Clinical trial NCT02782663: A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
Official title: A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Subjects With Crohn's Disease
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE2
Conditions: Crohn's Disease (CD)
Keywords: Crohn's Disease
Efficacy
Safety
Tolerability
ABT-494
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2016-05-25
Enrollment: 107
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).


Eligibility criteria: Inclusion Criteria:

* Participant must have completed Study M13-740 through Week 52.
* If female, participant must be postmenopausal, surgically sterile or on using a birth control method.

Exclusion Criteria:

* For any reason participant is considered by the investigator to be an unsuitable candidate
* Female participant with a positive pregnancy test at Baseline or who is considering becoming pregnant during the study.
* Participant is not in compliance with prior and concomitant medication requirements and procedures throughout Study M13-740.

Primary outcomes:
measure: Percentage of Participants Achieving Remission
timeFrame: Up to Month 96
measure: Percentage of Participants in Remission at Week 0 Who Maintain Remission
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Response
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Clinical Remission
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Modified Clinical Remission
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Enhanced Clinical Response
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Clinical Response
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Endoscopic Remission
timeFrame: Up to Month 96
measure: Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Endoscopic Improvement
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Endoscopic Response
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Enhanced CDAI Response
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving IBDQ Response
timeFrame: Up to Month 96
measure: Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free
timeFrame: Up to Month 96
measure: Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission
timeFrame: Up to Month 96
measure: Percentage of Participants Achieving Remission and Normal C-Reactive Protein
timeFrame: Up to Month 96
Secondary outcomes:
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: UC San Diego Health System /ID# 150041
state: California
city: San Francisco
country: United States
facility: Univ California, San Francisco /ID# 149987
state: California
city: Gainesville
country: United States
facility: Duplicate_University of Florida - Archer /ID# 150033
state: Florida
city: Hollywood
country: United States
facility: The Ctr for Gastro Disorders /ID# 150012
state: Florida
city: Inverness
country: United States
facility: Nature Coast Clinical Research - Inverness /ID# 149975
state: Florida
city: Macon
country: United States
facility: Gastroenterology Associates of Central Georgia, LLC /ID# 149870
state: Georgia
city: Marietta
country: United States
facility: GI Specialists of GA, PC /ID# 150015
state: Georgia
city: Topeka
country: United States
facility: Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900
state: Kansas
city: Louisville
country: United States
facility: Duplicate_University of Louisville /ID# 149884
state: Kentucky
city: Annapolis
country: United States
facility: Investigative Clinical Research /ID# 149886
state: Maryland
city: Towson
country: United States
facility: Charm City Research Group /ID# 150040
state: Maryland
city: Chesterfield
country: United States
facility: Clin Res Inst of Michigan, LLC /ID# 150008
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 149894
state: Minnesota
city: Kansas City
country: United States
facility: Kansas City Research Institute /ID# 149888
state: Missouri
city: Saint Louis
country: United States
facility: Washington University-School of Medicine /ID# 149899
state: Missouri
city: Lake Success
country: United States
facility: NYU Langone Long Island Clinical Research Associates /ID# 149976
state: New York
city: New York
country: United States
facility: Weill Cornell Medicine/NYP /ID# 149895
state: New York
city: Chapel Hill
country: United States
facility: Univ NC Chapel Hill /ID# 149982
state: North Carolina
city: Cincinnati
country: United States
facility: University of Cincinnati /ID# 149977
state: Ohio
city: Tulsa
country: United States
facility: Options Health Research, LLC /ID# 150010
state: Oklahoma
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake /ID# 149869
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consultants - Southlake /ID# 149989
state: Texas
city: Orem
country: United States
facility: Aspen Clinical Research /ID# 150020
state: Utah
city: Charlottesville
country: United States
facility: University of Virginia /ID# 149881
state: Virginia
city: Seattle
country: United States
facility: Virginia Mason Hospital & Medical Center /ID# 150042
state: Washington
city: Seattle
country: United States
facility: University of Washington /ID# 149988
state: Washington
city: Milwaukee
country: United States
facility: Wisconsin Center for Advanced Research /ID# 149863
state: Wisconsin
city: Liege
country: Belgium
facility: CHU de Liege /ID# 149912
city: Edmonton
country: Canada
facility: University of Alberta Hospital /ID# 149873
state: Alberta
city: Vancouver
country: Canada
facility: University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
state: British Columbia
city: Vancouver
country: Canada
facility: GIRI Gastrointestinal Research Institute /ID# 149878
state: British Columbia
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Associates, Inc. /ID# 149877
state: Ontario
city: Montreal
country: Canada
facility: Royal Victoria Hospital / McGill University Health Centre /ID# 149871
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
city: Hvidovre
country: Denmark
facility: Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
state: Hovedstaden
city: Aarhus N
country: Denmark
facility: Duplicate_Aarhus University Hospital /ID# 149919
state: Midtjylland
city: Vandoeuvre-les-Nancy
country: France
facility: CHRU Nancy - Hopitaux de Brabois /ID# 149896
state: Meurthe-et-Moselle
city: Lille
country: France
facility: CHRU Lille - Hopital Claude Huriez /ID# 149897
state: Nord
city: Amiens CEDEX 1
country: France
facility: CHU Amiens-Picardie Site Sud /ID# 149921
state: Somme
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: DRK Kliniken Berlin Westend /ID# 149905
city: Muenster
country: Germany
facility: Medizinisches Versorgungszentrum Portal 10 /ID# 149930
city: Budapest
country: Hungary
facility: Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
city: Zerifin
country: Israel
facility: Yitzhak Shamir Medical Center /ID# 149943
state: HaMerkaz
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 149945
state: Tel-Aviv
city: Haifa
country: Israel
facility: Rabin Medical Center /ID# 149942
city: Catanzaro
country: Italy
facility: University of Catanzaro /ID# 149927
state: Calabria
city: Bologna
country: Italy
facility: IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958
city: Amsterdam
country: Netherlands
facility: Amsterdam UMC, locatie AMC /ID# 149932
state: Noord-Holland
city: Utrecht
country: Netherlands
facility: Universitair Medisch Centrum Utrecht /ID# 149933
city: Otago
country: New Zealand
facility: Dunedin Hospital /ID# 149964
city: Oslo
country: Norway
facility: Lovisenberg Diakonale Sykehus /ID# 149967
city: Lodz
country: Poland
facility: Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979
state: Lodzkie
city: Warszawa
country: Poland
facility: Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978
state: Mazowieckie
city: Timișoara
country: Romania
facility: Cabinet Particular Policlinic Algomed /ID# 149993
city: Nitra
country: Slovakia
facility: Duplicate_KM Management, spol. s.r.o. /ID# 149949
state: Nitriansky Kraj
city: Prešov
country: Slovakia
facility: Gastro I., s.r.o. /ID# 149948
state: Presovsky Kraj
city: Ferrol
country: Spain
facility: Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
state: A Coruna
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 149997
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust /ID# 149963
state: Oxfordshire
city: Manchester
country: United Kingdom
facility: Duplicate_Manchester University NHS Foundation Trust /ID# 150006
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References:
citation: D'Haens G, Panes J, Louis E, Lacerda A, Zhou Q, Liu J, Loftus EV Jr. Upadacitinib Was Efficacious and Well-tolerated Over 30 Months in Patients With Crohn's Disease in the CELEST Extension Study. Clin Gastroenterol Hepatol. 2022 Oct;20(10):2337-2346.e3. doi: 10.1016/j.cgh.2021.12.030. Epub 2021 Dec 27.