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Eine Studie zur Bewertung der Wirksamkeit und Sicherheit von oralem Etrasimod bei der Behandlung von erwachsenen Teilnehmern mit mäßig bis schwer aktivem Morbus Crohn (CULTIVATE)

5. Juni 2026 aktualisiert von: Pfizer

Eine multizentrische, randomisierte, doppelblinde Parallelgruppenstudie zur Bewertung der Wirksamkeit und Sicherheit von oralem Etrasimod als Induktions- und Erhaltungstherapie für mäßig bis schwer aktiven Morbus Crohn

Dies ist eine Phase-2/3-Studie, die 5 Teilstudien umfasst, die darauf ausgelegt sind, die Wirksamkeit, Sicherheit und Verträglichkeit von oralem Etrasimod als Therapie bei erwachsenen Teilnehmern mit mittelschwerem bis schwerem aktivem Morbus Crohn (CD) zu bewerten, die gegenüber mindestens einem der Fälle refraktär oder intolerant sind die aktuellen Therapien für MC (dh Kortikosteroide, Immunsuppressiva oder Biologika). Die Gesamtdauer dieser Studie beträgt bis zu 282 Wochen, einschließlich des 28-tägigen Screening-Zeitraums, des Behandlungszeitraums von bis zu 274 Wochen (Induktion, Verlängerung oder Erhaltung und langfristige Verlängerungsperioden) und der 4-wöchigen Nachbeobachtungszeit. Aufwärts Zeitraum für die Sicherheitsbewertung.

Studienübersicht

Status

Status

Zeigt den aktuellen Rekrutierungsstatus oder den erweiterten Zugriffsstatus an.
Beendet

Bedingungen

Bedingungen

Die Krankheit, Störung, das Syndrom, die Krankheit oder die Verletzung, die untersucht wird. Auf ClinicalTrials.gov können die Bedingungen auch andere gesundheitsbezogene Themen wie Lebensdauer, Lebensqualität und Gesundheitsrisiken umfassen.

Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.

Detaillierte Beschreibung

Diese Studie umfasst 5 Teilstudien:

Teilstudie A – Phase 2: Eine randomisierte, doppelblinde Teilstudie der Phase 2 zur Bewertung der Sicherheit, Verträglichkeit und Wirksamkeit einer oralen Etrasimod-Therapie bei Teilnehmern mit mittelschwerer bis schwerer Zöliakie, die die Auswahl einer Induktions- und Erhaltungsdosis(en) unterstützt für Phase 3. Teilstudie A ist derzeit für die Einschreibung geschlossen.

Teilstudie 1 – Phase 2: Eine Phase-2b-randomisierte, doppelblinde, Placebo-kontrollierte Induktions-Teilstudie mit Dosisfindung zur Bewertung von Etrasimod als Induktionstherapie und Auswahl einer Induktions- und Erhaltungsdosis(en) für die weitere Bewertung in Phase 3. Teilstudie 1 ist derzeit angemeldete Teilnehmer.

Teilstudie 2 – Induktion: Eine randomisierte, doppelblinde, placebokontrollierte Teilstudie der Phase 3 zur Bewertung von Etrasimod als Induktionstherapie.

Teilstudie 3 – Erhaltungstherapie: Eine randomisierte, doppelblinde, placebokontrollierte Teilstudie der Phase 3 zur Bewertung von Etrasimod als Erhaltungstherapie. Teilnehmer aus Teilstudie 1 und Teilstudie 2 werden in Teilstudie 3 eingeschrieben.

Teilstudie 4 – Langzeitverlängerung: Eine Teilstudie zur Langzeitverlängerung für Teilnehmer, die mindestens 52 Behandlungswochen abgeschlossen haben. Teilnehmer aus Teilstudie 3 und Teilstudie A sollen in Teilstudie 4 eingeschrieben werden.

Studientyp

Studientyp

Beschreibt die Art einer klinischen Studie. Zu den Studientypen gehören Interventionsstudien (auch klinische Studien genannt), Beobachtungsstudien (einschließlich Patientenregister) und erweiterter Zugang.
Interventionell

Einschreibung (Tatsächlich)

Einschreibung

Die Anzahl der Teilnehmer an einer klinischen Studie. Die „erwartete“ Einschreibung ist die Zielzahl an Teilnehmern, die die Forscher für die Studie benötigen.
379

Phase

Phase

Das Stadium einer klinischen Studie, in der ein Medikament oder ein biologisches Produkt untersucht wird, basierend auf Definitionen, die von der U.S. Food and Drug Administration (FDA) entwickelt wurden. Die Phase richtet sich nach dem Ziel der Studie, der Anzahl der Teilnehmer und anderen Merkmalen. Es gibt fünf Phasen: Frühe Phase 1 (früher als Phase 0 aufgeführt), Phase 1, Phase 2, Phase 3 und Phase 4. Nicht zutreffend wird verwendet, um Studien ohne von der FDA definierte Phasen zu beschreiben, einschließlich Studien zu Geräten oder Verhaltensinterventionen.
  • Phase 2
  • Phase 3

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studienkontakt

Der Name und die Kontaktinformationen der Person, die Fragen zur Registrierung für eine klinische Studie beantworten kann. Jeder Standort, an dem die Studie durchgeführt wird, kann auch einen bestimmten Ansprechpartner haben, der diese Fragen möglicherweise besser beantworten kann.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Zulassungskriterien

Die wichtigsten Voraussetzungen, die Personen erfüllen müssen, die an einer klinischen Studie teilnehmen möchten, bzw. welche Eigenschaften sie mitbringen müssen. Auswahlkriterien bestehen sowohl aus Einschlusskriterien (die erforderlich sind, damit eine Person an der Studie teilnehmen kann) als auch aus Ausschlusskriterien (die eine Person an der Teilnahme hindern). Arten von Zulassungskriterien umfassen, ob eine Studie gesunde Freiwillige akzeptiert, Alters- oder Altersgruppenanforderungen hat oder durch das Geschlecht begrenzt ist.

Studienberechtigtes Alter

18 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Beschreibung

Für alle Teilstudien geltende Zulassungskriterien:

Einschlusskriterien:

  • Männer oder Frauen im Alter von 18 bis 80 Jahren,
  • Fähigkeit, eine schriftliche Einverständniserklärung oder Zustimmung zu erteilen und den Zeitplan der Protokollbewertungen einzuhalten
  • Diagnostiziert mit Morbus Crohn (CD) ≥ 3 Monate
  • Haben Sie mäßig bis schwer aktive CD beim Screening

  • Gezeigtes unzureichendes Ansprechen (d. h. primäres Nichtansprechen), Verlust des Ansprechens auf oder Unverträglichkeit gegenüber ≥ 1 der folgenden Therapien zur Behandlung von Zöliakie:

    1. Orale Kortikosteroide (z. B. Prednison oder sein Äquivalent, Budesonid)
    2. Immunsuppressiva (z. B. Azathioprin [AZA], 6-Mercaptopurin [6-MP] oder Methotrexat [MTX])
    3. Antagonisten des Tumornekrosefaktors alpha (TNFα) (z. B. Infliximab, Adalimumab, Certolizumab Pegol oder Biosimilars)
    4. Integrinrezeptorantagonist (z. B. Vedolizumab)
    5. Interleukin-12/-23-Antagonist (z. B. Ustekinumab)
  • Frauen im gebärfähigen Alter müssen nicht schwanger sein
  • Frauen im gebärfähigen Alter und Männer müssen Verhütungsmittel anwenden

Ausschlusskriterien:

  • Anamnestisches unzureichendes Ansprechen (d. h. primäres Nichtansprechen) auf Wirkstoffe aus ≥ 2 Klassen von Biologika, die für die Behandlung von CD vermarktet werden (d. h. TNFα-Antagonisten, Interleukin 12/23-Antagonisten und Integrin-Rezeptor-Antagonisten).
  • Colitis ulcerosa, unbestimmte Colitis, mikroskopische Colitis, ischämische Colitis, Strahlenkolitis, Kolitis im Zusammenhang mit Divertikulose, toxisches Megakolon oder aktive infektiöse Kolitis haben oder beim Screening positiv auf Clostridioides difficile-Toxin getestet werden.
  • Haben Sie ein funktionelles oder postoperatives Kurzdarmsyndrom oder damit verbundene Komplikationen, die eine Operation erfordern oder die Wirksamkeitsbewertung beeinträchtigen können
  • Hatte eine chirurgische Behandlung für intraabdominelle Abszesse ≤ 8 Wochen vor der Randomisierung oder eine chirurgische Behandlung für perianale Abszesse ≤ 4 Wochen vor der Randomisierung.
  • Hatte eine Darmresektion ≤ 24 Wochen vor der Randomisierung oder andere intraabdominelle Operationen ≤ 12 Wochen vor der Randomisierung.
  • Haben Sie ein Ileostoma oder eine Kolostomie.

Einschlusskriterien für Teilstudie 3:

- Teilnehmer, die an der erweiterten Einführungsphase von Teilstudie 1 und Teilstudie 2 teilgenommen haben, müssen den Besuch der erweiterten Einführungswoche 6 abgeschlossen haben

Einschlusskriterien für Teilstudie 4:

- Der Teilnehmer muss den Besuch in Woche 52 von Teilstudie 3 oder den Besuch in Woche 66 von Teilstudie A abgeschlossen haben

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Behandlung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Doppelt

Waffen und Interventionen

Teilnehmergruppe / Arm

Teilnehmergruppe / Arm

Eine Gruppe oder Untergruppe von Teilnehmern an einer klinischen Studie, die gemäß dem Protokoll der Studie eine bestimmte Intervention/Behandlung oder keine Intervention erhält.
Intervention / Behandlung

Intervention / Behandlung

Ein Prozess oder eine Handlung, die im Mittelpunkt einer klinischen Studie steht. Interventionen umfassen Medikamente, medizinische Geräte, Verfahren, Impfstoffe und andere Produkte, die entweder in der Erprobungsphase oder bereits verfügbar sind. Interventionen können auch nicht-invasive Ansätze umfassen, wie z. B. Aufklärung oder eine Änderung der Ernährung und Bewegung.
Placebo-Komparator: Placebo
Arzneimittel: Placebo
Etrasimod-entsprechende Placebo-Tablette einmal täglich zum Einnehmen.
Experimental: Etrasimod Dosis A
Arzneimittel: Etrasimod
Dosis A wird einmal täglich oral eingenommen.
Andere Namen:
  • APD334
Arzneimittel: Etrasimod
Dosis B einmal täglich oral einnehmen.
Andere Namen:
  • APD334
Experimental: Etrasimod Dosis B
Arzneimittel: Etrasimod
Dosis A wird einmal täglich oral eingenommen.
Andere Namen:
  • APD334
Arzneimittel: Etrasimod
Dosis B einmal täglich oral einnehmen.
Andere Namen:
  • APD334

Was misst die Studie?

Primäre Ergebnismessungen

Primäre Ergebnismessungen

Im Protokoll einer klinischen Studie die geplante Ergebnismessung, die für die Bewertung der Wirkung einer Intervention/Behandlung am wichtigsten ist. Die meisten klinischen Studien haben einen primären Endpunkt, aber einige haben mehr als einen.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Sekundäre Ergebnismessungen

Sekundäre Ergebnismessungen

Im Protokoll einer klinischen Studie ein geplantes Ergebnismaß, das nicht so wichtig ist wie das primäre Ergebnismaß für die Bewertung der Wirkung einer Intervention, aber dennoch von Interesse ist. Die meisten klinischen Studien haben mehr als einen sekundären Endpunkt.
Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Sponsor

Die Organisation oder Person, die die Studie initiiert und die Autorität und Kontrolle über die Studie hat.
Pfizer

Mitarbeiter

Mitarbeiter

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Arena is a wholly owned subsidiary of Pfizer

Ermittler

Ermittler

Ein Forscher, der an einer klinischen Studie beteiligt ist. Zu den verwandten Begriffen gehören Studienleiter, Unterprüfer am Standort, Studienleiter, Studienleiter und Studienleiter.
  • Studienleiter: Pfizer CT.gov Call Center, Pfizer

Publikationen und hilfreiche Links

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Allgemeine Veröffentlichungen

Nützliche Links

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

Studienbeginn

Das tatsächliche Datum, an dem der erste Teilnehmer in eine klinische Studie aufgenommen wurde. Das „voraussichtliche“ Studienstartdatum ist das Datum, von dem die Forscher glauben, dass es das Studienstartdatum sein wird.
6. Januar 2020

Primärer Abschluss (Tatsächlich)

Primärer Abschluss

Das Datum, an dem der letzte Teilnehmer einer klinischen Studie untersucht wurde oder eine Intervention erhalten hat, um endgültige Daten für das primäre Ergebnis zu sammeln. Ob die klinische Studie protokollgemäß endete oder beendet wurde, hat keinen Einfluss auf dieses Datum. Bei klinischen Studien mit mehr als einem primären Ergebnismaß mit unterschiedlichen Abschlussdaten bezieht sich dieser Begriff auf das Datum, an dem die Datenerhebung für alle primären Ergebnismaße abgeschlossen ist. Das „erwartete“ primäre Abschlussdatum ist das Datum, von dem die Forscher glauben, dass es das primäre Abschlussdatum für die Studie sein wird.
23. April 2025

Studienabschluss (Tatsächlich)

Studienabschluss

Das Datum, an dem der letzte Teilnehmer an einer klinischen Studie untersucht wurde oder eine Intervention/Behandlung erhielt, um endgültige Daten für die primären Ergebnismaße, sekundären Ergebnismaße und Nebenwirkungen zu sammeln (d. h. der letzte Besuch des letzten Teilnehmers). Das „voraussichtliche“ Abschlussdatum der Studie ist das Datum, von dem die Forscher glauben, dass es das Abschlussdatum der Studie sein wird.
9. Juni 2025

Studienanmeldedaten

Zuerst eingereicht

Zuerst eingereicht

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht bei ClinicalTrials.gov eingereicht hat. Zwischen dem Datum der ersten Einreichung und der Verfügbarkeit des Datensatzes auf ClinicalTrials.gov (dem ersten veröffentlichten Datum) liegt in der Regel eine Verzögerung von einigen Tagen.
20. November 2019

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

Das Datum, an dem der Studiensponsor oder Prüfer zum ersten Mal einen Studienbericht einreicht, der den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) entspricht. Der Sponsor oder Prüfer muss möglicherweise einen Studienbericht ein- oder mehrmals überarbeiten und einreichen, bevor die QC-Überprüfungskriterien von NLM erfüllt sind. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
20. November 2019

Zuerst gepostet (Tatsächlich)

Zuerst gepostet

Das Datum, an dem der Studienbericht zum ersten Mal auf ClinicalTrials.gov verfügbar war, nachdem die Qualitätskontrolle (QC) der National Library of Medicine (NLM) abgeschlossen wurde. Zwischen dem Datum, an dem der Studiensponsor oder Prüfer den Studienbericht eingereicht hat, und dem ersten veröffentlichten Datum liegt in der Regel eine Verzögerung von einigen Tagen.
21. November 2019

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

Letztes Update gepostet

Das letzte Datum, an dem Änderungen an einem Studienbericht auf ClinicalTrials.gov verfügbar gemacht wurden. Es kann eine Verzögerung zwischen der Übermittlung der Änderungen an ClinicalTrials.gov durch den Sponsor oder Prüfer der Studie (Datum der letzten eingereichten Aktualisierung) und dem Datum der letzten Veröffentlichung der Aktualisierung geben.
1. Juli 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

Das letzte Datum, an dem der Studiensponsor oder Prüfer Änderungen an einem Studienbericht eingereicht hat, die mit den Qualitätskontrollkriterien (QC) der National Library of Medicine (NLM) übereinstimmen. Es liegt in der Verantwortung des Sponsors oder Prüfers, sicherzustellen, dass die Studienaufzeichnung mit den NLM-QC-Überprüfungskriterien übereinstimmt.
5. Juni 2026

Zuletzt verifiziert

Zuletzt verifiziert

Das letzte Datum, an dem der Studiensponsor oder Prüfer die Informationen über eine klinische Studie auf ClinicalTrials.gov als richtig und aktuell bestätigt hat. Wenn eine Studie den Rekrutierungsstatus Recruiting hat; noch keine Rekrutierung; oder aktiv, keine Rekrutierung wurde innerhalb der letzten 2 Jahre nicht bestätigt, der Rekrutierungsstatus der Studie wird als unbekannt angezeigt.
1. Juni 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

Andere Studien-ID-Nummern

Andere Identifikatoren oder ID-Nummern als die NCT-Nummer, die einer klinischen Studie vom Sponsor der Studie, Geldgebern oder anderen zugewiesen werden. Diese Nummern können eindeutige Kennungen von anderen Studienregistern und Zuschussnummern der National Institutes of Health enthalten.
  • APD334-202
  • C5041006 (Andere Kennung: Alias Study Number)
  • 2024-513569-38-00 (Registrierungskennung: CTIS (EU))

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

JA

Beschreibung des IPD-Plans

Pfizer gewährt Zugang zu individuellen anonymisierten Teilnehmerdaten und zugehörigen Studiendokumenten (z. Protokoll, statistischer Analyseplan (SAP), klinischer Studienbericht (CSR)) auf Anfrage von qualifizierten Forschern und vorbehaltlich bestimmter Kriterien, Bedingungen und Ausnahmen. Weitere Einzelheiten zu Pfizers Kriterien für die gemeinsame Nutzung von Daten und das Verfahren zur Beantragung des Zugriffs finden Sie unter: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Ja

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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