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Um estudo avaliando a eficácia e a segurança do etrasimod oral no tratamento de participantes adultos com doença de Crohn moderada a grave (CULTIVATE)

5 de junho de 2026 atualizado por: Pfizer

Um estudo multicêntrico, randomizado, duplo-cego, de grupos paralelos para avaliar a eficácia e a segurança do etrasimod oral como terapia de indução e manutenção para doença de Crohn moderada a grave

Este é um estudo de Fase 2/3 que compreende 5 subestudos projetados para avaliar a eficácia, segurança e tolerabilidade do etrasimod oral como terapia em participantes adultos com doença de Crohn (DC) moderada a gravemente ativa que são refratários ou intolerantes a pelo menos 1 de as terapias atuais para DC (ou seja, corticosteróides, imunossupressores ou biológicos). A duração total deste estudo é de até 282 semanas, incluindo o período de triagem de 28 dias, o período de tratamento de até 274 semanas (indução, extensão ou manutenção e períodos de extensão de longo prazo) e o acompanhamento de 4 semanas. Up Período para avaliação de segurança.

Visão geral do estudo

Descrição detalhada

Este estudo inclui 5 subestudos:

Subestudo A - Fase 2: Um subestudo de Fase 2, randomizado, duplo-cego, para avaliar a segurança, tolerabilidade e eficácia da terapia oral com etrasimode em participantes com DC moderada a grave que suporta a seleção de dose(s) de indução e manutenção para a Fase 3. O Substudy A está atualmente fechado para inscrições.

Subestudo 1 - Fase 2: Um subestudo de indução randomizado, duplo-cego, controlado por placebo, de Fase 2b para avaliar o etrasimod como terapia de indução e selecionar uma(s) dose(s) de indução e manutenção para avaliação continuada na Fase 3. O Subestudo 1 é atualmente inscrevendo participantes.

Subestudo 2 - Indução: Um subestudo randomizado, duplo-cego, controlado por placebo de Fase 3 para avaliar o etrasimod como terapia de indução.

Subestudo 3 - Manutenção: Um subestudo randomizado, duplo-cego e controlado por placebo de Fase 3 para avaliar o etrasimod como terapia de manutenção. Os participantes do Subestudo 1 e do Subestudo 2 serão inscritos no Subestudo 3.

Subestudo 4 - Extensão de Longo Prazo: Um subestudo de extensão de longo prazo para participantes que completaram pelo menos 52 semanas de tratamento. Os participantes do Subestudo 3 e do Subestudo A estão planejados para serem inscritos no Subestudo 4.

Tipo de estudo

Intervencional

Inscrição (Real)

379

Estágio

  • Fase 2
  • Fase 3

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

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

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 80 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Descrição

Critérios de elegibilidade aplicáveis ​​a todos os subestudos:

Critério de inclusão:

  • Homens ou mulheres de 18 a 80 anos de idade,
  • Capacidade de fornecer consentimento informado por escrito ou consentimento e estar em conformidade com o cronograma de avaliações de protocolo
  • Diagnosticado com doença de Crohn (DC) ≥ 3 meses
  • Tem DC moderada a gravemente ativa na triagem
  • Resposta inadequada demonstrada (ou seja, não resposta primária), perda de resposta ou intolerância a ≥ 1 das seguintes terapias para o tratamento da DC:

    1. Corticosteróides orais (por exemplo, prednisona ou seu equivalente, budesonida)
    2. Imunossupressores (por exemplo, azatioprina [AZA], 6 mercaptopurina [6-MP] ou metotrexato [MTX])
    3. Antagonistas do fator de necrose tumoral alfa (TNFα) (por exemplo, infliximabe, adalimumabe, certolizumabe pegol ou biossimilares)
    4. Antagonista do receptor de integrina (por exemplo, vedolizumabe)
    5. Antagonista da interleucina -12/-23 (por exemplo, ustequinumabe)
  • Mulheres com potencial para engravidar não devem estar grávidas
  • Mulheres com potencial para engravidar e homens devem usar métodos contraceptivos

Critério de exclusão:

  • História de resposta inadequada (isto é, não resposta primária) a agentes de ≥ 2 classes de produtos biológicos comercializados para o tratamento da DC (isto é, antagonistas do TNFα, antagonista da interleucina 12/23 e antagonista do receptor da integrina).
  • Tem colite ulcerativa, colite indeterminada, colite microscópica, colite isquêmica, colite por radiação, colite associada à doença diverticular, megacólon tóxico ou colite infecciosa ativa ou teste positivo para toxina Clostridioides difficile na triagem.
  • Ter síndrome do intestino curto funcional ou pós-operatória ou qualquer complicação associada que possa exigir cirurgia ou interferir nas avaliações de eficácia
  • Teve tratamento cirúrgico para abscessos intra-abdominais ≤ 8 semanas antes da randomização ou tratamento cirúrgico para abscessos perianais ≤ 4 semanas antes da randomização.
  • Teve ressecção intestinal ≤ 24 semanas antes da randomização ou outras cirurgias intra-abdominais ≤ 12 semanas antes da randomização.
  • Ter uma ileostomia ou uma colostomia.

Critérios de inclusão para o subestudo 3:

- Os participantes que entraram no Período de Indução Estendida do Subestudo 1 e Subestudo 2 devem ter concluído a Visita de Indução Estendida - Semana 6

Critérios de inclusão para o Subestudo 4:

- O participante deve ter concluído a Visita da Semana 52 do Subestudo 3 ou a Visita da Semana 66 do Subestudo A

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Tratamento
  • Alocação: Randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Dobro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Comparador de Placebo: Placebo
Etrasimod comprimido placebo correspondente tomado por via oral, uma vez ao dia.
Experimental: Etrasimod Dose A
Dose A tomada por via oral, uma vez ao dia.
Outros nomes:
  • APD334
Dose B tomada por via oral, uma vez ao dia.
Outros nomes:
  • APD334
Experimental: Etrasimod Dose B
Dose A tomada por via oral, uma vez ao dia.
Outros nomes:
  • APD334
Dose B tomada por via oral, uma vez ao dia.
Outros nomes:
  • APD334

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Percentage of Participants With Clinical Remission by CDAI at Week 14: SSA
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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

Colaboradores e Investigadores

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Patrocinador

Investigadores

  • Diretor de estudo: Pfizer CT.gov Call Center, Pfizer

Publicações e links úteis

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Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

6 de janeiro de 2020

Conclusão Primária (Real)

23 de abril de 2025

Conclusão do estudo (Real)

9 de junho de 2025

Datas de inscrição no estudo

Enviado pela primeira vez

20 de novembro de 2019

Enviado pela primeira vez que atendeu aos critérios de CQ

20 de novembro de 2019

Primeira postagem (Real)

21 de novembro de 2019

Atualizações de registro de estudo

Última Atualização Postada (Real)

1 de julho de 2026

Última atualização enviada que atendeu aos critérios de controle de qualidade

5 de junho de 2026

Última verificação

1 de junho de 2026

Mais Informações

Termos relacionados a este estudo

Outros números de identificação do estudo

  • APD334-202
  • C5041006 (Outro identificador: Alias Study Number)
  • 2024-513569-38-00 (Identificador de registro: CTIS (EU))

Plano para dados de participantes individuais (IPD)

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Descrição do plano IPD

A Pfizer fornecerá acesso a dados de participantes não identificados individuais e documentos de estudo relacionados (por exemplo, protocolo, Plano de Análise Estatística (SAP), Relatório de Estudo Clínico (CSR)) mediante solicitação de pesquisadores qualificados e sujeito a certos critérios, condições e exceções. Mais detalhes sobre os critérios de compartilhamento de dados da Pfizer e o processo de solicitação de acesso podem ser encontrados em: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Informações sobre medicamentos e dispositivos, documentos de estudo

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Estuda um produto de dispositivo regulamentado pela FDA dos EUA

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produto fabricado e exportado dos EUA

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