A Study to Evaluate the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of Upadacitinib (ABT-494) in Participants With Crohn's Disease
- Conditions
- Crohn's Disease (CD)
- Interventions
- Drug: ABT-494
- 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
๐บ๐ธSeattle, Washington, United States
University of Washington /ID# 149988
๐บ๐ธSeattle, Washington, United States
Duplicate_University of Florida - Archer /ID# 150033
๐บ๐ธGainesville, Florida, United States
Nature Coast Clinical Research - Inverness /ID# 149975
๐บ๐ธInverness, Florida, United States
Clin Res Inst of Michigan, LLC /ID# 150008
๐บ๐ธChesterfield, Michigan, United States
Investigative Clinical Research /ID# 149886
๐บ๐ธAnnapolis, Maryland, United States
Amsterdam UMC, locatie AMC /ID# 149932
๐ณ๐ฑAmsterdam, Noord-Holland, Netherlands
Panstwowy Instytut Medyczny MSWiA w Warszawie /ID# 149978
๐ต๐ฑWarszawa, Mazowieckie, Poland
Duplicate_KM Management, spol. s.r.o. /ID# 149949
๐ธ๐ฐNitra, Nitriansky Kraj, Slovakia
Duplicate_Manchester University NHS Foundation Trust /ID# 150006
๐ฌ๐งManchester, United Kingdom
CHRU Nancy - Hopitaux de Brabois /ID# 149896
๐ซ๐ทVandoeuvre-les-Nancy, Meurthe-et-Moselle, France
Cotton O'Neil Clinical Research Center, Digestive Health /ID# 149900
๐บ๐ธTopeka, Kansas, United States
Universitaetsklinikum Schleswig-Holstein Campus Kiel /ID# 149936
๐ฉ๐ชKiel, Schleswig-Holstein, Germany
University of Cincinnati /ID# 149977
๐บ๐ธCincinnati, Ohio, United States
Mayo Clinic - Rochester /ID# 149894
๐บ๐ธRochester, Minnesota, United States
Wisconsin Center for Advanced Research /ID# 149863
๐บ๐ธMilwaukee, Wisconsin, United States
The Ctr for Gastro Disorders /ID# 150012
๐บ๐ธHollywood, Florida, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 149870
๐บ๐ธMacon, Georgia, United States
GI Specialists of GA, PC /ID# 150015
๐บ๐ธMarietta, Georgia, United States
Charm City Research Group /ID# 150040
๐บ๐ธTowson, Maryland, United States
Washington University-School of Medicine /ID# 149899
๐บ๐ธSaint Louis, Missouri, United States
NYU Langone Long Island Clinical Research Associates /ID# 149976
๐บ๐ธLake Success, New York, United States
Options Health Research, LLC /ID# 150010
๐บ๐ธTulsa, Oklahoma, United States
Aspen Clinical Research /ID# 150020
๐บ๐ธOrem, Utah, United States
University of Alberta Hospital /ID# 149873
๐จ๐ฆEdmonton, Alberta, Canada
University of British Columbia (UBC) - Gordon and Leslie Diamond Health Care Ce /ID# 149876
๐จ๐ฆVancouver, British Columbia, Canada
GIRI Gastrointestinal Research Institute /ID# 149878
๐จ๐ฆVancouver, British Columbia, Canada
Toronto Digestive Disease Associates, Inc. /ID# 149877
๐จ๐ฆVaughan, Ontario, Canada
Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
๐จ๐ฟHradec Kralove, Czechia
Duplicate_Aarhus University Hospital /ID# 149919
๐ฉ๐ฐAarhus N, Midtjylland, Denmark
Kobenhavns Universitet - Hvidovre Hospital (HH) /ID# 149890
๐ฉ๐ฐHvidovre, Hovedstaden, Denmark
DRK Kliniken Berlin Westend /ID# 149905
๐ฉ๐ชBerlin, Germany
Medizinisches Versorgungszentrum Portal 10 /ID# 149930
๐ฉ๐ชMuenster, Germany
Yitzhak Shamir Medical Center /ID# 149943
๐ฎ๐ฑZerifin, HaMerkaz, Israel
University of Catanzaro /ID# 149927
๐ฎ๐นCatanzaro, Calabria, Italy
Rabin Medical Center /ID# 149942
๐ฎ๐ฑHaifa, Israel
IRCCS Azienda Ospedaliero-Universitaria di Bologna /ID# 149958
๐ฎ๐นBologna, Italy
Dunedin Hospital /ID# 149964
๐ณ๐ฟOtago, New Zealand
Lovisenberg Diakonale Sykehus /ID# 149967
๐ณ๐ดOslo, Norway
Gastro I., s.r.o. /ID# 149948
๐ธ๐ฐPreลกov, Presovsky Kraj, Slovakia
Hospital Universitario La Paz /ID# 149997
๐ช๐ธMadrid, Spain
Hospital Arquitecto Marcide - Complejo Hospitalario Universitario de Ferrol /ID# 149996
๐ช๐ธFerrol, A Coruna, Spain
Oxford University Hospitals NHS Foundation Trust /ID# 149963
๐ฌ๐งOxford, Oxfordshire, United Kingdom
Weill Cornell Medicine/NYP /ID# 149895
๐บ๐ธNew York, New York, United States
UC San Diego Health System /ID# 150041
๐บ๐ธLa Jolla, California, United States
Univ California, San Francisco /ID# 149987
๐บ๐ธSan Francisco, California, United States
Texas Digestive Disease Consultants - Southlake /ID# 149869
๐บ๐ธSouthlake, Texas, United States
University of Virginia /ID# 149881
๐บ๐ธCharlottesville, Virginia, United States
Texas Digestive Disease Consultants - Southlake /ID# 149989
๐บ๐ธSouthlake, Texas, United States
Duplicate_University of Louisville /ID# 149884
๐บ๐ธLouisville, Kentucky, United States
Kansas City Research Institute /ID# 149888
๐บ๐ธKansas City, Missouri, United States
Univ NC Chapel Hill /ID# 149982
๐บ๐ธChapel Hill, North Carolina, United States
Royal Victoria Hospital / McGill University Health Centre /ID# 149871
๐จ๐ฆMontreal, Quebec, Canada
The Chaim Sheba Medical Center /ID# 149945
๐ฎ๐ฑRamat Gan, Tel-Aviv, Israel
CHU de Liege /ID# 149912
๐ง๐ชLiege, Belgium
Cabinet Particular Policlinic Algomed /ID# 149993
๐ท๐ดTimiศoara, Romania
Universitair Medisch Centrum Utrecht /ID# 149933
๐ณ๐ฑUtrecht, Netherlands
CHRU Lille - Hopital Claude Huriez /ID# 149897
๐ซ๐ทLille, Nord, France
Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
๐ญ๐บBudapest, Hungary
CHU Amiens-Picardie Site Sud /ID# 149921
๐ซ๐ทAmiens CEDEX 1, Somme, France
Santa Sp. z o.o. Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979
๐ต๐ฑLodz, Lodzkie, Poland