Tutkimus RO7790121:n induktiohoidon tehokkuuden ja turvallisuuden arvioimiseksi potilailla, joilla on kohtalaisen tai vaikeasti aktiivinen haavainen paksusuolitulehdus (Ametrine-2)
Vaiheen III, monikeskus, kaksoissokkoutettu, lumekontrolloitu tutkimus RO7790121:n induktiohoidon tehokkuuden ja turvallisuuden arvioimiseksi potilailla, joilla on kohtalaisen tai vaikeasti aktiivinen haavainen paksusuolitulehdus
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active ulcerative colitis (UC).
Tutkimuksen yleiskatsaus
Tila
Interventio / Hoito
Opintotyyppi
Ilmoittautuminen (Arvioitu)
Vaihe
- Vaihe 3
Yhteystiedot ja paikat
Opiskelupaikat
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-
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Tilburg, Alankomaat, 5022 GC
- ETZ Elisabeth
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Ciudad Autonoma Bs As, Argentiina, C1280AEB
- Hospital Britanico
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Quilmes, Argentiina, B1878DVB
- Instituto Medico CER
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New South Wales
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Macquarie Park, New South Wales, Australia, 2109
- Macquarie University Hospital
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Victoria
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Parkville, Victoria, Australia, 3050
- Royal Melbourne Hospital
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Brussels, Belgia, 1000
- CHU St Pierre (St Pierre)
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Brussels, Belgia, 1200
- Cliniques Universitaires St-Luc
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brasilia, 90035-000
- Hospital Moinhos de Vento
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Rio de Janeiro
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Volta Redonda, Rio de Janeiro, Brasilia, 27258-000
- Instituto Lobus Unimed Volta Redonda
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Sergipe
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Aracaju, Sergipe, Brasilia, 49055-000
- Newdata Clinical Trials
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São Paulo
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Jaú, São Paulo, Brasilia, 17210-190
- CECIP - Centro de Estudos Clínicos do Interior Paulista
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São Paulo, São Paulo, Brasilia, 04266-010
- Centro Paulista de Investigacao Clinica - CEPIC
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Plovdiv, Bulgaria, 4003
- MC " Sveti Ivan Rilski Chudotvorets- 2010
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Sofia, Bulgaria, 1407
- "City Clinic UMHAC" EOOD
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Santiago, Chile, 8330034
- Centro de Investigación Clínica UC-CICUC
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-
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Zaragoza, Espanja, 50009
- Hospital Universitario Miguel Servet
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Madrid
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Majadahonda, Madrid, Espanja, 28222
- Hospital Universitario Puerta de Hierro Majadahonda
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-
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Gujarat
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Surat, Gujarat, Intia, 395002
- Surat Institute of Digestive Sciences Hospitals
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Surat, Gujarat, Intia, 395009
- Gujarat Gastro and Vascular Hospital
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Maharashtra
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Nagpur (urban), Maharashtra, Intia, 440001
- Kingsway Hospital
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Nagpur (urban), Maharashtra, Intia, 440018
- MIDAS Multispeciality Hospital
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Rajasthan
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Jaipur, Rajasthan, Intia, 302006
- SR Kalla Memorial Gastro & General Hospital
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Jaipur, Rajasthan, Intia, 302007
- SMS Superspeciality Hospital
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Telangana
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Secunderabad, Telangana, Intia, 500003
- Yashoda Hospitals
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-
-
-
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Beersheba, Israel, 8410101
- Soroka Medical Center
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Ramat Gan, Israel, 5265601
- The Chaim Sheba Medical Center - The Edmond and Lily Safra Children's Hospital
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-
-
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Lazio
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Rome, Lazio, Italia, 00128
- Policlinico Universitario Campus Biomedico Di Roma
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Rome, Lazio, Italia, 00186
- Ospedale Isola Tiberina Gemelli
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Lombardy
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Brescia, Lombardy, Italia, 25123
- Asst Degli Spedali Civili Di Brescia
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Milan, Lombardy, Italia, 20132
- IRCCS Ospedale San Raffaele
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Monza MI, Lombardy, Italia, 20900
- Azienda Ospedaliera San Gerardo di Monza
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Rozzano (MI), Lombardy, Italia, 20089
- Istituto Clinico Humanitas
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Veneto
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Negrar, Veneto, Italia, 37024
- IRCCS Ospedale Sacro Cuore Don Calabria
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Linz, Itävalta, 4010
- Ordensklinikum Linz Barmherzige Schwestern
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Ontario
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Barrie, Ontario, Kanada, L4M 7G1
- Barrie GI Associates
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London, Ontario, Kanada, N6A 5A5
- London Health Sciences Centre Uni Campus
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London, Ontario, Kanada, N6K 1M6
- LDDI Clinical Trials Inc.
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Toronto, Ontario, Kanada, M6A 3B4
- TIDHI Innovation Inc.
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Quebec
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Montreal, Quebec, Kanada, H1T 2M4
- CIUSSS-de-l?Est-de-l?Île-de-Montréal
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-
-
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Changsha, Kiina, 410013
- Third Xiangya Hospital Centrel South University
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Chengdu, Kiina, 610041
- West China Hospital of Sichuan University
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Guangzhou, Kiina, 510180
- Guangzhou First People's Hospital
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Guangzhou, Kiina, 510260
- The second Affiliated Hospital of Guangzhou Medical University
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Hangzhou, Kiina, 310016
- Sir Run Run Shaw Hospital Zhejiang University
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Huizhou, Kiina, 516001
- Huizhou Central People's Hospital
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Nanning, Kiina, 530021
- The First Affiliate Hospital of Guangxi Medical University
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Ningbo, Kiina, 315000
- The First Affiliated Hospital of Ningbo University
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Qingdao, Kiina, 266000
- The Affiliated Hospital of Medical College Qingdao University
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Shanghai, Kiina, 200092
- Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
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Shanghai, Kiina, 200025
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Shenyang, Kiina, 110004
- Shengjing Hospital of China Medical University
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Suzhou, Kiina, 215006
- First Affiliated Hospital of Soochow University
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Xiamen, Kiina, 361004
- Zhongshan Hospital Xiamen University
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Beijing Municipality
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Beijing, Beijing Municipality, Kiina, 100007
- Beijing No.6 Hospital
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Yunnan
-
Kunming, Yunnan, Kiina, 650032
- The First Affilliated Hospital of Kunming Medical University
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Osijek, Kroatia, 31000
- Borzan Polyclinic
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Veracruz, Meksiko, 91900
- FAICIC S de R.L. de C.V
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Mexico CITY (federal District)
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Miguel Hidalgo, Mexico CITY (federal District), Meksiko, 01120
- Boca Clinical Trials Mexico S.C. (Cd. Mexico)
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Braga, Portugali, 4710-243
- Hospital de Braga
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Lisbon, Portugali, 1500-650
- Hospital da Luz Lisboa
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Portimão, Portugali, 8500-338
- Centro Hospitalar do Algarve - Hospital de Portimao
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Porto, Portugali, 4202-451
- Hospital de Sao Joao
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Santa Maria da Feira, Portugali, 4520-211
- Centro Hospitalar de Entre Douro e Vouga - H. São Sebastião
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Viseu, Portugali, 3504-509
- Hospital Sao Teotonio
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San Juan, Puerto Rico, 00909
- Klinical Investigations Group LLC
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?ód?, Puola, 93-357
- Szpital Zakonu Bonifratrow Sw. Jana Bozego w Lodzi sp. z o.o.
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Bydgoszcz, Puola, 85-231
- Medical Center Kermed
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Elblag, Puola, 82-300
- Szpital Miejski sw. Jana Paw?a II w Elblagu
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I?awa, Puola, 14-200
- Osrodek Badan Klinicznych Bd Research
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Knurów, Puola, 44-190
- MZ Badania Slowik Zymla Sp.j.
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Krakow, Puola, 31-513
- Centrum Medyczne Promed
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Lublin, Puola, 20-582
- Medrise sp z o.o
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Poznan, Puola, 61-731
- Clinical Research Center Sp. z o.o. MEDIC-R Spó?ka Komandytowa
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Późna, Puola, 60-309
- EMC Instytut Medyczny SA
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Późna, Puola, 61-441
- Gabinety Lekarskie Rivermed
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Sopot, Puola, 81-756
- Endoskopia Sp. z o.o.
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Szczecin, Puola, 71-685
- Sonomed Sp. z o.o.
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Warsaw, Puola, 00-189
- Centrum Zdrowia-MDM
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Warsaw, Puola, 02-679
- Medon Clinical Research sp. z o.o
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Warsaw, Puola, 03-580
- Vivamed Spolka Z Ograniczona Odpowiedzialnoscia
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Wroc?aw, Puola, 52-210
- PlanetMed sp. z o.o.
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Wroclaw, Puola, 52-416
- Centrum Medyczne Oporow
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Chambray-lès-Tours, Ranska, 37170
- CHU Tours - Hôpital Trousseau
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Clermont-Ferrand, Ranska, 63000
- CHU Clermont Ferrand - Hôtel Dieu
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Créteil, Ranska, 94000
- Hôpital Henri Mondor
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Nîmes, Ranska, 30900
- Polyclinique Grand Sud
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Vandœuvre-lès-Nancy, Ranska, 54511
- Hôpital de Brabois Adultes
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Lüneburg, Saksa, 21339
- Medizinisches Zentrum Klinikum Lueneburg
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Zrenjanin, Serbia, 23000
- General Hospital "Djordje Joanovic"
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Taichung, Taiwan, 40447
- China Medical University Hospital
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Aalborg, Tanska, 9000
- Ålborg Universitets Hospital
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Chiang Mai, Thaimaa, 50200
- Division of Gastroenterology, Depart of Internal Med., Fac of Med., Chiang Mai University
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Chon Buri, Thaimaa, 20131
- Burapha University Hospital
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Ubonratchathani, Thaimaa, 34000
- Sunpasitthiprasong Hospital
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-
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-
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Hradec Králové, Tšekki, 500 12
- Hepato-Gastroenterologie HK, s.r.o.
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Prague, Tšekki, 170 04
- ISCARE a.s.
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-
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Budapest, Unkari, 1082
- Semmelweis Egyetem
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Debrecen, Unkari, 4025
- Vasutegeszsegugyi Kft. - Debreceni Egeszsegugyi Kozpont
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Szombathely, Unkari, 9700
- Vas-Oxy Egeszsegugyi Kft
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Székesfehérvár, Unkari, 8000
- Fejer Varmegyei Szent György Egyetemi Oktatokorhaz
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Leicester, Yhdistynyt kuningaskunta, LE5 4PW
- Leicester General Hospital
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Llanrhystud, Yhdistynyt kuningaskunta, SY23 1ER
- Bronglais General Hospital
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London, Yhdistynyt kuningaskunta, SE5 9RS
- King College Hospital NHS Foundation Trust
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Stockport, Yhdistynyt kuningaskunta, SK2 7JE
- Stepping Hill Hospital
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Alabama
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Dothan, Alabama, Yhdysvallat, 36305
- Digestive Health Specialists of the Southeast (Gastroenterology Associates of Dothan) - Dothan
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Arizona
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Scottsdale, Arizona, Yhdysvallat, 85259
- Mayo Clinic Hospital
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Sun City, Arizona, Yhdysvallat, 85351
- Arizona Digestive Health, P.C (ADH)
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California
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Apple Valley, California, Yhdysvallat, 92307
- Om Research LLC
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Garden Grove, California, Yhdysvallat, 92845
- Valley View Internal Medicine
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Lancaster, California, Yhdysvallat, 93534
- Gastro Care Associates
-
Redwood City, California, Yhdysvallat, 94063
- Stanford Medicine Outpatient Center
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Colorado
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Colorado Springs, Colorado, Yhdysvallat, 80907
- Peak Gastroenterology Associates
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Florida
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Coral Gables, Florida, Yhdysvallat, 33134
- Hi Tech and Global Research, LLC
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Hialeah, Florida, Yhdysvallat, 33013
- The Sister Life Research
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Miami, Florida, Yhdysvallat, 33155
- Allied Biomedical Research Institute
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Miami, Florida, Yhdysvallat, 33126
- LCC Medical Research Institute, LLC
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Orlando, Florida, Yhdysvallat, 32825
- Digestive and Liver Center of Florida
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Orlando, Florida, Yhdysvallat, 32807
- Integrity Trials LLC
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Port Orange, Florida, Yhdysvallat, 32127
- Advanced Medical Research Center
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Tampa, Florida, Yhdysvallat, 33612
- University of South Florida School of Medicine Morsani Center for Advanced Health Care
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Tampa, Florida, Yhdysvallat, 33615
- Santos Research Center, CORP
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Tampa, Florida, Yhdysvallat, 33614
- Guardian Angel Research Center, LLC
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Weston, Florida, Yhdysvallat, 33331
- Cleveland Clinic Florida
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Georgia
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Atlanta, Georgia, Yhdysvallat, 30342
- Atlanta Gastroenterology Associates
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Atlanta, Georgia, Yhdysvallat, 30308
- Randomize Now, LLC
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Macon, Georgia, Yhdysvallat, 31201
- Gastroenterology Associates of Central Georgia
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Illinois
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Glenview, Illinois, Yhdysvallat, 60026
- Illinois Gastroenterology Group-Glenview powered by GI Alliance
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Gurnee, Illinois, Yhdysvallat, 60031
- GI Alliance - Gurnee
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Indiana
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New Albany, Indiana, Yhdysvallat, 47150
- Gastro Health Partners, LLC
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Kansas
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Wichita, Kansas, Yhdysvallat, 67226
- Kansas Gastroenterology, LLC under Clinical Trials Network
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Kentucky
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Louisville, Kentucky, Yhdysvallat, 40218
- One GI: GHP - Gastroenterology Health Partners Louisville
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Louisiana
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Shreveport, Louisiana, Yhdysvallat, 71105
- Louisiana Research Center - GastroIntestinal Associates
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Mississippi
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Flowood, Mississippi, Yhdysvallat, 39232
- Allied Gastrointestinal Associates, PA
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New Hampshire
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Lebanon, New Hampshire, Yhdysvallat, 03756
- Dartmouth-Hitchcock Medical Center-Norris Cotton Cancer Center
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New York
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Brooklyn, New York, Yhdysvallat, 11215
- Ellipsis Research Group
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New York, New York, Yhdysvallat, 10021
- Weill Cornell Medical College
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New York, New York, Yhdysvallat, 10016
- NYU Inflammatory Bowel Disease Center
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North Massapequa, New York, Yhdysvallat, 11758
- DiGiovanna Inst for Med Ed&Res
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Queens Village, New York, Yhdysvallat, 11428
- Queens Village Medical Care
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Rochester, New York, Yhdysvallat, 14618
- Gastroenterology Group Of Rochester, LLP
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North Carolina
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Charlotte, North Carolina, Yhdysvallat, 28207
- Charlotte Gastroenterology and Hepatology, P.L.L.C
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Fuquay-Varina, North Carolina, Yhdysvallat, 27526
- Omega Research North Carolina, LLC
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High Point, North Carolina, Yhdysvallat, 27260
- Peters Medical Research (PMR), LLC
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Ohio
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Beavercreek, Ohio, Yhdysvallat, 45440
- Dayton Gastroenterology, Inc.
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Cincinnati, Ohio, Yhdysvallat, 45267
- University of Cincinnati Hospital
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Cleveland, Ohio, Yhdysvallat, 44195
- Cleveland Clinic Foundation
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Columbus, Ohio, Yhdysvallat, 43210
- Ohio State University
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Columbus, Ohio, Yhdysvallat, 43202
- Ohio Gastroenterology Group
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Westlake, Ohio, Yhdysvallat, 44145
- Gastro Intestinal Research Institute of Northern Ohio
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Pennsylvania
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Uniontown, Pennsylvania, Yhdysvallat, 15401
- Frontier Clinical Re search, LLC
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Rhode Island
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Providence, Rhode Island, Yhdysvallat, 02904
- University Gastroenterology
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South Carolina
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Greenville, South Carolina, Yhdysvallat, 29607
- Gastroenterology Associates
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Tennessee
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Cordova, Tennessee, Yhdysvallat, 38018
- Gastro One
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Texas
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Galveston, Texas, Yhdysvallat, 77555
- Uni of Texas Medical Branch
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Garland, Texas, Yhdysvallat, 75044
- GI Alliance
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Georgetown, Texas, Yhdysvallat, 78628
- Amel Med LLC
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Harlingen, Texas, Yhdysvallat, 78550
- Texas Digestive Specialists
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Harlingen, Texas, Yhdysvallat, 78550
- Cano Medical Center
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Lubbock, Texas, Yhdysvallat, 79410
- GI Alliance - Bay Area Gastroenterology
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Mansfield, Texas, Yhdysvallat, 76063
- TDDC dba GI Alliance Research
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San Antonio, Texas, Yhdysvallat, 78229
- Southern Star Research Institute, LLC.
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Temple, Texas, Yhdysvallat, 76508
- Baylor Scott and White Medical Center
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Tyler, Texas, Yhdysvallat, 75708
- University of Texas Health Center at Tyler
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Tyler, Texas, Yhdysvallat, 75701
- Tyler Research Institute, LLC
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Webster, Texas, Yhdysvallat, 77598
- TDDC GI Alliance research Webster
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Virginia
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Chesapeake, Virginia, Yhdysvallat, 23320
- Gastroenterology Associates of Tidewater
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Lansdowne Town Center, Virginia, Yhdysvallat, 20176
- Emeritas Research Group
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Roanoke, Virginia, Yhdysvallat, 24018
- Gastroenterology Consultants of SWVA
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Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Kuvaus
Inclusion Criteria:
- Confirmed diagnosis of UC
- Moderately to severely active UC assessed by mMS
- Bodyweight >= 40 kilogram (kg)
- Up to date with colorectal cancer (CRC) screening performed according to local standards
- Demonstrated inadequate response, loss of response and/or intolerance to at least one protocol-specified conventional or advanced UC therapy
- Males and females of childbearing potential must meet protocol criteria for contraception requirements
Exclusion Criteria:
- Currently known complications of UC (e.g. fulminant colitis, toxic megacolon)
- Current diagnosis of Crohn's disease (CD) or indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, radiation colitis
- Presence of an ostomy or ileoanal pouch
- Current diagnosis or suspicion of primary sclerosing cholangitis
- Pregnancy or breastfeeding, or intention of becoming pregnant during the study
- Past or current evidence of definite low-grade or high-grade colonic dysplasia or adenomas or neoplasia not completely removed
- History of malignancy within 5 years, with the exception of malignancies adequately treated with resection for non-metastatic basal cell or squamous cell cancer or in situ cervical cancer
- Evidence of infection with Clostridioides difficile (C. difficile; formerly known as Clostridium difficile), cytomegalovirus (CMV), human immunodeficiency virus (HIV), Hepatitis B (HBV), Hepatitis C (HCV)
- Has evidence of active tuberculosis (TB), latent TB not successfully treated (per local guidance) or inadequately treated TB
- Has received protocol-specified prohibited medicines, including known exposure to any type of anti-TL1A therapy
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Ensisijainen käyttötarkoitus: Hoito
- Jako: Satunnaistettu
- Inventiomalli: Rinnakkaistehtävä
- Naamiointi: Kaksinkertainen
Aseet ja interventiot
Osallistujaryhmä / Arm |
Interventio / Hoito |
|---|---|
|
Kokeellinen: Afimkibart
Participants will receive afimkibart intravenously (IV) followed by afimkibart subcutaneous (SC) injection. |
Participants will receive afimkibart IV followed by afimkibart subcutaneous SC injection.
Muut nimet:
|
|
Placebo Comparator: Placebo
Participants will receive placebo IV followed by placebo SC. |
Placebo matching IV afimkibart. Placebo matching SC afimkibart. |
Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Percentage of Participants with Clinical Remission
Aikaikkuna: At Week 12
|
Percentage of participants achieving Modified Mayo Score (mMS) <=2 with stool frequency subscore (SFS) = 0 or 1 (up to 1-2 stools more than normal), rectal bleeding subscore (RBS) = 0 (no blood seen) and endoscopic subscore (ES) = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. |
At Week 12
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
|---|---|---|
|
Change in Partial Modified Mayo Score (pmMS)
Aikaikkuna: From baseline to Week 2
|
Change in pmMS from baseline to Week 2. pmMS is a composite score of ulcerative colitis signs and symptoms activity given by the sum of the SFS and RBS. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). |
From baseline to Week 2
|
|
Percentage of Participants with Endoscopic Improvement
Aikaikkuna: At Week 12
|
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. |
At Week 12
|
|
Percentage of Participants with Endoscopic Remission
Aikaikkuna: At Week 12
|
Percentage of participants achieving endoscopic subscore of 0 (normal appearance of mucosa) at Week 12. |
At Week 12
|
|
Percentage of Participants with Clinical Response
Aikaikkuna: At Week 12
|
Percentage of participants achieving a decrease in mMS of at least 2 points and 30% from baseline and either a decrease in RBS >= 1 or RBS = 0 or 1 (no blood seen or stool with streaks of blood) at Week 12. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. SFS is measured on a scale from 0 (normal number of stools) to 3 (5 or more stools than normal). RBS is measured on a scale from 0 (no blood seen) to 3 (blood alone passed). ES is measured on a scale from 0 (normal appearance of mucosa) to 3 (severe disease). |
At Week 12
|
|
Percentage of Participants with Histologic Improvement
Aikaikkuna: At Week 12
|
Percentage of participants achieving a histologic improvement, defined as Geboes <=3.1 at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Percentage of Participants with Histologic Remission
Aikaikkuna: At Week 12
|
Percentage of participants achieving a histologic remission, defined as Geboes <2B at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Participants with Histologic-Endoscopic Mucosal Improvement
Aikaikkuna: At Week 12
|
Percentage of participants achieving Geboes <= 3.1 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Percentage of Participants with Histologic-Endoscopic Remission
Aikaikkuna: At Week 12
|
Percentage of participants achieving Geboes < 2 and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12. Geboes is a grading system for histologic ulcerative colitis disease activity with scores ranging from 0 (no activity) to 5.4 (ulcer or granulation tissue). |
At Week 12
|
|
Percentage of Participants with Clinical Remission: Among Biomarker-Defined Subgroups of Participants
Aikaikkuna: At Week 12
|
Percentage of participants achieving mMS <= 2 with SFS = 0 or 1 (up to 1-2 stools more than normal), RBS = 0 (no blood seen) and ES = 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. mMS is a composite score of ulcerative colitis disease activity, given by the sum of three subscores: SFS, RBS and ES. Each subscore is measured on a scale from 0 to 3, with higher values associated with greater severity. |
At Week 12
|
|
Percentage of Participants with Endoscopic Improvement: Among Biomarker-Defined Subgroups of Participants
Aikaikkuna: At Week 12
|
Percentage of participants achieving endoscopic subscore of 0 or 1 (normal appearance of mucosa or mild disease) at Week 12 in biomarker-defined subgroups. |
At Week 12
|
|
Change in Bowel Urgency
Aikaikkuna: Baseline through Week 12
|
Change in bowel urgency from baseline through Week 12. Bowel urgency is measured on a scale from 0 (None) to 4 (Severe). |
Baseline through Week 12
|
|
Change in Abdominal Pain
Aikaikkuna: Baseline through Week 12
|
Change in abdominal pain from baseline through Week 12. Abdominal pain is measured on a scale from 0 (None) to 4 (Severe). |
Baseline through Week 12
|
|
Change in Fatigue
Aikaikkuna: Baseline to Week 12
|
Change in fatigue as measured by the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue) from baseline to Week 12. FACIT-Fatigue is a 13-item self-reported assessment of the level and impact of fatigue. The overall FACIT-Fatigue score ranges between 0 and 52, with higher scores associated with better quality of life concerns related to fatigue. |
Baseline to Week 12
|
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Change in Health-Related Quality of Life
Aikaikkuna: Baseline to Week 12
|
Change in Inflammatory Bowel Disease Questionnaire (IBDQ) score from baseline to Week 12. IBDQ is a 32-item self-reported assessment of health-related quality of life in participants with inflammatory bowel disease. The overall IBDQ score ranges from 32 to 224, with higher scores associated with better health-related quality of life. |
Baseline to Week 12
|
|
Overall Change in UC Symptoms
Aikaikkuna: Baseline to Week 2 and Week 12
|
Patient Global Impression of Change (PGIC) from baseline to Weeks 2 and 12. PGIC measures overall change in ulcerative colitis symptoms from "Much better" to"Much worse". |
Baseline to Week 2 and Week 12
|
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Overall Severity in UC Symptoms
Aikaikkuna: Baseline to Week 2 and Week 12
|
Patient Global Impression of Severity (PGIS) from baseline to Weeks 2 and 12. PGIS measures severity of ulcerative colitis symptoms from "None" to "Very severe". |
Baseline to Week 2 and Week 12
|
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Incidence and Severity of Adverse Events (AEs)
Aikaikkuna: Up to 30 Weeks after Baseline
|
Incidence and severity of AEs, including serious AEs, AEs leading to treatment discontinuation and AEs of special interest. |
Up to 30 Weeks after Baseline
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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojohtaja: Clinical Trials, Hoffmann-La Roche
Julkaisuja ja hyödyllisiä linkkejä
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Arvioitu)
Opintojen valmistuminen (Arvioitu)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
Lisää tietoa
Tähän tutkimukseen liittyvät termit
Muut tutkimustunnusnumerot
- GA45330
- 2024-513015-27-00 (Ctis)
Yksittäisten osallistujien tietojen suunnitelma (IPD)
Aiotko jakaa yksittäisten osallistujien tietoja (IPD)?
IPD-suunnitelman kuvaus
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing
Lääke- ja laitetiedot, tutkimusasiakirjat
Tutkii yhdysvaltalaista FDA sääntelemää lääkevalmistetta
Tutkii yhdysvaltalaista FDA sääntelemää laitetuotetta
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