A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
- Registration Number
- NCT02782663
- Lead Sponsor
- AbbVie
- Brief Summary
This is a open-label extension (OLE) study designed to evaluate the long-term efficacy, safety, and tolerability of Upadacitinib (ABT-494).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 107
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Upadacitinib (ABT-494) Dose A ABT-494 Open label dose A once daily (QD) Upadacitinib (ABT-494) Dose B ABT-494 Open label dose B QD
- Primary Outcome Measures
Name Time Method Percentage of Participants Achieving Remission Up to Month 96 It is defined as the percentage of participants achieving clinical remission and endoscopic remission.
Percentage of Participants Achieving Enhanced Clinical Response Up to Month 96 Enhanced clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Modified Clinical Remission Up to Month 96 Clinical remission is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Clinical Response Up to Month 96 Clinical response is defined as change from baseline in the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Inflammatory Bowel Disease Questionnaire (IBDQ) Remission Up to Month 96 IBDQ remission is defined as IBDQ \>= 170.
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free for At Least 90 Days and Achieve Remission Up to Month 96 Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free for at least 90 days over time and achieve Remission
Percentage of Participants Achieving Remission and Normal C-Reactive Protein Up to Month 96 Percentage of participants achieving Remission and normal C-reactive protein. Remission is defined as Clinical Remission AND Endoscopic Remission.
Percentage of Participants Achieving Clinical Remission Up to Month 96 Clinical remission is defined based on the patient reported outcomes: average daily stool frequency and average daily abdominal pain.
Percentage of Participants Achieving Endoscopic Improvement Up to Month 96 Endoscopic improvement is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease or endoscopic remission.
Percentage of Participants Achieving Enhanced CDAI Response Up to Month 96 Enhanced CDAI response is defined as reduction in CDAI by \>= 100 from baseline of Study M13-740.
Percentage of Participants in Remission at Week 0 Who Maintain Remission Up to Month 96 Remission is defined as participants achieving clinical remission and endoscopic remission.
Percentage of Participants Achieving Response Up to Month 96 It is defined as the percentage of participants achieving clinical response and endoscopic response.
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Remission Up to Month 96 It is defined as CDAI less than 150.
Percentage of Participants Achieving Endoscopic Remission Up to Month 96 Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants in Endoscopic Remission at Week 0 Who Maintain Endoscopic Remission Up to Month 96 Endoscopic remission is based on Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants Achieving Endoscopic Response Up to Month 96 Endoscopic response is based on changes from baseline on the Simplified Endoscopic Score for Crohn's disease.
Percentage of Participants Achieving Crohn's Disease Activity Index (CDAI) Response Up to Month 96 CDAI response is defined as a reduction in CDAI by \>= 70 from baseline of Study M13-740.
Percentage of Participants Achieving IBDQ Response Up to Month 96 IBDQ response is defined as an increase in IBDQ score \>= 16 point from Baseline of Study M13-740.
Percentage of Participants Taking Steroids at Baseline (of Study M13-740) Who Are Steroid-Free Up to Month 96 Percentage of participants taking steroids at Baseline (of Study M13-740) who are steroid-free
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (61)
Virginia Mason Hospital & Medical Center /ID# 150042
🇺🇸Seattle, Washington, United States
University of Washington /ID# 149988
🇺🇸Seattle, Washington, United States
Duplicate_University of Florida - Archer /ID# 150033
🇺🇸Gainesville, Florida, United States
Nature Coast Clinical Research - Inverness /ID# 149975
🇺🇸Inverness, Florida, United States
Clin Res Inst of Michigan, LLC /ID# 150008
🇺🇸Chesterfield, Michigan, United States
Investigative Clinical Research /ID# 149886
🇺🇸Annapolis, Maryland, United States
Amsterdam UMC, locatie AMC /ID# 149932
🇳🇱Amsterdam, Noord-Holland, Netherlands
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978
🇵🇱Warszawa, Mazowieckie, Poland
Duplicate_KM Management, spol. s.r.o. /ID# 149949
🇸🇰Nitra, Nitriansky Kraj, Slovakia
Duplicate_Manchester University NHS Foundation Trust /ID# 150006
🇬🇧Manchester, United Kingdom
CHRU Nancy - Hopitaux de Brabois /ID# 149896
🇫🇷Vandoeuvre-les-Nancy, Meurthe-et-Moselle, France
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900
🇺🇸Topeka, Kansas, United States
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
🇩🇪Kiel, Schleswig-Holstein, Germany
University of Cincinnati /ID# 149977
🇺🇸Cincinnati, Ohio, United States
Mayo Clinic - Rochester /ID# 149894
🇺🇸Rochester, Minnesota, United States
Wisconsin Center for Advanced Research /ID# 149863
🇺🇸Milwaukee, Wisconsin, United States
The Ctr for Gastro Disorders /ID# 150012
🇺🇸Hollywood, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 149870
🇺🇸Macon, Georgia, United States
GI Specialists of GA, PC /ID# 150015
🇺🇸Marietta, Georgia, United States
Charm City Research Group /ID# 150040
🇺🇸Towson, Maryland, United States
Washington University-School of Medicine /ID# 149899
🇺🇸Saint Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates /ID# 149976
🇺🇸Lake Success, New York, United States
Options Health Research, LLC /ID# 150010
🇺🇸Tulsa, Oklahoma, United States
Aspen Clinical Research /ID# 150020
🇺🇸Orem, Utah, United States
University of Alberta Hospital /ID# 149873
🇨🇦Edmonton, Alberta, Canada
University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
🇨🇦Vancouver, British Columbia, Canada
GIRI Gastrointestinal Research Institute /ID# 149878
🇨🇦Vancouver, British Columbia, Canada
Toronto Digestive Disease Associates, Inc. /ID# 149877
🇨🇦Vaughan, Ontario, Canada
Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
🇨🇿Hradec Kralove, Czechia
Duplicate_Aarhus University Hospital /ID# 149919
🇩🇰Aarhus N, Midtjylland, Denmark
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
🇩🇰Hvidovre, Hovedstaden, Denmark
DRK Kliniken Berlin Westend /ID# 149905
🇩🇪Berlin, Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 149930
🇩🇪Muenster, Germany
Yitzhak Shamir Medical Center /ID# 149943
🇮🇱Zerifin, HaMerkaz, Israel
University of Catanzaro /ID# 149927
🇮🇹Catanzaro, Calabria, Italy
Rabin Medical Center /ID# 149942
🇮🇱Haifa, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958
🇮🇹Bologna, Italy
Dunedin Hospital /ID# 149964
🇳🇿Otago, New Zealand
Lovisenberg Diakonale Sykehus /ID# 149967
🇳🇴Oslo, Norway
Gastro I., s.r.o. /ID# 149948
🇸🇰Prešov, Presovsky Kraj, Slovakia
Hospital Universitario La Paz /ID# 149997
🇪🇸Madrid, Spain
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
🇪🇸Ferrol, A Coruna, Spain
Oxford University Hospitals NHS Foundation Trust /ID# 149963
🇬🇧Oxford, Oxfordshire, United Kingdom
Weill Cornell Medicine/NYP /ID# 149895
🇺🇸New York, New York, United States
UC San Diego Health System /ID# 150041
🇺🇸La Jolla, California, United States
Univ California, San Francisco /ID# 149987
🇺🇸San Francisco, California, United States
Texas Digestive Disease Consultants - Southlake /ID# 149869
🇺🇸Southlake, Texas, United States
University of Virginia /ID# 149881
🇺🇸Charlottesville, Virginia, United States
Texas Digestive Disease Consultants - Southlake /ID# 149989
🇺🇸Southlake, Texas, United States
Duplicate_University of Louisville /ID# 149884
🇺🇸Louisville, Kentucky, United States
Kansas City Research Institute /ID# 149888
🇺🇸Kansas City, Missouri, United States
Univ NC Chapel Hill /ID# 149982
🇺🇸Chapel Hill, North Carolina, United States
Royal Victoria Hospital / McGill University Health Centre /ID# 149871
🇨🇦Montreal, Quebec, Canada
The Chaim Sheba Medical Center /ID# 149945
🇮🇱Ramat Gan, Tel-Aviv, Israel
CHU de Liege /ID# 149912
🇧🇪Liege, Belgium
Cabinet Particular Policlinic Algomed /ID# 149993
🇷🇴Timișoara, Romania
Universitair Medisch Centrum Utrecht /ID# 149933
🇳🇱Utrecht, Netherlands
CHRU Lille - Hopital Claude Huriez /ID# 149897
🇫🇷Lille, Nord, France
Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
ðŸ‡ðŸ‡ºBudapest, Hungary
CHU Amiens-Picardie Site Sud /ID# 149921
🇫🇷Amiens CEDEX 1, Somme, France
Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979
🇵🇱Lodz, Lodzkie, Poland