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Исследование по оценке эффективности и безопасности перорального этразимода при лечении взрослых участников с болезнью Крона от умеренной до тяжелой степени активности (CULTIVATE)

5 июня 2026 г. обновлено: Pfizer

Многоцентровое, рандомизированное, двойное слепое, параллельное групповое исследование для оценки эффективности и безопасности перорального приема этразимода в качестве индукционной и поддерживающей терапии при болезни Крона от умеренной до тяжелой степени активности

Это исследование фазы 2/3, которое включает 5 субисследований, предназначенных для оценки эффективности, безопасности и переносимости перорального этразимода в качестве терапии у взрослых участников с активной болезнью Крона (БК) от умеренной до тяжелой степени, которые рефрактерны или не переносят по крайней мере 1 из современные методы лечения целиакии (например, кортикостероиды, иммунодепрессанты или биологические препараты). Общая продолжительность этого исследования составляет до 282 недель, включая 28-дневный скрининговый период, период лечения до 274 недель (индукционный, продленный или поддерживающий и долгосрочный продленный периоды) и 4-недельный последующий период. Up Период для оценки безопасности.

Обзор исследования

Подробное описание

Это исследование включает 5 субисследований:

Подисследование A - Фаза 2: Фаза 2, рандомизированное, двойное слепое, подисследование для оценки безопасности, переносимости и эффективности пероральной терапии этрасимодом у участников с БК средней и тяжелой степени, которое поддерживает выбор индукционной и поддерживающей дозы (доз) для фазы 3. Подисследование A в настоящее время закрыто для регистрации.

Подисследование 1 - Фаза 2: Фаза 2b рандомизированное, двойное слепое, плацебо-контролируемое, индукционное подисследование с диапазоном доз для оценки этрасимода в качестве индукционной терапии и выбора индукционной и поддерживающей дозы (доз) для продолжения оценки в фазе 3. Подисследование 1 в настоящее время идет набор участников.

Подисследование 2 - Индукция: Фаза 3 рандомизированного, двойного слепого, плацебо-контролируемого подисследования для оценки этразимода в качестве индукционной терапии.

Подисследование 3 — Поддерживающая терапия: Рандомизированное двойное слепое плацебо-контролируемое подисследование фазы 3 для оценки этразимода в качестве поддерживающей терапии. Участники Подисследования 1 и Подисследования 2 будут зачислены в Подисследование 3.

Подисследование 4 — Долгосрочное продление: долгосрочное дополнительное подисследование для участников, прошедших курс лечения не менее 52 недель. Планируется, что участники из Подисследования 3 и Подисследования А будут зачислены в Подисследование 4.

Тип исследования

Интервенционный

Регистрация (Действительный)

379

Фаза

  • Фаза 2
  • Фаза 3

Контакты и местонахождение

В этом разделе приведены контактные данные лиц, проводящих исследование, и информация о том, где проводится это исследование.

Места учебы

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

Критерии участия

Исследователи ищут людей, которые соответствуют определенному описанию, называемому критериям приемлемости. Некоторыми примерами этих критериев являются общее состояние здоровья человека или предшествующее лечение.

Критерии приемлемости

Возраст, подходящий для обучения

От 18 лет до 80 лет (Взрослый, Пожилой взрослый)

Принимает здоровых добровольцев

Нет

Описание

Критерии приемлемости, применимые ко всем субисследованиям:

Критерии включения:

  • Мужчины или женщины от 18 до 80 лет,
  • Способность предоставить письменное информированное согласие или согласие и соблюдать график оценки протокола
  • Диагноз болезни Крона (БК) ≥ 3 месяцев
  • Иметь умеренно или сильно активный CD на скрининге
  • Продемонстрированный неадекватный ответ (т.е. первичное отсутствие ответа), потеря ответа или непереносимость ≥ 1 из следующих методов лечения БК:

    1. Пероральные кортикостероиды (например, преднизолон или его эквивалент, будесонид)
    2. Иммунодепрессанты (например, азатиоприн [AZA], 6-меркаптопурин [6-MP] или метотрексат [MTX])
    3. Антагонисты фактора некроза опухоли альфа (TNFα) (например, инфликсимаб, адалимумаб, цертолизумаб пегол или биоаналоги)
    4. Антагонист интегриновых рецепторов (например, ведолизумаб)
    5. Антагонист интерлейкина -12/-23 (например, устекинумаб)
  • Женщины детородного возраста должны быть небеременными.
  • Женщины детородного возраста и мужчины должны использовать средства контрацепции.

Критерий исключения:

  • Неадекватный ответ в анамнезе (т.е. первичное отсутствие ответа) на агенты из ≥ 2 классов биологических препаратов, продаваемых для лечения целиакии (т.е. антагонисты TNFα, антагонист интерлейкина 12/23 и антагонист рецептора интегрина).
  • Иметь язвенный колит, неопределенный колит, микроскопический колит, ишемический колит, радиационный колит, колит, связанный с дивертикулярной болезнью, токсический мегаколон или активный инфекционный колит, или положительный результат теста на токсин Clostridioides difficile при скрининге.
  • Имеют функциональный или послеоперационный синдром короткой кишки или любые сопутствующие осложнения, которые могут потребовать хирургического вмешательства или помешать оценке эффективности
  • Имели хирургическое лечение внутрибрюшных абсцессов ≤ 8 недель до рандомизации или хирургическое лечение перианальных абсцессов ≤ 4 недель до рандомизации.
  • Резекция кишечника ≤ 24 недель до рандомизации или другие внутриабдоминальные операции ≤ 12 недель до рандомизации.
  • Установите илеостому или колостому.

Критерии включения в подисследование 3:

- Участники, которые вошли в расширенный период индукции субисследования 1 и субисследования 2, должны пройти расширенный индукционный визит - неделя 6.

Критерии включения в подисследование 4:

- Участник должен завершить визит на неделе 52 подисследования 3 или визит на неделе 66 подисследования A.

Учебный план

В этом разделе представлена ​​подробная информация о плане исследования, в том числе о том, как планируется исследование и что оно измеряет.

Как устроено исследование?

Детали дизайна

  • Основная цель: Уход
  • Распределение: Рандомизированный
  • Интервенционная модель: Параллельное назначение
  • Маскировка: Двойной

Оружие и интервенции

Группа участников / Армия
Вмешательство/лечение
Плацебо Компаратор: Плацебо
Этрасимод, соответствующий плацебо, принимается перорально один раз в день.
Экспериментальный: Этрасимод Доза А
Дозу А принимают внутрь один раз в день.
Другие имена:
  • АПД334
Доза B принимается внутрь один раз в день.
Другие имена:
  • АПД334
Экспериментальный: Этрасимод доза B
Дозу А принимают внутрь один раз в день.
Другие имена:
  • АПД334
Доза B принимается внутрь один раз в день.
Другие имена:
  • АПД334

Что измеряет исследование?

Первичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
Временное ограничение: Week 14 of SSA
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from study baseline in SES-CD. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple, can be passed, 3= cannot be passed. Total SES-CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease) to 60 (severe disease), higher score indicated more severe disease.
Week 14 of SSA
Percentage of Participants With Endoscopic Response by SES-CD at Week 14: SS1
Временное ограничение: Week 14 of SS1
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from study baseline in SES-CD. SES-CD consisted of composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 bowel segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0= none, 1= aphthous ulcers, 2= large ulcers and 3= very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0= none, 1= single, can be passed, 2= multiple can be passed, 3= cannot be passed. Total SES CD= sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease. Multiple imputation (MI) method used; percentage calculated based on average response rate from MI datasets.
Week 14 of SS1
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Responder Cohort
Временное ограничение: Week 52 of study
Clinical remission was considered as CDAI score <150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); hematocrit (HCT): 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
Week 52 of study
Percentage of Participants With Clinical Remission by CDAI at Week 52: SS3 Non-Responder Cohort
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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

Вторичные показатели результатов

Мера результата
Мера Описание
Временное ограничение
Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 4 hours post-dose on Day 1
The plasma concentration of etrasimod at 4 hours post-dose has been reported in this outcome measure.
4 hours post-dose on Day 1
Steady State Trough Concentration (Ctrough,ss) of Etrasimod From Week 2 to Week 14: SSA
Временное ограничение: From Week 2 to Week 14
The average steady-state Ctrough for Week 2 through 14 was calculated based on individual Ctrough data from Week 2, Week 6 and Week 14.
From Week 2 to Week 14
Change From Baseline in Absolute Lymphocyte Count (ALC) at Week 14 in Induction Period: SSA
Временное ограничение: 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
Временное ограничение: Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Baseline (last measurement taken prior to the first dose of study treatment) and Week 14 of SSA
Change From Baseline in ALC at Week 66 in Extension Period: SSA
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Week 52 of study
Corticosteroid-free remission: CDAI score <150 without receiving corticosteroids for >=8 weeks prior to Week 52 (for participants receiving corticosteroids at baseline). CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid stools; extent of abdominal pain from 0 (none)-3 (severe); general well-being from 0 (generally well)-4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women; percentage deviation from standard weight, lower bound -10. Total CDAI score=sum of variable scores*weighting factor and was from 0 (no disease)-600 (severe disease), higher score indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Responder Cohort
Временное ограничение: Week 52 of study
Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed. Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
Week 52 of study
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Non-Responder Cohort
Временное ограничение: Week 52 of study
Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed. Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
Week 52 of study
Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
Временное ограничение: 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
Временное ограничение: Week 52 of study
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Week 52 of study
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Responder Cohort
Временное ограничение: Week 52 of study
Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150. CDAI: composite index consisting of weighted scoring of 8 disease activity variables. Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease. Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD. SES-CD comprised of 4 components assessed for 5 bowel segments. Each component score ranged from 0-3, higher scores indicated more severe condition. Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease. Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
Week 52 of study
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Non-Responder Cohort
Временное ограничение: Week 52 of study
Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150. CDAI: composite index consisting of weighted scoring of 8 disease activity variables. Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease. Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD. SES-CD comprised of 4 components assessed for 5 bowel segments. Each component score ranged from 0-3, higher scores indicated more severe condition. Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease. Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
Week 52 of study
Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Временное ограничение: Baseline, study Weeks 20, 28, 36, 44, 52
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44, 52
Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
Временное ограничение: Baseline, study Weeks 20, 28, 36, 44, 52
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44, 52
Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Responder Cohort
Временное ограничение: 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
Временное ограничение: Week 52 of study
Clinical Response was clinical remission by CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI= CDAI <150. CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none)-3 (severe); general well-being rating assessed from 0 (generally well) - 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide/opiates for diarrhea; presence of an abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score= sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), where higher scores indicated more severe disease. SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms. Each module ranged from 0 to 16, where higher scores indicated more severe disease. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Non-Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms. Each module ranged from 0 to 16, where higher scores indicated more severe disease. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 28 and 52: SS3 Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD. Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life. The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in IBDQ at Weeks 28 and 52: SS3 Non-Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD. Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life. The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Weeks 28 and 52: SS3 Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality. The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status. SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in SF-36 at Weeks 28 and 52: SS3 Non-Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality. The 8 domains are combined to form 2 component scores MCS and PCS. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status. SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 28 and 52: SS3 Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in FACIT-F at Weeks 28 and 52: SS3 Non-Responder Cohort
Временное ограничение: Baseline, study Weeks 28 and 52
The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at SS3 Baseline: SS3 Responder Cohort
Временное ограничение: 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
Временное ограничение: Week 52 of study
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Временное ограничение: Baseline, study Weeks 20, 28, 36, 44 and 52
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44 and 52
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
Временное ограничение: Baseline, study Weeks 20, 28, 36, 44 and 52
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44 and 52
Time to Remission by PRO2 and FCP Concentrations: SS3 Responder Cohort
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: 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
Временное ограничение: Week 52 of study
Endoscopic remission: SES-CD <=4 and at least 2-point reduction from baseline with no sub-score >1. SES-CD comprised of 4 components assessed for 5 bowel segments where, each component score ranged from 0 to 3, higher scores indicated more severe condition. Total SES CD score was determined by sum of each component score for all 5 bowel segments and ranged from 0 to 60, higher score indicated more severe disease. Clinical remission by PRO2 was defined as PRO2 score <8. PRO2 was patient-reported outcome measure based on abdominal pain and stool frequency components of CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. Stool frequency was number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as sum of averaged abdominal pain/stool frequency variable scores*weighting factor. PRO2 score had a minimum score of 0 and had no upper bound, with higher score indicating more frequent stools and more severe abdominal pain.
Week 52 of study
Number of Participants According to Markedly Abnormal Criteria for Electrocardiogram (ECG) Parameters: SS4
Временное ограничение: Baseline, Weeks 52, and 104 of SS4
Pre-defined markedly abnormal criteria for ECG parameters included: QT interval: >500 (milliseconds [msec]); change from SS4 baseline >30 msec and change from SS4 baseline >60 msec. QT interval corrected using Fridericia's formula (QTcF) (msec): >=450 (male) or >=470 (female) msec; change from SS4 baseline >30 msec; change from SS4 baseline >60 msec. PR interval (msec): >230 msec. Only those ECG parameters in which at least 1 participant in any of the reporting arm had markedly abnormal criteria are reported in this outcome measure. SS4 Baseline was defined as the last non-missing measurement taken up to the date of first dose in the SS4.
Baseline, Weeks 52, and 104 of SS4
Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs), TEAEs by Severity and Treatment Related TEAEs: SS3
Временное ограничение: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
AE: any untoward medical occurrence that did not necessarily have a causal relationship with treatment. SAE: an AE that met one of the following criteria: resulted in death; was life-threatening; required inpatient or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or medically significant. AEs were graded by the National Cancer Institute Common Terminology Criteria for AE version 5 where, Grade(G) 1: mild AE; G2: moderate; G3: severe; G4: life-threatening consequences, urgent intervention indicated; G5: death related to AE. AE was considered TEAE if it started or worsened in severity on or after the first dose of study treatment. Treatment related AEs were AEs that were related to the study treatment and relatedness was judged by investigator.
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
Number of Participants With TEAEs of Special Interest: SS3
Временное ограничение: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
The TEAEs of special interest included: cardiovascular events (bradycardia, atrioventricular [AV] conduction delay, and hypertension); macular edema; pulmonary disorders (airflow obstruction [forced expiratory volume in 1 second, and forced vital capacity], decreased gas exchange [diffusing capacity of the lung for carbon monoxide]); infections (severe infections, opportunistic infections, and herpes simplex and herpes zoster); liver injury (liver transaminases elevation, and bilirubin elevation); posterior reversible encephalopathy syndrome; and malignancies. Number of participants with any TEAEs of special interest were reported in this outcome measure.
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
Number of Participants With Clinically Meaningful Changes in Laboratory Parameters: SS3
Временное ограничение: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
Clinically meaningful laboratory abnormalities:Hemoglobin, Hematocrit, Erythrocytes (<0.8*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration <0.8*LLN or >1.5*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (>1.2*ULN), Prothrombin Time(>1.1*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (>3.0*ULN); Albumin, Urate (<0.8*LLN and >1.2*ULN; Urea Nitrogen,Creatinine Cholesterol >1.3*ULN; Cholesterol <0.8*LLN or >1.2*LLN, Triglycerides,Potassium,Calcium < 0.9x LLN & >1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite >=1; Leukocyte Erythrocytes, Leukocytes >=20; Epithelial Cells>=6, Hyaline Cast>1; Bacteria>20. Number of participants with any laboratory abnormality meeting specified criteria is included.
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 38 weeks; maximum follow-up: 42 weeks)
Number of Participants With TEAEs, SAEs, TEAEs by Severity and Treatment Related TEAEs: SS4
Временное ограничение: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
AE: any untoward medical occurrence that did not necessarily have a causal relationship with treatment. SAE: an AE that met one of the following criteria: resulted in death; was life-threatening; required inpatient or prolongation of existing hospitalization; persistent or significant disability/incapacity; congenital anomaly/birth defect or medically significant. AEs were graded by the National Cancer Institute Common Terminology Criteria for AE version 5 where, G1: mild AE; G2: moderate; G3: severe; G4: life-threatening consequences, urgent intervention indicated; G5: death related to AE. AE was considered TEAE if it started or worsened in severity on or after the first dose of study treatment. Treatment related AEs were AEs that were related to the study treatment and relatedness was judged by investigator.
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
Number of Participants With TEAEs of Special Interest: SS4
Временное ограничение: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
The TEAEs of special interest included: cardiovascular events (bradycardia, AV conduction delay, and hypertension); macular edema; pulmonary disorders (airflow obstruction [forced expiratory volume in 1 second, and forced vital capacity], decreased gas exchange [diffusing capacity of the lung for carbon monoxide]); infections (severe infections, opportunistic infections, and herpes simplex and herpes zoster); liver injury (liver transaminases elevation, and bilirubin elevation); posterior reversible encephalopathy syndrome; and malignancies. Number of participants with any TEAEs of special interest were reported in this outcome measure.
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
Number of Participants With Clinically Meaningful Changes in Laboratory Parameters: SS4
Временное ограничение: From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
Clinically meaningful laboratory abnormalities:Hemoglobin, Hematocrit, Erythrocytes (<0.8*LLN); Ery. Volume, Hemoglobin,Mean Corpuscular HGB Concentration <0.8*LLN or >1.5*LLN;Reticulocytes, Leukocytes, Lymphocytes, Neutrophils, Neutrophils, Basophils, Eosinophils, Monocytes (>1.2*ULN), Prothrombin Time(>1.1*ULN).Clinical Chemistry: Bilirubin, Direct Bilirubin, Indirect Bilirubin (1.5*ULN), Aspartate Aminotransferase, Alanine Aminotransferase, Gamma Glutamyl Transferase, Alkaline Phosphatase (>3.0*ULN); Albumin, Urate (<0.8*LLN and >1.2*ULN; Urea Nitrogen,Creatinine Cholesterol >1.3*ULN; Cholesterol <0.8*LLN or >1.2*LLN, Triglycerides,Potassium,Calcium < 0.9x LLN & >1.1x ULN; Bicarbonate, Glucose, Creatine Kinase. Urinalysis: Glucose, Ketones, Protein, Hemoglobin, Urobilinogen, Bilirubin, Nitrite >=1; Leukocyte Erythrocytes, Leukocytes >=20; Epithelial Cells>=6, Hyaline Cast>1; Bacteria>20. Number of participants with any laboratory abnormality meeting specified criteria is included.
From first dose of study treatment (Day 1) up to 4 weeks post last dose of study treatment (maximum treatment exposure: 166.3 weeks; maximum follow-up: 170.3 weeks)
Number of Participants According to Markedly Abnormal Criteria for Vital Signs: SS4
Временное ограничение: Baseline, Weeks 1, 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Pre-defined markedly abnormal criteria for vital signs included: Systolic blood pressure (millimeters of mercury [mmHg]): low: <=90 mmHg and high: >150 mmHg. Diastolic blood pressure (mmHg): low: <=50 mmHg and high: >90 mmHg. Heart rate (beats per minute [bpm]): low: <40 bpm, <50 bpm and high: >100 bpm. Only those vital signs parameters in which at least 1 participant in any of the reporting arm had markedly abnormal criteria are reported in this outcome measure. SS4 baseline=the last non-missing measurement taken up to the date of first dose in the SS4.
Baseline, Weeks 1, 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Percentage of Participants With Clinical Remission by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
Временное ограничение: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Clinical remission was considered as CDAI score <150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Percentage of Participants With Clinical Response by CDAI at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
Временное ограничение: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Clinical Response was defined as having clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission was considered as CDAI <150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Percentage of Participants With Clinical Remission by PRO2 at Weeks 12, 24, 36, 52, 64, 76, 88 and 104: SS4
Временное ограничение: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4

Соавторы и исследователи

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Спонсор

Следователи

  • Директор по исследованиям: Pfizer CT.gov Call Center, Pfizer

Публикации и полезные ссылки

Лицо, ответственное за внесение сведений об исследовании, добровольно предоставляет эти публикации. Это может быть что угодно, связанное с исследованием.

Даты записи исследования

Эти даты отслеживают ход отправки отчетов об исследованиях и сводных результатов на сайт ClinicalTrials.gov. Записи исследований и сообщаемые результаты проверяются Национальной медицинской библиотекой (NLM), чтобы убедиться, что они соответствуют определенным стандартам контроля качества, прежде чем публиковать их на общедоступном веб-сайте.

Изучение основных дат

Начало исследования (Действительный)

6 января 2020 г.

Первичное завершение (Действительный)

23 апреля 2025 г.

Завершение исследования (Действительный)

9 июня 2025 г.

Даты регистрации исследования

Первый отправленный

20 ноября 2019 г.

Впервые представлено, что соответствует критериям контроля качества

20 ноября 2019 г.

Первый опубликованный (Действительный)

21 ноября 2019 г.

Обновления учебных записей

Последнее опубликованное обновление (Действительный)

1 июля 2026 г.

Последнее отправленное обновление, отвечающее критериям контроля качества

5 июня 2026 г.

Последняя проверка

1 июня 2026 г.

Дополнительная информация

Термины, связанные с этим исследованием

Другие идентификационные номера исследования

  • APD334-202
  • C5041006 (Другой идентификатор: Alias Study Number)
  • 2024-513569-38-00 (Идентификатор реестра: CTIS (EU))

Планирование данных отдельных участников (IPD)

Планируете делиться данными об отдельных участниках (IPD)?

ДА

Описание плана IPD

Pfizer предоставит доступ к личным обезличенным данным участников и связанным с ними документам исследования (например, протокол, план статистического анализа (SAP), отчет о клиническом исследовании (CSR)) по запросу квалифицированных исследователей и при соблюдении определенных критериев, условий и исключений. Дополнительную информацию о критериях обмена данными Pfizer и процессе запроса доступа можно найти по адресу: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Информация о лекарствах и устройствах, исследовательские документы

Изучает лекарственный продукт, регулируемый FDA США.

Да

Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.

Нет

продукт, произведенный в США и экспортированный из США.

Нет

Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .

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