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Активно (без набиране) Фаза 3 NCT03006068

A Study to Evaluate the Long-Term Safety and Efficacy of Upadacitinib (ABT-494) in Participants With Ulcerative Colitis (UC)

Фаза 3 – широко изпитване преди одобрение
Заболявания: Ulcerative Colitis (UC)

Спонсор: AbbVie

Налично на: БГ
Обобщение
This study is designed to evaluate the long-term safety and efficacy of Upadacitinib in participants with ulcerative colitis (UC) who have not responded at the end of the induction period in Study M14-234 Substudy 1, who have had loss of response during the maintenance period of Study M14-234 Substudy 3, or who have successfully completed Study M14-234 Substudy 3.
Кой може да участва
Inclusion Criteria: Note: Participants aged 16 or 17 may enroll in M14-234 or M14-675 where locally permissible * Participant has not achieved clinical response at the end of the induction period (Week 8) in Study M14-234 Substudy 1, has had loss of response during the maintenance period of Study M14-234 Substudy 3, or has successfully completed Study M14-234 Substudy 3. During the COVID-19 pandemic, for participants with missing endoscopy at Week 8, Week 16 or Week 52 due to the COVID-19 pandemic in Studies M14-234 Substudy 2, M14-234 Substudy 3 and M14-675, participants may be enrolled if certain criteria are met. * If female, participant must meet the contraception criteria. * Women of childbearing potential must have a negative urine pregnancy test at Week 0 visit. * Participant is judged to be in otherwise good health as determined by the principal investigator based upon clinical evaluations performed during the preceding study (Study M14-234). * Must be able and willing to give written informed consent and to comply with the requirements of this study protocol. Exclusion Criteria: * For any reason participant is considered by the investigator to be an unsuitable candidate. * Female participant with a positive pregnancy test at the final visit of Study M14-234 or who is considering becoming pregnant during the study or within 30 days after the last dose of study drug. * Known hypersensitivity to upadacitinib or its excipients or had any adverse event (AE) during the preceding studies, that in the investigator's judgment makes the participant unsuitable for this study. * Participant with an active or recurrent infection that based on the investigator's clinical assessment makes the participant an unsuitable candidate for the study. Participants with ongoing infections undergoing treatment may be enrolled BUT NOT dosed until the infection has been successfully treated. * Current evidence of active tuberculosis (TB); current evidence of latent tuberculosis and for any reason the participant cannot take full course of TB prophylaxis treatment as required per protocol. * Participant with a poorly controlled medical condition, such as uncontrolled diabetes, unstable ischemic heart disease, moderate or severe congestive heart failure (New York Heart Association class III or IV), recent cerebrovascular accidents and any other condition which, in the opinion of the investigator or sponsor, would put the subject at risk by participation in this study. * Participants have malignancy, high-grade dysplasia, un-removed low-grade dysplasia of the gastrointestinal tract diagnosed at the endoscopy performed at the final visit of Study M14-234. * History of any malignancy except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix from evaluations performed in Study M14-234.
Места на провеждане 42
Argentina (1)
Hospital Britanico de Buenos Aires /ID# 209496
Ciudad Autonoma de Buenos Aire , Buenos Aires
Австралия (1)
Macquarie University Hospital /ID# 211953
Macquarie University , New South Wales
Belarus (1)
Vitebsk Regional Advanced Clin /ID# 169592
Vitebsk
Bosnia and Herzegovina (1)
Duplicate_University Clinical Centre of the Republic of Srpska /ID# 150223
Banja Luka , Republika Srpska
Бразилия (1)
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 153744
Goiânia , Goiás
Канада (1)
University of Calgary /ID# 151818
Calgary , Alberta
Chile (1)
Hospital Guillermo Grant Benavente de Concepción /ID# 212425
Concepción , Biobio
Китай (1)
The First Affiliated Hospital, Sun Yat-sen University /ID# 150517
Guangzhou , Guangdong
Colombia (1)
Hospital Universitario de San /ID# 155388
Medellín , Antioquia
Хърватия (1)
Duplicate_Poliklinika Solmed /ID# 211567
Grad Zagreb , City of Zagreb
Чехия (1)
Iscare Klinické Centrum /ID# 209279
Prague , Praha 9
Estonia (1)
North Estonia Medical Centre /ID# 160871
Mustamäe , Harju
Финландия (1)
Tampereen yliopistollinen sairaala /ID# 150376
Tampere , Pirkanmaa
Франция (1)
Chu de Nice-Hopital Larchet Ii /Id# 152608
Nice , Alpes-Maritimes
Германия (1)
Universitatsklinikum Mannheim /ID# 150405
Mannheim , Baden-Wurttemberg
Гърция (1)
General Hospital of Athens Laiko /ID# 208672
Athens , Attica
Унгария (1)
Meditres Kft. /ID# 151597
Kecskemét , Bács-Kiskun county
Ireland (1)
St James Hospital /ID# 150413
Dublin , Dublin
Израел (1)
Shaare Zedek Medical Center /ID# 163139
Jerusalem , Jerusalem
Италия (1)
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 150424
Bologna , Emilia-Romagna
Япония (1)
Aichi Medical University Hospital /ID# 151994
Nagakute , Aichi-ken
Latvia (1)
VCA Polyclinic Aura /ID# 150436
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 150439
Kaunas
Malaysia (1)
Hospital Sultanah Bahiyah /ID# 152310
Alor Star , Kedah
Mexico (1)
Morales Vargas Centro de Investigacion S.C. /ID# 211327
León , Guanajuato
Нидерландия (1)
Radboud Universitair Medisch Centrum /ID# 151701
Nijmegen , Gelderland
Норвегия (1)
Akershus Universitetssykehus_MAIN /ID# 150622
Lorenskog , Akershus
Полша (1)
Gastromed Sp. z o.o /ID# 216198
Torun , Kuyavian-Pomeranian Voivodeship
Puerto Rico (1)
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 150629
San Juan
Russia (1)
Immanuel Kant Baltic Federal University /ID# 202129
Kaliningrad , Kaliningrad Oblast
Сърбия (1)
Clinical Hosp Center Zvezdara /ID# 150641
Belgrade , Beograd
Сингапур (1)
National University Hospital /ID# 150583
Singapore
Словакия (1)
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 150869
Banská Bystrica , Banská Bystrica Region
South Africa (1)
MD Search /ID# 157524
Boksburg North , Gauteng
Южна Корея (1)
Dong-A University Medical Center /ID# 161568
Busan , Busan Gwang Yeogsi
Испания (1)
Complejo Hospitalario Universitario A Coruña /ID# 203912
A Coruña , A Coruna
Швеция (1)
Duplicate_Sahlgrenska University Hospital /ID# 152326
Gothenburg , Västra Götaland County
Taiwan (1)
National Taiwan University Hospital /ID# 150604
Taipei City , Taipei
Турция (1)
Gazi Universitesi Tip Fakultes /ID# 150493
Yenimahalle , Ankara
Ukraine (1)
CNCE of Kharkiv Regional Council Regional Clinical Hospital /ID# 206941
Kharkiv , Kharkivs’ka Oblast’
Великобритания (1)
Duplicate_Royal United Hospitals Bath /ID# 154211
Bath , Bath And North East Somerset
САЩ (1)
East View Medical Research, LLC /ID# 171184
Mobile , Alabama
Технически детайли
Статус
Активно (без набиране)
Фаза
Фаза 3
Вид изследване
INTERVENTIONAL
Пол
Мъже и жени
Минимална възраст
16 Years
Максимална възраст
75 Years
Здрави доброволци
Не
Начална дата
31.01.2017
Крайна дата
01.07.2027
Регистрационен номер
NCT03006068
Източник
anzctr
Запитване за медицински туризъм

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