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En undersøgelse, der evaluerer effektiviteten og sikkerheden af oral etrasimod i behandlingen af voksne deltagere med moderat til svært aktiv Crohns sygdom (CULTIVATE)

5. juni 2026 opdateret af: Pfizer

Et multicenter, randomiseret, dobbeltblindt, parallelgruppestudie for at vurdere effektiviteten og sikkerheden af oral Etrasimod som induktions- og vedligeholdelsesterapi til moderat til svær aktiv Crohns sygdom

Dette er et fase 2/3-studie, der omfatter 5 delstudier designet til at evaluere effektiviteten, sikkerheden og tolerabiliteten af oral etrasimod som terapi hos voksne deltagere med moderat til svær aktiv Crohns sygdom (CD), som er refraktær eller intolerant over for mindst 1 af de nuværende behandlinger for CD (dvs. kortikosteroider, immunsuppressiva eller biologiske midler). Den samlede varighed af denne undersøgelse er op til 282 uger, inklusive 28-dages screeningsperiode, behandlingsperiode på op til 274 uger (induktion, forlængelse eller vedligeholdelse og langsigtede forlængelsesperioder) og 4-ugers efter- Op-periode for sikkerhedsvurdering.

Studieoversigt

Status

Afsluttet

Betingelser

Crohns sygdom

Intervention / Behandling

Detaljeret beskrivelse

Denne undersøgelse omfatter 5 delstudier:

Delstudie A - Fase 2: Et fase 2, randomiseret, dobbeltblindt, delstudie til vurdering af sikkerheden, tolerabiliteten og effektiviteten af oral etrasimod-behandling hos deltagere med moderat til svær CD, der understøtter valget af induktions- og vedligeholdelsesdosis(er) for fase 3. Delstudie A er i øjeblikket lukket for tilmelding.

Delstudie 1 - Fase 2: Et fase 2b randomiseret, dobbelt-blindt, placebokontrolleret, dosisvarierende induktionssubstudie for at evaluere etrasimod som induktionsterapi og vælge en induktions- og vedligeholdelsesdosis(er) til fortsat evaluering i fase 3. Delstudie 1 er deltager i øjeblikket.

Delstudie 2 - Induktion: Et fase 3 randomiseret, dobbeltblindt, placebokontrolleret substudie til evaluering af etrasimod som induktionsterapi.

Delstudie 3 - Vedligeholdelse: Et fase 3 randomiseret, dobbeltblindt, placebokontrolleret substudie til evaluering af etrasimod som vedligeholdelsesterapi. Deltagere fra delstudie 1 og delstudie 2 vil blive optaget i delstudie 3.

Delstudie 4 - Langtidsforlængelse: Et langsigtet forlængelsesdelstudie for deltagere, der gennemfører mindst 52 ugers behandling. Deltagere fra delstudie 3 og delstudie A er planlagt til at blive optaget i delstudie 4.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

379

Fase

Fase 2
Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år til 80 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Beskrivelse

Kvalifikationskriterier, der gælder for alle delundersøgelser:

Inklusionskriterier:

Mænd eller kvinder i alderen 18 til 80 år,
Evne til at give skriftligt informeret samtykke eller samtykke og være i overensstemmelse med tidsplanen for protokolvurderinger
Diagnosticeret med Crohns sygdom (CD) ≥ 3 måneder
Har moderat til svær aktiv CD ved screening
Påvist utilstrækkelig respons (dvs. primær non-respons), tab af respons på eller intolerance over for ≥ 1 af følgende terapier til behandling af CD:
1. Orale kortikosteroider (f.eks. prednison eller tilsvarende budesonid)
2. Immunsuppressiva (f.eks. azathioprin [AZA], 6-mercaptopurin [6-MP] eller methotrexat [MTX])
3. Tumornekrosefaktor alfa (TNFα) antagonister (f.eks. infliximab, adalimumab, certolizumab pegol eller biosimilars)
4. Integrinreceptorantagonist (f.eks. vedolizumab)
5. Interleukin-12/-23-antagonist (f.eks. ustekinumab)
Kvinder i den fødedygtige alder skal være ikke-gravide
Kvinder i den fødedygtige alder og mænd skal bruge prævention

Ekskluderingskriterier:

Anamnese med utilstrækkelig respons (dvs. primær non-respons) på midler fra ≥ 2 klasser af biologiske lægemidler markedsført til behandling af CD (dvs. TNFα-antagonister, interleukin 12/23-antagonist og integrinreceptorantagonist).
Har colitis ulcerosa, ubestemt colitis, mikroskopisk colitis, iskæmisk colitis, strålingscolitis, divertikulær sygdomsassocieret colitis, toksisk megacolon eller aktiv infektiøs colitis eller test positiv for Clostridioides difficile-toksin ved screening.
Har funktionelt eller postoperativt korttarmssyndrom eller andre associerede komplikationer, der kan kræve operation eller forstyrre effektivitetsvurderinger
Havde kirurgisk behandling for intraabdominale abscesser ≤ 8 uger før randomisering eller kirurgisk behandling for perianale abscesser ≤ 4 uger før randomisering.
Havde intestinal resektion ≤ 24 uger før randomisering eller andre intraabdominale operationer ≤ 12 uger før randomisering.
Har en ileostomi eller en kolostomi.

Inklusionskriterier for delstudie 3:

- Deltagere, der gik ind i den forlængede induktionsperiode for delstudie 1 og delstudie 2, skal have gennemført det forlængede induktions-Uge 6-besøg

Inklusionskriterier for delstudie 4:

- Deltageren skal have gennemført uge 52-besøget i delstudie 3 eller uge 66-besøget i delstudie A

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Primært formål: Behandling
Tildeling: Randomiseret
Interventionel model: Parallel tildeling
Maskning: Dobbelt

Antal våben

Våben og indgreb

Deltagergruppe / Arm	Intervention / Behandling
Placebo komparator: Placebo	Medicin: Placebo Etrasimod matchende placebotablet tages gennem munden én gang dagligt.
Eksperimentel: Etrasimod dosis A	Medicin: Etrasimod Dosis A taget gennem munden en gang dagligt. Andre navne: APD334 Medicin: Etrasimod Dosis B tages gennem munden en gang dagligt. Andre navne: APD334
Eksperimentel: Etrasimod dosis B	Medicin: Etrasimod Dosis A taget gennem munden en gang dagligt. Andre navne: APD334 Medicin: Etrasimod Dosis B tages gennem munden en gang dagligt. Andre navne: APD334

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål	Foranstaltningsbeskrivelse	Tidsramme
Percentage of Participants With Endoscopic Response by Simple Endoscopic Score in Crohn's Disease (SES-CD) at Week 14: SSA Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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 Tidsramme: 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

Sekundære resultatmål

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Pfizer

Samarbejdspartnere

Arena is a wholly owned subsidiary of Pfizer

Efterforskere

Studieleder: Pfizer CT.gov Call Center, Pfizer

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Dubinsky MC, Wu J, McDonnell A, Lazin K, Goetsch M, Branquinho D, Modesto I, Armuzzi A. Low Incidence of Macular Edema and Other Ocular Events in the Etrasimod Development Program. J Crohns Colitis. 2025 May 8;19(5):jjae173. doi: 10.1093/ecco-jcc/jjae173.

Hjælpsomme links

To obtain contact information for a study center near you, click here.

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

6. januar 2020

Primær færdiggørelse (Faktiske)

23. april 2025

Studieafslutning (Faktiske)

9. juni 2025

Datoer for studieregistrering

Først indsendt

20. november 2019

Først indsendt, der opfyldte QC-kriterier

20. november 2019

Først opslået (Faktiske)

21. november 2019

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

5. juni 2026

Sidst verificeret

1. juni 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

APD334-202
C5041006 (Anden identifikator: Alias Study Number)
2024-513569-38-00 (Registry Identifier: CTIS (EU))

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Pfizer vil give adgang til individuelle afidentificerede deltagerdata og relaterede undersøgelsesdokumenter (f.eks. protokol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) efter anmodning fra kvalificerede forskere og underlagt visse kriterier, betingelser og undtagelser. Yderligere detaljer om Pfizers datadelingskriterier og proces for at anmode om adgang kan findes på: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

produkt fremstillet i og eksporteret fra U.S.A.

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

En undersøgelse, der evaluerer effektiviteten og sikkerheden af ​​oral etrasimod i behandlingen af ​​voksne deltagere med moderat til svært aktiv Crohns sygdom (CULTIVATE)

Et multicenter, randomiseret, dobbeltblindt, parallelgruppestudie for at vurdere effektiviteten og sikkerheden af ​​oral Etrasimod som induktions- og vedligeholdelsesterapi til moderat til svær aktiv Crohns sygdom

Studieoversigt

Status

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Undersøgelsestype

Tilmelding (Faktiske)

Fase

Kontakter og lokationer

Studiesteder

Deltagelseskriterier

Berettigelseskriterier

Aldre berettiget til at studere

Tager imod sunde frivillige

Beskrivelse

Studieplan

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Antal våben

Våben og indgreb

Deltagergruppe / Arm

Intervention / Behandling

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Sekundære resultatmål

Resultatmål

Foranstaltningsbeskrivelse

Tidsramme

Samarbejdspartnere og efterforskere

Sponsor

Samarbejdspartnere

Efterforskere

Publikationer og nyttige links

Generelle publikationer

Hjælpsomme links

Datoer for undersøgelser

Studer store datoer

Studiestart (Faktiske)

Primær færdiggørelse (Faktiske)

Studieafslutning (Faktiske)

Datoer for studieregistrering

Først indsendt

Først indsendt, der opfyldte QC-kriterier

Først opslået (Faktiske)

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

Sidst verificeret

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

IPD-planbeskrivelse

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Studerer et amerikansk FDA-reguleret enhedsprodukt

produkt fremstillet i og eksporteret fra U.S.A.

En undersøgelse, der evaluerer effektiviteten og sikkerheden af oral etrasimod i behandlingen af voksne deltagere med moderat til svært aktiv Crohns sygdom (CULTIVATE)

Et multicenter, randomiseret, dobbeltblindt, parallelgruppestudie for at vurdere effektiviteten og sikkerheden af oral Etrasimod som induktions- og vedligeholdelsesterapi til moderat til svær aktiv Crohns sygdom