Tämä sivu käännettiin automaattisesti, eikä käännösten tarkkuutta voida taata. Katso englanninkielinen versio lähdetekstiä varten.

Tutkimus, jossa arvioidaan oraalisen etrasimodin tehoa ja turvallisuutta aikuisten potilaiden hoidossa, joilla on kohtalaisen tai vaikeasti aktiivinen Crohnin tauti (CULTIVATE)

perjantai 5. kesäkuuta 2026 päivittänyt: Pfizer

Monikeskus, satunnaistettu, kaksoissokkoutettu, rinnakkaisryhmätutkimus suun kautta otettavan etrasimodin tehon ja turvallisuuden arvioimiseksi induktio- ja ylläpitohoitona kohtalaisen tai vaikeasti aktiivisen Crohnin taudin hoidossa

Tämä on vaiheen 2/3 tutkimus, joka käsittää 5 alatutkimusta, joiden tarkoituksena on arvioida suun kautta otettavan etrasimodin tehoa, turvallisuutta ja siedettävyyttä terapiana aikuisilla potilailla, joilla on keskivaikea tai vaikea aktiivinen Crohnin tauti (CD), jotka eivät kestä tai eivät siedä vähintään yhtä nykyiset CD:n hoidot (eli kortikosteroidit, immunosuppressantit tai biologiset lääkkeet). Tämän tutkimuksen kokonaiskesto on enintään 282 viikkoa, mukaan lukien 28 päivän seulontajakso, enintään 274 viikon hoitojakso (induktio-, jatko- tai ylläpitojaksot ja pitkäkestoiset jatkojaksot) ja 4 viikon seurantajaksot. Ylös Turvallisuusarvioinnin aika.

Tutkimuksen yleiskatsaus

Tila

Lopetettu

Ehdot

Interventio / Hoito

Yksityiskohtainen kuvaus

Tämä tutkimus sisältää 5 alatutkimusta:

Alatutkimus A – Vaihe 2: Vaihe 2, satunnaistettu, kaksoissokkoutettu alatutkimus, jossa arvioidaan oraalisen etrasimodihoidon turvallisuutta, siedettävyyttä ja tehoa potilailla, joilla on kohtalainen tai vaikea CD ja joka tukee induktio- ja ylläpitoannosten valintaa Vaiheelle 3. Osatutkimus A on tällä hetkellä suljettu ilmoittautumiselle.

Alatutkimus 1 - Vaihe 2: Vaiheen 2b satunnaistettu, kaksoissokkoutettu, lumekontrolloitu, annosvälitteinen induktioalatutkimus, jossa arvioitiin etrasimodia induktiohoitona ja valitaan induktio- ja ylläpitoannos(t) jatkuvaa arviointia varten vaiheessa 3. Alatutkimus 1 on tällä hetkellä ilmoittautuneita osallistujia.

Alatutkimus 2 - Induktio: Vaiheen 3 satunnaistettu, kaksoissokkoutettu, lumekontrolloitu alatutkimus etrasimodin arvioimiseksi induktiohoitona.

Alatutkimus 3 – Ylläpito: Vaiheen 3 satunnaistettu, kaksoissokkoutettu, lumekontrolloitu alatutkimus etrasimodin arvioimiseksi ylläpitohoitona. Osatutkimuksen 1 ja osatutkimuksen 2 osallistujat kirjataan osatutkimukseen 3.

Alatutkimus 4 – Pitkäaikainen jatkotutkimus: Pitkäaikainen jatkotutkimus osallistujille, jotka suorittavat vähintään 52 viikon hoidon. Osanottajat osatutkimuksesta 3 ja osatutkimuksesta A on tarkoitus ilmoittautua osatutkimukseen 4.

Opintotyyppi

Interventio

Ilmoittautuminen (Todellinen)

379

Vaihe

  • Vaihe 2
  • Vaihe 3

Yhteystiedot ja paikat

Tässä osiossa on tutkimuksen suorittajien yhteystiedot ja tiedot siitä, missä tämä tutkimus suoritetaan.

Opiskelupaikat

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

Osallistumiskriteerit

Tutkijat etsivät ihmisiä, jotka sopivat tiettyyn kuvaukseen, jota kutsutaan kelpoisuuskriteereiksi. Joitakin esimerkkejä näistä kriteereistä ovat henkilön yleinen terveydentila tai aiemmat hoidot.

Kelpoisuusvaatimukset

Opintokelpoiset iät

18 vuotta - 80 vuotta (Aikuinen, Vanhempi Aikuinen)

Hyväksyy terveitä vapaaehtoisia

Ei

Kuvaus

Kaikkiin osatutkimuksiin sovellettavat kelpoisuusvaatimukset:

Sisällyttämiskriteerit:

  • 18-80-vuotiaat miehet tai naiset,
  • Kyky antaa kirjallinen tietoinen suostumus tai suostumus ja noudattaa pöytäkirjan arviointien aikataulua
  • Diagnosoitu Crohnin tauti (CD) ≥ 3 kuukautta
  • Sinulla on kohtalaisen tai vaikeasti aktiivinen CD seulonnassa

  • Osoitettu riittämätön vaste (eli ensisijainen vasteen puuttuminen), vasteen menetys tai intoleranssi ≥ yhdelle seuraavista hoidoista CD:n hoidossa:

    1. Suun kautta otettavat kortikosteroidit (esim. prednisoni tai sen vastaava, budesonidi)
    2. Immunosuppressantit (esim. atsatiopriini [AZA], 6-merkaptopuriini [6-MP] tai metotreksaatti [MTX])
    3. Tuumorinekroositekijä alfa (TNFα) -antagonistit (esim. infliksimabi, adalimumabi, sertolitsumabipegol tai biologisesti samankaltaiset aineet)
    4. Integriinireseptorin antagonisti (esim. vedolitsumabi)
    5. Interleukiini-12/-23-antagonisti (esim. ustekinumabi)
  • Hedelmällisessä iässä olevien naisten tulee olla ei-raskaana
  • Hedelmällisessä iässä olevien naisten ja miesten on käytettävä ehkäisyä

Poissulkemiskriteerit:

  • Aiemmat riittämättömät vasteet (eli ensisijainen vasteen puuttuminen) aineille, jotka kuuluvat ≥ 2:n CD-taudin hoitoon markkinoitujen biologisten aineiden luokkaan (ts. TNFα-antagonistit, interleukiini 12/23 -antagonistit ja integriinireseptorin antagonistit).
  • Sinulla on haavainen paksusuolitulehdus, määrittelemätön paksusuolitulehdus, mikroskooppinen paksusuolitulehdus, iskeeminen paksusuolitulehdus, säteilyn paksusuolitulehdus, divertikulaariseen sairauteen liittyvä paksusuolentulehdus, toksinen megakooloni tai aktiivinen tarttuva paksusuolentulehdus tai Clostridioides difficile -toksiinitesti positiivinen seulonnassa.
  • sinulla on toiminnallinen tai leikkauksen jälkeinen lyhytsuolioireyhtymä tai muita siihen liittyviä komplikaatioita, jotka saattavat vaatia leikkausta tai häiritä tehon arviointeja
  • Oli kirurginen hoito vatsansisäisten paiseiden vuoksi ≤ 8 viikkoa ennen satunnaistamista tai kirurginen hoito perianaalisten paiseiden vuoksi ≤ 4 viikkoa ennen satunnaistamista.
  • Suolen resektio ≤ 24 viikkoa ennen satunnaistamista tai muita vatsansisäisiä leikkauksia ≤ 12 viikkoa ennen satunnaistamista.
  • Tee ileostomia tai kolostomia.

Osatutkimuksen 3 osallistumiskriteerit:

- Osallistujien, jotka tulivat osatutkimuksen 1 ja osatutkimuksen 2 pidennetylle perehdytysjaksolle, on täytynyt suorittaa pidennetty perehdytys -viikko 6 -käynti

Osatutkimuksen 4 osallistumiskriteerit:

- Osallistujan on täytynyt suorittaa osatutkimuksen 3 viikon 52 käynti tai osatutkimuksen A viikon 66 käynti

Opintosuunnitelma

Tässä osiossa on tietoja tutkimussuunnitelmasta, mukaan lukien kuinka tutkimus on suunniteltu ja mitä tutkimuksella mitataan.

Miten tutkimus on suunniteltu?

Suunnittelun yksityiskohdat

  • Ensisijainen käyttötarkoitus: Hoito
  • Jako: Satunnaistettu
  • Inventiomalli: Rinnakkaistehtävä
  • Naamiointi: Kaksinkertainen

Aseet ja interventiot

Osallistujaryhmä / Arm
Interventio / Hoito
Placebo Comparator: Plasebo
Lääke: Plasebo
Etrasimodia vastaava lumetabletti suun kautta kerran vuorokaudessa.
Kokeellinen: Etrasimodin annos A
Lääke: Etrasimod
Annos A otetaan suun kautta kerran päivässä.
Muut nimet:
  • APD334
Lääke: Etrasimod
Annos B suun kautta kerran päivässä.
Muut nimet:
  • APD334
Kokeellinen: Etrasimodin annos B
Lääke: Etrasimod
Annos A otetaan suun kautta kerran päivässä.
Muut nimet:
  • APD334
Lääke: Etrasimod
Annos B suun kautta kerran päivässä.
Muut nimet:
  • APD334

Mitä tutkimuksessa mitataan?

Ensisijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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

Toissijaiset tulostoimenpiteet

Tulosmittaus
Toimenpiteen kuvaus
Aikaikkuna
Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Week 14 of SS1
Clinical remission was considered as CDAI score <150. CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease. MI method was used; percentage was calculated based on average response rate from MI datasets.
Week 14 of SS1
Percentage of Participants With Clinical Remission by Patient Reported Outcomes 2 (PRO2) at Week 14: SS1
Aikaikkuna: Week 14 of SS1
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. MI method was used; percentage was calculated based on average response rate from MI datasets.
Week 14 of SS1
Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Clinical remission was CDAI score <150. CDAI was a composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score: sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores= more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Percentage of Participants With Clinical Remission by CDAI at Week 52 Among Participants With Clinical Remission by CDAI at SS3 Baseline: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Clinical remission was CDAI score <150. CDAI was a composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT: 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score: sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores= more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD. SES-CD= composite score based on 4 components: size of ulcers, ulcerated surface, affected surface, presence of narrowing in 5 segments: ileum; right; transverse; left colon; rectum. Size of ulcers score: 0=none,1= aphthous ulcers, 2= large ulcers, 3= very large ulcers. Ulcerated surface score: 0= none,1= <10%, 2= 10%-30%, 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50%-75%,3= >75%. Presence of narrowing score: 0= none,1= single, can be passed, 2= multiple can be passed, 3= can't be passed. Total SES CD=sum of component scores for 5 bowel segments and ranged from 0 (no disease) - 60 (severe disease), higher score indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to FMD date.
Week 52 of study
Percentage of Participants With Endoscopic Response at Week 52 Among Participants With Endoscopic Response at SS3 Baseline: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from parent study (SS1) baseline in SES-CD. SES-CD= composite score based on 4 components: size of ulcers, ulcerated surface, affected surface, presence of narrowing in 5 segments: ileum; right; transverse; left colon; rectum. Size of ulcers score: 0=none,1= aphthous ulcers, 2= large ulcers, 3= very large ulcers. Ulcerated surface score: 0= none,1= <10%, 2= 10%-30%, 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50%-75%,3= >75%. Presence of narrowing score: 0= none,1= single, can be passed, 2= multiple can be passed, 3= can't be passed. Total SES CD=sum of component scores for 5 bowel segments and ranged from 0 (no disease) - 60 (severe disease), higher score indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to FMD date.
Week 52 of study
Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Corticosteroid-free remission: CDAI score <150 without receiving corticosteroids for >=8 weeks prior to Week 52 (for participants receiving corticosteroids at baseline). CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid stools; extent of abdominal pain from 0 (none)-3 (severe); general well-being from 0 (generally well)-4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women; percentage deviation from standard weight, lower bound -10. Total CDAI score=sum of variable scores*weighting factor and was from 0 (no disease)-600 (severe disease), higher score indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Percentage of Participants With Corticosteroid-Free Clinical Remission by CDAI at Week 52 Among Participants Receiving Corticosteroids at SS3 Baseline: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Corticosteroid-free remission: CDAI score <150 without receiving corticosteroids for >=8 weeks prior to Week 52 (for participants receiving corticosteroids at baseline). CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid stools; extent of abdominal pain from 0 (none)-3 (severe); general well-being from 0 (generally well)-4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women; percentage deviation from standard weight, lower bound -10. Total CDAI score=sum of variable scores*weighting factor and was from 0 (no disease)-600 (severe disease), higher score indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed. Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
Week 52 of study
Percentage of Participants With Endoscopic Remission at Week 52: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Endoscopic remission: SES-CD score <=4 and at least 2-point reduction from baseline with no sub-score >1. SES-CD consisted of a composite score based on 4 components: size of ulcers, ulcerated surface, affected surface and presence of narrowing assessed in 5 segments: ileum; right; transverse; left colon and rectum. Size of ulcers score: 0=none, 1=aphthous ulcers, 2=large ulcers and 3=very large ulcers. Ulcerated surface score: 0= none, 1= <10%, 2= 10% - 30% and 3= >30%. Affected surface score: 0= unaffected segment, 1= <50%, 2= 50% - 75%, and 3= >75%. Presence of narrowing score: 0=none, 1= single, can be passed, 2=multiple, can be passed, 3= cannot be passed. Total SES CD=sum of each component score for all 5 bowel segments and ranged from 0 (no disease)-60 (severe disease), higher score indicated more severe disease.
Week 52 of study
Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Week 52 of study
Percentage of Participants With Clinical Remission by PRO2 at Week 52: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Week 52 of study
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150. CDAI: composite index consisting of weighted scoring of 8 disease activity variables. Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease. Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD. SES-CD comprised of 4 components assessed for 5 bowel segments. Each component score ranged from 0-3, higher scores indicated more severe condition. Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease. Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
Week 52 of study
Percentage of Participants With Clinical Response or Endoscopic Response at Week 52: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Clinical response: clinical remission CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI=CDAI <150. CDAI: composite index consisting of weighted scoring of 8 disease activity variables. Total CDAI: sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), higher scores indicated more severe disease. Endoscopic response: SES-CD score <=4 and at least 2-point reduction from baseline with no subscore >1 or >=50% decrease from baseline in SES-CD. SES-CD comprised of 4 components assessed for 5 bowel segments. Each component score ranged from 0-3, higher scores indicated more severe condition. Total SES CD: sum of each component score of 5 bowel segments and ranged from 0 (no D) - 60 (severe disease), higher score indicated more severe disease. Percentage of participants with clinical response or endoscopic response at Week 52 is reported.
Week 52 of study
Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Aikaikkuna: Baseline, study Weeks 20, 28, 36, 44, 52
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44, 52
Change From Baseline in CDAI Score at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
Aikaikkuna: Baseline, study Weeks 20, 28, 36, 44, 52
CDAI was a composite index consisting of a weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none) to 3 (severe); general well-being rating assessed from 0 (generally well) to 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide or opiates for diarrhea; presence of an abdominal mass (0 as none, 2 as questionable, 5 as definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score was calculated as the sum of variable scores*weighting factor and ranged from 0 (no disease) to 600 (severe disease), where higher scores indicated more severe disease. SS3 Baseline was last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44, 52
Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Clinical Response was clinical remission by CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI= CDAI <150. CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none)-3 (severe); general well-being rating assessed from 0 (generally well) - 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide/opiates for diarrhea; presence of an abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score= sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), where higher scores indicated more severe disease. SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Percentage of Participants With Clinical Response by CDAI at Week 52 Among Participants With Clinical Response by CDAI at SS3 Baseline: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Clinical Response was clinical remission by CDAI or >=100-point decrease from baseline in CDAI score where, clinical remission CDAI= CDAI <150. CDAI: composite index consisting of weighted scoring of 8 disease activity variables: number of liquid or soft stools; extent of abdominal pain graded from 0 (none)-3 (severe); general well-being rating assessed from 0 (generally well) - 4 (terrible); presence of complications; taking diphenoxylate/atropine, loperamide/opiates for diarrhea; presence of an abdominal mass (0=none, 2=questionable, 5=definite); HCT 47 in men and 42 in women and percentage deviation from standard weight, lower bound -10. Total CDAI score= sum of variable scores*weighting factor and ranged from 0 (no disease) - 600 (severe disease), where higher scores indicated more severe disease. SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms. Each module ranged from 0 to 16, where higher scores indicated more severe disease. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Crohn's Disease Patient-Reported Outcomes (CD-PRO) Module Scores at Weeks 28 and 52: SS3 Non-Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The CD-PRO was a validated instrument designed to assess the signs, symptoms, and impact of CD through 6 modules: Systemic Symptoms, Coping Strategies, Daily Life Impact, Emotional Impact, Bowel Signs and Symptoms and Functional Symptoms. Each module ranged from 0 to 16, where higher scores indicated more severe disease. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Inflammatory Bowel Disease Questionnaire (IBDQ) at Weeks 28 and 52: SS3 Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD. Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life. The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in IBDQ at Weeks 28 and 52: SS3 Non-Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The IBDQ was a validated 32 item questionnaire used to assess health related quality of life in participants with IBD. Response to each of the questions ranged from 1 to 7 where higher scores indicated better quality of life. The total IBDQ scores were calculated as sum of individual item scores and ranged from 32 (very poor health-related quality of life) to 224 (perfect health-related quality of life) where higher scores indicated better quality of life. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Medical Outcomes Study 36-Item Short Form Health Survey (SF-36) at Weeks 28 and 52: SS3 Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality. The 8 domains are combined to form 2 component scores mental (MCS) and physical (PCS). MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status. SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in SF-36 at Weeks 28 and 52: SS3 Non-Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The SF-36 was a health-related survey that assessed participant's health status and consisted of 36 questions measuring 8 health domains: physical functioning, bodily pain, role limitations due to physical problems, role limitations due to emotional problems, general health perceptions, mental health, social function and vitality. The 8 domains are combined to form 2 component scores MCS and PCS. MCS consisted of social functioning, vitality, mental health, and role-emotional scales. PCS consisted of physical functioning, bodily pain, role-physical, and general health scales. Each domain was scored by summing the individual items and transforming the total SF-36 scores into a 0 to 100 scale with higher scores indicating better health status. SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Weeks 28 and 52: SS3 Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Change From Baseline in FACIT-F at Weeks 28 and 52: SS3 Non-Responder Cohort
Aikaikkuna: Baseline, study Weeks 28 and 52
The FACIT-F was a participant completed questionnaire consisting of 13 items that assess fatigue. Participants responded to each item on a 5-point scale based on their experience of fatigue during the past 7 days (0 = not at all; 1 = a little bit; 2 =somewhat; 3 = quite a bit; 4 = very much). Instrument scoring yielded a total FACIT-F score range from 0 to 52 (negatively worded items were reversed during analysis), with higher scores representing better participant status (less fatigue). SS3 Baseline= last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 28 and 52
Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at SS3 Baseline: SS3 Responder Cohort
Aikaikkuna: Week 52 of study
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Percentage of Participants With Clinical Remission by PRO2 at Week 52 Among Participants With Clinical Remission by PRO2 at Study Entry: SS3 Non-Responder Cohort
Aikaikkuna: Week 52 of study
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Week 52 of study
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Responder Cohort
Aikaikkuna: Baseline, study Weeks 20, 28, 36, 44 and 52
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44 and 52
Change From Baseline in PRO2 Scores at Weeks 20, 28, 36, 44 and 52: SS3 Non-Responder Cohort
Aikaikkuna: Baseline, study Weeks 20, 28, 36, 44 and 52
The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. SS3 Baseline was defined as last non-missing measurement taken prior to date of FMD of SS3.
Baseline, study Weeks 20, 28, 36, 44 and 52
Time to Remission by PRO2 and FCP Concentrations: SS3 Responder Cohort
Aikaikkuna: From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks)
Time to remission by PRO2 and FCP concentrations was defined as time to onset of clinical remission by PRO2 and FCP normalization. Clinical remission by PRO2 was defined as PRO2 score <8. Normalization of FCP was defined as FCP <=150 milligrams per kilogram. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain. Participants who did not achieve remission or discontinued from study were censored at 7 days after last dose of study drug.
From first maintenance dose in SS3 until date of clinical remission and FCP normalization or censoring date (maximum up to 42 weeks)
Time to Remission by PRO2 and FCP Concentrations: SS3 Non-Responder Cohort
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4
Clinical remission was defined as PRO2 score <8. The PRO2 was a patient-reported outcome measure based on abdominal pain and stool frequency components of the CDAI. The abdominal pain rating was graded from 0 (none) to 3 (severe) each day for 7 days. The stool frequency was defined as number of liquid or soft stools each day for 7 days. Total PRO2 score was calculated as the sum of averaged abdominal pain/stool frequency variable scores*weighting factor. The PRO2 score had a minimum score of 0 and had no upper bound, with a higher score indicating more frequent stools and more severe abdominal pain.
Weeks 12, 24, 36, 52, 64, 76, 88 and 104 of SS4

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Muut tutkimustunnusnumerot

  • APD334-202
  • C5041006 (Muu tunniste: Alias Study Number)
  • 2024-513569-38-00 (Rekisterin tunniste: CTIS (EU))

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