Change From Baseline in Fecal Calprotectin (FCP) Concentration at Week 14 in Induction Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Percent Change From Baseline in FCP Concentration at Week 14 in Induction Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Change From Baseline in FCP Concentration at Week 66 in Extension Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Percent Change From Baseline in FCP Concentration at Week 66 in Extension Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Change From Baseline in C-Reactive Protein (CRP) at Week 14 in Induction Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Percent Change From Baseline in CRP at Week 14 in Induction Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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Change From Baseline in CRP at Week 66 in Extension Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Percent Change From Baseline in CRP at Week 66 in Extension Period: SSA
기간: Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
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Percentage of Participants With Clinical Remission by CDAI at Week 14: SS1
기간: Week 14 of SS1
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Clinical remission was considered as CDAI score <150.
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
MI method was used; percentage was calculated based on average response rate from MI datasets.
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Week 14 of SS1
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Percentage of Participants With Clinical Remission by Patient Reported Outcomes 2 (PRO2) at Week 14: SS1
기간: Week 14 of SS1
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Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
MI method was used; percentage was calculated based on average response rate from MI datasets.
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Week 14 of SS1
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Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Responder Cohort
기간: Week 52 of study
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Clinical remission was CDAI score <150.
CDAI was a composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score: sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores= more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Non-Responder Cohort
기간: Week 52 of study
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Clinical remission was CDAI score <150.
CDAI was a composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score: sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores= more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Responder Cohort
기간: Week 52 of study
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Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD.
SES-CD= composite score based on 4 components: size of ulcers, ulcerated surface, affected surface, presence of narrowing in 5 segments: ileum; right; transverse; left colon; rectum.
Size of ulcers score: 0=none,1= aphthous ulcers, 2= large ulcers, 3= very large ulcers.
Ulcerated surface score: 0= none,1= <10%, 2= 10%-30%, 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50%-75%,3= >75%.
Presence of narrowing score: 0= none,1= single, can be passed, 2= multiple can be passed, 3= can't be passed.
Total SES CD=sum of component scores for 5 bowel segments and ranged from 0 (no disease) - 60 (severe disease), higher score indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to FMD date.
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Week 52 of study
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Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Non-Responder Cohort
기간: Week 52 of study
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Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD.
SES-CD= composite score based on 4 components: size of ulcers, ulcerated surface, affected surface, presence of narrowing in 5 segments: ileum; right; transverse; left colon; rectum.
Size of ulcers score: 0=none,1= aphthous ulcers, 2= large ulcers, 3= very large ulcers.
Ulcerated surface score: 0= none,1= <10%, 2= 10%-30%, 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50%-75%,3= >75%.
Presence of narrowing score: 0= none,1= single, can be passed, 2= multiple can be passed, 3= can't be passed.
Total SES CD=sum of component scores for 5 bowel segments and ranged from 0 (no disease) - 60 (severe disease), higher score indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to FMD date.
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Week 52 of study
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Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Responder Cohort
기간: Week 52 of study
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Corticosteroid-free remission: CDAI score <150 without receiving corticosteroids for >=8 weeks prior to Week 52 (for participants receiving corticosteroids at baseline).
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid stools; extent of abdominal pain from 0 (none)-3 (severe); general well-being from 0 (generally well)-4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women; percentage deviation from standard weight, lower bound -10.
Total CDAI score=sum of variable scores*weighting factor and was from 0 (no disease)-600 (severe disease), higher score indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Non-Responder Cohort
기간: Week 52 of study
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Corticosteroid-free remission: CDAI score <150 without receiving corticosteroids for >=8 weeks prior to Week 52 (for participants receiving corticosteroids at baseline).
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid stools; extent of abdominal pain from 0 (none)-3 (severe); general well-being from 0 (generally well)-4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women; percentage deviation from standard weight, lower bound -10.
Total CDAI score=sum of variable scores*weighting factor and was from 0 (no disease)-600 (severe disease), higher score indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Endoscopic Remission at Week 52: SS3 Responder Cohort
기간: Week 52 of study
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Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1.
SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed.
Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
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Week 52 of study
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Percentage of Participants With Endoscopic Remission at Week 52: SS3 Non-Responder Cohort
기간: Week 52 of study
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Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1.
SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed.
Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
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Week 52 of study
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Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
기간: Week 52 of study
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Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
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Week 52 of study
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Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort
기간: Week 52 of study
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Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
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Week 52 of study
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Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Responder Cohort
기간: Week 52 of study
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Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables.
Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease.
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD.
SES-CD comprised of 4 components assessed for 5 bowel segments.
Each component score ranged from 0-3, higher scores indicated more severe condition.
Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease.
Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
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Week 52 of study
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Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Non-Responder Cohort
기간: Week 52 of study
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Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables.
Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease.
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD.
SES-CD comprised of 4 components assessed for 5 bowel segments.
Each component score ranged from 0-3, higher scores indicated more severe condition.
Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease.
Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
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Week 52 of study
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Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
기간: Baseline, study Weeks 20, 28, 36, 44, 52
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CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44, 52
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Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
기간: Baseline, study Weeks 20, 28, 36, 44, 52
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CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44, 52
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Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Responder Cohort
기간: Week 52 of study
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Clinical Response was clinical remission by CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI= CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none)-3 (severe); general well-being rating assessed from 0 (generally well) - 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide/opiates for diarrhea; presence of an abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score= sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Non-Responder Cohort
기간: Week 52 of study
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Clinical Response was clinical remission by CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI= CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none)-3 (severe); general well-being rating assessed from 0 (generally well) - 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide/opiates for diarrhea; presence of an abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score= sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms.
Each module ranged from 0 to 16, where higher scores indicated more severe disease.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Non-Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms.
Each module ranged from 0 to 16, where higher scores indicated more severe disease.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 28 and 52: SS3 Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD.
Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life.
The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in IBDQ at Weeks 28 and 52: SS3 Non-Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD.
Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life.
The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Weeks 28 and 52: SS3 Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality.
The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS).
MCS consisted of social functioning, vitality, mental health, and role-emotional scales.
PCS consisted of physical functioning, bodily pain, role-physical, and general health scales.
Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in SF-36 at Weeks 28 and 52: SS3 Non-Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality.
The 8 domains are combined to form 2 component scores MCS and PCS.
MCS consisted of social functioning, vitality, mental health, and role-emotional scales.
PCS consisted of physical functioning, bodily pain, role-physical, and general health scales.
Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 28 and 52: SS3 Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue.
Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much).
Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in FACIT-F at Weeks 28 and 52: SS3 Non-Responder Cohort
기간: Baseline, study Weeks 28 and 52
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The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue.
Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much).
Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at SS3 Baseline: SS3 Responder Cohort
기간: Week 52 of study
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Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
|
Week 52 of study
|
|
Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at Study Entry: SS3 Non-Responder Cohort
기간: Week 52 of study
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Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
|
Week 52 of study
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Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
기간: Baseline, study Weeks 20, 28, 36, 44 and 52
|
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44 and 52
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Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
기간: Baseline, study Weeks 20, 28, 36, 44 and 52
|
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44 and 52
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Time to Remission by PRO2 and FCP Concentrations: SS3 Responder Cohort
기간: From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks)
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Time to remission by PRO2 and FCP concentrations was defined as time to onset of clinical remission by PRO2 and FCP normalization.
Clinical remission by PRO2 was defined as PRO2 score <8.
Normalization of FCP was defined as FCP <=150 milligrams per kilogram.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Participants who did not achieve remission or discontinued from study were censored at 7 days after last dose of study drug.
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From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks)
|
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Time to Remission by PRO2 and FCP Concentrations: SS3 Non-Responder Cohort
기간: From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks)
|
Time to remission by PRO2 and FCP concentrations was defined as time to onset of clinical remission by PRO2 and FCP normalization.
Clinical remission by PRO2 was defined as PRO2 score <8.
Normalization of FCP was defined as FCP <=150 milligrams per kilogram.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Participants who did not achieve remission or discontinued from study were censored at 7 days after last dose of study drug.
|
From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks)
|
|
Time to Response by PRO2 and FCP Concentrations: SS3 Responder Cohort
기간: From first maintenance dose in SS3 until date of clinical response and FCP normalization or censoring date (maximum up to 42 weeks)
|
Time to response by PRO2 and FCP concentrations: time to onset of PRO2 response and FCP normalization.
Clinical response by PRO2: clinical remission by PRO2 or >= 8-point decrease from baseline in PRO2 score.
Clinical remission by PRO2: PRO2 score <8.
Normalization of FCP: FCP <=150 milligrams per kilogram.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Participants who did not achieve response or discontinued from study were censored at 7 days after last dose of study drug.
|
From first maintenance dose in SS3 until date of clinical response and FCP normalization or censoring date (maximum up to 42 weeks)
|
|
Time to Response by PRO2 and FCP Concentrations: SS3 Non-Responder Cohort
기간: From first maintenance dose in SS3 until date of clinical response and FCP normalization or censoring date (maximum up to 42 weeks)
|
Time to response by PRO2 and FCP concentrations: time to onset of PRO2 response and FCP normalization.
Clinical response by PRO2: clinical remission by PRO2 or >= 8-point decrease from baseline in PRO2 score.
Clinical remission by PRO2: PRO2 score <8.
Normalization of FCP: FCP <=150 milligrams per kilogram.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Participants who did not achieve response or discontinued from study were censored at 7 days after last dose of study drug.
|
From first maintenance dose in SS3 until date of clinical response and FCP normalization or censoring date (maximum up to 42 weeks)
|
|
Change From Baseline in SES-CD Score at Week 52: SS3 Responder Cohort
기간: Baseline and Week 52 of study
|
SES-CD was an endoscopic grading system which consisted of composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0= none, 1= aphthous ulcers, 2=large ulcers and 3=very large ulcers.
Ulcerated surface score: 0=none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0=unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0=none, 1=single, can be passed, 2=multiple can be passed, 3=cannot be passed.
Total SES CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
|
Baseline and Week 52 of study
|
|
Change From Baseline in SES-CD Score at Week 52: SS3 Non-Responder Cohort
기간: Baseline and Week 52 of study
|
SES-CD was an endoscopic grading system which consisted of composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0= none, 1= aphthous ulcers, 2=large ulcers and 3=very large ulcers.
Ulcerated surface score: 0=none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0=unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0=none, 1=single, can be passed, 2=multiple can be passed, 3=cannot be passed.
Total SES CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
|
Baseline and Week 52 of study
|
|
Percentage of Participants With Endoscopic Response and Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
기간: Week 52 of study
|
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD.
SES-CD had 4 components assessed for 5 bowel segments where, each component score ranged from 0 to 3, higher scores=more severe condition.
Total SES CD score was determined by sum of each component score for all 5 bowel segments and ranged from 0-60, higher score=more severe disease.
Clinical remission by PRO2: PRO2 score <8.
PRO2 was patient-reported outcome measure based on abdominal pain and stool frequency components of CDAI.
Abdominal pain graded from 0 (none)-3 (severe) each day for 7 days.
Stool frequency was number of liquid or soft stools each day for 7 days.
Total PRO2 score calculated as sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
PRO2 score had minimum score of 0 and had no upper bound, with higher score indicating more frequent stools and more severe abdominal pain.
|
Week 52 of study
|
|
Percentage of Participants With Endoscopic Response and Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort
기간: Week 52 of study
|
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD.
SES-CD had 4 components assessed for 5 bowel segments where, each component score ranged from 0 to 3, higher scores=more severe condition.
Total SES CD score was determined by sum of each component score for all 5 bowel segments and ranged from 0-60, higher score=more severe disease.
Clinical remission by PRO2: PRO2 score <8.
PRO2 was patient-reported outcome measure based on abdominal pain and stool frequency components of CDAI.
Abdominal pain graded from 0 (none)-3 (severe) each day for 7 days.
Stool frequency was number of liquid or soft stools each day for 7 days.
Total PRO2 score calculated as sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
PRO2 score had minimum score of 0 and had no upper bound, with higher score indicating more frequent stools and more severe abdominal pain.
|
Week 52 of study
|
|
Percentage of Participants With Endoscopic Remission and Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
기간: Week 52 of study
|
Endoscopic remission: SES-CD <=4 and at least 2-point reduction from baseline with no sub-score >1.
SES-CD comprised of 4 components assessed for 5 bowel segments where, each component score ranged from 0 to 3, higher scores indicated more severe condition.
Total SES CD score was determined by sum of each component score for all 5 bowel segments and ranged from 0 to 60, higher score indicated more severe disease.
Clinical remission by PRO2 was defined as PRO2 score <8.
PRO2 was patient-reported outcome measure based on abdominal pain and stool frequency components of CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
Stool frequency was number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
PRO2 score had a minimum score of 0 and had no upper bound, with higher score indicating more frequent stools and more severe abdominal pain.
|
Week 52 of study
|
|
Percentage of Participants With Endoscopic Remission and Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort
기간: Week 52 of study
|
Endoscopic remission: SES-CD <=4 and at least 2-point reduction from baseline with no sub-score >1.
SES-CD comprised of 4 components assessed for 5 bowel segments where, each component score ranged from 0 to 3, higher scores indicated more severe condition.
Total SES CD score was determined by sum of each component score for all 5 bowel segments and ranged from 0 to 60, higher score indicated more severe disease.
Clinical remission by PRO2 was defined as PRO2 score <8.
PRO2 was patient-reported outcome measure based on abdominal pain and stool frequency components of CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
Stool frequency was number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
PRO2 score had a minimum score of 0 and had no upper bound, with higher score indicating more frequent stools and more severe abdominal pain.
|
Week 52 of study
|
|
Number of Participants According to Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters: SS4
기간: Baseline, Weeks 52, and 104 of SS4
|
Pre-defined markedly abnormal criteria for ECG parameters included: QT interval: >500 (milliseconds [msec]); change from SS4 baseline >30 msec and change from SS4 baseline >60 msec.
QT interval corrected using Fridericia's formula (QTcF) (msec): >=450 (male) or >=470 (female) msec; change from SS4 baseline >30 msec; change from SS4 baseline >60 msec.
PR interval (msec): >230 msec.
Only those ECG parameters in which at least 1 participant in any of the reporting arm had markedly abnormal criteria are reported in this outcome measure.
SS4 Baseline was defined as the last non-missing measurement taken up to the date of first dose in the SS4.
|
Baseline, Weeks 52, and 104 of SS4
|
|
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs by Severity and Treatment Related TEAEs: SS3
기간: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
|
AE: any untoward medical occurrence that did not necessarily have a causal relationship with treatment.
SAE: an AE that met one of the following criteria: resulted in death; was life-threatening; required inpatient or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or medically significant.
AEs were graded by the National Cancer Institute Common Terminology Criteria for AE version 5 where, Grade(G) 1: mild AE; G2: moderate; G3: severe; G4: life-threatening consequences, urgent intervention indicated; G5: death related to AE. AE was considered TEAE if it started or worsened in severity on or after the first dose of study treatment.
Treatment related AEs were AEs that were related to the study treatment and relatedness was judged by investigator.
|
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
|
|
Number of Participants With TEAEs of Special Interest: SS3
기간: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
|
The TEAEs of special interest included: cardiovascular events (bradycardia, atrioventricular [AV] conduction delay, and hypertension); macular edema; pulmonary disorders (airflow obstruction [forced expiratory volume in 1 second, and forced vital capacity], decreased gas exchange [diffusing capacity of the lung for carbon monoxide]); infections (severe infections, opportunistic infections, and herpes simplex and herpes zoster); liver injury (liver transaminases elevation, and bilirubin elevation); posterior reversible encephalopathy syndrome; and malignancies.
Number of participants with any TEAEs of special interest were reported in this outcome measure.
|
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
|
|
Number of Participants With Clinically Meaningful Changes in Laboratory Parameters: SS3
기간: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
|
Clinically meaningful laboratory abnormalities:Hemoglobin, Hematocrit, Erythrocytes (<0.8*LLN);
Ery.
Volume, Hemoglobin,Mean Corpuscular HGB Concentration <0.8*LLN or >1.5*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (>1.2*ULN),
Prothrombin Time(>1.1*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (>3.0*ULN);
Albumin, Urate (<0.8*LLN and >1.2*ULN; Urea Nitrogen,Creatinine Cholesterol >1.3*ULN; Cholesterol <0.8*LLN or >1.2*LLN, Triglycerides,Potassium,Calcium < 0.9x LLN & >1.1x ULN; Bicarbonate, Glucose, Creatine Kinase.
Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite >=1; Leukocyte Erythrocytes, Leukocytes >=20; Epithelial Cells>=6, Hyaline Cast>1; Bacteria>20.
Number of participants with any laboratory abnormality meeting specified criteria is included.
|
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
|
|
Number of Participants With TEAEs, SAEs, TEAEs by Severity and Treatment Related TEAEs: SS4
기간: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
|
AE: any untoward medical occurrence that did not necessarily have a causal relationship with treatment.
SAE: an AE that met one of the following criteria: resulted in death; was life-threatening; required inpatient or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or medically significant.
AEs were graded by the National Cancer Institute Common Terminology Criteria for AE version 5 where, G1: mild AE; G2: moderate; G3: severe; G4: life-threatening consequences, urgent intervention indicated; G5: death related to AE. AE was considered TEAE if it started or worsened in severity on or after the first dose of study treatment.
Treatment related AEs were AEs that were related to the study treatment and relatedness was judged by investigator.
|
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
|
|
Number of Participants With TEAEs of Special Interest: SS4
기간: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
|
The TEAEs of special interest included: cardiovascular events (bradycardia, AV conduction delay, and hypertension); macular edema; pulmonary disorders (airflow obstruction [forced expiratory volume in 1 second, and forced vital capacity], decreased gas exchange [diffusing capacity of the lung for carbon monoxide]); infections (severe infections, opportunistic infections, and herpes simplex and herpes zoster); liver injury (liver transaminases elevation, and bilirubin elevation); posterior reversible encephalopathy syndrome; and malignancies.
Number of participants with any TEAEs of special interest were reported in this outcome measure.
|
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
|
|
Number of Participants With Clinically Meaningful Changes in Laboratory Parameters: SS4
기간: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
|
Clinically meaningful laboratory abnormalities:Hemoglobin, Hematocrit, Erythrocytes (<0.8*LLN);
Ery.
Volume, Hemoglobin,Mean Corpuscular HGB Concentration <0.8*LLN or >1.5*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (>1.2*ULN),
Prothrombin Time(>1.1*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (>3.0*ULN);
Albumin, Urate (<0.8*LLN and >1.2*ULN; Urea Nitrogen,Creatinine Cholesterol >1.3*ULN; Cholesterol <0.8*LLN or >1.2*LLN, Triglycerides,Potassium,Calcium < 0.9x LLN & >1.1x ULN; Bicarbonate, Glucose, Creatine Kinase.
Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite >=1; Leukocyte Erythrocytes, Leukocytes >=20; Epithelial Cells>=6, Hyaline Cast>1; Bacteria>20.
Number of participants with any laboratory abnormality meeting specified criteria is included.
|
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
|
|
Number of Participants According to Markedly Abnormal Criteria for Vital Signs: SS4
기간: Baseline, Weeks 1, 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
Pre-defined markedly abnormal criteria for vital signs included: Systolic blood pressure (millimeters of mercury [mmHg]): low: <=90 mmHg and high: >150 mmHg.
Diastolic blood pressure (mmHg): low: <=50 mmHg and high: >90 mmHg.
Heart rate (beats per minute [bpm]): low: <40 bpm, <50 bpm and high: >100 bpm.
Only those vital signs parameters in which at least 1 participant in any of the reporting arm had markedly abnormal criteria are reported in this outcome measure.
SS4 baseline=the last non-missing measurement taken up to the date of first dose in the SS4.
|
Baseline, Weeks 1, 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
|
Percentage of Participants With Clinical Remission by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
기간: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
Clinical remission was considered as CDAI score <150.
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
|
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
|
Percentage of Participants With Clinical Response by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
기간: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
Clinical Response was defined as having clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission was considered as CDAI <150.
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
|
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
|
Percentage of Participants With Clinical Remission by PRO2 at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
기간: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
|
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
|
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기타 연구 ID 번호
- APD334-202
- C5041006 (기타 식별자: Alias Study Number)
- 2024-513569-38-00 (레지스트리 식별자: CTIS (EU))
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미국 FDA 규제 기기 제품 연구
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