En undersøgelse til evaluering af Mirikizumabs langsigtede effektivitet og sikkerhed hos deltagere med moderat til svær aktiv colitis ulcerosa (LUCENT 3)
17. april 2026 opdateret af: Eli Lilly and Company
Et fase 3, multicenter, open-label forlængelsesstudie for at evaluere den langsigtede effektivitet og sikkerhed af Mirikizumab hos patienter med moderat til svær aktiv colitis ulcerosa LUCENT 3
Denne undersøgelse er designet til at evaluere den langsigtede effekt og sikkerhed af mirikizumab hos deltagere med moderat til svær aktiv colitis ulcerosa (UC).
Studieoversigt
Status
Status
Aktiv, ikke rekrutterende
Betingelser
Betingelser
Intervention / Behandling
Intervention / Behandling
Undersøgelsestype
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
Tilmelding
1058
Fase
Fase
- Fase 3
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
Studiekontakt
- Navn: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
- Telefonnummer: 1-317-615-4559
- E-mail: clinical_inquiry_hub@lilly.com
Studiesteder
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Buenos Aires, Argentina, C1128AAF
- Mautalen Salud e investigación
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Quilmes, Argentina, 1879
- CER medical Institute
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Rosario, Argentina, S2000DEG
- Fundacion Estudios Clinicos
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SAN M. de Tucuman, Argentina, T4000AXL
- Centro de Investigaciones Médicas Tucuman
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San Miguel de Tucumán, Argentina, 4000
- C.I.C.E. 9 de Julio
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Adelaide, Australien, 5000
- Royal Adelaide Hospital
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Box Hill, Australien, 3128
- Box Hill Hospital
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Brisbane, Australien, 4102
- Princess Alexandra Hospital
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Brisbane, Australien, 4101
- Mater Misericordiae Limited
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Maroochydore, Australien, 4558
- Coastal Digestive Health
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Melbourne, Australien, 3065
- St Vincent's Hospital
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Parkville, Australien, 3050
- The Royal Melbourne Hospital
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Ghent, Belgien, 9000
- UZ Gent
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Leuven, Belgien, 3000
- UZ Leuven
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Tournai, Belgien, 7500
- Centre Hospitalier de Wallonie Picarde - Site Notre Dame
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Greenfield Park, Canada, J4V 2H1
- CISSS de la Monteregie-Centre
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London, Canada, N6A 5A5
- University Hospital - London Health Sciences Centre
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London, Canada, N6A 4G5
- Victoria Hospital
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Montreal, Canada, H3G 1A4
- Montreal General Hospital
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Montreal, Canada, H1T 2M4
- CIUSSS de l'Est-de-l'Ile-de-Montreal
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New Westminster, Canada, V3L 3W4
- Fraser Clinical Trials Inc
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Vancouver, Canada, V5Z 1M9
- Vancouver General Hospital
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Vancouver, Canada, V5Z 2K5
- GIRI GI Research Institute - Vancouver
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Victoria, Canada, V8V 3M9
- PerCuro Clinical Research
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Copenhagen, Danmark, 2730
- Herlev and Gentofte Hospital
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Køge, Danmark, 4600
- Sjællands Universitetshospital Køge
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Nyborg, Danmark, 5800
- Sygehusenheden Nyborg
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Bury, Det Forenede Kongerige, BL9 7TD
- Fairfield General Hospital
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London, Det Forenede Kongerige, E1 1RD
- Barts Health NHS Trust
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London, Det Forenede Kongerige, NW1 2PG
- Guy's & St Thomas' NHS Foundation Trust
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Oxford, Det Forenede Kongerige, OX3 9DU
- The John Radcliffe Hospital
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Alabama
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Dothan, Alabama, Forenede Stater, 36305
- Digestive Health Specialists
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Arizona
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Litchfield Park, Arizona, Forenede Stater, 85340
- Research Solutions of Arizona
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Phoenix, Arizona, Forenede Stater, 85008
- Valleywise Health Medical Center
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California
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Arcadia, California, Forenede Stater, 91006
- InSite Digestive Health Care
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Berkeley, California, Forenede Stater, 94705
- Care Access - Berkeley
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Lancaster, California, Forenede Stater, 93534
- Om Research LLC
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Northridge, California, Forenede Stater, 91324
- California Medical Research Associates
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Rialto, California, Forenede Stater, 92377
- Inland Empire Clinical Trials, LLC
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San Diego, California, Forenede Stater, 92103
- Clinical Applications Laboratories, Inc.
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Florida
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Hialeah, Florida, Forenede Stater, 33012
- Direct Helpers Research Center
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Jacksonville, Florida, Forenede Stater, 32256
- Encore Borland-Groover Clinical Research
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Miami Lakes, Florida, Forenede Stater, 33016
- Wellness Clinical Research
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Orlando, Florida, Forenede Stater, 32803
- AdventHealth Orlando
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Orlando, Florida, Forenede Stater, 32819
- Clintheory Healthcare
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Pensacola, Florida, Forenede Stater, 32503
- Gastroenterology Associates of Pensacola, PA
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Zephyrhills, Florida, Forenede Stater, 33542-7505
- Florida Medical Clinic LLC
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Georgia
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Atlanta, Georgia, Forenede Stater, 30327
- Digestive Healthcare of Georgia
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Idaho
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Idaho Falls, Idaho, Forenede Stater, 83404
- Grand Teton Research Group
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Illinois
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Evanston, Illinois, Forenede Stater, 60201
- NorthShore University HealthSystem - Evanston Hospital
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Indiana
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Indianapolis, Indiana, Forenede Stater, 46202
- Indiana University Health University Hospital
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Kansas
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Topeka, Kansas, Forenede Stater, 66606
- Cotton O'Neil Digestive Health Center
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Louisiana
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Baton Rouge, Louisiana, Forenede Stater, 70809
- GI Alliance Research Baton Rouge
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Monroe, Louisiana, Forenede Stater, 71201
- Delta Research Partners
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New Orleans, Louisiana, Forenede Stater, 70125
- Nola Research Works, LLC
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Michigan
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Ann Arbor, Michigan, Forenede Stater, 48109
- University of Michigan
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Chesterfield, Michigan, Forenede Stater, 48047
- Clinical Research Institute of Michigan, LLC
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Novi, Michigan, Forenede Stater, 48377
- Henry Ford Medical Center - Columbus Center
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Wyoming, Michigan, Forenede Stater, 49519
- West Michigan Clinical Research Center
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Minnesota
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Plymouth, Minnesota, Forenede Stater, 55446
- MNGI Digestive Health - Plymouth Endoscopy Center & Clinic
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New York
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New York, New York, Forenede Stater, 10032
- Columbia University Medical Center
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North Carolina
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Chapel Hill, North Carolina, Forenede Stater, 27599-7080
- Clinical & Translational Research Center (CTRC)
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Greenville, North Carolina, Forenede Stater, 27834
- Carolina Digestive Diseases and Endoscopy Center
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Ohio
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Poland, Ohio, Forenede Stater, 44514
- Care Access - Youngstown
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Oklahoma
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Oklahoma City, Oklahoma, Forenede Stater, 73104-5008
- The University of Oklahoma Health Sciences Center
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Oklahoma City, Oklahoma, Forenede Stater, 73118
- Central Sooner Research - Oklahoma - Northwest 47th Street
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Pennsylvania
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Pottsville, Pennsylvania, Forenede Stater, 17901
- Care Access - Pottsville
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Wyomissing, Pennsylvania, Forenede Stater, 19610
- Digestive Disease Associates
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South Dakota
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Sioux Falls, South Dakota, Forenede Stater, 57108
- Midwest Medical Care
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Texas
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Garland, Texas, Forenede Stater, 75044
- GI Alliance
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Houston, Texas, Forenede Stater, 77084
- Biopharma Informatic, LLC
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San Antonio, Texas, Forenede Stater, 78229
- Gastroenterology Research of San Antonio
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San Antonio, Texas, Forenede Stater, 78229
- Southern Star Research Institute
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Southlake, Texas, Forenede Stater, 76092
- Texas Digestive Disease Consultants
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Southlake, Texas, Forenede Stater, 76092
- GI Alliance
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Utah
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Ogden, Utah, Forenede Stater, 84403
- Care Access-Ogden
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Salt Lake City, Utah, Forenede Stater, 84124
- Care Access Research LLC - Salt Lake City
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Virginia
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Roanoke, Virginia, Forenede Stater, 24014
- Carilion Clinic
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Washington
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Tacoma, Washington, Forenede Stater, 98405
- Washington Gastroenterology - Tacoma
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Amiens, Frankrig, 80054
- Chu D'Amiens-Picardie - Hopital Sud
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Chambray-lès-Tours, Frankrig, 37170
- CHRU Troussau
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Lille, Frankrig, 59037
- Hopital Claude Huriez - CHU de Lille
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Montpellier, Frankrig, 34295
- CHU Saint Eloi
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Neuilly-sur-Seine, Frankrig, 92200
- Centres Médico Chirurgicaux - Clinique Ambroise Paré
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Nice, Frankrig, 06202
- Centre Hospitalier Universitaire de Nice - Hopital l'Archet
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Paris, Frankrig, 75010
- Hôpital Saint-Louis
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Pau, Frankrig, 64000
- Centre Hospitalier de Pau
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Pessac, Frankrig, 33600
- CHU Bordeaux Haut-Leveque
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Pierre-Bénite, Frankrig, 69310
- Centre Hospitalier LYON SUD
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Saint-Priest-en-Jarez, Frankrig, 42270
- Centre Hospitalier Universitaire de Saint Étienne - Hôpital Nord
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Strasbourg, Frankrig, 67091
- Nouvel Hôpital Civil (NHC)
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Vandœuvre-lès-Nancy, Frankrig, 54511
- Centre Hospitalier Régional Universitaire de Nancy - Hôpitaux de Brabois
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Tbilisi, Georgien, 0112
- LLC Arensia Exploratory Medicine
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Amsterdam, Holland, 1081 HZ
- Amsterdam UMC, locatie VUmc
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Tilburg, Holland, 5022 GC
- Elisabeth-TweeSteden Ziekenhuis
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Uden, Holland, 5406 PT
- Ziekenhuis Bernhoven
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Utrecht, Holland, 3584 CX
- Universitair Medisch Centrum Utrecht
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Ahmedabad, Indien, 382428
- Apollo Hospitals Ahmedabad
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Bangalore, Indien, 560054
- M S Ramaiah Medical College and Hospitals
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Hyderabad, Indien, 500058
- Owaisi Hospital and Research Center
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Jaipur, Indien, 302006
- SR Kalla Memorial Gastro & General Hospital
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Ludhiana, Indien, 141001
- Dayanand Medical College and Hospital
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Nagpur, Indien, 440010
- Midas Multispeciality Hospital Pvt.Ltd.
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Noida, Indien, 201301
- Fortis Hospital
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Pune, Indien, 411001
- Grant Medical Foundation - Ruby Hall Clinic
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Rajkot, Indien, 360005
- Shree Giriraj Multispeciality Hospital
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Secunderabad, Indien, 500003
- Gandhi Hospital
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Surat, Indien, 395002
- Nirmal Hospital
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Wardha, Indien, 442004
- Acharya Vinoba Bhave Rural Hospital
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Dublin, Irland, D9
- Beaumont Hospital, Dublin
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Beersheba, Israel, 8410101
- Soroka Medical Center
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Jerusalem, Israel, 9778419
- Shaare Zedek Medical Center
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Nahariya, Israel, 2210001
- Galilee Medical Center
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Rehovot, Israel, 7610001
- Kaplan Medical Center
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Tel Aviv, Israel, 6423906
- Sourasky Medical Center
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Ẕerifin, Israel, 70300
- Yitzhak Shamir Medical Center
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Catanzaro, Italien, 88100
- Azienda Ospedaliera Mater Domini
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Genova, Italien, 16132
- Ospedale San Martino
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Pisa, Italien, 56124
- Azienda Ospedaliera Universitaria Pisana
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Rho, Italien, 20017
- Ospedale di Circolo
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Roma, Italien, 00168
- Fondazione Policlinico Universitario Agostino Gemelli
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Roma, Italien, 00133
- Fondazione Policlinico Tor Vergata
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Rome, Italien, 00157
- Ospedale Sandro Pertini
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Rozzano, Italien, 20089
- Humanitas
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Torino, Italien, 10128
- Ospedale Mauriziano
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Asahikawa, Japan, 070-8610
- Asahikawa City Hospital
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Bunkyō, Japan, 113-8519
- Tokyo Medical and Dental University Hospital
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Bunkyō City, Japan, 113-8431
- Juntendo University Hospital
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Chiyoda-ku, Japan, 101-8643
- Mitsui Memorial Hospital
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Chuo-ku, Sapporo-shi, Japan, 060-0033
- Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital
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Fujiidera, Japan, 583-0027
- Sai Gastroenterologist Proctology
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Fukuoka, Japan, 814-0180
- Fukuoka University Hospital
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Hamamatsu, Japan, 432-8061
- Matsuaikai Matsuda Hospital
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Higashiibaraki, Japan, 311-3117
- Mito Medical Center
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Hirosaki, Japan, 036-8545
- National Hospital Organization Hirosaki National Hospital
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Kagoshima, Japan, 892-0846
- Sameshima Hospital
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Kamakura, Japan, 247-0056
- Ofuna Central Hospital
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Kawasaki, Japan, 210-0013
- Kawasaki Municipal Hospital
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Kitakyusyu-shi, Japan, 802-0077
- Kitakyushu Municipal Medical Center
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Kobe, Japan, 650 0015
- Aoyama Clinic GI Endoscopy & IBD Center
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Kumagaya-shi, Japan, 360-8567
- Kumagaya General Hospital
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Kurume-shi, Japan, 839 0809
- Hidaka Coloproctology Clinic
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Kyoto, Japan, 612-8555
- National Hospital Organization Kyoto Medical Center
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Kōtoku, Japan, 135 8577
- Showa University Koto Toyosu Hospital
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Maebashi, Japan, 371-8511
- Gunma University Hospital
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Minatoku, Japan, 108 8642
- Kitasato University Kitasato Institute Hospital
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Mitaka, Japan, 181-8611
- Kyorin University Hospital
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Nagaoka, Japan, 940-8653
- Nagaoka Chuo General Hospital
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Nishinomiya, Japan, 663-8501
- Hyogo College of Medicine
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Okayama, Japan, 700-8558
- Okayama University Hospital
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Osaka, Japan, 540-0006
- National Hospital Organization - Osaka National Hospital - Institute For Clinical Research
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Osaka, Japan, 530-0011
- Infusion Clinic
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Saga, Japan, 840-8571
- Saga-Ken Medical Center Koseikan
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Saitama, Japan, 336-0963
- Tokitokai Tokito Clinic Coloproctology Center
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Sakura, Japan, 285-0841
- Toho University Sakura Medical Center
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Sapporo, Japan, 065-0033
- Sapporo Higashi Tokushukai Hospital
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Sapporo, Japan, 004 0041
- Tokushukai Sapporo Tokushukai Hospital
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Sendai, Japan, 981-3213
- Takagi Clinic - Sendai
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Shimotsuke, Japan, 329-0498
- Jichi Medical University Hospital
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Shinjyuku-ku, Japan, 162-8655
- Center Hospital of the National Center for Global Health and Medicine
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Takamatsu, Japan, 760-8557
- Kagawa Prefectural Central Hospital
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Takasaki, Japan, 370-0829
- National Hospital Organization Takasaki General Medical Centar
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Tokyo, Japan, 169-0073
- Tokyo Yamate Medical Center
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Toyama, Japan, 930-8550
- Toyama Prefectural Central Hospital
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Tsu, Japan, 514-8507
- Mie University Hospital
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Yokohama, Japan, 232-0024
- Yokohama City University Medical Center
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Yokohama, Japan, 220-0041
- Matsushima Hospital
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Yokohama, Japan, 234-0032
- Showa University Northern Yokohama Hospital
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Ōita, Japan, 870 0823
- Ishida Clinic of IBD and Gastroenterology
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Changsha, Kina, 410008
- Xiangya Hospital Central South University
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Changzhou, Kina
- Changzhou No.2 People's Hospital
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Chengdu, Kina, 610041
- West China Hospital of Sichuan University
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Fuzhou, Kina, 350005
- The First Affiliated Hospital of Fujian Medical University
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Guangzhou, Kina, 510655
- The Sixth Affiliated Hospital of Sun Yat-sen University
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Haikou, Kina, 570311
- Hainan General Hospital
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Hangzhou, Kina, 310016
- Sir Run Run Shaw Hospital
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Hangzhou, Kina, 310003
- The First Affiliated Hospital, Zhejiang University
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Hangzhou, Kina, 310052
- The Second Affiliated Hospital of Zhejiang University School of Medicine
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Hefei, Kina, 230022
- The First Affiliated Hospital of Anhui Medical University
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Hefei, Kina, 230071
- Anhui Provincial Hospital
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Jilin, Kina, 132011
- Center-Jilin Center Hospital
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Jinan, Kina, 250012
- Qilu Hospital of Shandong University
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Jinan, Kina, 250001
- Shandong Provincial Hospital
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Kunming, Kina, 650034
- The First People's Hospital of Yunnan Province
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Kunming, Kina, 650032
- First Affiliated Hospital of Kunming Medical University
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Liaocheng, Kina, 252000
- Liaocheng People's Hospital
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Nanchang, Kina, 330006
- The First Affiliated Hospital of Nanchang University
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Nanjing, Kina, 210009
- Zhongda Hospital Southeast University
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Nanjing, Kina, 211100
- Nanjing Medical University - Nanjing Jiangning Hospital
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Nanjing, Kina, 210000
- Nanjing Drum Tower Hospital The Affiliated Hospital of Nanjing University Medical School
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Qingdao, Kina, 266003
- The Affiliated Hospital of Qingdao University
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Shanghai, Kina
- Shanghai Jiaotong University School of Medicine Ruijin Hospital
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Shanghai, Kina, 200001
- Renji Hospital Shanghai Jiao Tong University School of Medicine
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Shenyang, Kina, 110004
- Shengjing Hospital of China Medical University
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Shijiazhuang, Kina, 050000
- The Second Afilliated Hospital of Hebei Medical University
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Taian, Kina, 271000
- Taian City Central Hospital
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Wenzhou, Kina, 315100
- The 2nd Affiliated Hospital and Yuying Children's Hospital of Wenzhou Medical University
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Wuhan, Kina, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Kina, 430022
- Wuhan Union Hospital
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Wuhan, Kina, 430030
- Tongji Hospital Tongji Medical,Science & Technology
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Zhengzhou, Kina, 450014
- The Second Affiliated Hospital of Zhengzhou University
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Zhuzhou, Kina, 412007
- Zhuzhou Central Hospital
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Riga, Letland, 1079
- Digestive Diseases Center "Gastro"
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Riga, Letland, LV-1002
- Pauls Stradins Clinical Univeristy Hospital
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Riga, Letland, LV1079
- RIGA EAST UNIVERSITY HOSPITAL ,Oncology Centre of Latvia
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Kaunas, Litauen, 50161
- Hospital of Lithuanian University of Health Sciences Kaunas
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Klaipėda, Litauen, 93200
- Viesoji Istaiga Klaipedos Miesto Poliklinika
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Klaipėda, Litauen, LT-91251
- Republic Hospital of Klaipeda
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Panevezys, Litauen, LT-35144
- Respublikine Panevezio ligonine
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Vilnius, Litauen, LT-08661
- Vilnius University Hospital Santaros Klinikos
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Kuala Selangor, Malaysia, 43300
- Hospital Serdang
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Kubang Kerian, Malaysia, 16150
- Hospital Universiti Sains Malaysia
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Lembah Pantai, Malaysia, 59100
- University Malaya Medical Centre
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Chihuahua City, Mexico, 31207
- Scientia Investigacion Clinica S.C.
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Culiacán, Mexico, 80230
- Centro para el Desarrollo de la Medicina y de Asistencia Medica Especializada S.C.
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Veracruz, Mexico, 91900
- Sociedad de Metabolismo y Corazon
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Chisinau, Moldova, MD2025
- Republican Clinical Hospital
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Bydgoszcz, Polen, 85-796
- Centrum medyczne Pratia Bydgoszcz
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Bydgoszcz, Polen, 85-229
- Centrum Medyczne "Medis" Manermed
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Będzin, Polen, 42-500
- Promedica Dental Clinic
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Elblag, Polen, 02-300
- Szpital Miejski im. Jana Pawła II w Elblagu
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Katowice, Polen, 40-659
- All-Medicus
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Krakow, Polen, 31-009
- Gabinet Endoskopii Przewodu Pokarmowego
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Krakow, Polen, 31-506
- Topolowa Medicenter
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Lublin, Polen, 20-090
- Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
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Lublin, Polen, 20-582
- ZOZ Gastromed
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Nowy Targ, Polen, 34-400
- Medicenter Nowy Targ
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Olsztyn, Polen, 11-041
- Wojewodzki Szpital Specjalistyczny w Olsztynie
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Rzeszów, Polen, 35-068
- Centrum Medyczne LUX MED - Rzeszow
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Sopot, Polen, 81-756
- Endoskopia Sp. z.o.o.
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Szczecin, Polen, 71-434
- Twoja Przychodnia - Szczecinskie Centrum Medyczne
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Szczecin, Polen, 71-685
- SONOMED Centrum Medyczne
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Torun, Polen, 87-100
- Gastromed
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Wadowice, Polen, 34-100
- NZOZ Formed
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Warsaw, Polen, 02-507
- Centralny Szpital Kliniczny MSWiA w Warszawie
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Warsaw, Polen, 04-501
- WIP Warsaw IBD Point Profesor Kierkus
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Warsaw, Polen, 00-189
- Centrum Zdrowia MDM
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Warsaw, Polen, 03-580
- Vivamed Sp. z o.o.
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Wroclaw, Polen, 53-114
- LexMedica
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Wroclaw, Polen, 52-210
- Planetmed
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Zamość, Polen, 22-400
- ETG Zamość
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Bucharest, Rumænien, 20125
- Spitalul Clinic Colentina
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Bucharest, Rumænien, 30463
- CCBR Clinical Research
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Bucharest, Rumænien, 021967
- Monza - Ares
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Bucharest, Rumænien, 013823
- SC Memorial Healthcare International SRL
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Oradea, Rumænien, 410469
- Spitalul Pelican
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Barnaul, Rusland, 656038
- Poliklinika Agmu "Konsul'tativno-Diagnosticheskiy Tsentr"
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Irkutsk, Rusland, 664079
- Scientific Centre of Reconstructive and Restorative Surgery
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Izhevsk, Rusland, 426061
- Alliance Biomedical URAL Group
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Kazan', Rusland, 420064
- Kazan State Medical University
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Kemerovo, Rusland, 620109
- SIH Kemerovo Regional Clinical Hosptial
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Nizhny Novgorod, Rusland, 603126
- Nizhny Novgorod Regional Hospital N.A. Semashko
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Novosibirsk, Rusland, 630008
- Medical Center SibNovoMed
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Novosibirsk, Rusland, 630117
- Research Institute of Physiology and Fundamental Medicine
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Omsk, Rusland, 644024
- Ultramed
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Petrozavodsk, Rusland, 620109
- Karelia Republican Hospital V.A. Baranova
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Rostov-on-Don, Rusland, 344022
- Rostov State Medical University
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Saint Petersburg, Rusland, 191015
- North-Western State Medical University named after I.I.Mechnikov
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Saint Petersburg, Rusland, 191104
- City Mariinskaya Hospital
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Saint Petersburg, Rusland, 196143
- Scientific research center ECO-security
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Saint Petersburg, Rusland, 197022
- First Pavlov State Medical University of Saint Petersburg
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Saint Petersburg, Rusland, 197110
- Saint Petersburg State Budgetary Healthcare Institution City Clinical Hospital No.31
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Stavropol, Rusland, 355017
- Stavropol State Medical University
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Yaroslavl, Rusland, 150030
- SHI of Yaroslavl Region Clinical Hospital #8
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Yekaterinburg, Rusland, 620109
- LLC MA New Hospital
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Bern, Schweiz, 3010
- Inselspital Bern
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Bern, Schweiz, 3012
- Gastroenterologische Praxis Balsiger, Seibold & Partner
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Sankt Gallen, Schweiz, 9007
- Cantonal Hospital St.Gallen
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Zurich, Schweiz, 8091
- Universitätsspital Zürich
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Belgrade, Serbien, 11000
- Clinical Hospital Center Zvezdara
-
Belgrade, Serbien, 11080
- University Medical Center "Bezanijska kosa"
-
Kragujevac, Serbien, 34000
- Clinical Center Kragujevac
-
Sombor, Serbien, 25000
- Regional Hospital Dr Radivoj Simonovic Sombor
-
Sremska Mitrovica, Serbien, 22000
- Sremska Mitrovica Health Centre
-
Zrenjanin, Serbien, 23000
- General Hospital "Djordje Joanovic"
-
-
-
-
-
Banská Bystrica, Slovakiet, 97517
- Fakultna nemocnica s poliklinikou F.D.Roosevelta Banska Bystrica
-
Bratislava, Slovakiet, 81109
- Cliniq s.r.o.
-
Nitra, Slovakiet, 949 01
- KM Management
-
Prešov, Slovakiet, 080 01
- Gastro
-
Vranov N. Toplou, Slovakiet, 093 01
- Endomed, s.r.o.
-
-
-
-
-
Alicante, Spanien, 3004
- Instituto de Ciencias Médicas
-
Fuenlabrada, Spanien, 28942
- Hospital Universitario de Fuenlabrada
-
Girona, Spanien, 17007
- Hospital Universitari de Girona Doctor Josep Trueta
-
Huelva, Spanien, 21005
- Hospital Universitario Juan Ramón Jiménez
-
Las Palmas de GC, Spanien, 35019
- Hospital Universitario de Gran Canaria Doctor Negrin
-
Madrid, Spanien, 28046
- Hospital Universitario La Paz
-
Oviedo, Spanien, 33011
- Hospital Universitario Central de Asturias
-
Sagunto, Spanien, 46520
- Hospital de Sagunto y C.E.
-
Santander, Spanien, 39008
- Hospital Universitario Marqués de Valdecilla
-
-
-
-
-
Busan, Sydkorea, 49201
- Dong-A University Hospital
-
Daejeon, Sydkorea, 34943
- The Catholic University of Korea, Daejeon ST. Mary's Hospital
-
Gyeongsan-si, Sydkorea, 42415
- Yeungnam Univeristy Medical Center
-
Haeundae-gu, Sydkorea, 48108
- Inje University Haeundae Paik Hospital
-
Seoul, Sydkorea, 05505
- Asan Medical Center
-
Seoul, Sydkorea, 02447
- Kyung Hee University Hospital
-
Seoul, Sydkorea, 6351
- Samsung Medical Center
-
Seoul, Sydkorea, 3181
- Kangbuk Samsung Hospital
-
Wŏnju, Sydkorea, 26426
- Yonsei University-Wonju Severance Christian Hospital
-
-
-
-
-
Taichung, Taiwan, 40447
- China Medical University Hospital
-
Taipei, Taiwan, 10002
- National Taiwan University Hospital
-
-
-
-
-
Brno, Tjekkiet, 656 91
- Fakultni nemocnice u sv. Anny v Brne
-
Brno, Tjekkiet, 636 00
- Vojenska nemocnice Brno
-
Hradec Králové, Tjekkiet, 500 12
- Hepato-Gastroenterologie HK
-
Olomouc, Tjekkiet, 779 00
- MUDr. Gregar, s.r.o.
-
Olomouc, Tjekkiet, 779 00
- PreventaMed
-
Pilsen, Tjekkiet, 312 00
- A-Shine
-
Prague, Tjekkiet, 10034
- Fakultni nemocnice Kralovske Vinohrady
-
Prague, Tjekkiet, 186 00
- MEDIENDO
-
Prague, Tjekkiet
- ISCARE klinické centrum
-
-
-
-
-
Antalya, Tyrkiet (Türkiye), 7100
- Antalya Egitim ve Arastırma Hastanesi
-
Bornova, Tyrkiet (Türkiye), 35100
- Ege University Medicine of Faculty
-
Kocaeli, Tyrkiet (Türkiye), 41380
- Kocaeli Üniversitesi
-
Mersin, Tyrkiet (Türkiye), 33110
- Mersin University
-
-
-
-
-
Berlin, Tyskland, 14163
- Krankenhaus Waldfriede
-
Berlin, Tyskland, 12203
- Charite Universitatsmedizin Berlin Campus Benjamin Franklin
-
Brandenburg, Tyskland, 14770
- Städtisches Klinikum Brandenburg
-
Halle, Tyskland, 06108
- Studiengesellschaft BSF Unternehmergesellschaft
-
Halle, Tyskland, 6120
- Universitätsklinikum Halle
-
Hamburg, Tyskland, 20251
- HaFCED e.K. - Hamburgisches Forschungsinstitut für chronisch entzündliche Darmerkrankungen
-
Hanover, Tyskland, 30625
- Medizinische Hochschule Hannover
-
Ludwigshafen, Tyskland, 67067
- Haus der Gesundheit
-
-
-
-
-
Ivano-Frankivsk, Ukraine, 76008
- Communal Non-Profit Enterprise "Regional Clinical Hospital of Ivano-Frankivsk Regional Council"
-
Kharkiv, Ukraine, 61037
- City Clinical Hospital No. 2
-
Kharkiv, Ukraine, 61039
- L.T. Mala National Institute of Therapy of NAMS of Ukraine
-
Kherson, Ukraine, 73000
- Kherson City Clinical Hospital
-
Kiev, Ukraine, 4050
- Medical Center of Limited Liability Company "Medical Center "Consilium Medical"
-
Kropyvnytskyi, Ukraine, 25006
- Private Enterprise Private Manufacturing Company Acinus
-
Kyiv, Ukraine, 2091
- Medical Center Ok!Clinic+
-
Kyiv, Ukraine, 04106
- Municipal Nonprofit Enterprise of Kyiv Region Council "Kyiv Regional Clinical Hospital"
-
Kyiv, Ukraine, 4078
- Municipal non-profit enterprise of Kyiv Regional Council "Kyiv Regional Center for Rehabilitation Medicine"
-
Lviv, Ukraine, 79000
- Lviv Railway Clinical Hospital
-
Lviv, Ukraine, 79000
- Municipal non-profit enterprise "Lviv Territorial Medical Union "Multidisciplinary Clinical Hospital of Em -T
-
Lviv, Ukraine, 79010
- Lviv Regional Clinical Hospital - Lviv National Medical University named Danylo Galician
-
Odesa, Ukraine, 65025
- Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
-
Poltava, Ukraine, 36000
- Poltova Oblast Clinical Hospital IM.M.V.Sklifosovskoho
-
Uzhhorod, Ukraine, 88000
- Transcarpathian Regional Hospital im.Andriya Novak
-
Vinnytsia, Ukraine, 21000
- City Clinical Hospital #1, Vinnitsya National Medical University
-
Vinnytsia, Ukraine, 21009
- Medical Clinical Investigational Center of Medical Center Health Clinic
-
Vinnytsia, Ukraine, 21018
- VNMU
-
Zaporizhzhia, Ukraine, 69076
- Diacenter
-
Zaporizhzhia, Ukraine, 69059
- NOVA Hospital
-
-
-
-
-
Budapest, Ungarn, 1088
- Semmelweis University
-
Budapest, Ungarn, 1125
- Eszak-budai Szent Janos Centrumkorhaz
-
Békéscsaba, Ungarn, 5600
- Békés Megyei Központi Kórház Dr. Réthy Pál Tagkórház
-
Győr, Ungarn, 9024
- Petz Aladar Egyetemi Oktato Korhaz
-
Miskolc, Ungarn, 3526
- Endomedix Diagnosztikai Központ - Miskolc
-
Szeged, Ungarn, 6725
- Szegedi Tudomanyegyetem Szent-Gyorgyi Albert Klinikai Kozpont
-
Szekszárd, Ungarn, 7100
- CLINFAN Szolgáltató Kft
-
Vác, Ungarn, 2600
- Jávorszky Ödön Kórház
-
-
-
-
-
Innsbruck, Østrig, 6020
- Medizinische Universitaet Innsbruck
-
Salzburg, Østrig, 5020
- Uniklinikum Salzburg
-
Vienna, Østrig, 1090
- Universitaetsklinikum Allgemeines Krankenhaus Wien
-
-
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
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 80 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ingen
Beskrivelse
Inklusionskriterier
- Deltagere fra studie AMAC (NCT02589665) eller AMBG (NCT03524092), som har haft mindst én administration af studielægemidlet og ikke har haft tidlig afbrydelse af studielægemidlet.
- Kvindelige deltagere skal acceptere præventionskrav.
Eksklusionskriterier
- Deltagerne må ikke have udviklet en ny tilstand, herunder kræft i originalstudiet.
- Deltagerne må ikke have nogen vigtige infektioner, herunder, men ikke begrænset til, hepatitis B, hepatitis C, HIV/AIDS og aktiv tuberkulose (TB) under nogen af de oprindelige undersøgelser
- Deltagerne er muligvis ikke blevet opereret for UC i originalundersøgelsen eller vil sandsynligvis have behov for operation for behandling af UC under undersøgelsen.
- Deltagerne må ikke have udviklet adenomatøse polypper under originalundersøgelsen, som ikke er blevet fjernet før starten af denne undersøgelse.
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: N/A
- Interventionel model: Enkelt gruppeopgave
- Maskning: Ingen (Åben etiket)
Antal våben
1
Våben og indgreb
Deltagergruppe / ArmDeltagergruppe / Arm |
Intervention / BehandlingIntervention / Behandling |
|---|---|
|
Eksperimentel: Mirikizumab
Mirikizumab administreret subkutant (SC).
|
Administreret SC.
Andre navne:
|
Hvad måler undersøgelsen?
Primære resultatmål
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere i klinisk remission
Tidsramme: Uge 52
|
Klinisk remission baseret på den modificerede Mayo Score (MMS).
|
Uge 52
|
Sekundære resultatmål
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Procentdel af deltagere i endoskopisk remission
Tidsramme: Uge 52
|
Endoskopisk remission baseret på MMS Endoscopic Subscore (ES).
|
Uge 52
|
|
Procentdel af deltagere i kortikosteroidfri remission
Tidsramme: Uge 52
|
Deltagere i kortikosteroidfri remission.
|
Uge 52
|
|
Procentdel af deltagere med histologisk-endoskopisk slimhinderemission i uge 52
Tidsramme: Uge 52
|
Endoskopisk remission baseret på MMS ES og histologisk remission baseret på histologisk sygdomsaktivitetsindeks.
|
Uge 52
|
|
Sundhedsrelateret livskvalitet: Score for inflammatorisk tarmsygdomme (IBDQ).
Tidsramme: Baseline til uge 52
|
Sundhedsrelateret livskvalitet baseret på IBDQ-score.
|
Baseline til uge 52
|
|
UC-symptomer: Numerisk vurderingsscore
Tidsramme: Uge 160
|
UC-symptomer baseret på numerisk vurderingsscore.
|
Uge 160
|
|
Procentdel af deltagere, der er indlagt på grund af UC
Tidsramme: Baseline til uge 160
|
Deltagere, der er indlagt på grund af UC.
|
Baseline til uge 160
|
|
Procentdel af deltagere, der gennemgår UC-operationer, inklusive kolektomi
Tidsramme: Baseline til uge 160
|
Deltagere, der gennemgår UC-operationer, herunder kolektomi.
|
Baseline til uge 160
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Sponsor
Efterforskere
Efterforskere
- Studieleder: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company
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
- Sands BE, D'Haens G, Clemow DB, Irving PM, Johns JT, Gibble TH, Abreu MT, Lee SD, Hisamatsu T, Kobayashi T, Dubinsky MC, Vermeire S, Siegel CA, Peyrin-Biroulet L, Moses RE, Milata J, Panaccione R, Dignass A. Three-Year Efficacy and Safety of Mirikizumab Following 152 Weeks of Continuous Treatment for Ulcerative Colitis: Results From the LUCENT-3 Open-Label Extension Study. Inflamm Bowel Dis. 2025 Jul 7;31(7):1876-1890. doi: 10.1093/ibd/izae253.
- Lee SD, Ehrlich AC, Pellanda P, Kaiser C, Todd K, Moses R, Walsh A. Long-Term Safety of Mirikizumab in Patients With Moderately to Severely Active Ulcerative Colitis: An Integrated 2-Year Safety Analysis. Am J Gastroenterol. 2025 Dec 1;120(12):2857-2866. doi: 10.14309/ajg.0000000000003407. Epub 2025 Mar 12.
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)
Studiestart
18. juli 2018
Primær færdiggørelse (Faktiske)
Primær færdiggørelse
4. marts 2026
Studieafslutning (Anslået)
Studieafslutning
1. december 2027
Datoer for studieregistrering
Først indsendt
Først indsendt
7. maj 2018
Først indsendt, der opfyldte QC-kriterier
Først indsendt, der opfyldte QC-kriterier
7. maj 2018
Først opslået (Faktiske)
Først opslået
9. maj 2018
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering sendt
20. april 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
17. april 2026
Sidst verificeret
Sidst verificeret
1. april 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Tarmsygdomme
- Sygdomme i fordøjelsessystemet
- Gastrointestinale sygdomme
- Tyktarmssygdomme
- Gastroenteritis
- Colitis
- Colitis, Ulcerativ
- Inflammatoriske tarmsygdomme
- Lægemidlers fysiologiske virkninger
- Anti-inflammatoriske midler
- Agenter fra det perifere nervesystem
- Gastrointestinale midler
- Antirheumatiske midler
- Sensoriske systemagenter
- Analgetika, ikke-narkotisk
- Analgetika
- Anti-inflammatoriske midler, ikke-steroide
- Anti-ulcus midler
- Mirikizumab
Andre undersøgelses-id-numre
Andre undersøgelses-id-numre
- 16596
- I6T-MC-AMAP (Anden identifikator: Eli Lilly and Company)
- 2017 004092 31 (EudraCT nummer)
- 2023-507657-15-00 (Anden identifikator: EUCTR)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
JA
IPD-planbeskrivelse
Lilly giver adgang til de individuelle patientdata fra undersøgelser af godkendte lægemidler og indikationer som defineret af sponsorspecifik information på ClinicalStudyDataRequest.com.
Denne adgang gives rettidigt, efter at den primære publikation er accepteret. Forskere skal have et godkendt forskningsforslag indsendt via ClinicalStudyDataRequest.com. Adgang til dataene vil blive givet i et sikkert datadelingsmiljø efter underskrivelse af en datadelingsaftale.
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Ja
Studerer et amerikansk FDA-reguleret enhedsprodukt
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 .