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Active (not recruiting) Phase 3 NCT03345823

A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-433

Phase 3 – large-scale trial before approval
Conditions: Crohn's Disease

Sponsor: AbbVie

trial.available_in: БГ
Overview
A multicenter study to evaluate the efficacy and safety of maintenance and long-term treatment administration of upadacitinib, an orally administered Janus kinase 1 inhibitor, in adult participants with Crohn's Disease.
Who can participate
Inclusion Criteria: For Substudy 1: * Participant who achieve clinical response in Study M14-431 or Study M14-433. * Participant completes study procedures in the parent study. The final endoscopy for Studies M14-431 or M14-433 may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic. For Substudy 2: * Participant completes Substudy 1. The Week 52 endoscopy may be missing, if the endoscopy cannot be performed during the COVID-19 pandemic. * Participant who achieved clinical response at the time described in the protocol and completes study procedures in the parent study/ substudy. Exclusion Criteria: For Substudies 1 and 2: * Participant is considered by the investigator, for any reason, to be an unsuitable candidate for the study. * Participant who has a known hypersensitivity to upadacitinib or its excipients, or had an adverse event during Studies M14-431 and M14-433 or Substudy 1 or 2 of Study M14-430 that in the investigator's judgment makes the participant unsuitable for this study. * Participant at the final visit of M14-431 or M14-433 with any active or chronic recurring infections based on the investigator's assessment that makes the participant an unsuitable candidate for the study. Participants with serious infections undergoing treatment may be enrolled BUT NOT dosed until the infection treatment has been completed and the infection is resolved, based on the investigator's assessment. * Participants with high grade colonic dysplasia or malignancy diagnosed at the endoscopy performed at the final visit of Studies M14-431, M14-433 or Substudy 1 of Study M14-430 (Week 52).
Locations 44
Argentina (1)
Cemic /Id# 169183
Ciudad Autonoma Buenos Aires , Buenos Aires
Australia (1)
Concord Repatriation General Hospital /ID# 171506
Concord , New South Wales
Belgium (1)
Cliniques Universitaires UCL Saint-Luc /ID# 200293
Brussels , Brussels Capital
Bosnia and Herzegovina (1)
Duplicate_University Clinical Centre of the Republic of Srpska /ID# 200743
Banja Luka , Republika Srpska
Brazil (1)
Instituto Goiano de Gastroenterologia e Endoscopia Digestiva /ID# 166853
Goiânia , Goiás
Bulgaria (1)
Duplicate_UMHAT Kaspela EOOD /ID# 167615
Plovdiv
Canada (1)
University of Calgary /ID# 166990
Calgary , Alberta
Chile (1)
Hospital Guillermo Grant Benavente de Concepción /ID# 212421
Concepción , Biobio
China (1)
Beijing Friendship Hospital /ID# 204175
Beijing , Beijing Municipality
Colombia (1)
Duplicate_Hospital Pablo Tobon Uribe /ID# 202403
Medellín , Antioquia
Croatia (1)
Clinical Hospital Dubrava /ID# 171165
Zagreb , City of Zagreb
Czech Republic (1)
Nemocnice Ceske Budejovice a.s. /ID# 224390
České Budějovice
Denmark (1)
Herlev Hospital /ID# 200785
Herlev , Capital Region
Egypt (1)
Alexandria University /ID# 171008
Alexandria , Alexandria Governorate
Estonia (1)
West Tallinn Central Hospital /ID# 202787
Tallinn , Harju
France (1)
Chu de Nice-Hopital Larchet Ii /Id# 171004
Nice , Alpes-Maritimes
Greece (1)
General Hospital of Athens Ippokratio /ID# 167032
Athens , Attica
Hong Kong (1)
Queen Mary Hospital /ID# 171214
Hong Kong
Hungary (1)
Pecsi Tudomanyegyetem Klinikai Kozpont Mohacsi Korhaz /ID# 209440
Mohács , Baranya
Ireland (1)
Mercy University Hospital /ID# 206512
Cork
Israel (1)
Duplicate_Kaplan Medical Center /ID# 170275
Rehovot , Central District
Italy (1)
Duplicate_IRCCS AOU di Bologna - Policlinico Sant'Orsola-Malpighi /ID# 168155
Bologna , Emilia-Romagna
Japan (1)
Aichi Medical University Hospital /ID# 165989
Nagakute , Aichi-ken
Latvia (1)
VCA Polyclinic Aura /ID# 169499
Riga
Lithuania (1)
Hospital of Lithuanian University of Health Sciences Kaunas Clinics /ID# 207030
Kaunas
Malaysia (1)
Duplicate_Hospital Sultanah Bahiyah /ID# 201317
Alor Star , Kedah
Mexico (1)
Instituto de Investigaciones Aplicadas a la Neurociencias A.C. /ID# 207681
Durango , Durango
Netherlands (1)
Radboud Universitair Medisch Centrum /ID# 166931
Nijmegen , Gelderland
Poland (1)
Malopolskie Centrum Kliniczne /ID# 202169
Krakow , Lesser Poland Voivodeship
Puerto Rico (1)
Mindful Medical Research /ID# 203356
San Juan
Romania (1)
Fundeni Clinical Institute /ID# 167831
Bucharest , Bucharest
Russia (1)
Immanuel Kant Baltic Federal University /ID# 203810
Kaliningrad , Kaliningrad Oblast
Serbia (1)
Clinical Hosp Center Zvezdara /ID# 168216
Belgrade , Beograd
Singapore (1)
Duplicate_KL Ling Gastroenterology and Liver Clinic /ID# 205739
Singapore , Central Singapore
Slovakia (1)
Fakultna nemocnica s poliklinikou F.D. Roosevelta Banska Bystrica /ID# 169960
Banská Bystrica , Banská Bystrica Region
South Africa (1)
Farmovs (Pty) Ltd /Id# 207534
Bloemfontein , Free State
South Korea (1)
Inje University Haeundae Hospital /ID# 202631
Busan , Busan Gwang Yeogsi
Spain (1)
Hospital Universitari Son Espases /ID# 201969
Palma de Mallorca , Balearic Islands
Sweden (1)
Hallands Hospital Halmstad /ID# 170815
Halmstad , Halland County
Taiwan (1)
National Taiwan University Hospital /ID# 169805
Taipei City , Taipei
Turkey (1)
Gazi Universitesi Tip Fakultes /ID# 217445
Yenimahalle , Ankara
Ukraine (1)
Lviv Railway Clinical Hospital of branch Healthcare Centers of Public Joint Stoc /ID# 167917
Lviv , Lviv Oblast
United Kingdom (1)
Duplicate_Royal United Hospitals Bath /ID# 169062
Bath , Bath And North East Somerset
United States (1)
East View Medical Research, LLC /ID# 171132
Mobile , Alabama
Technical details
Status
Active (not recruiting)
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
21.03.2018
Completion date
01.09.2027
Registry ID
NCT03345823
Source
anzctr
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