此页面是自动翻译的,不保证翻译的准确性。请参阅 英文版 对于源文本。

一项评估口服依曲莫德治疗中度至重度活动性克罗恩病成人参与者的疗效和安全性的研究 (CULTIVATE)

2026年6月5日 更新者:Pfizer

一项多中心、随机、双盲、平行组研究,以评估口服依曲莫德作为中度至重度活动性克罗恩病的诱导和维持治疗的疗效和安全性

这是一项 2/3 期研究,包括 5 项子研究,旨在评估口服依曲西莫德作为治疗对至少一种药物难治或不耐受的中度至重度活动性克罗恩病 (CD) 成年参与者的疗效、安全性和耐受性目前的 CD 疗法(即皮质类固醇、免疫抑制剂或生物制剂)。 这项研究的总持续时间长达 282 周,包括 28 天的筛选期、长达 274 周的治疗期(诱导期、延长期或维持期以及长期延长期),以及 4 周的随访期安全评估期。

研究概览

详细说明

本研究包括 5 个子研究:

子研究 A - 2 期:一项 2 期、随机、双盲、子研究,用于评估口服依曲莫德治疗中度至重度 CD 参与者的安全性、耐受性和有效性,支持选择诱导剂量和维持剂量对于第 3 阶段。子研究 A 目前已关闭注册。

子研究 1 - 2 期:一项 2b 期随机、双盲、安慰剂对照、剂量范围诱导子研究,以评估 etrasimod 作为诱导治疗并选择诱导和维持剂量以在 3 期继续评估。子研究 1 是目前正在招募参与者。

子研究 2 - 诱导:一项 3 期随机、双盲、安慰剂对照子研究,以评估依曲莫德作为诱导治疗。

子研究 3 - 维持:一项 3 期随机、双盲、安慰剂对照子研究,以评估依曲莫德作为维持治疗。 来自子研究 1 和子研究 2 的参与者将被纳入子研究 3。

子研究 4 - 长期扩展:针对完成至少 52 周治疗的参与者的长期扩展子研究。 来自子研究 3 和子研究 A 的参与者计划被纳入子研究 4。

研究类型

介入性

注册 (实际的)

379

阶段

  • 阶段2
  • 第三阶段

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Aalborg、丹麦、9000
        • Aalborg University Hospital, Department of Medical Gastroenterology, Medicinerhuset
      • Hvidovre、丹麦、2650
        • Hvidovre University Hospital
      • Kharkiv、乌克兰、61124
        • Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
      • Kharkiv、乌克兰、61024
        • LLC "EyeQClinic"
      • Kharkiv、乌克兰、61022
        • Llc "Ldts Skaymed'
      • Kharkiv、乌克兰、61037
        • Communal Non-commercial Enterprise Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv
      • Kharkiv、乌克兰、61045
        • Llc "Medical Center Oftalmika"
      • Kharkiv、乌克兰、61103
        • Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care
      • Kyiv、乌克兰、01135
        • Medical Center of Limited Liability Company Harmoniia Krasy
      • Kyiv、乌克兰、02091
        • Med Center 'Ok!Clinic+' of Comp with limited liability "Int Inst of Clin Research", Unit of Gastro
      • Kyiv、乌克兰、04210
        • Private Enterprise "Clinic Medicom"
      • Lutsk、乌克兰、43005
        • CE Volyn Reg Clinical Hospital ofVolyn Reg Council, Surgical (Endocrine and Abdominal Pathology)
      • Vinnytsia、乌克兰、21000
        • Private Enterprise Diagnostic Center "Mediscan"
      • Vinnytsia、乌克兰、21009
        • Medical Center of LLC Health Clinic, Medical Clinical Research Center, Unit of Gastroenterology,
      • Vinnytsia、乌克兰、21018
        • CNE of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Reg
      • Vinnytsia、乌克兰、21029
        • Scientific and Research Institute of Invalid Rehabilitation (Educational, Scientific and Treatment
      • Tbilisi、乔治亚州、0160
        • LTD Aversi Clinic
      • Tbilisi、乔治亚州、0159
        • LTD Institute of Clinical Cardiology
      • Tbilisi、乔治亚州、0160
        • JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
      • Tbilisi、乔治亚州、0160
        • LTD Academician Nikoloz Kipshidze Central University Clinic
      • Tbilisi、乔治亚州、0172
        • Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD
      • Tbilisi、乔治亚州、0179
        • LTD Medical Center "CITO"
      • Afula、以色列、1834111
        • Haemek Medical Center
      • Jerusalem、以色列、9103102
        • Shaare Zedek Medical Center
      • Ramat Gan、以色列、5262000
        • Chaim Sheba Medical Center
      • Tel Aviv、以色列、6423906
        • Tel Aviv Sourasky Medical Center
      • Kemerovo、俄罗斯、650066
        • SAIH "Kemerovo Regional Clinical Hospital"
      • Novosibirsk、俄罗斯、630005
        • LLC "SibNovoMed"
      • Novosibirsk、俄罗斯、630007
        • Gastrocenter
      • Novosibirsk、俄罗斯、630007
        • LLC "Novosibirskiy Gastrocentr''
      • Novosibirsk、俄罗斯、630084
        • Hospital #12
      • Novosibirsk、俄罗斯、630091
        • LLC "Siberian Center for Prevention and Treatment of Myopia Eye"
      • Novosibirsk、俄罗斯、630099
        • Joint Stock Company Medical Center "AVICENNA"
      • Omsk、俄罗斯、644013
        • BHI of Omsk region "Clinical Oncology Dispensary"
      • Omsk、俄罗斯、644024
        • Clinicodiagnostic Center "Ultramed"
      • Omsk、俄罗斯、644070
        • Medical center "Intervzglyad"
      • Saint Petersburg、俄罗斯、191015
        • FSBI of Higher Education " North-Western Medical University n.a.I.I. Mechnikov '' of MoH RF
      • Saint Petersburg、俄罗斯、195067
        • FSBI of Higher Education "North-Western Medical University n.a.I.I. Mechnikov'' of MoH RF
      • Stavropol、俄罗斯、355017
        • Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical
    • Stavropol Kray
      • Pyatigorsk、Stavropol Kray、俄罗斯、357502
        • LLC "Polyclinic of ultrasonography 4D"
      • Sofia、保加利亚、1527
        • UMHAT "Tsaritsa Yoanna-ISUL" EAD
      • Sofia、保加利亚、1431
        • "DCC Alexandrovska", EOOD
      • Sofia、保加利亚、1606
        • ,,University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov" EAD
      • Zagreb、克罗地亚、10000
        • University Hospital Center Zagreb
    • Quebec
      • Montreal、Quebec、加拿大、H3G 1A4
        • McGill University Health Centre - Montreal General Hospital (Electrocardiogram Clinic)
      • Montreal、Quebec、加拿大、H3G 1A4
        • McGill University Health Centre - Montreal General Hospital (Endoscopy Clinic)
      • Montreal、Quebec、加拿大、H3G 1A4
        • McGill University Health Centre - Montreal General Hospital (Pharmacy)
      • Montreal、Quebec、加拿大、H3G 1A4
        • McGill University Health Centre - Montreal General Hospital (Radiology)
      • Montreal、Quebec、加拿大、H3G 1A4
        • McGill University Health Centre - Montreal General Hospital (Research Site)
      • Montreal、Quebec、加拿大、H4A 3J1
        • Centre for Innovative Medicine - Research Institute of the McGill University Health Centre(Pulmonary
      • Montreal、Quebec、加拿大、H4P 2S4
        • Eye Health MD (Ophthalmology)
      • Budapest、匈牙利、1136
        • Pannonia Maganorvosi Centrum
      • Budapest、匈牙利、1033
        • Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. (abbreviated name: Clinexpert Kft.)
      • Budapest、匈牙利、1062
        • Ophthalmology procedures: Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest、匈牙利、1062
        • Pulmonary procedures: Vasutegeszsegugyi Nonprofit Kozhasznu K ft.
      • Budapest、匈牙利、1134
        • Ophthalmology, OCT: Medicover Zrt.
      • Budapest、匈牙利、1139
        • Chest X-ray: XIII. keruleti Egeszsegugyi Szolgalat Kozhasznu Nonprofit Kft.
      • Békéscsaba、匈牙利、5600
        • Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
    • Heves County
      • Gyöngyös、Heves County、匈牙利、3200
        • Bugat Pal Korhaz, Gasztroenterologia
    • Komárom-Esztergom
      • Tatabánya、Komárom-Esztergom、匈牙利、2800
        • Szent Borbala Korhaz
      • Tatabánya、Komárom-Esztergom、匈牙利、2800
        • DLCO and ophthalmology tests: Szent Borbala Korhaz
    • Free State
      • Bloemfontein、Free State、南非、9301
        • Dr W Simmonds (Gastroenterology Department)
    • Gauteng
      • Benoni、Gauteng、南非、1501
        • Worthwhile Clinical Trials
      • Benoni、Gauteng、南非、1500
        • Dr K Rahman (OTC and Opthalmoscopy)
      • Benoni、Gauteng、南非、1500
        • Lakeview Hospital radiology (Radiology)
      • Benoni、Gauteng、南非、1500
        • Worthwhile Clinical trials (PFT)
      • Centurion、Gauteng、南非、0157
        • Dr E Meyer & Partners, Centurion Eye Hospital (OTC and Opthalmoscopy)
      • Centurion、Gauteng、南非、0157
        • Dr Jorg Reichenberger (Endoscopy)
      • Centurion、Gauteng、南非、0157
        • Drs Burger Radiologists Inc (X-ray/CT)
      • Centurion、Gauteng、南非、0157
        • Johese Clinical Research, Unitas Hospital
      • Johannesburg、Gauteng、南非、2193
        • Wits Clinical Research
      • Kempton Park、Gauteng、南非、1619
        • Clinresco Centres (Pty) Ltd
      • Kempton Park、Gauteng、南非、1619
        • Burger Radiology (Radiology)
      • Kempton Park、Gauteng、南非、1619
        • Dr KJP Lubuya (OCT and Opthalmology)
      • Kempton Park、Gauteng、南非、1619
        • Prof O Mwantembe (Endoscopy)
      • Pretoria、Gauteng、南非、0002
        • Emmed Research
      • Springs、Gauteng、南非、1559
        • Dr K Rahman(OTC and Opthalmoscopy)
      • Sunninghill、Gauteng、南非、2196
        • Dr I Moola (Endoscopy)
    • Western Cape
      • Cape Town、Western Cape、南非、7405
        • Dr Peter Chapman (PFT + DLCO)
      • Cape Town、Western Cape、南非、7441
        • Dr Chris Stander (OCT)
      • Cape Town、Western Cape、南非、7441
        • Morton & Partners Radiologists (Radiology)
      • Cape Town、Western Cape、南非、7441
        • Spoke Research Inc. Room 109
      • Kochi、印度、682027
        • Aster Medcity, Aster DM Healthcare Ltd.
    • Gujarat
      • Surat、Gujarat、印度、395002
        • Surat Institute of Digestive Sciences
    • Haryana
      • Gurugram、Haryana、印度、122002
        • Fortis Memorial Research Institute
    • Maharashtra
      • Nagpur、Maharashtra、印度、440010
        • Midas Multispeciality Hospital Pvt. Ltd
    • Rajasthan
      • Jaipur、Rajasthan、印度、302001
        • S. R. Kalla Memorial Gastro & General Hospital
    • Quindío Department
      • Armenia、Quindío Department、哥伦比亚、630004
        • IPS Fundacion Cardiomet CEQUIN
    • Valle del Cauca Department
      • Cali、Valle del Cauca Department、哥伦比亚、760035
        • Centro de lnvestigaciones Clinicas S.A.S
      • Ankara、土耳其(türkiye)、06500
        • Gazi University Medical Faculty
      • Ankara、土耳其(türkiye)、06100
        • Hacettepe University Medical Faculty
      • Ankara、土耳其(türkiye)、06800
        • T.C. Saglik Bakanligi Ankara Sehir Hastanesi
      • Antalya、土耳其(türkiye)、07100
        • Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
      • Izmir、土耳其(türkiye)、35100
        • Ege Universitesi Tip Fakultesi Hastanesi
      • Kocaeli、土耳其(türkiye)、41380
        • Kocaeli University Research and Training Hospital
      • Yenişehir、土耳其(türkiye)、33343
        • Mersin University Faculty of Medicine
      • Alexandria、埃及、21131
        • Alexandria Clinical Research Center , Faculty of Medicine , Alexandria University
      • Cairo、埃及
        • National Hepatology and Tropical Medicine Research Institute
      • Cairo、埃及、11556
        • Ain Shams University Hospital
      • Cairo、埃及
        • Air Force Specialized Hospital(AFSH)
      • Cairo、埃及
        • Cairo University , Kasr Al Aini Hospital
      • Dakahlia、埃及
        • Egyptian Liver Research Institute and Hospital ( ELRIAH)
      • Giza、埃及
        • Theodor Bilharz Research Institute Research Ethics Committee
      • Menofeya、埃及、32511
        • National Liver Institute
      • Belgrade、塞尔维亚、11000
        • Clinical Center Zvezdara
      • Chihuahua City、墨西哥、31203
        • Scientia Investigacion Clinica S.C.
      • Chihuahua City、墨西哥、31020
        • Sanatorio Palmore A.C.
      • Chihuahua City、墨西哥、31203
        • Vista Lasser de Chihuahua S.C.
      • Chihuahua City、墨西哥、31283
        • Servicios Hospitalarios de México, S.A. de C.V.
      • Veracruz、墨西哥、91900
        • FAICIC S. de R.L. de C.V.
      • Veracruz、墨西哥、91910
        • Gabinete de Diagnostico COVADONGA
      • Veracruz、墨西哥、91918
        • Alberto Collado Solorzano (Clinica Vision)
    • Jalisco
      • Guadalajara、Jalisco、墨西哥、44130
        • Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.
      • Guadalajara、Jalisco、墨西哥、44600
        • Global Glaucoma Institute
      • Guadalajara、Jalisco、墨西哥、44600
        • Video Endoscopia Americas
      • Guadalajara、Jalisco、墨西哥、44670
        • Comercializadora Winco S.A. de C.V.
    • Veracruz
      • Boca del Rio、Veracruz、墨西哥、94299
        • Cirugia y Gastro de Veracruz S.A. de C.V. (Progastro)
      • Graz、奥地利、8036
        • LKH Universitats-Klinikum Graz
      • Innsbruck、奥地利、A-6020
        • Medical University Innsbruck, Internal Medicine Ⅰ
      • Vienna、奥地利、1090
        • AKH Wien- Universitatsklinik fiir Innere Medizin III
      • Vienna、奥地利、1090
        • Univ.-Professor Dr. Mehrdad Baghestanian
      • Vienna、奥地利、1090
        • AKH Wien- Universitatsklinik fur Innere Medizin III
      • Alexandroupoli、希腊、681 00
        • University General Hospital of Alexandroupoli
      • Athens、希腊、10676
        • General Hospital of Athens "Evangelismos"
    • Crete
      • Heraklion、Crete、希腊、71500
        • Univerisity General Hospital of Heraklion
      • Augsburg、德国、86156
        • Universitaetsklinikum Augsburg
      • Brandenburg an der Havel、德国、14770
        • Staedtisches Klinikum Brandenburg
      • Frankfurt、德国、60431
        • Prof. Dr. med. Dr. med. Habil. Jens Buhren, FEBO
      • Frankfurt am Main、德国、60431
        • Agaplesion Markus Krankenhaus
      • Hamburg、德国、20251
        • HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
      • Jena、德国、07747
        • Universitaetsklinikum Jena
      • Jena、德国、07747
        • OCT/Ophtalmoscopy address: Universitaetsklinikum Jena
      • Jena、德国、07747
        • PFT address: Universitaetsklinikum Jena
      • Kassel、德国、34121
        • PFT address: Praxis fur Pneumologie und Allergologie
      • Kassel、德国、34177
        • OCT/Ophtalmoscopy address: Augenarztpraxis Dr. Karola Hassan
      • Kiel、德国、24105
        • Nordblick Augenklinik
      • Kiel、德国、24105
        • Universitatsklinikum Schleswig-Holstein- Campus Kiel
      • Nürtingen、德国、72622
        • Dr. Irina Hasewinkel
      • Nürtingen、德国、72622
        • Medius Klinik Nuertingen
    • Hassen
      • Kassel、Hassen、德国、34117
        • Gastroenterologie Opernstraβe
      • Catania、意大利、829-95126
        • Azienda Ospedaliera Ospedale Cannizzaro
      • Catanzaro、意大利、88100
        • A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente Campus Universitario "Salvatore Venuta"
      • Catanzaro、意大利、88100
        • A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente
      • Catanzaro、意大利、88100
        • CAMPUS GERMANETO Magazzino farmaci e dispositivi medici, uffici
      • Pavia、意大利、27100
        • Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
      • Rome、意大利、00189
        • PFT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Pneumologia
      • Verona、意大利、37024
        • IRCCS Ospedale Sacro Cuore Don Calabria
      • Verona、意大利、37134
        • OCT/PFT/Endoscopy address: CRC - Cenro Ricerche Cliniche di Verona
    • Foggia
      • San Giovanni Rotondo、Foggia、意大利、71013
        • IRCCS Ospedale Casa Sollievo della Sofferenza
      • San Giovanni Rotondo、Foggia、意大利、71013
        • OCT/ PFT/ Endoscopy address: IRCCS Ospedale Casa Sollievo della Sofferenza
    • MI
      • Milan、MI、意大利、20132
        • Ospedale San Raffaele
    • Milan
      • Garbagnate Milanese、Milan、意大利、20024
        • ASST Rhodense - Pneumology Unit
      • Milan、Milan、意大利、20017 Rho
        • ASST Rhodense, U.O.C. Gastroenterologia ed Endoscopia Digestiva
      • Rho、Milan、意大利、20017
        • ASST Rhodense - Ophthalmology Unit
    • Milano
      • Rozzano、Milano、意大利、20089
        • Irccs Humanitas Research Hospital
    • Verona
      • Negrar、Verona、意大利、37024
        • OCT/ PFT/ Endoscopy address: IRCCS Ospedale Sacro Cuore Don Calabria
      • Horažďovice、捷克语、341 01
        • MUDr. Jaroslava Skalova
      • Hradec Králové、捷克语、500 12
        • Hepato-gastroenterologie HK, s.r.o.
      • Hradec Králové、捷克语、500 12
        • VISUS, spol s.r.o.
      • Klatovy、捷克语、339 01
        • GASTRO JeKa, s.r.o.
      • Klatovy、捷克语、339 01
        • Klatovska nemocnice a.s.
      • Olomouc、捷克语、779 00
        • PreventaMed s.r.o.
      • Olomouc、捷克语、779 00
        • Ocni ordinace Olomouc
      • Olomouc、捷克语、779 00
        • MUDr. Pavlina Kazinotova s.r.o.
      • Chisinau、摩尔多瓦、2005
        • "Sf. Arhanghel Mihail" Municipal Clinical Hospital, Department of Gastroenterology
      • Chisinau、摩尔多瓦、MD2025
        • PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery
      • Chisinau、摩尔多瓦、MD2025
        • PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Gastroenterology
      • Chisinau、摩尔多瓦、MD2025
        • PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department
      • Banská Bystrica、斯洛伐克、975 17
        • Fakultna nemocnica s poliklinikou F.D.Roosevelta
      • Bardejov、斯洛伐克、08501
        • ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva
      • Košice、斯洛伐克、040 13
        • ENDOMED, s.r.o. Gastroenterologicka ambulancia
      • Lipany、斯洛伐克、082 71
        • Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.
      • Nitra、斯洛伐克、949 01
        • KM Management spol.s.r.o. Gastroenterologicke a hepatologicke centrum
      • Prešov、斯洛伐克、080 01
        • GASTRO LM s.r.o., Gastroenterologicka ambulancia
      • Prešov、斯洛伐克、080 01
        • Pneumology: PULMO, s.r.o.
    • Chiba
      • Kashiwa-shi、Chiba、日本、277-0871
        • Kokikai Tsujinaka Hospital Kashiwanoha
      • Nagareyama-shi、Chiba、日本、270-0116
        • Ishii Eye Clinic
    • Fukuoka
      • Kitakyushu-shi、Fukuoka、日本、807-8555
        • Hospital of the University of Occupational and Environmental Health
      • Kitakyusyu-shi、Fukuoka、日本、802-8561
        • Kitakyushu Municipal Medical Center
    • Ibaraki
      • Toride-shi、Ibaraki、日本、302-0014
        • Matsumoto Eye Clinic
    • Kagoshima-ken
      • Kagoshima、Kagoshima-ken、日本、892-0846
        • Sameshima Hospital
      • Kagoshima、Kagoshima-ken、日本、892-0824
        • Jiaikai Idzuro Imamura Hospital
      • Kagoshima、Kagoshima-ken、日本、890-0062
        • Kagoshima Kouseiren Hospital
      • Kagoshima、Kagoshima-ken、日本、892-0825
        • Sameshima Eye Clinic
    • Kumamoto
      • Kumamoto、Kumamoto、日本、861-8520
        • Japanese Red Cross Kumamoto Hospital
    • Saga-ken
      • Saga、Saga-ken、日本、849-8501
        • Saga University Hospital
    • Tokyo
      • Shinjuku-ku、Tokyo、日本、169-0073
        • Japan Community Health Care Organization Tokyo Yamate Medical Center
    • RM
      • Santiago、RM、智利、8330034
        • Centro de Investigaciones Clinicas de la Universidad Catolica
    • Santiago Metropolitan
      • Santiago、Santiago Metropolitan、智利、7620157
        • Clinica Universidad de Los Andes
      • Santiago、Santiago Metropolitan、智利、8330336
        • CeCim Biocinetic
      • Ghent、比利时、9000
        • Universitair Ziekenhuis Gent
      • Ghent、比利时、9000
        • AZ Maria-Middelares
      • Leuven、比利时、3000
        • Universitaire Ziekenhuizen Leuven
      • Roeselare、比利时、8800
        • Campus Brugsesteenweg
      • Roeselare、比利时、8800
        • Campus Rumbeke
      • Torhout、比利时、8820
        • Campus Rembert Torhout
      • Yvoir、比利时、5530
        • Centre Hospitalier Universitaire UCL Namur - Site Godinne
      • Amiens、法国、80054
        • CHU Amiens Picardie
      • Clermont-Ferrand、法国、63000
        • Chu Gabriel Montpied
      • Clermont-Ferrand、法国、63000
        • CHU De Clermont Ferrand - Hopital Estaing
      • Grenoble、法国、38043
        • CHU Grenoble Alpes - Hopital Michallon
      • Grenoble、法国、38043
        • Endoscopy: CHU Grenoble Alpes- Hopital Michallon
      • La Roche-sur-Yon、法国、85925
        • CHD Vendee, Unite de Recherche Clinique
      • Lille、法国、59037
        • CHU de Lille - Hôpital Claude Huriez
      • Lille、法国、59037
        • Optical Coherence Tomography and Ophthalmology CHU de Lille Hopital Roger Salengro
      • Lille、法国、59037
        • Pulmonary Function Test CHU Lille, Institut Coeur Poumon
      • Montpellier、法国、34295
        • CHU Saint-Eloi
      • Montpellier、法国、34295
        • Hopital Saint-Eloi - Pole Digestif - Hgea Recherche Clinique - Rdc
      • Nice、法国、06202
        • CHU de Nice, Hopital 1'Archet 2
      • Reims、法国、51100
        • Hopital Maison Blanche, CHU DE REIMS
      • Reims、法国、51092
        • Hopital Robert Debre
      • Reims、法国、51100
        • Hopital Robert Debre CHU DE REIMS
      • Saint-Etienne、法国、42055
        • CHU Saint Etienne - Hôpital Nord
      • Saint-Priest-en-Jarez、法国、42270
        • Optical Coherence Tomography and Ophthalmology
      • Saint-Priest-en-Jarez、法国、42270
        • Pulmonary Function Test
      • Toulouse、法国、31059
        • Hopital Rangueil
      • Toulouse、法国、31300
        • Hopital Purpan PPR pole cephalique
      • Vandœuvre-lès-Nancy、法国、54511
        • CHRU Nancy Brabois
      • Bystra、波兰、43-360
        • Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
      • Karkow、波兰、31-156
        • Specjalistyczne Gabinety Lekarskie LANDA
      • Krakow、波兰、30-033
        • Centre De La Vision Centrum Okulistyczne(OCT, Ophthalmoscopy)
      • Krakow、波兰、30-307
        • Medicina (Endoscopy)
      • Krakow、波兰、31-153
        • Centrum Medyczne EVITA(Endoscopy)
      • Lodz、波兰、90-752
        • IP Clinic Sp. z o.o.
      • Lodz、波兰、90-338
        • Centrum Medyczne "Ksiezy Mlyn" (OCT, Ophtalmoscopy)
      • Lodz、波兰、93-513
        • Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatolog i im. M. Kopernika w Lodzi
      • Lodz、波兰、90-338
        • (Centrum Medyczne Ksiezy Mlyn (OCT and Ophthalmoscopy)
      • Lodz、波兰、90-644
        • AMICARE Sp. z o.o. sp.k
      • Lodz、波兰、91-053
        • Centra Medyczne Medyceusz (DLCO)
      • Lodz、波兰、92-551
        • Salve Health Care Sp. o.o., (PFT and Endoscopy)
      • Nowy Targ、波兰、34-400
        • Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
      • Oświęcim、波兰、32-600
        • Medicome Sp. Z O.O
      • Piotrkow Trybunalski、波兰、97-300
        • Przychodnia Okulistyczna "Oculus" Barbara Cybulska (OCT, Ophtalmoscopy)
      • Piotrkow Trybunalski、波兰、97-300
        • Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika (Endoscopy)
      • Piotrokow Trybunalski、波兰、97-300
        • Trialmed CRS
      • Poznan、波兰、60-529
        • Solurmed Centrum Medyczne
      • Poznan、波兰、60-538
        • OCU Service Mikolaj Meller Sp.j.(OCT, Ophtalmoscopy)
      • Rzeszów、波兰、35-326
        • Centrum Medyczne Medyk
      • Rzeszów、波兰、35-055
        • Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie (Ophthalmpscopy)
      • Rzeszów、波兰、35-241
        • Podkarpackie Centrum Chorob Plue w Rzeszowie (DLCO)
      • Strzegom、波兰、58-150
        • Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)
      • Swidnica、波兰、58-100
        • DC-MED
      • Swidnica、波兰、58-100
        • Centrum Medyczne EZ-MEDICA (OCT, Ophtalmoscopy)
      • Swidnica、波兰、58-100
        • Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)
      • Warsaw、波兰、00-635
        • Centrum Zdrowia MDM
      • Warsaw、波兰、00-631
        • Centrum Zdrowia MDM (OCT,opthalmoscopy)
      • Warsaw、波兰、01-138
        • Instytut Gruzlicy i Chorob Pluc(DLCO)
      • Warsaw、波兰、02-653
        • Endoterapia PFG (Endoscopy)
      • Warsaw、波兰、02-653
        • Instytut Oka (OCT, Ophtalmoscopy)
      • Warsaw、波兰、03-712
        • Specjalistyczne Gabinety Lekarskie Body Clinic
      • Warsaw、波兰、03-731
        • Centrum Okulistyczne JASKRA (OCT, Ophthalmoscopy)
      • Warsaw、波兰、04-141
        • Wojskowy lnstytut Medyczny (PFT)
      • Wroclaw、波兰、60-681
        • EuroMediCare Szpital Specjalistyczny z Przychodniit (Endoscopy)
    • Greater Poland Voivodeship
      • Poznan、Greater Poland Voivodeship、波兰、60-681
        • NSZOZ Termedica
    • New South Wales
      • Macquarie University、New South Wales、澳大利亚、2109
        • Macquarie University Hospital
      • Macquarie University、New South Wales、澳大利亚、2109
        • Macquarie University Hospital Pharmacy
      • Macquarie University、New South Wales、澳大利亚、2109
        • Macquarie Respiratory Services
      • Macquarie University、New South Wales、澳大利亚、2109
        • Macquarie University Hospital Clinical Trials
      • Macquarie University、New South Wales、澳大利亚、2109
        • MQ Health Ophthalmology
    • Queensland
      • Brisbane、Queensland、澳大利亚、4029
        • Royal Brisbane & Women's Hospital
      • North Mackay、Queensland、澳大利亚、4740
        • Coral Sea Clinical Research Institute
    • Victoria
      • Bellfield、Victoria、澳大利亚、3081
        • MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons
      • Epping、Victoria、澳大利亚、3076
        • The Northern Hospital
      • Heidelberg、Victoria、澳大利亚、3084
        • Austin Hospital
      • Melbourne、Victoria、澳大利亚、3011
        • Vision Eye Institute
      • Melbourne、Victoria、澳大利亚、3011
        • Footscray Hospital
      • Parkville、Victoria、澳大利亚、3050
        • The Royal Melbourne Hospital
      • Rosanna、Victoria、澳大利亚、3084
        • Heidelberg Eye Clinic
    • Western Australia
      • Murdoch、Western Australia、澳大利亚、6150
        • Fiona Stanley Hospital
      • Nedlands、Western Australia、澳大利亚、6009
        • Lions Eye Institute Limited
      • O'Connor、Western Australia、澳大利亚、6163
        • The trustee for The RTS Unit Trust trading as Respiratory Testing Services
      • Bern、瑞士、3010
        • Inselspital Bern
      • Bern、瑞士、3012
        • OCT/Ophtalmoscopy: Berner Augenklinik am Lindenhofspital
      • Homyel、白俄罗斯、246029
        • Institution "Gomel Regional Clinical Hospital"
      • Minsk、白俄罗斯、220096
        • Health care Institution "10th City Clinical Hospital"
      • Mogilev、白俄罗斯、212018
        • Health Care Institution "Mogilev Hospital #1"
      • Vitebsk、白俄罗斯、210037
        • Health Care Institution "Vitebsk Regional Clinical Hospital"
      • Vitebsk、白俄罗斯、210604
        • Healthcare Institution "Vitebsk Regional Clinical Specialized Center"
      • Vilnius、立陶宛、LT-08661
        • Vilnius University Hospital Santaros Klinikos
      • Bucharest、罗马尼亚、012015
        • SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
      • Bucharest、罗马尼亚、022328
        • Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
    • JUD. CLUJ
      • Cluj-Napoca、JUD. CLUJ、罗马尼亚、400006
        • Spitalul Clinic Judetean de Urgenta Cluj Napoca
    • Jud.constanta
      • Constanța、Jud.constanta、罗马尼亚、900591
        • Centrul de Diagnostic si Tratament Affidea, Specialitatea Medicina Interna
    • Alabama
      • Dothan、Alabama、美国、36301
        • Digestive Health Specialists
      • Dothan、Alabama、美国、36301
        • Dothan Eyecare-Dr. Brent McKinley (OCT Location)
      • Dothan、Alabama、美国、36301
        • Center for Digestive Health (Endoscopy Location)
      • Dothan、Alabama、美国、36301
        • Pulmonary Associates (PFT Location)
      • Dothan、Alabama、美国、36305
        • Flowers Hospital (Imaging Location)
      • Mobile、Alabama、美国、36608
        • Digestive Health Specialists (Satellite Clinic Location)
      • Mobile、Alabama、美国、36608
        • Premier Medical Group East (Opthalmology & Optometry Facility)
      • Mobile、Alabama、美国、36608
        • Pulmonary Associates (Chest X-Ray & PFT Facility)
      • Mobile、Alabama、美国、36608
        • Surgicare of Mobile (Endoscopy & Biopsy Facility)
    • Arizona
      • Peoria、Arizona、美国、85381
        • Arizona Retina Institute/ Phoenix Retina Associates(OCT)
      • Peoria、Arizona、美国、85381
        • SimonMed Imaging (Imaging)
      • Sun City、Arizona、美国、85351
        • Sun City Endoscopy Center (Endoscopy)
    • California
      • Apple Valley、California、美国、92307
        • Om Research LLC
      • Apple Valley、California、美国、92307
        • Victor Valley Advanced Imaging
      • La Jolla、California、美国、92037
        • UCSD lnvestigational Drug Service Pharmacy
      • La Jolla、California、美国、92093
        • Shiley Eye Institute (OCT)
      • La Jolla、California、美国、92037
        • Koman Family Outpatient Pavilion (ENDO)
      • La Jolla、California、美国、92037
        • Perlman Medical Offices
      • La Jolla、California、美国、92037
        • UCSD Clinical and Translational Research Institute
      • La Jolla、California、美国、92037
        • UCSD Health System (Endo/PFT/DLCO)
      • Lancaster、California、美国、93534
        • Om Research LLC
      • Lancaster、California、美国、93534
        • A V Pediatrics, Allergy and Family Medicine - PFT
      • Lancaster、California、美国、93534
        • Advanced Endoscopy and Pain Center - Colonoscopy
      • Lancaster、California、美国、93534
        • Advanced Imaging Center - Chest X-Ray
      • Lancaster、California、美国、93534
        • Antelope Valley Eye Care - Ophthalmologist
      • Lancaster、California、美国、93534
        • AV Pediatrics Allergy and Family Medicine
      • Lancaster、California、美国、93534
        • Jatinder S. Pruthi, MD FACG CPI
      • Murrieta、California、美国、92563
        • United Medical Doctors
      • Victorville、California、美国、92392
        • Retina Consultants of Southern California
      • Victorville、California、美国、92395
        • Physicians Surgery Center
    • Colorado
      • Colorado Springs、Colorado、美国、80907
        • Peak Gastroenterology Associates
      • Colorado Springs、Colorado、美国、80903
        • Front Range Endoscopy Center
      • Colorado Springs、Colorado、美国、80909
        • Colorado Springs Pulmonary Consultants, PC
      • Colorado Springs、Colorado、美国、80909
        • The Wright Eye Center (OCT Facility)
      • Colorado Springs、Colorado、美国、80919
        • Colorado Springs Imaging (Ultrasound and MRE Location)
    • Florida
      • Boca Raton、Florida、美国、33487
        • Xera Med Research
      • Boynton Beach、Florida、美国、33472
        • RecioMed Clinical Research Network, Inc
      • Brandon、Florida、美国、33511
        • Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
      • Clearwater、Florida、美国、33756
        • West Coast Endoscopy Center (Endoscopy Procedures)
      • Clearwater、Florida、美国、33756
        • Bay Area Chest Physicians, P.A. (Pulmonary Function Test)
      • Clearwater、Florida、美国、33761
        • Northwood Vision (Optical Coherence Tomography)
      • Clearwater、Florida、美国、33761
        • Safety Harbor Surgery (Endoscopy Procedures)
      • Clearwater、Florida、美国、33762
        • Gastro Florida (Regulatory Administrative Duties)
      • Coral Gables、Florida、美国、33134
        • Beraja Medical Institute (OCT)
      • Hialeah、Florida、美国、33012
        • Advanced Eye Center
      • Jacksonville、Florida、美国、32256
        • Encore Borland-Groover Clinical Research
      • Jacksonville、Florida、美国、32207
        • UF Health Imaging Center-Emerson (chest x-rays)
      • Jacksonville、Florida、美国、32207
        • UF Health Laboratory Emerson (blood draws)
      • Jacksonville、Florida、美国、32209
        • UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
      • Jacksonville、Florida、美国、32209
        • UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)
      • Jacksonville、Florida、美国、32209
        • UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)
      • Jacksonville、Florida、美国、32209
        • UF Health Radiology-Jacksonville (chest x-rays)
      • Jacksonville、Florida、美国、32216
        • Cisca Pulmonary & Critical Care (PFT Facility)
      • Jacksonville、Florida、美国、32216
        • Nicolitz Eye Consultants (OCT Facility)
      • Jacksonville、Florida、美国、32256
        • Borland-Groover Clinic (Endoscopy Facility)
      • Jupiter、Florida、美国、33458
        • Jupiter Outpatient Surgery Center
      • Kissimmee、Florida、美国、34741
        • IHS Health, LLC
      • Largo、Florida、美国、33773
        • Lee Shettle Eye & Hearing (Ophthalmoscopy Only)
      • Miami、Florida、美国、33133
        • Infinite Clinical Research
      • Miami、Florida、美国、33156
        • Research Associates of South Florida
      • Miami、Florida、美国、33176
        • Anchor Medical Research, LLC
      • Miami、Florida、美国、33134
        • The Endoscopy Center (Endoscopy Procedure)
      • Miami、Florida、美国、33173
        • Juan Barrio, MD (PFT when needed)
      • Miami、Florida、美国、33133
        • Pulmonology Physicians of South Florida
      • Miami、Florida、美国、33133
        • Reina Eye Care P.A.
      • Miami、Florida、美国、33155
        • La Salud Research Clinic Inc.
      • Miami、Florida、美国、33156
        • South Florida Center for Endoscopy and Digestive Disease, LLC
      • Naples、Florida、美国、34102
        • Gastroenterology Group of Naples
      • Naples、Florida、美国、34102
        • Gulfshore Endoscopy Center
      • Naples、Florida、美国、34103
        • Retina Consultants of Southwest Florida OCT only
      • Naples、Florida、美国、34109
        • Lisette Delgado Sanchez, MD PFT only
      • Orlando、Florida、美国、32825
        • Pediatric & Adult Research Center
      • Palmetto Bay、Florida、美国、33157
        • IMIC Inc.
      • Palmetto Bay、Florida、美国、33157
        • IMIC Inc
      • Port Orange、Florida、美国、32127
        • Advanced Medical Research Center
      • Seminole、Florida、美国、33777
        • Bardmoor GastroEnterology
      • South Miami、Florida、美国、33143
        • Larkin Community Hospital (Endoscopy Procedure)
      • St. Petersburg、Florida、美国、33705
        • St. Petersburg Endoscopy Center (Endoscopy Procedures)
      • St. Petersburg、Florida、美国、33707
        • Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)
      • St. Petersburg、Florida、美国、33709
        • Bay Area Endoscopy and Surgery Center (Endoscopy only)
      • St. Petersburg、Florida、美国、33709
        • Theia Clinical Research, LLC
      • St. Petersburg、Florida、美国、33710
        • Advanced Research Institute Inc.(IP and PFT)
      • Sun City Center、Florida、美国、33573
        • Absolute Surgical Specialist - Craig Amshel, MD
      • Tampa、Florida、美国、33612
        • USF Health Morsani Center for Advanced Healthcare
      • Tampa、Florida、美国、33606
        • USF Health South Tampa Center for Advanced Healthcare
      • Tampa、Florida、美国、33609
        • GCP Clinical Research,LLC
      • Tampa、Florida、美国、33609
        • South Tampa Surgery Center
      • Tampa、Florida、美国、33609
        • Newsome Eye Specialist (OCT Procedures Only)
      • Tampa、Florida、美国、33606
        • Lab - Processing/ Storage
      • Tampa、Florida、美国、33609
        • LoCicero Medical Group
    • Georgia
      • Atlanta、Georgia、美国、30342
        • Atlanta Gastroenterology Associates
      • Atlanta、Georgia、美国、30309
        • Digestive Healthcare of Georgia
      • Atlanta、Georgia、美国、30324
        • Ross Eyecare - Opthalmoscopy and OCT
      • Atlanta、Georgia、美国、30342
        • Atlanta Gastroenterology Associates (endoscopy only)
      • Atlanta、Georgia、美国、30342
        • Atlanta Gastroenterology Associates(IP only)
      • Atlanta、Georgia、美国、30309
        • Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs
    • Illinois
      • Arlington Heights、Illinois、美国、60005
        • GI Alliance
      • Arlington Heights、Illinois、美国、60005
        • Northwest Endoscopy Center (Endoscopy)
      • Gurnee、Illinois、美国、60031
        • GI Alliance (PFT)
      • Gurnee、Illinois、美国、60031
        • Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
      • Gurnee、Illinois、美国、60031
        • Medical Eye Services LTD (Ophthalmoscopy with OCT)
      • Lake Bluff、Illinois、美国、60044
        • North Shore Endoscopy Center (Endoscopy)
      • Libertyville、Illinois、美国、60048
        • Libertyville Imaging Center (Diagnostic Imaging)
      • Morton Grove、Illinois、美国、60053
        • 3T Imaging of Morton Grove (Diagnostic Imaging)
    • Maryland
      • Columbia、Maryland、美国、21045
        • Cascades Endoscopy Center
      • Columbia、Maryland、美国、21044
        • Charter Radiology
      • Columbia、Maryland、美国、21045
        • Gastro Center of Maryland, LLC
      • Hanover、Maryland、美国、21076
        • Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
      • Laurel、Maryland、美国、20707
        • Lung Center (Pulmonary Function Test only)
    • Mississippi
      • Jackson、Mississippi、美国、39216
        • Southern Therapy and Advanced Research, LLC
      • Jackson、Mississippi、美国、39216
        • A Terrell Williams, MD, PLLC (OCT)
      • Jackson、Mississippi、美国、39216
        • Jackson Pulmonary Associates (PFT)
      • Jackson、Mississippi、美国、39216
        • St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)
    • Missouri
      • Creve Coeur、Missouri、美国、63141
        • Barnes-Jewish West County Hospital (Additional Endoscopy Location)
      • St Louis、Missouri、美国、63110
        • Barnes-Jewish Hospital
      • St Louis、Missouri、美国、63110
        • Washington University School of Medicine
      • St Louis、Missouri、美国、63108
        • Washington University School of Medicine
    • New Jersey
      • Freehold、New Jersey、美国、07728
        • Allied Health Clinical Research Organization, LLC
      • Freehold、New Jersey、美国、07728
        • Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County
      • Freehold、New Jersey、美国、07728
        • Freehold Ophthalmology
      • Freehold、New Jersey、美国、07728
        • Monmouth Ocean Pulmonary Medicine
      • Freehold、New Jersey、美国、07728
        • Princeton Radiology
    • New York
      • New York、New York、美国、10016
        • NYU Langone Health
      • New York、New York、美国、10016
        • NYU Langone Inflammatory Bowel Disease Center
      • New York、New York、美国、10016
        • NYU Langone Eye Center (Ophthalmology)
      • New York、New York、美国、10016
        • NYU Langone Health - Ambulatory Care Center
      • New York、New York、美国、10016
        • NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center
      • New York、New York、美国、10016
        • NYU Pulmonary and Critical Care Associates (Pulmonary)
    • North Carolina
      • Charlotte、North Carolina、美国、28215
        • Carolinas Research Center
      • Charlotte、North Carolina、美国、28204
        • Queen City Gastroenterology and Hepatology (Endoscopy)
      • Charlotte、North Carolina、美国、28211
        • Greenman Eye Associates (OCT)
      • Charlotte、North Carolina、美国、28273
        • Cornerstone Medical (Imaging & PFT)
    • Ohio
      • Chardon、Ohio、美国、44024
        • Geauga Sleep Center(PFT only)
      • Cincinnati、Ohio、美国、45219
        • UC Health Physicians Office
      • Cincinnati、Ohio、美国、45229
        • UC Health (Pulmonary Function Testing)
      • Cincinnati、Ohio、美国、45219
        • UC Health Hoxworth (OCT only)
      • Cincinnati、Ohio、美国、45219
        • University of Cincinnati Medical Center (PFT and Endoscopy location)
      • Mentor、Ohio、美国、44060
        • Great Lakes Gastroenterology Research, LLC
      • Mentor、Ohio、美国、44060
        • The Endoscopy Center of Lake County
      • Mentor、Ohio、美国、44060
        • Ophthalmic Physicians Incorporated (OCT Only)
      • Mentor、Ohio、美国、44060
        • Vitreo Retinal Consultants(OCT only)
      • Willoughby、Ohio、美国、44094
        • Lake Pulmonary Associates (PFT only)
      • Willoughby Hills、Ohio、美国、44094
        • Retina Specialists of Ohio(OCT only)
    • Oklahoma
      • Norman、Oklahoma、美国、73071
        • Norman Endoscopy Center
      • Norman、Oklahoma、美国、73071
        • Physicians and Surgeons X-Ray
      • Oklahoma City、Oklahoma、美国、73118
        • Central Sooner Research
      • Oklahoma City、Oklahoma、美国、73102
        • Hightower Clinical
      • Oklahoma City、Oklahoma、美国、73102
        • Saint Anthony Endoscopy Center
      • Oklahoma City、Oklahoma、美国、73102
        • SSM Health, Saint Anthony Hospital
      • Oklahoma City、Oklahoma、美国、73120
        • Johnston Opthalmology
    • Pennsylvania
      • Hershey、Pennsylvania、美国、17033
        • Penn State Milton S. Hershey Medical Center
    • Texas
      • Austin、Texas、美国、78705
        • Central Texas Clinical Research
      • Cypress、Texas、美国、77429
        • Houston Pulmonary Sleep and Allergy Associates (PFT)
      • Houston、Texas、美国、77030
        • The University of Texas Health Science Center at Houston
      • Houston、Texas、美国、77030
        • Baylor St. Luke's Medical Center
      • Houston、Texas、美国、77047
        • Pearland Surgery Center
      • Houston、Texas、美国、77030
        • Alkek Eye Center Jamail Specialty Care Center (OCT)
      • Houston、Texas、美国、77024
        • Houston Eye Associates (For Eye Examination)
      • Houston、Texas、美国、77030
        • Baylor College of Medicine - Baylor St. Luke's Medical Center
      • Houston、Texas、美国、77030
        • Baylor St. Luke's Medical Center - McNair Campus (pharmacy)
      • Houston、Texas、美国、77030
        • Baylor St. Luke's Medical Center - McNair Campus
      • Houston、Texas、美国、77030
        • Baylor St. Luke's Medical Center Endoscopy - McNair Campus
      • Houston、Texas、美国、77030
        • Mann Eye Institute
      • Houston、Texas、美国、77030
        • Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)
      • Houston、Texas、美国、77034
        • Bay Area Endoscopy Center, LLC
      • Houston、Texas、美国、77055
        • Memorial Endoscopy Center (For Colonoscopy)
      • Houston、Texas、美国、77065
        • Eye Specialists of Texas
      • Houston、Texas、美国、77065
        • Northside Gastroenterology Associates PA
      • Houston、Texas、美国、77079
        • Memorial Pulmonology(For PFT)
      • Houston、Texas、美国、77204
        • Digestive Health Associates
      • Houston、Texas、美国、77204
        • Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)
      • Pearland、Texas、美国、77584
        • LinQ Research, LLC
      • Tyler、Texas、美国、75701
        • Tyler Research Institute, LLC
      • Tyler、Texas、美国、75701
        • UT Health East Texas Physicians (pulmonary functions only)
      • Tyler、Texas、美国、75701
        • Christus Trinity Mother Frances Endoscopy Center (endoscopies only)
      • Tyler、Texas、美国、75701
        • Heaton Eye Associates (OCT only)
      • Victoria、Texas、美国、77904
        • Victoria Gastroenterology
      • Victoria、Texas、美国、77904
        • Citizens Healthplex (for PFT only)
      • Victoria、Texas、美国、77904
        • Surgery Center (For endoscopy only)
      • Victoria、Texas、美国、77904
        • Victoria Eye Center (For OCT only)
      • Webster、Texas、美国、77598
        • GI Alliance Webster
    • Virginia
      • Forest、Virginia、美国、24551
        • Harman Eye Center (OCT only)
      • Lynchburg、Virginia、美国、24502
        • Blue Ridge Medical Research
      • Lynchburg、Virginia、美国、24501
        • Lynchburg Pulmonary Associates, Inc. (PFT only)
    • Washington
      • Issaquah、Washington、美国、98029
        • Swedish Endoscopy Center - Issaquah
      • Seattle、Washington、美国、98122
        • Swedish Medical Center
      • Seattle、Washington、美国、98104
        • Swedish Gastroenterology
      • Seattle、Washington、美国、98104
        • Pacific Northwest Retina
      • Seattle、Washington、美国、98104
        • Richard Bensinger, MD
      • Seattle、Washington、美国、98122
        • First Hill Endoscopy Center
      • Seattle、Washington、美国、98122
        • Pulmonary Function Lab
    • Wisconsin
      • Milwaukee、Wisconsin、美国、53226
        • Froedtert Memorial Lutheran Hospital
      • Liverpool、英国、L7 8XP
        • Royal Liverpool University Hospital
      • London、英国、SE1 9RT
        • Guys & St Thomas Hospital
      • Norwich、英国、NR4 7UQ
        • Quadram Institute Clinical Research Facility
      • Amsterdam、荷兰、1105 AZ
        • Academic Medical Centre
      • Utrecht、荷兰、3584 CX
        • UMC Utrecht
      • Las Palmas de Gran Canaria、西班牙、35010
        • Hospital Universitario de Gran Canaria Dr. Negrín
      • Madrid、西班牙、28046
        • Hospital Universitario La Paz
    • Ciudad REAL
      • Tomellso、Ciudad REAL、西班牙、13700
        • Hospital General de Tomelloso
    • Prov. de Buenos Aires
      • Ciudadela、Prov. de Buenos Aires、阿根廷、1702
        • Instituto Medico Elsa Perez(I.M.E.P)
      • Ciudadela、Prov. de Buenos Aires、阿根廷、B1702GIK
        • Instituto Medico Elsa Perez (I.M.E.P.) (Local Lab)
      • Ciudadela、Prov. de Buenos Aires、阿根廷、B1702GIK
        • Instituto Medico Elsa Perez (I.M.E.P.) (Pharmacy)
      • Hurlingham、Prov. de Buenos Aires、阿根廷、B1686NCI
        • Estudio de La Vision (OCT, Ophthalmoscopy)
    • Santa Fe Province
      • Rosario、Santa Fe Province、阿根廷、S2000DEJ
        • Instituto Medico de la Fundacion Estudios Clinicos
      • Rosario、Santa Fe Province、阿根廷、S2000AUC
        • Gastroenterologia Rosario (Endoscopy)
      • Rosario、Santa Fe Province、阿根廷、S2000CTC
        • Microcirugia Ocular SA (OCT, Ophthalmoscopy)
      • Rosario、Santa Fe Province、阿根廷、S2000KZD
        • Consultorios extemos de Sanatorio Parque (PFT with DLCO, Pulmonar Functional Test with DLCO)
    • Tucumán Province
      • San Miguel de Tucumán、Tucumán Province、阿根廷、T4000AXL
        • Centro de Investigaciones Médicas Tucuman
      • Daegu、韩国、41404
        • Kyungpook National University Chilgok Hospital
      • Daegu、韩国、41944
        • Kyungpook National University Hospital
      • Daegu、韩国、41944
        • Endoscopy Facility in kyungpook National University Hospital
      • Daegu、韩国、41944
        • OCT Facility In kyungpook National University Hospital
      • Daegu、韩国、41944
        • PFT Facility in Kyungpook National University Hospital
      • Daejeon、韩国、34943
        • The Catholic University of Korea, Daejeon ST. Mary's Hospital
      • Incheon、韩国、21565
        • Gachon University Gil Medical Center
      • Seongnam-si、韩国、13496
        • CHA University Bundang CHA Hospital
      • Seoul、韩国、06273
        • Gangnam Severance Hospital, Yonsei University Health System
      • Seoul、韩国、06973
        • Chung-Ang University Hospital
      • Seoul、韩国、02447
        • Kyunghee University Medical Center
    • Gyeonggi-do
      • Goyang-si、Gyeonggi-do、韩国、10326
        • Dongguk University Ilsan Hospital
      • Kuala Lumpur、马来西亚、59100
        • University Malaya Medical Centre
      • Beirut、黎巴嫩、166830
        • Hotel Dieu de France Hospital
      • Beirut、黎巴嫩、1100 2807
        • Saint George University Hospital Medical Center
      • Beirut、黎巴嫩、113-6044
        • Rafik Hariri University Hospital
      • Saida、黎巴嫩
        • Hammoud Hospital University Medical Center
      • Tripoli、黎巴嫩
        • Nini Hospital s.a:l

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

不

描述

适用于所有子研究的资格标准:

纳入标准:

  • 18至80岁的男性或女性,
  • 提供书面知情同意或同意并遵守协议评估时间表的能力
  • 被诊断患有克罗恩病 (CD) ≥ 3 个月
  • 筛选时有中度至重度活动性 CD
  • 证明对 CD 的以下 ≥ 1 种疗法反应不足(即原发性无反应)、反应丧失或不耐受:

    1. 口服皮质类固醇(例如,泼尼松或其等效物,布地奈德)
    2. 免疫抑制剂(例如,硫唑嘌呤 [AZA]、6 巯基嘌呤 [6-MP] 或甲氨蝶呤 [MTX])
    3. 肿瘤坏死因子 α (TNFα) 拮抗剂(例如,英夫利昔单抗、阿达木单抗、赛妥珠单抗聚乙二醇或生物仿制药)
    4. 整合素受体拮抗剂(如维多珠单抗)
    5. 白细胞介素 -12/-23 拮抗剂(如优特克单抗)
  • 有生育能力的女性必须未怀孕
  • 有生育能力的女性和男性必须采取避孕措施

排除标准:

  • 对 ≥ 2 类市售用于治疗 CD 的生物制剂(即 TNFα 拮抗剂、白细胞介素 12/23 拮抗剂和整合素受体拮抗剂)的药物反应不足(即原发性无反应)的历史。
  • 患有溃疡性结肠炎、不确定性结肠炎、显微镜下结肠炎、缺血性结肠炎、放射性结肠炎、憩室病相关性结肠炎、中毒性巨结肠或活动性感染性结肠炎或筛选时艰难梭菌毒素检测呈阳性。
  • 患有功能性或术后短肠综合征或任何可能需要手术或干扰疗效评估的相关并发症
  • 在随机分组前 ≤ 8 周接受过腹腔内脓肿的手术治疗,或在随机分组前 ≤ 4 周接受过肛周脓肿的手术治疗。
  • 在随机分组前 ≤ 24 周进行过肠切除术或在随机分组前 ≤ 12 周进行过其他腹腔内手术。
  • 进行回肠造口术或结肠造口术。

子研究 3 的纳入标准:

-进入子研究 1 和子研究 2 的延长诱导期的参与者必须完成延长诱导 - 第 6 周访问

子研究 4 的纳入标准:

-参与者必须完成子研究 3 的第 52 周访问或子研究 A 的第 66 周访问

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较:安慰剂
Etrasimod 匹配安慰剂片剂,口服,每日一次。
实验性的:依曲莫德剂量 A
口服剂量 A,每日一次。
其他名称:
  • APD334
B 剂口服,每日一次。
其他名称:
  • APD334
实验性的:依曲莫德剂量 B
口服剂量 A,每日一次。
其他名称:
  • APD334
B 剂口服,每日一次。
其他名称:
  • APD334

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

次要结果测量

结果测量
措施说明
大体时间
Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
大体时间:Week 14 of SSA
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 14 of SSA
Change From Baseline in SES-CD Score at Week 14: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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.
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Change From Baseline in CDAI Score at Week 14: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
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.
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Plasma Concentration of Etrasimod at 4 Hours Post-dose: SSA
大体时间:4 hours post-dose on Day 1
The plasma concentration of etrasimod at 4 hours post-dose has been reported in this outcome measure.
4 hours post-dose on Day 1
Steady State Trough Concentration (Ctrough,ss) of Etrasimod From Week 2 to Week 14: SSA
大体时间:From Week 2 to Week 14
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.
From Week 2 to Week 14
Change From Baseline in Absolute Lymphocyte Count (ALC) at Week 14 in Induction Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Percent Change From Baseline in ALC at Week 14 in Induction Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Change From Baseline in ALC at Week 66 in Extension Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Percent Change From Baseline in ALC at Week 66 in Extension Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Change From Baseline in Fecal Calprotectin (FCP) Concentration at Week 14 in Induction Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Percent Change From Baseline in FCP Concentration at Week 14 in Induction Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Change From Baseline in FCP Concentration at Week 66 in Extension Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Percent Change From Baseline in FCP Concentration at Week 66 in Extension Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Change From Baseline in C-Reactive Protein (CRP) at Week 14 in Induction Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Percent Change From Baseline in CRP at Week 14 in Induction Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Change From Baseline in CRP at Week 66 in Extension Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Percent Change From Baseline in CRP at Week 66 in Extension Period: SSA
大体时间:Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 66 of SSA
Percentage of Participants With Clinical Remission by CDAI at Week 14: SS1
大体时间:Week 14 of SS1
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.
Week 14 of SS1
Percentage of Participants With Clinical Remission by Patient Reported Outcomes 2 (PRO2) at Week 14: SS1
大体时间:Week 14 of SS1
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.
Week 14 of SS1
Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
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
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Responder Cohort
大体时间: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= 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.
Week 52 of study
Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Non-Responder Cohort
大体时间: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= 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.
Week 52 of study
Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Non-Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Non-Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Non-Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
大体时间:Baseline, study Weeks 20, 28, 36, 44, 52
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.
Baseline, study Weeks 20, 28, 36, 44, 52
Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
大体时间:Baseline, study Weeks 20, 28, 36, 44, 52
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.
Baseline, study Weeks 20, 28, 36, 44, 52
Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Responder Cohort
大体时间:Week 52 of study
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.
Week 52 of study
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
大体时间:Week 52 of study
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.
Week 52 of study
Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Non-Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 28 and 52: SS3 Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Change From Baseline in IBDQ at Weeks 28 and 52: SS3 Non-Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Weeks 28 and 52: SS3 Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Change From Baseline in SF-36 at Weeks 28 and 52: SS3 Non-Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 28 and 52: SS3 Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Change From Baseline in FACIT-F at Weeks 28 and 52: SS3 Non-Responder Cohort
大体时间:Baseline, study Weeks 28 and 52
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.
Baseline, study Weeks 28 and 52
Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at SS3 Baseline: SS3 Responder Cohort
大体时间:Week 52 of study
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
大体时间:Week 52 of study
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
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
大体时间: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.
Baseline, study Weeks 20, 28, 36, 44 and 52
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
大体时间: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.
Baseline, study Weeks 20, 28, 36, 44 and 52
Time to Remission by PRO2 and FCP Concentrations: SS3 Responder Cohort
大体时间: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 Remission by PRO2 and FCP Concentrations: SS3 Non-Responder Cohort
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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
大体时间: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

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

调查人员

  • 研究主任:Pfizer CT.gov Call Center、Pfizer

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年1月6日

初级完成 (实际的)

2025年4月23日

研究完成 (实际的)

2025年6月9日

研究注册日期

首次提交

2019年11月20日

首先提交符合 QC 标准的

2019年11月20日

首次发布 (实际的)

2019年11月21日

研究记录更新

最后更新发布 (实际的)

2026年7月1日

上次提交的符合 QC 标准的更新

2026年6月5日

最后验证

2026年6月1日

更多信息

与本研究相关的术语

其他研究编号

  • APD334-202
  • C5041006 (其他标识符:Alias Study Number)
  • 2024-513569-38-00 (注册表标识符:CTIS (EU))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

是的

IPD 计划说明

辉瑞将提供对个人去识别参与者数据和相关研究文件(例如 协议、统计分析计划 (SAP)、临床研究报告 (CSR))根据合格研究人员的要求,并遵守某些标准、条件和例外情况。 有关辉瑞数据共享标准和请求访问流程的更多详细信息,请访问:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests。

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

不

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

订阅