- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT04173273
Un estudio que evalúa la eficacia y la seguridad de etrasimod oral en el tratamiento de participantes adultos con enfermedad de Crohn activa de moderada a grave (CULTIVATE)
Un estudio multicéntrico, aleatorizado, doble ciego, de grupos paralelos para evaluar la eficacia y la seguridad de etrasimod oral como terapia de inducción y mantenimiento para la enfermedad de Crohn activa de moderada a grave
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
Este estudio incluye 5 subestudios:
Subestudio A - Fase 2: Un subestudio de fase 2, aleatorizado, doble ciego, para evaluar la seguridad, la tolerabilidad y la eficacia del tratamiento con etrasimod oral en participantes con EC de moderada a grave que respalda la selección de una dosis de inducción y mantenimiento para la Fase 3. El subestudio A actualmente está cerrado para la inscripción.
Subestudio 1 - Fase 2: Un subestudio de fase 2b aleatorizado, doble ciego, controlado con placebo, de inducción de rango de dosis para evaluar etrasimod como terapia de inducción y seleccionar una(s) dosis de inducción y mantenimiento para la evaluación continua en la Fase 3. El subestudio 1 es actualmente inscribiendo participantes.
Subestudio 2: Inducción: un subestudio de fase 3, aleatorizado, doble ciego, controlado con placebo para evaluar etrasimod como terapia de inducción.
Subestudio 3 - Mantenimiento: un subestudio de fase 3 aleatorizado, doble ciego, controlado con placebo para evaluar etrasimod como terapia de mantenimiento. Los participantes del Subestudio 1 y del Subestudio 2 se inscribirán en el Subestudio 3.
Subestudio 4 - Extensión a largo plazo: un subestudio de extensión a largo plazo para participantes que completen al menos 52 semanas de tratamiento. Está previsto que los participantes del Subestudio 3 y del Subestudio A se inscriban en el Subestudio 4.
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 2
- Fase 3
Contactos y Ubicaciones
Ubicaciones de estudio
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Augsburg, Alemania, 86156
- Universitaetsklinikum Augsburg
-
Brandenburg an der Havel, Alemania, 14770
- Staedtisches Klinikum Brandenburg
-
Frankfurt, Alemania, 60431
- Prof. Dr. med. Dr. med. Habil. Jens Buhren, FEBO
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Frankfurt am Main, Alemania, 60431
- Agaplesion Markus Krankenhaus
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Hamburg, Alemania, 20251
- HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
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Jena, Alemania, 07747
- Universitaetsklinikum Jena
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Jena, Alemania, 07747
- OCT/Ophtalmoscopy address: Universitaetsklinikum Jena
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Jena, Alemania, 07747
- PFT address: Universitaetsklinikum Jena
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Kassel, Alemania, 34121
- PFT address: Praxis fur Pneumologie und Allergologie
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Kassel, Alemania, 34177
- OCT/Ophtalmoscopy address: Augenarztpraxis Dr. Karola Hassan
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Kiel, Alemania, 24105
- Nordblick Augenklinik
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Kiel, Alemania, 24105
- Universitatsklinikum Schleswig-Holstein- Campus Kiel
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Nürtingen, Alemania, 72622
- Dr. Irina Hasewinkel
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Nürtingen, Alemania, 72622
- Medius Klinik Nuertingen
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Hassen
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Kassel, Hassen, Alemania, 34117
- Gastroenterologie Opernstraβe
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Prov. de Buenos Aires
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Ciudadela, Prov. de Buenos Aires, Argentina, 1702
- Instituto Medico Elsa Perez(I.M.E.P)
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Ciudadela, Prov. de Buenos Aires, Argentina, B1702GIK
- Instituto Medico Elsa Perez (I.M.E.P.) (Local Lab)
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Ciudadela, Prov. de Buenos Aires, Argentina, B1702GIK
- Instituto Medico Elsa Perez (I.M.E.P.) (Pharmacy)
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Hurlingham, Prov. de Buenos Aires, Argentina, B1686NCI
- Estudio de La Vision (OCT, Ophthalmoscopy)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentina, S2000AUC
- Gastroenterologia Rosario (Endoscopy)
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Rosario, Santa Fe Province, Argentina, S2000CTC
- Microcirugia Ocular SA (OCT, Ophthalmoscopy)
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Rosario, Santa Fe Province, Argentina, S2000KZD
- Consultorios extemos de Sanatorio Parque (PFT with DLCO, Pulmonar Functional Test with DLCO)
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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New South Wales
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Macquarie University, New South Wales, Australia, 2109
- Macquarie University Hospital
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Macquarie University, New South Wales, Australia, 2109
- Macquarie University Hospital Pharmacy
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Macquarie University, New South Wales, Australia, 2109
- Macquarie Respiratory Services
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Macquarie University, New South Wales, Australia, 2109
- Macquarie University Hospital Clinical Trials
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Macquarie University, New South Wales, Australia, 2109
- MQ Health Ophthalmology
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Queensland
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Brisbane, Queensland, Australia, 4029
- Royal Brisbane & Women's Hospital
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North Mackay, Queensland, Australia, 4740
- Coral Sea Clinical Research Institute
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Victoria
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Bellfield, Victoria, Australia, 3081
- MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons
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Epping, Victoria, Australia, 3076
- The Northern Hospital
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Heidelberg, Victoria, Australia, 3084
- Austin Hospital
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Melbourne, Victoria, Australia, 3011
- Vision Eye Institute
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Melbourne, Victoria, Australia, 3011
- Footscray Hospital
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Parkville, Victoria, Australia, 3050
- The Royal Melbourne Hospital
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Rosanna, Victoria, Australia, 3084
- Heidelberg Eye Clinic
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Western Australia
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Murdoch, Western Australia, Australia, 6150
- Fiona Stanley Hospital
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Nedlands, Western Australia, Australia, 6009
- Lions Eye Institute Limited
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O'Connor, Western Australia, Australia, 6163
- The trustee for The RTS Unit Trust trading as Respiratory Testing Services
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Graz, Austria, 8036
- LKH Universitats-Klinikum Graz
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Innsbruck, Austria, A-6020
- Medical University Innsbruck, Internal Medicine Ⅰ
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Vienna, Austria, 1090
- AKH Wien- Universitatsklinik fiir Innere Medizin III
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Vienna, Austria, 1090
- Univ.-Professor Dr. Mehrdad Baghestanian
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Vienna, Austria, 1090
- AKH Wien- Universitatsklinik fur Innere Medizin III
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Homyel, Bielorrusia, 246029
- Institution "Gomel Regional Clinical Hospital"
-
Minsk, Bielorrusia, 220096
- Health care Institution "10th City Clinical Hospital"
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Mogilev, Bielorrusia, 212018
- Health Care Institution "Mogilev Hospital #1"
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Vitebsk, Bielorrusia, 210037
- Health Care Institution "Vitebsk Regional Clinical Hospital"
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Vitebsk, Bielorrusia, 210604
- Healthcare Institution "Vitebsk Regional Clinical Specialized Center"
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Sofia, Bulgaria, 1527
- UMHAT "Tsaritsa Yoanna-ISUL" EAD
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Sofia, Bulgaria, 1431
- "DCC Alexandrovska", EOOD
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Sofia, Bulgaria, 1606
- ,,University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov" EAD
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Ghent, Bélgica, 9000
- Universitair Ziekenhuis Gent
-
Ghent, Bélgica, 9000
- AZ Maria-Middelares
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Leuven, Bélgica, 3000
- Universitaire Ziekenhuizen Leuven
-
Roeselare, Bélgica, 8800
- Campus Brugsesteenweg
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Roeselare, Bélgica, 8800
- Campus Rumbeke
-
Torhout, Bélgica, 8820
- Campus Rembert Torhout
-
Yvoir, Bélgica, 5530
- Centre Hospitalier Universitaire UCL Namur - Site Godinne
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Quebec
-
Montreal, Quebec, Canadá, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Electrocardiogram Clinic)
-
Montreal, Quebec, Canadá, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Endoscopy Clinic)
-
Montreal, Quebec, Canadá, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Pharmacy)
-
Montreal, Quebec, Canadá, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Radiology)
-
Montreal, Quebec, Canadá, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Research Site)
-
Montreal, Quebec, Canadá, H4A 3J1
- Centre for Innovative Medicine - Research Institute of the McGill University Health Centre(Pulmonary
-
Montreal, Quebec, Canadá, H4P 2S4
- Eye Health MD (Ophthalmology)
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Horažďovice, Chequia, 341 01
- MUDr. Jaroslava Skalova
-
Hradec Králové, Chequia, 500 12
- Hepato-gastroenterologie HK, s.r.o.
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Hradec Králové, Chequia, 500 12
- VISUS, spol s.r.o.
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Klatovy, Chequia, 339 01
- GASTRO JeKa, s.r.o.
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Klatovy, Chequia, 339 01
- Klatovska nemocnice a.s.
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Olomouc, Chequia, 779 00
- PreventaMed s.r.o.
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Olomouc, Chequia, 779 00
- Ocni ordinace Olomouc
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Olomouc, Chequia, 779 00
- MUDr. Pavlina Kazinotova s.r.o.
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RM
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Santiago, RM, Chile, 8330034
- Centro de Investigaciones Clinicas de la Universidad Catolica
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7620157
- Clinica Universidad de Los Andes
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Santiago, Santiago Metropolitan, Chile, 8330336
- CeCim Biocinetic
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Quindío Department
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Armenia, Quindío Department, Colombia, 630004
- IPS Fundacion Cardiomet CEQUIN
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Colombia, 760035
- Centro de lnvestigaciones Clinicas S.A.S
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Daegu, Corea del Sur, 41404
- Kyungpook National University Chilgok Hospital
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Daegu, Corea del Sur, 41944
- Kyungpook National University Hospital
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Daegu, Corea del Sur, 41944
- Endoscopy Facility in kyungpook National University Hospital
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Daegu, Corea del Sur, 41944
- OCT Facility In kyungpook National University Hospital
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Daegu, Corea del Sur, 41944
- PFT Facility in Kyungpook National University Hospital
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Daejeon, Corea del Sur, 34943
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
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Incheon, Corea del Sur, 21565
- Gachon University Gil Medical Center
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Seongnam-si, Corea del Sur, 13496
- CHA University Bundang CHA Hospital
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Seoul, Corea del Sur, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Corea del Sur, 06973
- Chung-Ang University Hospital
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Seoul, Corea del Sur, 02447
- Kyunghee University Medical Center
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Corea del Sur, 10326
- Dongguk University Ilsan Hospital
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-
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Zagreb, Croacia, 10000
- University Hospital Center Zagreb
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-
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Aalborg, Dinamarca, 9000
- Aalborg University Hospital, Department of Medical Gastroenterology, Medicinerhuset
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Hvidovre, Dinamarca, 2650
- Hvidovre University Hospital
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Alexandria, Egipto, 21131
- Alexandria Clinical Research Center , Faculty of Medicine , Alexandria University
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Cairo, Egipto
- National Hepatology and Tropical Medicine Research Institute
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Cairo, Egipto, 11556
- Ain Shams University Hospital
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Cairo, Egipto
- Air Force Specialized Hospital(AFSH)
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Cairo, Egipto
- Cairo University , Kasr Al Aini Hospital
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Dakahlia, Egipto
- Egyptian Liver Research Institute and Hospital ( ELRIAH)
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Giza, Egipto
- Theodor Bilharz Research Institute Research Ethics Committee
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Menofeya, Egipto, 32511
- National Liver Institute
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Banská Bystrica, Eslovaquia, 975 17
- Fakultna nemocnica s poliklinikou F.D.Roosevelta
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Bardejov, Eslovaquia, 08501
- ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva
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Košice, Eslovaquia, 040 13
- ENDOMED, s.r.o. Gastroenterologicka ambulancia
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Lipany, Eslovaquia, 082 71
- Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.
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Nitra, Eslovaquia, 949 01
- KM Management spol.s.r.o. Gastroenterologicke a hepatologicke centrum
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Prešov, Eslovaquia, 080 01
- GASTRO LM s.r.o., Gastroenterologicka ambulancia
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Prešov, Eslovaquia, 080 01
- Pneumology: PULMO, s.r.o.
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Las Palmas de Gran Canaria, España, 35010
- Hospital Universitario de Gran Canaria Dr. Negrín
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Madrid, España, 28046
- Hospital Universitario La Paz
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Ciudad REAL
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Tomellso, Ciudad REAL, España, 13700
- Hospital General de Tomelloso
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Alabama
-
Dothan, Alabama, Estados Unidos, 36301
- Digestive Health Specialists
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Dothan, Alabama, Estados Unidos, 36301
- Dothan Eyecare-Dr. Brent McKinley (OCT Location)
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Dothan, Alabama, Estados Unidos, 36301
- Center for Digestive Health (Endoscopy Location)
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Dothan, Alabama, Estados Unidos, 36301
- Pulmonary Associates (PFT Location)
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Dothan, Alabama, Estados Unidos, 36305
- Flowers Hospital (Imaging Location)
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Mobile, Alabama, Estados Unidos, 36608
- Digestive Health Specialists (Satellite Clinic Location)
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Mobile, Alabama, Estados Unidos, 36608
- Premier Medical Group East (Opthalmology & Optometry Facility)
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Mobile, Alabama, Estados Unidos, 36608
- Pulmonary Associates (Chest X-Ray & PFT Facility)
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Mobile, Alabama, Estados Unidos, 36608
- Surgicare of Mobile (Endoscopy & Biopsy Facility)
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Arizona
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Peoria, Arizona, Estados Unidos, 85381
- Arizona Retina Institute/ Phoenix Retina Associates(OCT)
-
Peoria, Arizona, Estados Unidos, 85381
- SimonMed Imaging (Imaging)
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Sun City, Arizona, Estados Unidos, 85351
- Sun City Endoscopy Center (Endoscopy)
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California
-
Apple Valley, California, Estados Unidos, 92307
- Om Research LLC
-
Apple Valley, California, Estados Unidos, 92307
- Victor Valley Advanced Imaging
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La Jolla, California, Estados Unidos, 92037
- UCSD lnvestigational Drug Service Pharmacy
-
La Jolla, California, Estados Unidos, 92093
- Shiley Eye Institute (OCT)
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La Jolla, California, Estados Unidos, 92037
- Koman Family Outpatient Pavilion (ENDO)
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La Jolla, California, Estados Unidos, 92037
- Perlman Medical Offices
-
La Jolla, California, Estados Unidos, 92037
- UCSD Clinical and Translational Research Institute
-
La Jolla, California, Estados Unidos, 92037
- UCSD Health System (Endo/PFT/DLCO)
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Lancaster, California, Estados Unidos, 93534
- Om Research LLC
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Lancaster, California, Estados Unidos, 93534
- A V Pediatrics, Allergy and Family Medicine - PFT
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Lancaster, California, Estados Unidos, 93534
- Advanced Endoscopy and Pain Center - Colonoscopy
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Lancaster, California, Estados Unidos, 93534
- Advanced Imaging Center - Chest X-Ray
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Lancaster, California, Estados Unidos, 93534
- Antelope Valley Eye Care - Ophthalmologist
-
Lancaster, California, Estados Unidos, 93534
- AV Pediatrics Allergy and Family Medicine
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Lancaster, California, Estados Unidos, 93534
- Jatinder S. Pruthi, MD FACG CPI
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Murrieta, California, Estados Unidos, 92563
- United Medical Doctors
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Victorville, California, Estados Unidos, 92392
- Retina Consultants of Southern California
-
Victorville, California, Estados Unidos, 92395
- Physicians Surgery Center
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Colorado
-
Colorado Springs, Colorado, Estados Unidos, 80907
- Peak Gastroenterology Associates
-
Colorado Springs, Colorado, Estados Unidos, 80903
- Front Range Endoscopy Center
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Colorado Springs, Colorado, Estados Unidos, 80909
- Colorado Springs Pulmonary Consultants, PC
-
Colorado Springs, Colorado, Estados Unidos, 80909
- The Wright Eye Center (OCT Facility)
-
Colorado Springs, Colorado, Estados Unidos, 80919
- Colorado Springs Imaging (Ultrasound and MRE Location)
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Florida
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Boca Raton, Florida, Estados Unidos, 33487
- Xera Med Research
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Boynton Beach, Florida, Estados Unidos, 33472
- RecioMed Clinical Research Network, Inc
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Brandon, Florida, Estados Unidos, 33511
- Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
-
Clearwater, Florida, Estados Unidos, 33756
- West Coast Endoscopy Center (Endoscopy Procedures)
-
Clearwater, Florida, Estados Unidos, 33756
- Bay Area Chest Physicians, P.A. (Pulmonary Function Test)
-
Clearwater, Florida, Estados Unidos, 33761
- Northwood Vision (Optical Coherence Tomography)
-
Clearwater, Florida, Estados Unidos, 33761
- Safety Harbor Surgery (Endoscopy Procedures)
-
Clearwater, Florida, Estados Unidos, 33762
- Gastro Florida (Regulatory Administrative Duties)
-
Coral Gables, Florida, Estados Unidos, 33134
- Beraja Medical Institute (OCT)
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Hialeah, Florida, Estados Unidos, 33012
- Advanced Eye Center
-
Jacksonville, Florida, Estados Unidos, 32256
- Encore Borland-Groover Clinical Research
-
Jacksonville, Florida, Estados Unidos, 32207
- UF Health Imaging Center-Emerson (chest x-rays)
-
Jacksonville, Florida, Estados Unidos, 32207
- UF Health Laboratory Emerson (blood draws)
-
Jacksonville, Florida, Estados Unidos, 32209
- UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
-
Jacksonville, Florida, Estados Unidos, 32209
- UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)
-
Jacksonville, Florida, Estados Unidos, 32209
- UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)
-
Jacksonville, Florida, Estados Unidos, 32209
- UF Health Radiology-Jacksonville (chest x-rays)
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Jacksonville, Florida, Estados Unidos, 32216
- Cisca Pulmonary & Critical Care (PFT Facility)
-
Jacksonville, Florida, Estados Unidos, 32216
- Nicolitz Eye Consultants (OCT Facility)
-
Jacksonville, Florida, Estados Unidos, 32256
- Borland-Groover Clinic (Endoscopy Facility)
-
Jupiter, Florida, Estados Unidos, 33458
- Jupiter Outpatient Surgery Center
-
Kissimmee, Florida, Estados Unidos, 34741
- IHS Health, LLC
-
Largo, Florida, Estados Unidos, 33773
- Lee Shettle Eye & Hearing (Ophthalmoscopy Only)
-
Miami, Florida, Estados Unidos, 33133
- Infinite Clinical Research
-
Miami, Florida, Estados Unidos, 33156
- Research Associates of South Florida
-
Miami, Florida, Estados Unidos, 33176
- Anchor Medical Research, LLC
-
Miami, Florida, Estados Unidos, 33134
- The Endoscopy Center (Endoscopy Procedure)
-
Miami, Florida, Estados Unidos, 33173
- Juan Barrio, MD (PFT when needed)
-
Miami, Florida, Estados Unidos, 33133
- Pulmonology Physicians of South Florida
-
Miami, Florida, Estados Unidos, 33133
- Reina Eye Care P.A.
-
Miami, Florida, Estados Unidos, 33155
- La Salud Research Clinic Inc.
-
Miami, Florida, Estados Unidos, 33156
- South Florida Center for Endoscopy and Digestive Disease, LLC
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Naples, Florida, Estados Unidos, 34102
- Gastroenterology Group of Naples
-
Naples, Florida, Estados Unidos, 34102
- Gulfshore Endoscopy Center
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Naples, Florida, Estados Unidos, 34103
- Retina Consultants of Southwest Florida OCT only
-
Naples, Florida, Estados Unidos, 34109
- Lisette Delgado Sanchez, MD PFT only
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Orlando, Florida, Estados Unidos, 32825
- Pediatric & Adult Research Center
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Palmetto Bay, Florida, Estados Unidos, 33157
- IMIC Inc.
-
Palmetto Bay, Florida, Estados Unidos, 33157
- IMIC Inc
-
Port Orange, Florida, Estados Unidos, 32127
- Advanced Medical Research Center
-
Seminole, Florida, Estados Unidos, 33777
- Bardmoor GastroEnterology
-
South Miami, Florida, Estados Unidos, 33143
- Larkin Community Hospital (Endoscopy Procedure)
-
St. Petersburg, Florida, Estados Unidos, 33705
- St. Petersburg Endoscopy Center (Endoscopy Procedures)
-
St. Petersburg, Florida, Estados Unidos, 33707
- Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)
-
St. Petersburg, Florida, Estados Unidos, 33709
- Bay Area Endoscopy and Surgery Center (Endoscopy only)
-
St. Petersburg, Florida, Estados Unidos, 33709
- Theia Clinical Research, LLC
-
St. Petersburg, Florida, Estados Unidos, 33710
- Advanced Research Institute Inc.(IP and PFT)
-
Sun City Center, Florida, Estados Unidos, 33573
- Absolute Surgical Specialist - Craig Amshel, MD
-
Tampa, Florida, Estados Unidos, 33612
- USF Health Morsani Center for Advanced Healthcare
-
Tampa, Florida, Estados Unidos, 33606
- USF Health South Tampa Center for Advanced Healthcare
-
Tampa, Florida, Estados Unidos, 33609
- GCP Clinical Research,LLC
-
Tampa, Florida, Estados Unidos, 33609
- South Tampa Surgery Center
-
Tampa, Florida, Estados Unidos, 33609
- Newsome Eye Specialist (OCT Procedures Only)
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Tampa, Florida, Estados Unidos, 33606
- Lab - Processing/ Storage
-
Tampa, Florida, Estados Unidos, 33609
- LoCicero Medical Group
-
-
Georgia
-
Atlanta, Georgia, Estados Unidos, 30342
- Atlanta Gastroenterology Associates
-
Atlanta, Georgia, Estados Unidos, 30309
- Digestive Healthcare of Georgia
-
Atlanta, Georgia, Estados Unidos, 30324
- Ross Eyecare - Opthalmoscopy and OCT
-
Atlanta, Georgia, Estados Unidos, 30342
- Atlanta Gastroenterology Associates (endoscopy only)
-
Atlanta, Georgia, Estados Unidos, 30342
- Atlanta Gastroenterology Associates(IP only)
-
Atlanta, Georgia, Estados Unidos, 30309
- Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs
-
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Illinois
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Arlington Heights, Illinois, Estados Unidos, 60005
- GI Alliance
-
Arlington Heights, Illinois, Estados Unidos, 60005
- Northwest Endoscopy Center (Endoscopy)
-
Gurnee, Illinois, Estados Unidos, 60031
- GI Alliance (PFT)
-
Gurnee, Illinois, Estados Unidos, 60031
- Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
-
Gurnee, Illinois, Estados Unidos, 60031
- Medical Eye Services LTD (Ophthalmoscopy with OCT)
-
Lake Bluff, Illinois, Estados Unidos, 60044
- North Shore Endoscopy Center (Endoscopy)
-
Libertyville, Illinois, Estados Unidos, 60048
- Libertyville Imaging Center (Diagnostic Imaging)
-
Morton Grove, Illinois, Estados Unidos, 60053
- 3T Imaging of Morton Grove (Diagnostic Imaging)
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-
Maryland
-
Columbia, Maryland, Estados Unidos, 21045
- Cascades Endoscopy Center
-
Columbia, Maryland, Estados Unidos, 21044
- Charter Radiology
-
Columbia, Maryland, Estados Unidos, 21045
- Gastro Center of Maryland, LLC
-
Hanover, Maryland, Estados Unidos, 21076
- Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
-
Laurel, Maryland, Estados Unidos, 20707
- Lung Center (Pulmonary Function Test only)
-
-
Mississippi
-
Jackson, Mississippi, Estados Unidos, 39216
- Southern Therapy and Advanced Research, LLC
-
Jackson, Mississippi, Estados Unidos, 39216
- A Terrell Williams, MD, PLLC (OCT)
-
Jackson, Mississippi, Estados Unidos, 39216
- Jackson Pulmonary Associates (PFT)
-
Jackson, Mississippi, Estados Unidos, 39216
- St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)
-
-
Missouri
-
Creve Coeur, Missouri, Estados Unidos, 63141
- Barnes-Jewish West County Hospital (Additional Endoscopy Location)
-
St Louis, Missouri, Estados Unidos, 63110
- Barnes-Jewish Hospital
-
St Louis, Missouri, Estados Unidos, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Estados Unidos, 63108
- Washington University School of Medicine
-
-
New Jersey
-
Freehold, New Jersey, Estados Unidos, 07728
- Allied Health Clinical Research Organization, LLC
-
Freehold, New Jersey, Estados Unidos, 07728
- Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County
-
Freehold, New Jersey, Estados Unidos, 07728
- Freehold Ophthalmology
-
Freehold, New Jersey, Estados Unidos, 07728
- Monmouth Ocean Pulmonary Medicine
-
Freehold, New Jersey, Estados Unidos, 07728
- Princeton Radiology
-
-
New York
-
New York, New York, Estados Unidos, 10016
- NYU Langone Health
-
New York, New York, Estados Unidos, 10016
- NYU Langone Inflammatory Bowel Disease Center
-
New York, New York, Estados Unidos, 10016
- NYU Langone Eye Center (Ophthalmology)
-
New York, New York, Estados Unidos, 10016
- NYU Langone Health - Ambulatory Care Center
-
New York, New York, Estados Unidos, 10016
- NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center
-
New York, New York, Estados Unidos, 10016
- NYU Pulmonary and Critical Care Associates (Pulmonary)
-
-
North Carolina
-
Charlotte, North Carolina, Estados Unidos, 28215
- Carolinas Research Center
-
Charlotte, North Carolina, Estados Unidos, 28204
- Queen City Gastroenterology and Hepatology (Endoscopy)
-
Charlotte, North Carolina, Estados Unidos, 28211
- Greenman Eye Associates (OCT)
-
Charlotte, North Carolina, Estados Unidos, 28273
- Cornerstone Medical (Imaging & PFT)
-
-
Ohio
-
Chardon, Ohio, Estados Unidos, 44024
- Geauga Sleep Center(PFT only)
-
Cincinnati, Ohio, Estados Unidos, 45219
- UC Health Physicians Office
-
Cincinnati, Ohio, Estados Unidos, 45229
- UC Health (Pulmonary Function Testing)
-
Cincinnati, Ohio, Estados Unidos, 45219
- UC Health Hoxworth (OCT only)
-
Cincinnati, Ohio, Estados Unidos, 45219
- University of Cincinnati Medical Center (PFT and Endoscopy location)
-
Mentor, Ohio, Estados Unidos, 44060
- Great Lakes Gastroenterology Research, LLC
-
Mentor, Ohio, Estados Unidos, 44060
- The Endoscopy Center of Lake County
-
Mentor, Ohio, Estados Unidos, 44060
- Ophthalmic Physicians Incorporated (OCT Only)
-
Mentor, Ohio, Estados Unidos, 44060
- Vitreo Retinal Consultants(OCT only)
-
Willoughby, Ohio, Estados Unidos, 44094
- Lake Pulmonary Associates (PFT only)
-
Willoughby Hills, Ohio, Estados Unidos, 44094
- Retina Specialists of Ohio(OCT only)
-
-
Oklahoma
-
Norman, Oklahoma, Estados Unidos, 73071
- Norman Endoscopy Center
-
Norman, Oklahoma, Estados Unidos, 73071
- Physicians and Surgeons X-Ray
-
Oklahoma City, Oklahoma, Estados Unidos, 73118
- Central Sooner Research
-
Oklahoma City, Oklahoma, Estados Unidos, 73102
- Hightower Clinical
-
Oklahoma City, Oklahoma, Estados Unidos, 73102
- Saint Anthony Endoscopy Center
-
Oklahoma City, Oklahoma, Estados Unidos, 73102
- SSM Health, Saint Anthony Hospital
-
Oklahoma City, Oklahoma, Estados Unidos, 73120
- Johnston Opthalmology
-
-
Pennsylvania
-
Hershey, Pennsylvania, Estados Unidos, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Texas
-
Austin, Texas, Estados Unidos, 78705
- Central Texas Clinical Research
-
Cypress, Texas, Estados Unidos, 77429
- Houston Pulmonary Sleep and Allergy Associates (PFT)
-
Houston, Texas, Estados Unidos, 77030
- The University of Texas Health Science Center at Houston
-
Houston, Texas, Estados Unidos, 77030
- Baylor St. Luke's Medical Center
-
Houston, Texas, Estados Unidos, 77047
- Pearland Surgery Center
-
Houston, Texas, Estados Unidos, 77030
- Alkek Eye Center Jamail Specialty Care Center (OCT)
-
Houston, Texas, Estados Unidos, 77024
- Houston Eye Associates (For Eye Examination)
-
Houston, Texas, Estados Unidos, 77030
- Baylor College of Medicine - Baylor St. Luke's Medical Center
-
Houston, Texas, Estados Unidos, 77030
- Baylor St. Luke's Medical Center - McNair Campus (pharmacy)
-
Houston, Texas, Estados Unidos, 77030
- Baylor St. Luke's Medical Center - McNair Campus
-
Houston, Texas, Estados Unidos, 77030
- Baylor St. Luke's Medical Center Endoscopy - McNair Campus
-
Houston, Texas, Estados Unidos, 77030
- Mann Eye Institute
-
Houston, Texas, Estados Unidos, 77030
- Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)
-
Houston, Texas, Estados Unidos, 77034
- Bay Area Endoscopy Center, LLC
-
Houston, Texas, Estados Unidos, 77055
- Memorial Endoscopy Center (For Colonoscopy)
-
Houston, Texas, Estados Unidos, 77065
- Eye Specialists of Texas
-
Houston, Texas, Estados Unidos, 77065
- Northside Gastroenterology Associates PA
-
Houston, Texas, Estados Unidos, 77079
- Memorial Pulmonology(For PFT)
-
Houston, Texas, Estados Unidos, 77204
- Digestive Health Associates
-
Houston, Texas, Estados Unidos, 77204
- Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)
-
Pearland, Texas, Estados Unidos, 77584
- LinQ Research, LLC
-
Tyler, Texas, Estados Unidos, 75701
- Tyler Research Institute, LLC
-
Tyler, Texas, Estados Unidos, 75701
- UT Health East Texas Physicians (pulmonary functions only)
-
Tyler, Texas, Estados Unidos, 75701
- Christus Trinity Mother Frances Endoscopy Center (endoscopies only)
-
Tyler, Texas, Estados Unidos, 75701
- Heaton Eye Associates (OCT only)
-
Victoria, Texas, Estados Unidos, 77904
- Victoria Gastroenterology
-
Victoria, Texas, Estados Unidos, 77904
- Citizens Healthplex (for PFT only)
-
Victoria, Texas, Estados Unidos, 77904
- Surgery Center (For endoscopy only)
-
Victoria, Texas, Estados Unidos, 77904
- Victoria Eye Center (For OCT only)
-
Webster, Texas, Estados Unidos, 77598
- GI Alliance Webster
-
-
Virginia
-
Forest, Virginia, Estados Unidos, 24551
- Harman Eye Center (OCT only)
-
Lynchburg, Virginia, Estados Unidos, 24502
- Blue Ridge Medical Research
-
Lynchburg, Virginia, Estados Unidos, 24501
- Lynchburg Pulmonary Associates, Inc. (PFT only)
-
-
Washington
-
Issaquah, Washington, Estados Unidos, 98029
- Swedish Endoscopy Center - Issaquah
-
Seattle, Washington, Estados Unidos, 98122
- Swedish Medical Center
-
Seattle, Washington, Estados Unidos, 98104
- Swedish Gastroenterology
-
Seattle, Washington, Estados Unidos, 98104
- Pacific Northwest Retina
-
Seattle, Washington, Estados Unidos, 98104
- Richard Bensinger, MD
-
Seattle, Washington, Estados Unidos, 98122
- First Hill Endoscopy Center
-
Seattle, Washington, Estados Unidos, 98122
- Pulmonary Function Lab
-
-
Wisconsin
-
Milwaukee, Wisconsin, Estados Unidos, 53226
- Froedtert Memorial Lutheran Hospital
-
-
-
-
-
Amiens, Francia, 80054
- CHU Amiens Picardie
-
Clermont-Ferrand, Francia, 63000
- Chu Gabriel Montpied
-
Clermont-Ferrand, Francia, 63000
- CHU De Clermont Ferrand - Hopital Estaing
-
Grenoble, Francia, 38043
- CHU Grenoble Alpes - Hopital Michallon
-
Grenoble, Francia, 38043
- Endoscopy: CHU Grenoble Alpes- Hopital Michallon
-
La Roche-sur-Yon, Francia, 85925
- CHD Vendee, Unite de Recherche Clinique
-
Lille, Francia, 59037
- CHU de Lille - Hôpital Claude Huriez
-
Lille, Francia, 59037
- Optical Coherence Tomography and Ophthalmology CHU de Lille Hopital Roger Salengro
-
Lille, Francia, 59037
- Pulmonary Function Test CHU Lille, Institut Coeur Poumon
-
Montpellier, Francia, 34295
- CHU Saint-Eloi
-
Montpellier, Francia, 34295
- Hopital Saint-Eloi - Pole Digestif - Hgea Recherche Clinique - Rdc
-
Nice, Francia, 06202
- CHU de Nice, Hopital 1'Archet 2
-
Reims, Francia, 51100
- Hopital Maison Blanche, CHU DE REIMS
-
Reims, Francia, 51092
- Hopital Robert Debre
-
Reims, Francia, 51100
- Hopital Robert Debre CHU DE REIMS
-
Saint-Etienne, Francia, 42055
- CHU Saint Etienne - Hôpital Nord
-
Saint-Priest-en-Jarez, Francia, 42270
- Optical Coherence Tomography and Ophthalmology
-
Saint-Priest-en-Jarez, Francia, 42270
- Pulmonary Function Test
-
Toulouse, Francia, 31059
- Hopital Rangueil
-
Toulouse, Francia, 31300
- Hopital Purpan PPR pole cephalique
-
Vandœuvre-lès-Nancy, Francia, 54511
- CHRU Nancy Brabois
-
-
-
-
-
Tbilisi, Georgia, 0160
- LTD Aversi Clinic
-
Tbilisi, Georgia, 0159
- LTD Institute of Clinical Cardiology
-
Tbilisi, Georgia, 0160
- JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
-
Tbilisi, Georgia, 0160
- LTD Academician Nikoloz Kipshidze Central University Clinic
-
Tbilisi, Georgia, 0172
- Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD
-
Tbilisi, Georgia, 0179
- LTD Medical Center "CITO"
-
-
-
-
-
Alexandroupoli, Grecia, 681 00
- University General Hospital of Alexandroupoli
-
Athens, Grecia, 10676
- General Hospital of Athens "Evangelismos"
-
-
Crete
-
Heraklion, Crete, Grecia, 71500
- Univerisity General Hospital of Heraklion
-
-
-
-
-
Budapest, Hungría, 1136
- Pannonia Maganorvosi Centrum
-
Budapest, Hungría, 1033
- Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. (abbreviated name: Clinexpert Kft.)
-
Budapest, Hungría, 1062
- Ophthalmology procedures: Magyar Honvedseg Egeszsegugyi Kozpont
-
Budapest, Hungría, 1062
- Pulmonary procedures: Vasutegeszsegugyi Nonprofit Kozhasznu K ft.
-
Budapest, Hungría, 1134
- Ophthalmology, OCT: Medicover Zrt.
-
Budapest, Hungría, 1139
- Chest X-ray: XIII. keruleti Egeszsegugyi Szolgalat Kozhasznu Nonprofit Kft.
-
Békéscsaba, Hungría, 5600
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
-
-
Heves County
-
Gyöngyös, Heves County, Hungría, 3200
- Bugat Pal Korhaz, Gasztroenterologia
-
-
Komárom-Esztergom
-
Tatabánya, Komárom-Esztergom, Hungría, 2800
- Szent Borbala Korhaz
-
Tatabánya, Komárom-Esztergom, Hungría, 2800
- DLCO and ophthalmology tests: Szent Borbala Korhaz
-
-
-
-
-
Kochi, India, 682027
- Aster Medcity, Aster DM Healthcare Ltd.
-
-
Gujarat
-
Surat, Gujarat, India, 395002
- Surat Institute of Digestive Sciences
-
-
Haryana
-
Gurugram, Haryana, India, 122002
- Fortis Memorial Research Institute
-
-
Maharashtra
-
Nagpur, Maharashtra, India, 440010
- Midas Multispeciality Hospital Pvt. Ltd
-
-
Rajasthan
-
Jaipur, Rajasthan, India, 302001
- S. R. Kalla Memorial Gastro & General Hospital
-
-
-
-
-
Afula, Israel, 1834111
- Haemek Medical Center
-
Jerusalem, Israel, 9103102
- Shaare Zedek Medical Center
-
Ramat Gan, Israel, 5262000
- Chaim Sheba Medical Center
-
Tel Aviv, Israel, 6423906
- Tel Aviv Sourasky Medical Center
-
-
-
-
-
Catania, Italia, 829-95126
- Azienda Ospedaliera Ospedale Cannizzaro
-
Catanzaro, Italia, 88100
- A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente Campus Universitario "Salvatore Venuta"
-
Catanzaro, Italia, 88100
- A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente
-
Catanzaro, Italia, 88100
- CAMPUS GERMANETO Magazzino farmaci e dispositivi medici, uffici
-
Pavia, Italia, 27100
- Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
-
Rome, Italia, 00189
- PFT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Pneumologia
-
Verona, Italia, 37024
- IRCCS Ospedale Sacro Cuore Don Calabria
-
Verona, Italia, 37134
- OCT/PFT/Endoscopy address: CRC - Cenro Ricerche Cliniche di Verona
-
-
Foggia
-
San Giovanni Rotondo, Foggia, Italia, 71013
- IRCCS Ospedale Casa Sollievo della Sofferenza
-
San Giovanni Rotondo, Foggia, Italia, 71013
- OCT/ PFT/ Endoscopy address: IRCCS Ospedale Casa Sollievo della Sofferenza
-
-
MI
-
Milan, MI, Italia, 20132
- Ospedale San Raffaele
-
-
Milan
-
Garbagnate Milanese, Milan, Italia, 20024
- ASST Rhodense - Pneumology Unit
-
Milan, Milan, Italia, 20017 Rho
- ASST Rhodense, U.O.C. Gastroenterologia ed Endoscopia Digestiva
-
Rho, Milan, Italia, 20017
- ASST Rhodense - Ophthalmology Unit
-
-
Milano
-
Rozzano, Milano, Italia, 20089
- Irccs Humanitas Research Hospital
-
-
Verona
-
Negrar, Verona, Italia, 37024
- OCT/ PFT/ Endoscopy address: IRCCS Ospedale Sacro Cuore Don Calabria
-
-
-
-
Chiba
-
Kashiwa-shi, Chiba, Japón, 277-0871
- Kokikai Tsujinaka Hospital Kashiwanoha
-
Nagareyama-shi, Chiba, Japón, 270-0116
- Ishii Eye Clinic
-
-
Fukuoka
-
Kitakyushu-shi, Fukuoka, Japón, 807-8555
- Hospital of the University of Occupational and Environmental Health
-
Kitakyusyu-shi, Fukuoka, Japón, 802-8561
- Kitakyushu Municipal Medical Center
-
-
Ibaraki
-
Toride-shi, Ibaraki, Japón, 302-0014
- Matsumoto Eye Clinic
-
-
Kagoshima-ken
-
Kagoshima, Kagoshima-ken, Japón, 892-0846
- Sameshima Hospital
-
Kagoshima, Kagoshima-ken, Japón, 892-0824
- Jiaikai Idzuro Imamura Hospital
-
Kagoshima, Kagoshima-ken, Japón, 890-0062
- Kagoshima Kouseiren Hospital
-
Kagoshima, Kagoshima-ken, Japón, 892-0825
- Sameshima Eye Clinic
-
-
Kumamoto
-
Kumamoto, Kumamoto, Japón, 861-8520
- Japanese Red Cross Kumamoto Hospital
-
-
Saga-ken
-
Saga, Saga-ken, Japón, 849-8501
- Saga University Hospital
-
-
Tokyo
-
Shinjuku-ku, Tokyo, Japón, 169-0073
- Japan Community Health Care Organization Tokyo Yamate Medical Center
-
-
-
-
-
Vilnius, Lituania, LT-08661
- Vilnius University Hospital Santaros Klinikos
-
-
-
-
-
Beirut, Líbano, 166830
- Hotel Dieu de France Hospital
-
Beirut, Líbano, 1100 2807
- Saint George University Hospital Medical Center
-
Beirut, Líbano, 113-6044
- Rafik Hariri University Hospital
-
Saida, Líbano
- Hammoud Hospital University Medical Center
-
Tripoli, Líbano
- Nini Hospital s.a:l
-
-
-
-
-
Kuala Lumpur, Malasia, 59100
- University Malaya Medical Centre
-
-
-
-
-
Chisinau, Moldava, 2005
- "Sf. Arhanghel Mihail" Municipal Clinical Hospital, Department of Gastroenterology
-
Chisinau, Moldava, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery
-
Chisinau, Moldava, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Gastroenterology
-
Chisinau, Moldava, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department
-
-
-
-
-
Chihuahua City, México, 31203
- Scientia Investigacion Clinica S.C.
-
Chihuahua City, México, 31020
- Sanatorio Palmore A.C.
-
Chihuahua City, México, 31203
- Vista Lasser de Chihuahua S.C.
-
Chihuahua City, México, 31283
- Servicios Hospitalarios de México, S.A. de C.V.
-
Veracruz, México, 91900
- FAICIC S. de R.L. de C.V.
-
Veracruz, México, 91910
- Gabinete de Diagnostico COVADONGA
-
Veracruz, México, 91918
- Alberto Collado Solorzano (Clinica Vision)
-
-
Jalisco
-
Guadalajara, Jalisco, México, 44130
- Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.
-
Guadalajara, Jalisco, México, 44600
- Global Glaucoma Institute
-
Guadalajara, Jalisco, México, 44600
- Video Endoscopia Americas
-
Guadalajara, Jalisco, México, 44670
- Comercializadora Winco S.A. de C.V.
-
-
Veracruz
-
Boca del Rio, Veracruz, México, 94299
- Cirugia y Gastro de Veracruz S.A. de C.V. (Progastro)
-
-
-
-
-
Amsterdam, Países Bajos, 1105 AZ
- Academic Medical Centre
-
Utrecht, Países Bajos, 3584 CX
- UMC Utrecht
-
-
-
-
-
Bystra, Polonia, 43-360
- Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
-
Karkow, Polonia, 31-156
- Specjalistyczne Gabinety Lekarskie LANDA
-
Krakow, Polonia, 30-033
- Centre De La Vision Centrum Okulistyczne(OCT, Ophthalmoscopy)
-
Krakow, Polonia, 30-307
- Medicina (Endoscopy)
-
Krakow, Polonia, 31-153
- Centrum Medyczne EVITA(Endoscopy)
-
Lodz, Polonia, 90-752
- IP Clinic Sp. z o.o.
-
Lodz, Polonia, 90-338
- Centrum Medyczne "Ksiezy Mlyn" (OCT, Ophtalmoscopy)
-
Lodz, Polonia, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatolog i im. M. Kopernika w Lodzi
-
Lodz, Polonia, 90-338
- (Centrum Medyczne Ksiezy Mlyn (OCT and Ophthalmoscopy)
-
Lodz, Polonia, 90-644
- AMICARE Sp. z o.o. sp.k
-
Lodz, Polonia, 91-053
- Centra Medyczne Medyceusz (DLCO)
-
Lodz, Polonia, 92-551
- Salve Health Care Sp. o.o., (PFT and Endoscopy)
-
Nowy Targ, Polonia, 34-400
- Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
-
Oświęcim, Polonia, 32-600
- Medicome Sp. Z O.O
-
Piotrkow Trybunalski, Polonia, 97-300
- Przychodnia Okulistyczna "Oculus" Barbara Cybulska (OCT, Ophtalmoscopy)
-
Piotrkow Trybunalski, Polonia, 97-300
- Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika (Endoscopy)
-
Piotrokow Trybunalski, Polonia, 97-300
- Trialmed CRS
-
Poznan, Polonia, 60-529
- Solurmed Centrum Medyczne
-
Poznan, Polonia, 60-538
- OCU Service Mikolaj Meller Sp.j.(OCT, Ophtalmoscopy)
-
Rzeszów, Polonia, 35-326
- Centrum Medyczne Medyk
-
Rzeszów, Polonia, 35-055
- Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie (Ophthalmpscopy)
-
Rzeszów, Polonia, 35-241
- Podkarpackie Centrum Chorob Plue w Rzeszowie (DLCO)
-
Strzegom, Polonia, 58-150
- Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)
-
Swidnica, Polonia, 58-100
- DC-MED
-
Swidnica, Polonia, 58-100
- Centrum Medyczne EZ-MEDICA (OCT, Ophtalmoscopy)
-
Swidnica, Polonia, 58-100
- Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)
-
Warsaw, Polonia, 00-635
- Centrum Zdrowia MDM
-
Warsaw, Polonia, 00-631
- Centrum Zdrowia MDM (OCT,opthalmoscopy)
-
Warsaw, Polonia, 01-138
- Instytut Gruzlicy i Chorob Pluc(DLCO)
-
Warsaw, Polonia, 02-653
- Endoterapia PFG (Endoscopy)
-
Warsaw, Polonia, 02-653
- Instytut Oka (OCT, Ophtalmoscopy)
-
Warsaw, Polonia, 03-712
- Specjalistyczne Gabinety Lekarskie Body Clinic
-
Warsaw, Polonia, 03-731
- Centrum Okulistyczne JASKRA (OCT, Ophthalmoscopy)
-
Warsaw, Polonia, 04-141
- Wojskowy lnstytut Medyczny (PFT)
-
Wroclaw, Polonia, 60-681
- EuroMediCare Szpital Specjalistyczny z Przychodniit (Endoscopy)
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polonia, 60-681
- NSZOZ Termedica
-
-
-
-
-
Liverpool, Reino Unido, L7 8XP
- Royal Liverpool University Hospital
-
London, Reino Unido, SE1 9RT
- Guys & St Thomas Hospital
-
Norwich, Reino Unido, NR4 7UQ
- Quadram Institute Clinical Research Facility
-
-
-
-
-
Bucharest, Rumania, 012015
- SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
-
Bucharest, Rumania, 022328
- Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
-
-
JUD. CLUJ
-
Cluj-Napoca, JUD. CLUJ, Rumania, 400006
- Spitalul Clinic Judetean de Urgenta Cluj Napoca
-
-
Jud.constanta
-
Constanța, Jud.constanta, Rumania, 900591
- Centrul de Diagnostic si Tratament Affidea, Specialitatea Medicina Interna
-
-
-
-
-
Kemerovo, Rusia, 650066
- SAIH "Kemerovo Regional Clinical Hospital"
-
Novosibirsk, Rusia, 630005
- LLC "SibNovoMed"
-
Novosibirsk, Rusia, 630007
- Gastrocenter
-
Novosibirsk, Rusia, 630007
- LLC "Novosibirskiy Gastrocentr''
-
Novosibirsk, Rusia, 630084
- Hospital #12
-
Novosibirsk, Rusia, 630091
- LLC "Siberian Center for Prevention and Treatment of Myopia Eye"
-
Novosibirsk, Rusia, 630099
- Joint Stock Company Medical Center "AVICENNA"
-
Omsk, Rusia, 644013
- BHI of Omsk region "Clinical Oncology Dispensary"
-
Omsk, Rusia, 644024
- Clinicodiagnostic Center "Ultramed"
-
Omsk, Rusia, 644070
- Medical center "Intervzglyad"
-
Saint Petersburg, Rusia, 191015
- FSBI of Higher Education " North-Western Medical University n.a.I.I. Mechnikov '' of MoH RF
-
Saint Petersburg, Rusia, 195067
- FSBI of Higher Education "North-Western Medical University n.a.I.I. Mechnikov'' of MoH RF
-
Stavropol, Rusia, 355017
- Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical
-
-
Stavropol Kray
-
Pyatigorsk, Stavropol Kray, Rusia, 357502
- LLC "Polyclinic of ultrasonography 4D"
-
-
-
-
-
Belgrade, Serbia, 11000
- Clinical Center Zvezdara
-
-
-
-
Free State
-
Bloemfontein, Free State, Sudáfrica, 9301
- Dr W Simmonds (Gastroenterology Department)
-
-
Gauteng
-
Benoni, Gauteng, Sudáfrica, 1501
- Worthwhile Clinical Trials
-
Benoni, Gauteng, Sudáfrica, 1500
- Dr K Rahman (OTC and Opthalmoscopy)
-
Benoni, Gauteng, Sudáfrica, 1500
- Lakeview Hospital radiology (Radiology)
-
Benoni, Gauteng, Sudáfrica, 1500
- Worthwhile Clinical trials (PFT)
-
Centurion, Gauteng, Sudáfrica, 0157
- Dr E Meyer & Partners, Centurion Eye Hospital (OTC and Opthalmoscopy)
-
Centurion, Gauteng, Sudáfrica, 0157
- Dr Jorg Reichenberger (Endoscopy)
-
Centurion, Gauteng, Sudáfrica, 0157
- Drs Burger Radiologists Inc (X-ray/CT)
-
Centurion, Gauteng, Sudáfrica, 0157
- Johese Clinical Research, Unitas Hospital
-
Johannesburg, Gauteng, Sudáfrica, 2193
- Wits Clinical Research
-
Kempton Park, Gauteng, Sudáfrica, 1619
- Clinresco Centres (Pty) Ltd
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Kempton Park, Gauteng, Sudáfrica, 1619
- Burger Radiology (Radiology)
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Kempton Park, Gauteng, Sudáfrica, 1619
- Dr KJP Lubuya (OCT and Opthalmology)
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Kempton Park, Gauteng, Sudáfrica, 1619
- Prof O Mwantembe (Endoscopy)
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Pretoria, Gauteng, Sudáfrica, 0002
- Emmed Research
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Springs, Gauteng, Sudáfrica, 1559
- Dr K Rahman(OTC and Opthalmoscopy)
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Sunninghill, Gauteng, Sudáfrica, 2196
- Dr I Moola (Endoscopy)
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Western Cape
-
Cape Town, Western Cape, Sudáfrica, 7405
- Dr Peter Chapman (PFT + DLCO)
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Cape Town, Western Cape, Sudáfrica, 7441
- Dr Chris Stander (OCT)
-
Cape Town, Western Cape, Sudáfrica, 7441
- Morton & Partners Radiologists (Radiology)
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Cape Town, Western Cape, Sudáfrica, 7441
- Spoke Research Inc. Room 109
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-
-
-
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Bern, Suiza, 3010
- Inselspital Bern
-
Bern, Suiza, 3012
- OCT/Ophtalmoscopy: Berner Augenklinik am Lindenhofspital
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-
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-
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Ankara, Turquía (Türkiye), 06500
- Gazi University Medical Faculty
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Ankara, Turquía (Türkiye), 06100
- Hacettepe University Medical Faculty
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Ankara, Turquía (Türkiye), 06800
- T.C. Saglik Bakanligi Ankara Sehir Hastanesi
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Antalya, Turquía (Türkiye), 07100
- Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
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Izmir, Turquía (Türkiye), 35100
- Ege Universitesi Tip Fakultesi Hastanesi
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Kocaeli, Turquía (Türkiye), 41380
- Kocaeli University Research and Training Hospital
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Yenişehir, Turquía (Türkiye), 33343
- Mersin University Faculty of Medicine
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-
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Kharkiv, Ucrania, 61124
- Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
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Kharkiv, Ucrania, 61024
- LLC "EyeQClinic"
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Kharkiv, Ucrania, 61022
- Llc "Ldts Skaymed'
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Kharkiv, Ucrania, 61037
- Communal Non-commercial Enterprise Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv
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Kharkiv, Ucrania, 61045
- Llc "Medical Center Oftalmika"
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Kharkiv, Ucrania, 61103
- Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care
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Kyiv, Ucrania, 01135
- Medical Center of Limited Liability Company Harmoniia Krasy
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Kyiv, Ucrania, 02091
- Med Center 'Ok!Clinic+' of Comp with limited liability "Int Inst of Clin Research", Unit of Gastro
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Kyiv, Ucrania, 04210
- Private Enterprise "Clinic Medicom"
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Lutsk, Ucrania, 43005
- CE Volyn Reg Clinical Hospital ofVolyn Reg Council, Surgical (Endocrine and Abdominal Pathology)
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Vinnytsia, Ucrania, 21000
- Private Enterprise Diagnostic Center "Mediscan"
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Vinnytsia, Ucrania, 21009
- Medical Center of LLC Health Clinic, Medical Clinical Research Center, Unit of Gastroenterology,
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Vinnytsia, Ucrania, 21018
- CNE of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Reg
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Vinnytsia, Ucrania, 21029
- Scientific and Research Institute of Invalid Rehabilitation (Educational, Scientific and Treatment
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Descripción
Criterios de elegibilidad aplicables a todos los subestudios:
Criterios de inclusión:
- Hombres o mujeres de 18 a 80 años de edad,
- Capacidad para proporcionar consentimiento o asentimiento informado por escrito y para cumplir con el cronograma de evaluaciones del protocolo
- Diagnosticado con enfermedad de Crohn (EC) ≥ 3 meses
- Tener CD activo de moderado a severo en la selección
Respuesta inadecuada demostrada (es decir, falta de respuesta primaria), pérdida de respuesta o intolerancia a ≥ 1 de las siguientes terapias para el tratamiento de la EC:
- Corticosteroides orales (p. ej., prednisona o su equivalente, budesonida)
- Inmunosupresores (p. ej., azatioprina [AZA], 6 mercaptopurina [6-MP] o metotrexato [MTX])
- Antagonistas del factor de necrosis tumoral alfa (TNFα) (p. ej., infliximab, adalimumab, certolizumab pegol o biosimilares)
- Antagonista del receptor de integrina (p. ej., vedolizumab)
- Antagonista de la interleucina -12/-23 (p. ej., ustekinumab)
- Las mujeres en edad fértil no deben estar embarazadas
- Las mujeres en edad fértil y los hombres deben usar métodos anticonceptivos
Criterio de exclusión:
- Antecedentes de respuesta inadecuada (es decir, falta de respuesta primaria) a agentes de ≥ 2 clases de productos biológicos comercializados para el tratamiento de la EC (es decir, antagonistas de TNFα, antagonista de interleucina 12/23 y antagonista del receptor de integrina).
- Tiene colitis ulcerosa, colitis indeterminada, colitis microscópica, colitis isquémica, colitis por radiación, colitis asociada a enfermedad diverticular, megacolon tóxico o colitis infecciosa activa o prueba positiva para la toxina Clostridioides difficile en la selección.
- Tiene síndrome de intestino corto posoperatorio o funcional o cualquier complicación asociada que pueda requerir cirugía o interferir con las evaluaciones de eficacia.
- Tuvo tratamiento quirúrgico para abscesos intraabdominales ≤ 8 semanas antes de la aleatorización o tratamiento quirúrgico para abscesos perianales ≤ 4 semanas antes de la aleatorización.
- Tuvo resección intestinal ≤ 24 semanas antes de la aleatorización u otras cirugías intraabdominales ≤ 12 semanas antes de la aleatorización.
- Tener una ileostomía o una colostomía.
Criterios de inclusión para el subestudio 3:
- Los participantes que ingresaron al Período de inducción extendido del Subestudio 1 y el Subestudio 2 deben haber completado la Visita de inducción extendida - Semana 6
Criterios de inclusión para el subestudio 4:
- El participante debe haber completado la visita de la semana 52 del subestudio 3 o la visita de la semana 66 del subestudio A
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Doble
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador de placebos: Placebo
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Comprimido de placebo equivalente de Etrasimod tomado por vía oral, una vez al día.
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Experimental: Etrasimod Dosis A
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Dosis A tomada por vía oral, una vez al día.
Otros nombres:
Dosis B tomada por vía oral, una vez al día.
Otros nombres:
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Experimental: Etrasimod Dosis B
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Dosis A tomada por vía oral, una vez al día.
Otros nombres:
Dosis B tomada por vía oral, una vez al día.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
Periodo de tiempo: Week 14 of SSA
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Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from 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.
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Week 14 of SSA
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Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1
Periodo de tiempo: 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.
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Week 14 of SS1
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Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort
Periodo de tiempo: 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.
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Week 52 of study
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Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Week 52 of study
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
|
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Steady State Trough Concentration (Ctrough,ss) of Etrasimod From Week 2 to Week 14: SSA
Periodo de tiempo: 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
|
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Change From Baseline in Absolute Lymphocyte Count (ALC) at Week 14 in Induction Period: SSA
Periodo de tiempo: 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
Periodo de tiempo: 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
|
|
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Change From Baseline in ALC at Week 66 in Extension Period: SSA
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Week 52 of study
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|
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Responder Cohort
Periodo de tiempo: 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.
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Week 52 of study
|
|
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Non-Responder Cohort
Periodo de tiempo: 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.
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Week 52 of study
|
|
Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Week 52 of study
|
|
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Responder Cohort
Periodo de tiempo: 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.
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Week 52 of study
|
|
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Non-Responder Cohort
Periodo de tiempo: 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.
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Week 52 of study
|
|
Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Periodo de tiempo: 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.
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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
Periodo de tiempo: 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.
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Baseline, study Weeks 20, 28, 36, 44, 52
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|
Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Responder Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Week 52 of study
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Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Responder Cohort
Periodo de tiempo: 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.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Non-Responder Cohort
Periodo de tiempo: Baseline, study Weeks 28 and 52
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The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms.
Each module ranged from 0 to 16, where higher scores indicated more severe disease.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 28 and 52: SS3 Responder Cohort
Periodo de tiempo: Baseline, study Weeks 28 and 52
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The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD.
Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life.
The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in IBDQ at Weeks 28 and 52: SS3 Non-Responder Cohort
Periodo de tiempo: Baseline, study Weeks 28 and 52
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The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD.
Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life.
The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Weeks 28 and 52: SS3 Responder Cohort
Periodo de tiempo: Baseline, study Weeks 28 and 52
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The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality.
The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS).
MCS consisted of social functioning, vitality, mental health, and role-emotional scales.
PCS consisted of physical functioning, bodily pain, role-physical, and general health scales.
Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in SF-36 at Weeks 28 and 52: SS3 Non-Responder Cohort
Periodo de tiempo: 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.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 28 and 52: SS3 Responder Cohort
Periodo de tiempo: Baseline, study Weeks 28 and 52
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The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue.
Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much).
Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
|
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Change From Baseline in FACIT-F at Weeks 28 and 52: SS3 Non-Responder Cohort
Periodo de tiempo: 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.
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Baseline, study Weeks 28 and 52
|
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Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at SS3 Baseline: SS3 Responder Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Week 52 of study
|
|
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Periodo de tiempo: Baseline, study Weeks 20, 28, 36, 44 and 52
|
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44 and 52
|
|
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
Periodo de tiempo: Baseline, study Weeks 20, 28, 36, 44 and 52
|
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44 and 52
|
|
Time to Remission by PRO2 and FCP Concentrations: SS3 Responder Cohort
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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.
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Week 52 of study
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Number of Participants According to Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters: SS4
Periodo de tiempo: Baseline, Weeks 52, and 104 of SS4
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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.
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Baseline, Weeks 52, and 104 of SS4
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Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs by Severity and Treatment Related TEAEs: SS3
Periodo de tiempo: 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)
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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.
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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)
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Number of Participants With TEAEs of Special Interest: SS3
Periodo de tiempo: 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)
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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.
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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)
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Number of Participants With Clinically Meaningful Changes in Laboratory Parameters: SS3
Periodo de tiempo: 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)
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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.
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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)
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Number of Participants With TEAEs, SAEs, TEAEs by Severity and Treatment Related TEAEs: SS4
Periodo de tiempo: 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)
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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
Periodo de tiempo: 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)
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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
Periodo de tiempo: 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.
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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)
|
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Number of Participants According to Markedly Abnormal Criteria for Vital Signs: SS4
Periodo de tiempo: Baseline, Weeks 1, 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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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.
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Baseline, Weeks 1, 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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Percentage of Participants With Clinical Remission by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
Periodo de tiempo: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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Clinical remission was considered as CDAI score <150.
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
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Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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Percentage of Participants With Clinical Response by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
Periodo de tiempo: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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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.
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Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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Percentage of Participants With Clinical Remission by PRO2 at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
Periodo de tiempo: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
|
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
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Colaboradores e Investigadores
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- Director de estudio: Pfizer CT.gov Call Center, Pfizer
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Otros números de identificación del estudio
- APD334-202
- C5041006 (Otro identificador: Alias Study Number)
- 2024-513569-38-00 (Identificador de registro: CTIS (EU))
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Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
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