Studie hodnotící účinnost a bezpečnost perorálního etrasimodu při léčbě dospělých účastníků se středně těžkou až těžkou aktivní Crohnovou chorobou (CULTIVATE)
5. června 2026 aktualizováno: Pfizer
Multicentrická, randomizovaná, dvojitě zaslepená, paralelně skupinová studie k posouzení účinnosti a bezpečnosti perorálního etrasimodu jako indukční a udržovací terapie pro středně těžkou až těžkou aktivní Crohnovu chorobu
Toto je studie fáze 2/3, která zahrnuje 5 podstudií navržených k hodnocení účinnosti, bezpečnosti a snášenlivosti perorálního etrasimodu jako terapie u dospělých účastníků se středně těžkou až těžkou aktivní Crohnovou chorobou (CD), kteří jsou refrakterní nebo netolerují alespoň 1 z současné terapie CD (tj. kortikosteroidy, imunosupresiva nebo biologická léčiva).
Celková doba trvání této studie je až 282 týdnů, včetně 28denního screeningového období, léčebného období až 274 týdnů (indukční, prodloužení nebo udržovací období a dlouhodobého prodloužení) a 4týdenní následné- Up období pro posouzení bezpečnosti.
Přehled studie
Postavení
Ukončeno
Podmínky
Intervence / Léčba
Detailní popis
Tato studie obsahuje 5 dílčích studií:
Podstudie A – Fáze 2: Fáze 2, randomizovaná, dvojitě zaslepená, podstudie k posouzení bezpečnosti, snášenlivosti a účinnosti perorální léčby etrasimodem u účastníků se středně těžkou až těžkou CD, která podporuje výběr indukční a udržovací dávky (dávek) pro fázi 3. Podstudie A je v současné době uzavřena pro zápis.
Podstudie 1 – Fáze 2: Fáze 2b randomizovaná, dvojitě zaslepená, placebem kontrolovaná indukční podstudie s rozsahem dávek k vyhodnocení etrasimodu jako indukční terapie a výběru indukční a udržovací dávky (dávek) pro pokračování ve fázi 3. Podstudie 1 je aktuálně přihlašování účastníků.
Podstudie 2 – Indukce: Randomizovaná, dvojitě zaslepená, placebem kontrolovaná podstudie fáze 3 k vyhodnocení etrasimodu jako indukční terapie.
Podstudie 3 – Udržovací: Randomizovaná, dvojitě zaslepená, placebem kontrolovaná podstudie fáze 3 k hodnocení etrasimodu jako udržovací terapie. Účastníci z dílčí studie 1 a dílčí studie 2 budou zapsáni do dílčí studie 3.
Substudie 4 – Long-Term Extension: Dlouhodobá prodloužená substudie pro účastníky, kteří absolvují alespoň 52 týdnů léčby. Účastníci z dílčí studie 3 a dílčí studie A mají být zapsáni do dílčí studie 4.
Typ studie
Intervenční
Zápis (Aktuální)
379
Fáze
- Fáze 2
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní místa
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Prov. de Buenos Aires
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Ciudadela, Prov. de Buenos Aires, Argentina, 1702
- Instituto Medico Elsa Perez(I.M.E.P)
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Ciudadela, Prov. de Buenos Aires, Argentina, B1702GIK
- Instituto Medico Elsa Perez (I.M.E.P.) (Local Lab)
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Ciudadela, Prov. de Buenos Aires, Argentina, B1702GIK
- Instituto Medico Elsa Perez (I.M.E.P.) (Pharmacy)
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Hurlingham, Prov. de Buenos Aires, Argentina, B1686NCI
- Estudio de La Vision (OCT, Ophthalmoscopy)
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Santa Fe Province
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Rosario, Santa Fe Province, Argentina, S2000DEJ
- Instituto Medico de la Fundacion Estudios Clinicos
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Rosario, Santa Fe Province, Argentina, S2000AUC
- Gastroenterologia Rosario (Endoscopy)
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Rosario, Santa Fe Province, Argentina, S2000CTC
- Microcirugia Ocular SA (OCT, Ophthalmoscopy)
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Rosario, Santa Fe Province, Argentina, S2000KZD
- Consultorios extemos de Sanatorio Parque (PFT with DLCO, Pulmonar Functional Test with DLCO)
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Tucumán Province
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San Miguel de Tucumán, Tucumán Province, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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New South Wales
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Macquarie University, New South Wales, Austrálie, 2109
- Macquarie University Hospital
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Macquarie University, New South Wales, Austrálie, 2109
- Macquarie University Hospital Pharmacy
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Macquarie University, New South Wales, Austrálie, 2109
- Macquarie Respiratory Services
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Macquarie University, New South Wales, Austrálie, 2109
- Macquarie University Hospital Clinical Trials
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Macquarie University, New South Wales, Austrálie, 2109
- MQ Health Ophthalmology
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Queensland
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Brisbane, Queensland, Austrálie, 4029
- Royal Brisbane & Women's Hospital
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North Mackay, Queensland, Austrálie, 4740
- Coral Sea Clinical Research Institute
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Victoria
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Bellfield, Victoria, Austrálie, 3081
- MCES Practice Pty Ltd operating as Comprehensive Eye Surgeons
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Epping, Victoria, Austrálie, 3076
- The Northern Hospital
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Heidelberg, Victoria, Austrálie, 3084
- Austin Hospital
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Melbourne, Victoria, Austrálie, 3011
- Vision Eye Institute
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Melbourne, Victoria, Austrálie, 3011
- Footscray Hospital
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Parkville, Victoria, Austrálie, 3050
- The Royal Melbourne Hospital
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Rosanna, Victoria, Austrálie, 3084
- Heidelberg Eye Clinic
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Western Australia
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Murdoch, Western Australia, Austrálie, 6150
- Fiona Stanley Hospital
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Nedlands, Western Australia, Austrálie, 6009
- Lions Eye Institute Limited
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O'Connor, Western Australia, Austrálie, 6163
- The trustee for The RTS Unit Trust trading as Respiratory Testing Services
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Ghent, Belgie, 9000
- Universitair Ziekenhuis Gent
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Ghent, Belgie, 9000
- AZ Maria-Middelares
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Leuven, Belgie, 3000
- Universitaire Ziekenhuizen Leuven
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Roeselare, Belgie, 8800
- Campus Brugsesteenweg
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Roeselare, Belgie, 8800
- Campus Rumbeke
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Torhout, Belgie, 8820
- Campus Rembert Torhout
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Yvoir, Belgie, 5530
- Centre Hospitalier Universitaire UCL Namur - Site Godinne
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Sofia, Bulharsko, 1527
- UMHAT "Tsaritsa Yoanna-ISUL" EAD
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Sofia, Bulharsko, 1431
- "DCC Alexandrovska", EOOD
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Sofia, Bulharsko, 1606
- ,,University multiprofile hospital for active treatment and emergency medicine N.I. Pirogov" EAD
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Homyel, Bělorusko, 246029
- Institution "Gomel Regional Clinical Hospital"
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Minsk, Bělorusko, 220096
- Health care Institution "10th City Clinical Hospital"
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Mogilev, Bělorusko, 212018
- Health Care Institution "Mogilev Hospital #1"
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Vitebsk, Bělorusko, 210037
- Health Care Institution "Vitebsk Regional Clinical Hospital"
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Vitebsk, Bělorusko, 210604
- Healthcare Institution "Vitebsk Regional Clinical Specialized Center"
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RM
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Santiago, RM, Chile, 8330034
- Centro de Investigaciones Clinicas de la Universidad Catolica
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Santiago Metropolitan
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Santiago, Santiago Metropolitan, Chile, 7620157
- Clinica Universidad de Los Andes
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Santiago, Santiago Metropolitan, Chile, 8330336
- CeCim Biocinetic
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Zagreb, Chorvatsko, 10000
- University Hospital Center Zagreb
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Aalborg, Dánsko, 9000
- Aalborg University Hospital, Department of Medical Gastroenterology, Medicinerhuset
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Hvidovre, Dánsko, 2650
- Hvidovre University Hospital
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Alexandria, Egypt, 21131
- Alexandria Clinical Research Center , Faculty of Medicine , Alexandria University
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Cairo, Egypt
- National Hepatology and Tropical Medicine Research Institute
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Cairo, Egypt, 11556
- Ain Shams University Hospital
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Cairo, Egypt
- Air Force Specialized Hospital(AFSH)
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Cairo, Egypt
- Cairo University , Kasr Al Aini Hospital
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Dakahlia, Egypt
- Egyptian Liver Research Institute and Hospital ( ELRIAH)
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Giza, Egypt
- Theodor Bilharz Research Institute Research Ethics Committee
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Menofeya, Egypt, 32511
- National Liver Institute
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Amiens, Francie, 80054
- CHU Amiens Picardie
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Clermont-Ferrand, Francie, 63000
- Chu Gabriel Montpied
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Clermont-Ferrand, Francie, 63000
- CHU De Clermont Ferrand - Hopital Estaing
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Grenoble, Francie, 38043
- CHU Grenoble Alpes - Hopital Michallon
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Grenoble, Francie, 38043
- Endoscopy: CHU Grenoble Alpes- Hopital Michallon
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La Roche-sur-Yon, Francie, 85925
- CHD Vendee, Unite de Recherche Clinique
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Lille, Francie, 59037
- CHU de Lille - Hôpital Claude Huriez
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Lille, Francie, 59037
- Optical Coherence Tomography and Ophthalmology CHU de Lille Hopital Roger Salengro
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Lille, Francie, 59037
- Pulmonary Function Test CHU Lille, Institut Coeur Poumon
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Montpellier, Francie, 34295
- CHU Saint-Eloi
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Montpellier, Francie, 34295
- Hopital Saint-Eloi - Pole Digestif - Hgea Recherche Clinique - Rdc
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Nice, Francie, 06202
- CHU de Nice, Hopital 1'Archet 2
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Reims, Francie, 51100
- Hopital Maison Blanche, CHU DE REIMS
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Reims, Francie, 51092
- Hopital Robert Debre
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Reims, Francie, 51100
- Hopital Robert Debre CHU DE REIMS
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Saint-Etienne, Francie, 42055
- CHU Saint Etienne - Hôpital Nord
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Saint-Priest-en-Jarez, Francie, 42270
- Optical Coherence Tomography and Ophthalmology
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Saint-Priest-en-Jarez, Francie, 42270
- Pulmonary Function Test
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Toulouse, Francie, 31059
- Hopital Rangueil
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Toulouse, Francie, 31300
- Hopital Purpan PPR pole cephalique
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Vandœuvre-lès-Nancy, Francie, 54511
- CHRU Nancy Brabois
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Tbilisi, Gruzie, 0160
- LTD Aversi Clinic
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Tbilisi, Gruzie, 0159
- LTD Institute of Clinical Cardiology
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Tbilisi, Gruzie, 0160
- JSC Infectious Diseases, AIDS and Clinical Immunology Research Center
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Tbilisi, Gruzie, 0160
- LTD Academician Nikoloz Kipshidze Central University Clinic
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Tbilisi, Gruzie, 0172
- Malkhaz Katsiashvili Multiprofile Emergency Medicine Center, LTD
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Tbilisi, Gruzie, 0179
- LTD Medical Center "CITO"
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Amsterdam, Holandsko, 1105 AZ
- Academic Medical Centre
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Utrecht, Holandsko, 3584 CX
- UMC Utrecht
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Kochi, Indie, 682027
- Aster Medcity, Aster DM Healthcare Ltd.
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Gujarat
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Surat, Gujarat, Indie, 395002
- Surat Institute of Digestive Sciences
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Haryana
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Gurugram, Haryana, Indie, 122002
- Fortis Memorial Research Institute
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Maharashtra
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Nagpur, Maharashtra, Indie, 440010
- Midas Multispeciality Hospital Pvt. Ltd
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Rajasthan
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Jaipur, Rajasthan, Indie, 302001
- S. R. Kalla Memorial Gastro & General Hospital
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Catania, Itálie, 829-95126
- Azienda Ospedaliera Ospedale Cannizzaro
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Catanzaro, Itálie, 88100
- A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente Campus Universitario "Salvatore Venuta"
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Catanzaro, Itálie, 88100
- A.O. Mater Domini, U.O. Fisiopatologia Apparato Digerente
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Catanzaro, Itálie, 88100
- CAMPUS GERMANETO Magazzino farmaci e dispositivi medici, uffici
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Pavia, Itálie, 27100
- Fondazione IRCCS Policlinico San Matteo - Centro per lo Studio e la Cura delle Amiloidosi Sistemiche
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Rome, Itálie, 00189
- PFT address: Azienda Ospedaliero-Universitaria Sant' Andrea UOC Pneumologia
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Verona, Itálie, 37024
- IRCCS Ospedale Sacro Cuore Don Calabria
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Verona, Itálie, 37134
- OCT/PFT/Endoscopy address: CRC - Cenro Ricerche Cliniche di Verona
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Foggia
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San Giovanni Rotondo, Foggia, Itálie, 71013
- IRCCS Ospedale Casa Sollievo della Sofferenza
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San Giovanni Rotondo, Foggia, Itálie, 71013
- OCT/ PFT/ Endoscopy address: IRCCS Ospedale Casa Sollievo della Sofferenza
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MI
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Milan, MI, Itálie, 20132
- Ospedale San Raffaele
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Milan
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Garbagnate Milanese, Milan, Itálie, 20024
- ASST Rhodense - Pneumology Unit
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Milan, Milan, Itálie, 20017 Rho
- ASST Rhodense, U.O.C. Gastroenterologia ed Endoscopia Digestiva
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Rho, Milan, Itálie, 20017
- ASST Rhodense - Ophthalmology Unit
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Milano
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Rozzano, Milano, Itálie, 20089
- Irccs Humanitas Research Hospital
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Verona
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Negrar, Verona, Itálie, 37024
- OCT/ PFT/ Endoscopy address: IRCCS Ospedale Sacro Cuore Don Calabria
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Afula, Izrael, 1834111
- Haemek Medical Center
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Jerusalem, Izrael, 9103102
- Shaare Zedek Medical Center
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Ramat Gan, Izrael, 5262000
- Chaim Sheba Medical Center
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Tel Aviv, Izrael, 6423906
- Tel Aviv Sourasky Medical Center
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Chiba
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Kashiwa-shi, Chiba, Japonsko, 277-0871
- Kokikai Tsujinaka Hospital Kashiwanoha
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Nagareyama-shi, Chiba, Japonsko, 270-0116
- Ishii Eye Clinic
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Fukuoka
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Kitakyushu-shi, Fukuoka, Japonsko, 807-8555
- Hospital of the University of Occupational and Environmental Health
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Kitakyusyu-shi, Fukuoka, Japonsko, 802-8561
- Kitakyushu Municipal Medical Center
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Ibaraki
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Toride-shi, Ibaraki, Japonsko, 302-0014
- Matsumoto Eye Clinic
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Kagoshima-ken
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Kagoshima, Kagoshima-ken, Japonsko, 892-0846
- Sameshima Hospital
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Kagoshima, Kagoshima-ken, Japonsko, 892-0824
- Jiaikai Idzuro Imamura Hospital
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Kagoshima, Kagoshima-ken, Japonsko, 890-0062
- Kagoshima Kouseiren Hospital
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Kagoshima, Kagoshima-ken, Japonsko, 892-0825
- Sameshima Eye Clinic
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Kumamoto
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Kumamoto, Kumamoto, Japonsko, 861-8520
- Japanese Red Cross Kumamoto Hospital
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Saga-ken
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Saga, Saga-ken, Japonsko, 849-8501
- Saga University Hospital
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Tokyo
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Shinjuku-ku, Tokyo, Japonsko, 169-0073
- Japan Community Health Care Organization Tokyo Yamate Medical Center
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Free State
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Bloemfontein, Free State, Jižní Afrika, 9301
- Dr W Simmonds (Gastroenterology Department)
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Gauteng
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Benoni, Gauteng, Jižní Afrika, 1501
- Worthwhile Clinical Trials
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Benoni, Gauteng, Jižní Afrika, 1500
- Dr K Rahman (OTC and Opthalmoscopy)
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Benoni, Gauteng, Jižní Afrika, 1500
- Lakeview Hospital radiology (Radiology)
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Benoni, Gauteng, Jižní Afrika, 1500
- Worthwhile Clinical trials (PFT)
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Centurion, Gauteng, Jižní Afrika, 0157
- Dr E Meyer & Partners, Centurion Eye Hospital (OTC and Opthalmoscopy)
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Centurion, Gauteng, Jižní Afrika, 0157
- Dr Jorg Reichenberger (Endoscopy)
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Centurion, Gauteng, Jižní Afrika, 0157
- Drs Burger Radiologists Inc (X-ray/CT)
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Centurion, Gauteng, Jižní Afrika, 0157
- Johese Clinical Research, Unitas Hospital
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Johannesburg, Gauteng, Jižní Afrika, 2193
- Wits Clinical Research
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Kempton Park, Gauteng, Jižní Afrika, 1619
- Clinresco Centres (Pty) Ltd
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Kempton Park, Gauteng, Jižní Afrika, 1619
- Burger Radiology (Radiology)
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Kempton Park, Gauteng, Jižní Afrika, 1619
- Dr KJP Lubuya (OCT and Opthalmology)
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Kempton Park, Gauteng, Jižní Afrika, 1619
- Prof O Mwantembe (Endoscopy)
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Pretoria, Gauteng, Jižní Afrika, 0002
- Emmed Research
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Springs, Gauteng, Jižní Afrika, 1559
- Dr K Rahman(OTC and Opthalmoscopy)
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Sunninghill, Gauteng, Jižní Afrika, 2196
- Dr I Moola (Endoscopy)
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Western Cape
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Cape Town, Western Cape, Jižní Afrika, 7405
- Dr Peter Chapman (PFT + DLCO)
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Cape Town, Western Cape, Jižní Afrika, 7441
- Dr Chris Stander (OCT)
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Cape Town, Western Cape, Jižní Afrika, 7441
- Morton & Partners Radiologists (Radiology)
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Cape Town, Western Cape, Jižní Afrika, 7441
- Spoke Research Inc. Room 109
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Daegu, Jižní Korea, 41404
- Kyungpook National University Chilgok Hospital
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Daegu, Jižní Korea, 41944
- Kyungpook National University Hospital
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Daegu, Jižní Korea, 41944
- Endoscopy Facility in kyungpook National University Hospital
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Daegu, Jižní Korea, 41944
- OCT Facility In kyungpook National University Hospital
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Daegu, Jižní Korea, 41944
- PFT Facility in Kyungpook National University Hospital
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Daejeon, Jižní Korea, 34943
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
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Incheon, Jižní Korea, 21565
- Gachon University Gil Medical Center
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Seongnam-si, Jižní Korea, 13496
- CHA University Bundang CHA Hospital
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Seoul, Jižní Korea, 06273
- Gangnam Severance Hospital, Yonsei University Health System
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Seoul, Jižní Korea, 06973
- Chung-Ang University Hospital
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Seoul, Jižní Korea, 02447
- Kyunghee University Medical Center
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Gyeonggi-do
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Goyang-si, Gyeonggi-do, Jižní Korea, 10326
- Dongguk University Ilsan Hospital
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Quebec
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Montreal, Quebec, Kanada, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Electrocardiogram Clinic)
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Montreal, Quebec, Kanada, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Endoscopy Clinic)
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Montreal, Quebec, Kanada, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Pharmacy)
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Montreal, Quebec, Kanada, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Radiology)
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Montreal, Quebec, Kanada, H3G 1A4
- McGill University Health Centre - Montreal General Hospital (Research Site)
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Montreal, Quebec, Kanada, H4A 3J1
- Centre for Innovative Medicine - Research Institute of the McGill University Health Centre(Pulmonary
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Montreal, Quebec, Kanada, H4P 2S4
- Eye Health MD (Ophthalmology)
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Quindío Department
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Armenia, Quindío Department, Kolumbie, 630004
- IPS Fundacion Cardiomet CEQUIN
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Valle del Cauca Department
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Cali, Valle del Cauca Department, Kolumbie, 760035
- Centro de lnvestigaciones Clinicas S.A.S
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Beirut, Libanon, 166830
- Hotel Dieu de France Hospital
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Beirut, Libanon, 1100 2807
- Saint George University Hospital Medical Center
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Beirut, Libanon, 113-6044
- Rafik Hariri University Hospital
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Saida, Libanon
- Hammoud Hospital University Medical Center
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Tripoli, Libanon
- Nini Hospital s.a:l
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Vilnius, Litva, LT-08661
- Vilnius University Hospital Santaros Klinikos
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Kuala Lumpur, Malajsie, 59100
- University Malaya Medical Centre
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Budapest, Maďarsko, 1136
- Pannonia Maganorvosi Centrum
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Budapest, Maďarsko, 1033
- Clinexpert Egeszsegugyi Szolgaltato es Kereskedelmi Kft. (abbreviated name: Clinexpert Kft.)
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Budapest, Maďarsko, 1062
- Ophthalmology procedures: Magyar Honvedseg Egeszsegugyi Kozpont
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Budapest, Maďarsko, 1062
- Pulmonary procedures: Vasutegeszsegugyi Nonprofit Kozhasznu K ft.
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Budapest, Maďarsko, 1134
- Ophthalmology, OCT: Medicover Zrt.
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Budapest, Maďarsko, 1139
- Chest X-ray: XIII. keruleti Egeszsegugyi Szolgalat Kozhasznu Nonprofit Kft.
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Békéscsaba, Maďarsko, 5600
- Bekes Megyei Kozponti Korhaz Dr. Rethy Pal Tagkorhaz, 4. Belgyogyaszat es 2. Gasztroenterologia
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Heves County
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Gyöngyös, Heves County, Maďarsko, 3200
- Bugat Pal Korhaz, Gasztroenterologia
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Komárom-Esztergom
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Tatabánya, Komárom-Esztergom, Maďarsko, 2800
- Szent Borbala Korhaz
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Tatabánya, Komárom-Esztergom, Maďarsko, 2800
- DLCO and ophthalmology tests: Szent Borbala Korhaz
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Chihuahua City, Mexiko, 31203
- Scientia Investigacion Clinica S.C.
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Chihuahua City, Mexiko, 31020
- Sanatorio Palmore A.C.
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Chihuahua City, Mexiko, 31203
- Vista Lasser de Chihuahua S.C.
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Chihuahua City, Mexiko, 31283
- Servicios Hospitalarios de México, S.A. de C.V.
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Veracruz, Mexiko, 91900
- FAICIC S. de R.L. de C.V.
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Veracruz, Mexiko, 91910
- Gabinete de Diagnostico COVADONGA
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Veracruz, Mexiko, 91918
- Alberto Collado Solorzano (Clinica Vision)
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Jalisco
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Guadalajara, Jalisco, Mexiko, 44130
- Centro de Investigacion Medico Biologica Y Terapia Avanzada S.C.
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Guadalajara, Jalisco, Mexiko, 44600
- Global Glaucoma Institute
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Guadalajara, Jalisco, Mexiko, 44600
- Video Endoscopia Americas
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Guadalajara, Jalisco, Mexiko, 44670
- Comercializadora Winco S.A. de C.V.
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Veracruz
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Boca del Rio, Veracruz, Mexiko, 94299
- Cirugia y Gastro de Veracruz S.A. de C.V. (Progastro)
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Chisinau, Moldavsko, 2005
- "Sf. Arhanghel Mihail" Municipal Clinical Hospital, Department of Gastroenterology
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Chisinau, Moldavsko, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Colorectal Surgery
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Chisinau, Moldavsko, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Department of Gastroenterology
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Chisinau, Moldavsko, MD2025
- PMSI Republican Clinical Hospital "Timofei Mosneaga", Outpatient Department
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Augsburg, Německo, 86156
- Universitaetsklinikum Augsburg
-
Brandenburg an der Havel, Německo, 14770
- Staedtisches Klinikum Brandenburg
-
Frankfurt, Německo, 60431
- Prof. Dr. med. Dr. med. Habil. Jens Buhren, FEBO
-
Frankfurt am Main, Německo, 60431
- Agaplesion Markus Krankenhaus
-
Hamburg, Německo, 20251
- HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
-
Jena, Německo, 07747
- Universitaetsklinikum Jena
-
Jena, Německo, 07747
- OCT/Ophtalmoscopy address: Universitaetsklinikum Jena
-
Jena, Německo, 07747
- PFT address: Universitaetsklinikum Jena
-
Kassel, Německo, 34121
- PFT address: Praxis fur Pneumologie und Allergologie
-
Kassel, Německo, 34177
- OCT/Ophtalmoscopy address: Augenarztpraxis Dr. Karola Hassan
-
Kiel, Německo, 24105
- Nordblick Augenklinik
-
Kiel, Německo, 24105
- Universitatsklinikum Schleswig-Holstein- Campus Kiel
-
Nürtingen, Německo, 72622
- Dr. Irina Hasewinkel
-
Nürtingen, Německo, 72622
- Medius Klinik Nuertingen
-
-
Hassen
-
Kassel, Hassen, Německo, 34117
- Gastroenterologie Opernstraβe
-
-
-
-
-
Bystra, Polsko, 43-360
- Centrum Pulmonologii i Torakochirurgii w Bystrej (DLCO)
-
Karkow, Polsko, 31-156
- Specjalistyczne Gabinety Lekarskie LANDA
-
Krakow, Polsko, 30-033
- Centre De La Vision Centrum Okulistyczne(OCT, Ophthalmoscopy)
-
Krakow, Polsko, 30-307
- Medicina (Endoscopy)
-
Krakow, Polsko, 31-153
- Centrum Medyczne EVITA(Endoscopy)
-
Lodz, Polsko, 90-752
- IP Clinic Sp. z o.o.
-
Lodz, Polsko, 90-338
- Centrum Medyczne "Ksiezy Mlyn" (OCT, Ophtalmoscopy)
-
Lodz, Polsko, 93-513
- Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatolog i im. M. Kopernika w Lodzi
-
Lodz, Polsko, 90-338
- (Centrum Medyczne Ksiezy Mlyn (OCT and Ophthalmoscopy)
-
Lodz, Polsko, 90-644
- AMICARE Sp. z o.o. sp.k
-
Lodz, Polsko, 91-053
- Centra Medyczne Medyceusz (DLCO)
-
Lodz, Polsko, 92-551
- Salve Health Care Sp. o.o., (PFT and Endoscopy)
-
Nowy Targ, Polsko, 34-400
- Allmedica Badania Kliniczne Sp. z o.o. Sp. k.
-
Oświęcim, Polsko, 32-600
- Medicome Sp. Z O.O
-
Piotrkow Trybunalski, Polsko, 97-300
- Przychodnia Okulistyczna "Oculus" Barbara Cybulska (OCT, Ophtalmoscopy)
-
Piotrkow Trybunalski, Polsko, 97-300
- Samodzielny Szpital Wojewodzki im. Mikolaja Kopernika (Endoscopy)
-
Piotrokow Trybunalski, Polsko, 97-300
- Trialmed CRS
-
Poznan, Polsko, 60-529
- Solurmed Centrum Medyczne
-
Poznan, Polsko, 60-538
- OCU Service Mikolaj Meller Sp.j.(OCT, Ophtalmoscopy)
-
Rzeszów, Polsko, 35-326
- Centrum Medyczne Medyk
-
Rzeszów, Polsko, 35-055
- Kliniczny Szpital Wojewodzki Nr 1 im. Fryderyka Chopina w Rzeszowie (Ophthalmpscopy)
-
Rzeszów, Polsko, 35-241
- Podkarpackie Centrum Chorob Plue w Rzeszowie (DLCO)
-
Strzegom, Polsko, 58-150
- Strzegomskie Centrum Medyczno - Diagnostyczne Sp. z o.o. (Endoscopy)
-
Swidnica, Polsko, 58-100
- DC-MED
-
Swidnica, Polsko, 58-100
- Centrum Medyczne EZ-MEDICA (OCT, Ophtalmoscopy)
-
Swidnica, Polsko, 58-100
- Szpital "Latawiec" -Poradnia Gruzlicy i Chorob Pluc (PFT)
-
Warsaw, Polsko, 00-635
- Centrum Zdrowia MDM
-
Warsaw, Polsko, 00-631
- Centrum Zdrowia MDM (OCT,opthalmoscopy)
-
Warsaw, Polsko, 01-138
- Instytut Gruzlicy i Chorob Pluc(DLCO)
-
Warsaw, Polsko, 02-653
- Endoterapia PFG (Endoscopy)
-
Warsaw, Polsko, 02-653
- Instytut Oka (OCT, Ophtalmoscopy)
-
Warsaw, Polsko, 03-712
- Specjalistyczne Gabinety Lekarskie Body Clinic
-
Warsaw, Polsko, 03-731
- Centrum Okulistyczne JASKRA (OCT, Ophthalmoscopy)
-
Warsaw, Polsko, 04-141
- Wojskowy lnstytut Medyczny (PFT)
-
Wroclaw, Polsko, 60-681
- EuroMediCare Szpital Specjalistyczny z Przychodniit (Endoscopy)
-
-
Greater Poland Voivodeship
-
Poznan, Greater Poland Voivodeship, Polsko, 60-681
- NSZOZ Termedica
-
-
-
-
-
Graz, Rakousko, 8036
- LKH Universitats-Klinikum Graz
-
Innsbruck, Rakousko, A-6020
- Medical University Innsbruck, Internal Medicine Ⅰ
-
Vienna, Rakousko, 1090
- AKH Wien- Universitatsklinik fiir Innere Medizin III
-
Vienna, Rakousko, 1090
- Univ.-Professor Dr. Mehrdad Baghestanian
-
Vienna, Rakousko, 1090
- AKH Wien- Universitatsklinik fur Innere Medizin III
-
-
-
-
-
Bucharest, Rumunsko, 012015
- SC Centrul Medical Medicum SRL, Specialitatea Gastroenterologie
-
Bucharest, Rumunsko, 022328
- Institutul Clinic Fundeni, Centrul de Gastroenterologie si Hepatologie
-
-
JUD. CLUJ
-
Cluj-Napoca, JUD. CLUJ, Rumunsko, 400006
- Spitalul Clinic Judetean de Urgenta Cluj Napoca
-
-
Jud.constanta
-
Constanța, Jud.constanta, Rumunsko, 900591
- Centrul de Diagnostic si Tratament Affidea, Specialitatea Medicina Interna
-
-
-
-
-
Kemerovo, Rusko, 650066
- SAIH "Kemerovo Regional Clinical Hospital"
-
Novosibirsk, Rusko, 630005
- LLC "SibNovoMed"
-
Novosibirsk, Rusko, 630007
- Gastrocenter
-
Novosibirsk, Rusko, 630007
- LLC "Novosibirskiy Gastrocentr''
-
Novosibirsk, Rusko, 630084
- Hospital #12
-
Novosibirsk, Rusko, 630091
- LLC "Siberian Center for Prevention and Treatment of Myopia Eye"
-
Novosibirsk, Rusko, 630099
- Joint Stock Company Medical Center "AVICENNA"
-
Omsk, Rusko, 644013
- BHI of Omsk region "Clinical Oncology Dispensary"
-
Omsk, Rusko, 644024
- Clinicodiagnostic Center "Ultramed"
-
Omsk, Rusko, 644070
- Medical center "Intervzglyad"
-
Saint Petersburg, Rusko, 191015
- FSBI of Higher Education " North-Western Medical University n.a.I.I. Mechnikov '' of MoH RF
-
Saint Petersburg, Rusko, 195067
- FSBI of Higher Education "North-Western Medical University n.a.I.I. Mechnikov'' of MoH RF
-
Stavropol, Rusko, 355017
- Autonomous Noncommercial Medical Organization "Stavropol Regional Clinical
-
-
Stavropol Kray
-
Pyatigorsk, Stavropol Kray, Rusko, 357502
- LLC "Polyclinic of ultrasonography 4D"
-
-
-
-
-
Banská Bystrica, Slovensko, 975 17
- Fakultna nemocnica s poliklinikou F.D.Roosevelta
-
Bardejov, Slovensko, 08501
- ALIAN. s.r.o .. Ambulancia vnutorneho lekarstva
-
Košice, Slovensko, 040 13
- ENDOMED, s.r.o. Gastroenterologicka ambulancia
-
Lipany, Slovensko, 082 71
- Opthalmology outpatient clinic, MUDr. Michal Popovec, s.r.o.
-
Nitra, Slovensko, 949 01
- KM Management spol.s.r.o. Gastroenterologicke a hepatologicke centrum
-
Prešov, Slovensko, 080 01
- GASTRO LM s.r.o., Gastroenterologicka ambulancia
-
Prešov, Slovensko, 080 01
- Pneumology: PULMO, s.r.o.
-
-
-
-
-
Liverpool, Spojené království, L7 8XP
- Royal Liverpool University Hospital
-
London, Spojené království, SE1 9RT
- Guys & St Thomas Hospital
-
Norwich, Spojené království, NR4 7UQ
- Quadram Institute Clinical Research Facility
-
-
-
-
Alabama
-
Dothan, Alabama, Spojené státy, 36301
- Digestive Health Specialists
-
Dothan, Alabama, Spojené státy, 36301
- Dothan Eyecare-Dr. Brent McKinley (OCT Location)
-
Dothan, Alabama, Spojené státy, 36301
- Center for Digestive Health (Endoscopy Location)
-
Dothan, Alabama, Spojené státy, 36301
- Pulmonary Associates (PFT Location)
-
Dothan, Alabama, Spojené státy, 36305
- Flowers Hospital (Imaging Location)
-
Mobile, Alabama, Spojené státy, 36608
- Digestive Health Specialists (Satellite Clinic Location)
-
Mobile, Alabama, Spojené státy, 36608
- Premier Medical Group East (Opthalmology & Optometry Facility)
-
Mobile, Alabama, Spojené státy, 36608
- Pulmonary Associates (Chest X-Ray & PFT Facility)
-
Mobile, Alabama, Spojené státy, 36608
- Surgicare of Mobile (Endoscopy & Biopsy Facility)
-
-
Arizona
-
Peoria, Arizona, Spojené státy, 85381
- Arizona Retina Institute/ Phoenix Retina Associates(OCT)
-
Peoria, Arizona, Spojené státy, 85381
- SimonMed Imaging (Imaging)
-
Sun City, Arizona, Spojené státy, 85351
- Sun City Endoscopy Center (Endoscopy)
-
-
California
-
Apple Valley, California, Spojené státy, 92307
- Om Research LLC
-
Apple Valley, California, Spojené státy, 92307
- Victor Valley Advanced Imaging
-
La Jolla, California, Spojené státy, 92037
- UCSD lnvestigational Drug Service Pharmacy
-
La Jolla, California, Spojené státy, 92093
- Shiley Eye Institute (OCT)
-
La Jolla, California, Spojené státy, 92037
- Koman Family Outpatient Pavilion (ENDO)
-
La Jolla, California, Spojené státy, 92037
- Perlman Medical Offices
-
La Jolla, California, Spojené státy, 92037
- UCSD Clinical and Translational Research Institute
-
La Jolla, California, Spojené státy, 92037
- UCSD Health System (Endo/PFT/DLCO)
-
Lancaster, California, Spojené státy, 93534
- Om Research LLC
-
Lancaster, California, Spojené státy, 93534
- A V Pediatrics, Allergy and Family Medicine - PFT
-
Lancaster, California, Spojené státy, 93534
- Advanced Endoscopy and Pain Center - Colonoscopy
-
Lancaster, California, Spojené státy, 93534
- Advanced Imaging Center - Chest X-Ray
-
Lancaster, California, Spojené státy, 93534
- Antelope Valley Eye Care - Ophthalmologist
-
Lancaster, California, Spojené státy, 93534
- AV Pediatrics Allergy and Family Medicine
-
Lancaster, California, Spojené státy, 93534
- Jatinder S. Pruthi, MD FACG CPI
-
Murrieta, California, Spojené státy, 92563
- United Medical Doctors
-
Victorville, California, Spojené státy, 92392
- Retina Consultants of Southern California
-
Victorville, California, Spojené státy, 92395
- Physicians Surgery Center
-
-
Colorado
-
Colorado Springs, Colorado, Spojené státy, 80907
- Peak Gastroenterology Associates
-
Colorado Springs, Colorado, Spojené státy, 80903
- Front Range Endoscopy Center
-
Colorado Springs, Colorado, Spojené státy, 80909
- Colorado Springs Pulmonary Consultants, PC
-
Colorado Springs, Colorado, Spojené státy, 80909
- The Wright Eye Center (OCT Facility)
-
Colorado Springs, Colorado, Spojené státy, 80919
- Colorado Springs Imaging (Ultrasound and MRE Location)
-
-
Florida
-
Boca Raton, Florida, Spojené státy, 33487
- Xera Med Research
-
Boynton Beach, Florida, Spojené státy, 33472
- RecioMed Clinical Research Network, Inc
-
Brandon, Florida, Spojené státy, 33511
- Florida Advanced Gastroenterology Center - Rahman Nakshabendi MD and Imad Nakshabendi, MD
-
Clearwater, Florida, Spojené státy, 33756
- West Coast Endoscopy Center (Endoscopy Procedures)
-
Clearwater, Florida, Spojené státy, 33756
- Bay Area Chest Physicians, P.A. (Pulmonary Function Test)
-
Clearwater, Florida, Spojené státy, 33761
- Northwood Vision (Optical Coherence Tomography)
-
Clearwater, Florida, Spojené státy, 33761
- Safety Harbor Surgery (Endoscopy Procedures)
-
Clearwater, Florida, Spojené státy, 33762
- Gastro Florida (Regulatory Administrative Duties)
-
Coral Gables, Florida, Spojené státy, 33134
- Beraja Medical Institute (OCT)
-
Hialeah, Florida, Spojené státy, 33012
- Advanced Eye Center
-
Jacksonville, Florida, Spojené státy, 32256
- Encore Borland-Groover Clinical Research
-
Jacksonville, Florida, Spojené státy, 32207
- UF Health Imaging Center-Emerson (chest x-rays)
-
Jacksonville, Florida, Spojené státy, 32207
- UF Health Laboratory Emerson (blood draws)
-
Jacksonville, Florida, Spojené státy, 32209
- UF Health Jacksonville Respiratory Therapy (PFT and DLCO)
-
Jacksonville, Florida, Spojené státy, 32209
- UF Health Jacksonville-Faculty Clinic (ileocolonoscopy and biopsy)
-
Jacksonville, Florida, Spojené státy, 32209
- UF Health Opthalmology - Jacksonville (Ophthalmology with OCT)
-
Jacksonville, Florida, Spojené státy, 32209
- UF Health Radiology-Jacksonville (chest x-rays)
-
Jacksonville, Florida, Spojené státy, 32216
- Cisca Pulmonary & Critical Care (PFT Facility)
-
Jacksonville, Florida, Spojené státy, 32216
- Nicolitz Eye Consultants (OCT Facility)
-
Jacksonville, Florida, Spojené státy, 32256
- Borland-Groover Clinic (Endoscopy Facility)
-
Jupiter, Florida, Spojené státy, 33458
- Jupiter Outpatient Surgery Center
-
Kissimmee, Florida, Spojené státy, 34741
- IHS Health, LLC
-
Largo, Florida, Spojené státy, 33773
- Lee Shettle Eye & Hearing (Ophthalmoscopy Only)
-
Miami, Florida, Spojené státy, 33133
- Infinite Clinical Research
-
Miami, Florida, Spojené státy, 33156
- Research Associates of South Florida
-
Miami, Florida, Spojené státy, 33176
- Anchor Medical Research, LLC
-
Miami, Florida, Spojené státy, 33134
- The Endoscopy Center (Endoscopy Procedure)
-
Miami, Florida, Spojené státy, 33173
- Juan Barrio, MD (PFT when needed)
-
Miami, Florida, Spojené státy, 33133
- Pulmonology Physicians of South Florida
-
Miami, Florida, Spojené státy, 33133
- Reina Eye Care P.A.
-
Miami, Florida, Spojené státy, 33155
- La Salud Research Clinic Inc.
-
Miami, Florida, Spojené státy, 33156
- South Florida Center for Endoscopy and Digestive Disease, LLC
-
Naples, Florida, Spojené státy, 34102
- Gastroenterology Group of Naples
-
Naples, Florida, Spojené státy, 34102
- Gulfshore Endoscopy Center
-
Naples, Florida, Spojené státy, 34103
- Retina Consultants of Southwest Florida OCT only
-
Naples, Florida, Spojené státy, 34109
- Lisette Delgado Sanchez, MD PFT only
-
Orlando, Florida, Spojené státy, 32825
- Pediatric & Adult Research Center
-
Palmetto Bay, Florida, Spojené státy, 33157
- IMIC Inc.
-
Palmetto Bay, Florida, Spojené státy, 33157
- IMIC Inc
-
Port Orange, Florida, Spojené státy, 32127
- Advanced Medical Research Center
-
Seminole, Florida, Spojené státy, 33777
- Bardmoor GastroEnterology
-
South Miami, Florida, Spojené státy, 33143
- Larkin Community Hospital (Endoscopy Procedure)
-
St. Petersburg, Florida, Spojené státy, 33705
- St. Petersburg Endoscopy Center (Endoscopy Procedures)
-
St. Petersburg, Florida, Spojené státy, 33707
- Pasadena Center for Asthma and Lung Disorders (PFT and DLCO Only)
-
St. Petersburg, Florida, Spojené státy, 33709
- Bay Area Endoscopy and Surgery Center (Endoscopy only)
-
St. Petersburg, Florida, Spojené státy, 33709
- Theia Clinical Research, LLC
-
St. Petersburg, Florida, Spojené státy, 33710
- Advanced Research Institute Inc.(IP and PFT)
-
Sun City Center, Florida, Spojené státy, 33573
- Absolute Surgical Specialist - Craig Amshel, MD
-
Tampa, Florida, Spojené státy, 33612
- USF Health Morsani Center for Advanced Healthcare
-
Tampa, Florida, Spojené státy, 33606
- USF Health South Tampa Center for Advanced Healthcare
-
Tampa, Florida, Spojené státy, 33609
- GCP Clinical Research,LLC
-
Tampa, Florida, Spojené státy, 33609
- South Tampa Surgery Center
-
Tampa, Florida, Spojené státy, 33609
- Newsome Eye Specialist (OCT Procedures Only)
-
Tampa, Florida, Spojené státy, 33606
- Lab - Processing/ Storage
-
Tampa, Florida, Spojené státy, 33609
- LoCicero Medical Group
-
-
Georgia
-
Atlanta, Georgia, Spojené státy, 30342
- Atlanta Gastroenterology Associates
-
Atlanta, Georgia, Spojené státy, 30309
- Digestive Healthcare of Georgia
-
Atlanta, Georgia, Spojené státy, 30324
- Ross Eyecare - Opthalmoscopy and OCT
-
Atlanta, Georgia, Spojené státy, 30342
- Atlanta Gastroenterology Associates (endoscopy only)
-
Atlanta, Georgia, Spojené státy, 30342
- Atlanta Gastroenterology Associates(IP only)
-
Atlanta, Georgia, Spojené státy, 30309
- Peachtree Allergy and Asthma Clinic - Chest X-rays and PFTs
-
-
Illinois
-
Arlington Heights, Illinois, Spojené státy, 60005
- GI Alliance
-
Arlington Heights, Illinois, Spojené státy, 60005
- Northwest Endoscopy Center (Endoscopy)
-
Gurnee, Illinois, Spojené státy, 60031
- GI Alliance (PFT)
-
Gurnee, Illinois, Spojené státy, 60031
- Illinois Gastroenterology Group-Gurnee (Patients Seen; IP Delivered)
-
Gurnee, Illinois, Spojené státy, 60031
- Medical Eye Services LTD (Ophthalmoscopy with OCT)
-
Lake Bluff, Illinois, Spojené státy, 60044
- North Shore Endoscopy Center (Endoscopy)
-
Libertyville, Illinois, Spojené státy, 60048
- Libertyville Imaging Center (Diagnostic Imaging)
-
Morton Grove, Illinois, Spojené státy, 60053
- 3T Imaging of Morton Grove (Diagnostic Imaging)
-
-
Maryland
-
Columbia, Maryland, Spojené státy, 21045
- Cascades Endoscopy Center
-
Columbia, Maryland, Spojené státy, 21044
- Charter Radiology
-
Columbia, Maryland, Spojené státy, 21045
- Gastro Center of Maryland, LLC
-
Hanover, Maryland, Spojené státy, 21076
- Kaylani Eye Care ( Optical Coherence Tomography and Opthalmoscopy only)
-
Laurel, Maryland, Spojené státy, 20707
- Lung Center (Pulmonary Function Test only)
-
-
Mississippi
-
Jackson, Mississippi, Spojené státy, 39216
- Southern Therapy and Advanced Research, LLC
-
Jackson, Mississippi, Spojené státy, 39216
- A Terrell Williams, MD, PLLC (OCT)
-
Jackson, Mississippi, Spojené státy, 39216
- Jackson Pulmonary Associates (PFT)
-
Jackson, Mississippi, Spojené státy, 39216
- St. Dominic Ambulatory Surgery Center (colonoscopy, Endoscopy)
-
-
Missouri
-
Creve Coeur, Missouri, Spojené státy, 63141
- Barnes-Jewish West County Hospital (Additional Endoscopy Location)
-
St Louis, Missouri, Spojené státy, 63110
- Barnes-Jewish Hospital
-
St Louis, Missouri, Spojené státy, 63110
- Washington University School of Medicine
-
St Louis, Missouri, Spojené státy, 63108
- Washington University School of Medicine
-
-
New Jersey
-
Freehold, New Jersey, Spojené státy, 07728
- Allied Health Clinical Research Organization, LLC
-
Freehold, New Jersey, Spojené státy, 07728
- Freehold Endoscopy Associates, LLC d/b/a Endoscopy Center of Monmouth County
-
Freehold, New Jersey, Spojené státy, 07728
- Freehold Ophthalmology
-
Freehold, New Jersey, Spojené státy, 07728
- Monmouth Ocean Pulmonary Medicine
-
Freehold, New Jersey, Spojené státy, 07728
- Princeton Radiology
-
-
New York
-
New York, New York, Spojené státy, 10016
- NYU Langone Health
-
New York, New York, Spojené státy, 10016
- NYU Langone Inflammatory Bowel Disease Center
-
New York, New York, Spojené státy, 10016
- NYU Langone Eye Center (Ophthalmology)
-
New York, New York, Spojené státy, 10016
- NYU Langone Health - Ambulatory Care Center
-
New York, New York, Spojené státy, 10016
- NYU Langone Health, Investigational Pharmacy, Perlmutter Cancer Center
-
New York, New York, Spojené státy, 10016
- NYU Pulmonary and Critical Care Associates (Pulmonary)
-
-
North Carolina
-
Charlotte, North Carolina, Spojené státy, 28215
- Carolinas Research Center
-
Charlotte, North Carolina, Spojené státy, 28204
- Queen City Gastroenterology and Hepatology (Endoscopy)
-
Charlotte, North Carolina, Spojené státy, 28211
- Greenman Eye Associates (OCT)
-
Charlotte, North Carolina, Spojené státy, 28273
- Cornerstone Medical (Imaging & PFT)
-
-
Ohio
-
Chardon, Ohio, Spojené státy, 44024
- Geauga Sleep Center(PFT only)
-
Cincinnati, Ohio, Spojené státy, 45219
- UC Health Physicians Office
-
Cincinnati, Ohio, Spojené státy, 45229
- UC Health (Pulmonary Function Testing)
-
Cincinnati, Ohio, Spojené státy, 45219
- UC Health Hoxworth (OCT only)
-
Cincinnati, Ohio, Spojené státy, 45219
- University of Cincinnati Medical Center (PFT and Endoscopy location)
-
Mentor, Ohio, Spojené státy, 44060
- Great Lakes Gastroenterology Research, LLC
-
Mentor, Ohio, Spojené státy, 44060
- The Endoscopy Center of Lake County
-
Mentor, Ohio, Spojené státy, 44060
- Ophthalmic Physicians Incorporated (OCT Only)
-
Mentor, Ohio, Spojené státy, 44060
- Vitreo Retinal Consultants(OCT only)
-
Willoughby, Ohio, Spojené státy, 44094
- Lake Pulmonary Associates (PFT only)
-
Willoughby Hills, Ohio, Spojené státy, 44094
- Retina Specialists of Ohio(OCT only)
-
-
Oklahoma
-
Norman, Oklahoma, Spojené státy, 73071
- Norman Endoscopy Center
-
Norman, Oklahoma, Spojené státy, 73071
- Physicians and Surgeons X-Ray
-
Oklahoma City, Oklahoma, Spojené státy, 73118
- Central Sooner Research
-
Oklahoma City, Oklahoma, Spojené státy, 73102
- Hightower Clinical
-
Oklahoma City, Oklahoma, Spojené státy, 73102
- Saint Anthony Endoscopy Center
-
Oklahoma City, Oklahoma, Spojené státy, 73102
- SSM Health, Saint Anthony Hospital
-
Oklahoma City, Oklahoma, Spojené státy, 73120
- Johnston Opthalmology
-
-
Pennsylvania
-
Hershey, Pennsylvania, Spojené státy, 17033
- Penn State Milton S. Hershey Medical Center
-
-
Texas
-
Austin, Texas, Spojené státy, 78705
- Central Texas Clinical Research
-
Cypress, Texas, Spojené státy, 77429
- Houston Pulmonary Sleep and Allergy Associates (PFT)
-
Houston, Texas, Spojené státy, 77030
- The University of Texas Health Science Center at Houston
-
Houston, Texas, Spojené státy, 77030
- Baylor St. Luke's Medical Center
-
Houston, Texas, Spojené státy, 77047
- Pearland Surgery Center
-
Houston, Texas, Spojené státy, 77030
- Alkek Eye Center Jamail Specialty Care Center (OCT)
-
Houston, Texas, Spojené státy, 77024
- Houston Eye Associates (For Eye Examination)
-
Houston, Texas, Spojené státy, 77030
- Baylor College of Medicine - Baylor St. Luke's Medical Center
-
Houston, Texas, Spojené státy, 77030
- Baylor St. Luke's Medical Center - McNair Campus (pharmacy)
-
Houston, Texas, Spojené státy, 77030
- Baylor St. Luke's Medical Center - McNair Campus
-
Houston, Texas, Spojené státy, 77030
- Baylor St. Luke's Medical Center Endoscopy - McNair Campus
-
Houston, Texas, Spojené státy, 77030
- Mann Eye Institute
-
Houston, Texas, Spojené státy, 77030
- Memorial Hermann Hospital- TMC Investigational Drugs Services Pharmacy (Drug Storage)
-
Houston, Texas, Spojené státy, 77034
- Bay Area Endoscopy Center, LLC
-
Houston, Texas, Spojené státy, 77055
- Memorial Endoscopy Center (For Colonoscopy)
-
Houston, Texas, Spojené státy, 77065
- Eye Specialists of Texas
-
Houston, Texas, Spojené státy, 77065
- Northside Gastroenterology Associates PA
-
Houston, Texas, Spojené státy, 77079
- Memorial Pulmonology(For PFT)
-
Houston, Texas, Spojené státy, 77204
- Digestive Health Associates
-
Houston, Texas, Spojené státy, 77204
- Memorial Hermann Memorial City Digestive Health Center (For Colonoscopy)
-
Pearland, Texas, Spojené státy, 77584
- LinQ Research, LLC
-
Tyler, Texas, Spojené státy, 75701
- Tyler Research Institute, LLC
-
Tyler, Texas, Spojené státy, 75701
- UT Health East Texas Physicians (pulmonary functions only)
-
Tyler, Texas, Spojené státy, 75701
- Christus Trinity Mother Frances Endoscopy Center (endoscopies only)
-
Tyler, Texas, Spojené státy, 75701
- Heaton Eye Associates (OCT only)
-
Victoria, Texas, Spojené státy, 77904
- Victoria Gastroenterology
-
Victoria, Texas, Spojené státy, 77904
- Citizens Healthplex (for PFT only)
-
Victoria, Texas, Spojené státy, 77904
- Surgery Center (For endoscopy only)
-
Victoria, Texas, Spojené státy, 77904
- Victoria Eye Center (For OCT only)
-
Webster, Texas, Spojené státy, 77598
- GI Alliance Webster
-
-
Virginia
-
Forest, Virginia, Spojené státy, 24551
- Harman Eye Center (OCT only)
-
Lynchburg, Virginia, Spojené státy, 24502
- Blue Ridge Medical Research
-
Lynchburg, Virginia, Spojené státy, 24501
- Lynchburg Pulmonary Associates, Inc. (PFT only)
-
-
Washington
-
Issaquah, Washington, Spojené státy, 98029
- Swedish Endoscopy Center - Issaquah
-
Seattle, Washington, Spojené státy, 98122
- Swedish Medical Center
-
Seattle, Washington, Spojené státy, 98104
- Swedish Gastroenterology
-
Seattle, Washington, Spojené státy, 98104
- Pacific Northwest Retina
-
Seattle, Washington, Spojené státy, 98104
- Richard Bensinger, MD
-
Seattle, Washington, Spojené státy, 98122
- First Hill Endoscopy Center
-
Seattle, Washington, Spojené státy, 98122
- Pulmonary Function Lab
-
-
Wisconsin
-
Milwaukee, Wisconsin, Spojené státy, 53226
- Froedtert Memorial Lutheran Hospital
-
-
-
-
-
Belgrade, Srbsko, 11000
- Clinical Center Zvezdara
-
-
-
-
-
Ankara, Turecko (Türkiye), 06500
- Gazi University Medical Faculty
-
Ankara, Turecko (Türkiye), 06100
- Hacettepe University Medical Faculty
-
Ankara, Turecko (Türkiye), 06800
- T.C. Saglik Bakanligi Ankara Sehir Hastanesi
-
Antalya, Turecko (Türkiye), 07100
- Saglik Bilimleri Universitesi Antalya Egitim ve Arastirma Hastanesi
-
Izmir, Turecko (Türkiye), 35100
- Ege Universitesi Tip Fakultesi Hastanesi
-
Kocaeli, Turecko (Türkiye), 41380
- Kocaeli University Research and Training Hospital
-
Yenişehir, Turecko (Türkiye), 33343
- Mersin University Faculty of Medicine
-
-
-
-
-
Kharkiv, Ukrajina, 61124
- Communal Non-commercial Enterprise City Clinical Hospital #13 of Kharkiv City Council
-
Kharkiv, Ukrajina, 61024
- LLC "EyeQClinic"
-
Kharkiv, Ukrajina, 61022
- Llc "Ldts Skaymed'
-
Kharkiv, Ukrajina, 61037
- Communal Non-commercial Enterprise Prof. O.O. Shalimov City Clinical Hospital #2 of Kharkiv
-
Kharkiv, Ukrajina, 61045
- Llc "Medical Center Oftalmika"
-
Kharkiv, Ukrajina, 61103
- Municipal Health Care "Kharkiv City Hospital Ambulance and Emergency Medical care
-
Kyiv, Ukrajina, 01135
- Medical Center of Limited Liability Company Harmoniia Krasy
-
Kyiv, Ukrajina, 02091
- Med Center 'Ok!Clinic+' of Comp with limited liability "Int Inst of Clin Research", Unit of Gastro
-
Kyiv, Ukrajina, 04210
- Private Enterprise "Clinic Medicom"
-
Lutsk, Ukrajina, 43005
- CE Volyn Reg Clinical Hospital ofVolyn Reg Council, Surgical (Endocrine and Abdominal Pathology)
-
Vinnytsia, Ukrajina, 21000
- Private Enterprise Diagnostic Center "Mediscan"
-
Vinnytsia, Ukrajina, 21009
- Medical Center of LLC Health Clinic, Medical Clinical Research Center, Unit of Gastroenterology,
-
Vinnytsia, Ukrajina, 21018
- CNE of M.I. Pyrohov Vinnytsia Regional Clinical Hospital of Vinnytsia Regional Council, Reg
-
Vinnytsia, Ukrajina, 21029
- Scientific and Research Institute of Invalid Rehabilitation (Educational, Scientific and Treatment
-
-
-
-
-
Horažďovice, Česko, 341 01
- MUDr. Jaroslava Skalova
-
Hradec Králové, Česko, 500 12
- Hepato-gastroenterologie HK, s.r.o.
-
Hradec Králové, Česko, 500 12
- VISUS, spol s.r.o.
-
Klatovy, Česko, 339 01
- GASTRO JeKa, s.r.o.
-
Klatovy, Česko, 339 01
- Klatovska nemocnice a.s.
-
Olomouc, Česko, 779 00
- PreventaMed s.r.o.
-
Olomouc, Česko, 779 00
- Ocni ordinace Olomouc
-
Olomouc, Česko, 779 00
- MUDr. Pavlina Kazinotova s.r.o.
-
-
-
-
-
Alexandroupoli, Řecko, 681 00
- University General Hospital of Alexandroupoli
-
Athens, Řecko, 10676
- General Hospital of Athens "Evangelismos"
-
-
Crete
-
Heraklion, Crete, Řecko, 71500
- Univerisity General Hospital of Heraklion
-
-
-
-
-
Las Palmas de Gran Canaria, Španělsko, 35010
- Hospital Universitario de Gran Canaria Dr. Negrín
-
Madrid, Španělsko, 28046
- Hospital Universitario La Paz
-
-
Ciudad REAL
-
Tomellso, Ciudad REAL, Španělsko, 13700
- Hospital General de Tomelloso
-
-
-
-
-
Bern, Švýcarsko, 3010
- Inselspital Bern
-
Bern, Švýcarsko, 3012
- OCT/Ophtalmoscopy: Berner Augenklinik am Lindenhofspital
-
-
Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
18 let až 80 let (Dospělý, Starší dospělý)
Přijímá zdravé dobrovolníky
Ne
Popis
Kritéria způsobilosti platná pro všechny dílčí studie:
Kritéria pro zařazení:
- Muži nebo ženy ve věku 18 až 80 let,
- Schopnost poskytnout písemný informovaný souhlas nebo souhlas a být v souladu s harmonogramem hodnocení protokolu
- Diagnóza Crohnovy choroby (CD) ≥ 3 měsíce
- Mějte středně až silně aktivní CD při screeningu
Prokázaná nepřiměřená odpověď (tj. primární nereagování), ztráta odpovědi nebo intolerance na ≥ 1 z následujících terapií pro léčbu CD:
- Perorální kortikosteroidy (např. prednison nebo jeho ekvivalent, budesonid)
- Imunosupresiva (např. azathioprin [AZA], 6-merkaptopurin [6-MP] nebo methotrexát [MTX])
- Antagonisté tumor nekrotizujícího faktoru alfa (TNFα) (např. infliximab, adalimumab, certolizumab pegol nebo biosimilars)
- Antagonista integrinového receptoru (např. vedolizumab)
- Antagonista interleukinu-12/-23 (např. ustekinumab)
- Ženy ve fertilním věku musí být netěhotné
- Ženy ve fertilním věku a muži musí používat antikoncepci
Kritéria vyloučení:
- Anamnéza nedostatečné odpovědi (tj. primární nereagování) na látky z ≥ 2 tříd biologických látek prodávaných pro léčbu CD (tj. antagonisté TNFa, antagonista interleukinu 12/23 a antagonista integrinového receptoru).
- Mít ulcerózní kolitidu, neurčitou kolitidu, mikroskopickou kolitidu, ischemickou kolitidu, radiační kolitidu, kolitidu spojenou s divertikulárním onemocněním, toxický megakolon nebo aktivní infekční kolitidu nebo pozitivní test na toxin Clostridioides difficile při screeningu.
- Máte funkční nebo pooperační syndrom krátkého střeva nebo jakékoli související komplikace, které mohou vyžadovat chirurgický zákrok nebo interferovat s hodnocením účinnosti
- Měli chirurgickou léčbu intraabdominálních abscesů ≤ 8 týdnů před randomizací nebo chirurgickou léčbu perianálních abscesů ≤ 4 týdny před randomizací.
- Měl intestinální resekci ≤ 24 týdnů před randomizací nebo jiné intraabdominální operace ≤ 12 týdnů před randomizací.
- Mít ileostomii nebo kolostomii.
Kritéria pro zařazení do dílčí studie 3:
- Účastníci, kteří vstoupili do prodlouženého indukčního období dílčí studie 1 a dílčí studie 2, musí absolvovat prodlouženou indukční návštěvu – týden 6
Kritéria pro zařazení do dílčí studie 4:
- Účastník musí absolvovat návštěvu 52. týdne dílčí studie 3 nebo návštěvu 66. týdne dílčí studie A
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Dvojnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
|
Komparátor placeba: Placebo
|
Etrasimod odpovídající placebo tableta užívaná ústy, jednou denně.
|
|
Experimentální: Etrasimod dávka A
|
Dávka A užívaná ústy, jednou denně.
Ostatní jména:
Dávka B užívaná ústy, jednou denně.
Ostatní jména:
|
|
Experimentální: Etrasimod dávka B
|
Dávka A užívaná ústy, jednou denně.
Ostatní jména:
Dávka B užívaná ústy, jednou denně.
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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.
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Week 14 of SS1
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Percentage of Participants With Clinical Remission by Patient Reported Outcomes 2 (PRO2) at Week 14: SS1
Časové okno: Week 14 of SS1
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Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
MI method was used; percentage was calculated based on average response rate from MI datasets.
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Week 14 of SS1
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Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Responder Cohort
Časové okno: Week 52 of study
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Clinical remission was CDAI score <150.
CDAI was a composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score: sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores= more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Non-Responder Cohort
Časové okno: Week 52 of study
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Clinical remission was CDAI score <150.
CDAI was a composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score: sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores= more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Responder Cohort
Časové okno: Week 52 of study
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Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD.
SES-CD= composite score based on 4 components: size of ulcers, ulcerated surface, affected surface, presence of narrowing in 5 segments: ileum; right; transverse; left colon; rectum.
Size of ulcers score: 0=none,1= aphthous ulcers, 2= large ulcers, 3= very large ulcers.
Ulcerated surface score: 0= none,1= <10%, 2= 10%-30%, 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50%-75%,3= >75%.
Presence of narrowing score: 0= none,1= single, can be passed, 2= multiple can be passed, 3= can't be passed.
Total SES CD=sum of component scores for 5 bowel segments and ranged from 0 (no disease) - 60 (severe disease), higher score indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to FMD date.
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Week 52 of study
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Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Non-Responder Cohort
Časové okno: 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.
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Week 52 of study
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Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Responder Cohort
Časové okno: Week 52 of study
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Corticosteroid-free remission: CDAI score <150 without receiving corticosteroids for >=8 weeks prior to Week 52 (for participants receiving corticosteroids at baseline).
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid stools; extent of abdominal pain from 0 (none)-3 (severe); general well-being from 0 (generally well)-4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women; percentage deviation from standard weight, lower bound -10.
Total CDAI score=sum of variable scores*weighting factor and was from 0 (no disease)-600 (severe disease), higher score indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Non-Responder Cohort
Časové okno: Week 52 of study
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Corticosteroid-free remission: CDAI score <150 without receiving corticosteroids for >=8 weeks prior to Week 52 (for participants receiving corticosteroids at baseline).
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid stools; extent of abdominal pain from 0 (none)-3 (severe); general well-being from 0 (generally well)-4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women; percentage deviation from standard weight, lower bound -10.
Total CDAI score=sum of variable scores*weighting factor and was from 0 (no disease)-600 (severe disease), higher score indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Percentage of Participants With Endoscopic Remission at Week 52: SS3 Responder Cohort
Časové okno: Week 52 of study
|
Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1.
SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed.
Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
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Week 52 of study
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Percentage of Participants With Endoscopic Remission at Week 52: SS3 Non-Responder Cohort
Časové okno: Week 52 of study
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Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1.
SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum.
Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers.
Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%.
Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%.
Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed.
Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
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Week 52 of study
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Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
Časové okno: 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
|
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Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort
Časové okno: Week 52 of study
|
Clinical remission was defined as PRO2 score <8.
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
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Week 52 of study
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Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Responder Cohort
Časové okno: Week 52 of study
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Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables.
Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease.
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD.
SES-CD comprised of 4 components assessed for 5 bowel segments.
Each component score ranged from 0-3, higher scores indicated more severe condition.
Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease.
Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
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Week 52 of study
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Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Non-Responder Cohort
Časové okno: Week 52 of study
|
Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables.
Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease.
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD.
SES-CD comprised of 4 components assessed for 5 bowel segments.
Each component score ranged from 0-3, higher scores indicated more severe condition.
Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease.
Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
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Week 52 of study
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Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Časové okno: Baseline, study Weeks 20, 28, 36, 44, 52
|
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44, 52
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Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
Časové okno: Baseline, study Weeks 20, 28, 36, 44, 52
|
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44, 52
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Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Responder Cohort
Časové okno: Week 52 of study
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Clinical Response was clinical remission by CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI= CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none)-3 (severe); general well-being rating assessed from 0 (generally well) - 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide/opiates for diarrhea; presence of an abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score= sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
|
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Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Non-Responder Cohort
Časové okno: Week 52 of study
|
Clinical Response was clinical remission by CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI= CDAI <150.
CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none)-3 (severe); general well-being rating assessed from 0 (generally well) - 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide/opiates for diarrhea; presence of an abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10.
Total CDAI score= sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), where higher scores indicated more severe disease.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Week 52 of study
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Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Responder Cohort
Časové okno: Baseline, study Weeks 28 and 52
|
The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms.
Each module ranged from 0 to 16, where higher scores indicated more severe disease.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Non-Responder Cohort
Časové okno: Baseline, study Weeks 28 and 52
|
The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms.
Each module ranged from 0 to 16, where higher scores indicated more severe disease.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 28 and 52: SS3 Responder Cohort
Časové okno: 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.
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Baseline, study Weeks 28 and 52
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Change From Baseline in IBDQ at Weeks 28 and 52: SS3 Non-Responder Cohort
Časové okno: Baseline, study Weeks 28 and 52
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The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD.
Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life.
The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Weeks 28 and 52: SS3 Responder Cohort
Časové okno: 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.
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Baseline, study Weeks 28 and 52
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Change From Baseline in SF-36 at Weeks 28 and 52: SS3 Non-Responder Cohort
Časové okno: Baseline, study Weeks 28 and 52
|
The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality.
The 8 domains are combined to form 2 component scores MCS and PCS.
MCS consisted of social functioning, vitality, mental health, and role-emotional scales.
PCS consisted of physical functioning, bodily pain, role-physical, and general health scales.
Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status.
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 28 and 52: SS3 Responder Cohort
Časové okno: Baseline, study Weeks 28 and 52
|
The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue.
Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much).
Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Change From Baseline in FACIT-F at Weeks 28 and 52: SS3 Non-Responder Cohort
Časové okno: Baseline, study Weeks 28 and 52
|
The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue.
Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much).
Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue).
SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 28 and 52
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Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at SS3 Baseline: SS3 Responder Cohort
Časové okno: 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
|
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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
Časové okno: 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
|
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Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Časové okno: Baseline, study Weeks 20, 28, 36, 44 and 52
|
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44 and 52
|
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Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
Časové okno: Baseline, study Weeks 20, 28, 36, 44 and 52
|
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI.
The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days.
The stool frequency was defined as number of liquid or soft stools each day for 7 days.
Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor.
The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
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Baseline, study Weeks 20, 28, 36, 44 and 52
|
|
Time to Remission by PRO2 and FCP Concentrations: SS3 Responder Cohort
Časové okno: 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.
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From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks)
|
|
Time to Remission by PRO2 and FCP Concentrations: SS3 Non-Responder Cohort
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Spolupracovníci
Vyšetřovatelé
- Ředitel studie: Pfizer CT.gov Call Center, Pfizer
Publikace a užitečné odkazy
Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Aktuální)
6. ledna 2020
Primární dokončení (Aktuální)
23. dubna 2025
Dokončení studie (Aktuální)
9. června 2025
Termíny zápisu do studia
První předloženo
20. listopadu 2019
První předloženo, které splnilo kritéria kontroly kvality
20. listopadu 2019
První zveřejněno (Aktuální)
21. listopadu 2019
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
1. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
5. června 2026
Naposledy ověřeno
1. června 2026
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- APD334-202
- C5041006 (Jiný identifikátor: Alias Study Number)
- 2024-513569-38-00 (Identifikátor registru: CTIS (EU))
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
ANO
Popis plánu IPD
Společnost Pfizer poskytne přístup k jednotlivým neidentifikovaným údajům účastníků a souvisejícím studijním dokumentům (např.
protokol, plán statistické analýzy (SAP), zprávu o klinické studii (CSR)) na žádost kvalifikovaných výzkumných pracovníků a za určitých kritérií, podmínek a výjimek.
Další podrobnosti o kritériích sdílení dat společnosti Pfizer a procesu žádosti o přístup naleznete na adrese: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
produkt vyrobený a vyvážený z USA
Ne
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .