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Summary

for people ages 18–75 (full criteria)
at San Francisco, California and other locations
study started
estimated completion:

Description

Summary

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

Official Title

A Phase 2, Multicenter, Open-Label Extension (OLE) Study to Observe the Long-Term Efficacy, Safety, and Tolerability of Repeated Administration of ABT-494 in Subjects With Crohn's Disease

Keywords

Crohn's Disease (CD) Crohn's Disease Tolerability ABT-494 Efficacy Safety

Eligibility

You can join if…

Open to people ages 18–75

  • 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.

You CAN'T join if...

  • 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.

Locations

  • UCSD Health System (Pharma Only) /ID# 150041
    La Jolla, California, 92093, United States
  • Aspen Clinical Research /ID# 150020
    Orem, Utah, 84058, United States
  • University of Washington /ID# 149988
    Seattle, Washington, 98195, United States
  • The Gordon and Leslie Diamond Centre /ID# 149876
    Vancouver, V5Z 1M9, Canada
  • GIRI Gastrointestinal Research Institute /ID# 149878
    Vancouver, V6Z-2K5, Canada
  • University of Alberta /ID# 149873
    Edmonton, T6G 2X8, Canada
  • Texas Digestive Disease Consultants /ID# 149869
    Southlake, Texas, 76092, United States
  • Texas Digestive Disease Consultants /ID# 149989
    Southlake, Texas, 76092, United States
  • Cotton-O'Neil Clinical Research Center /ID# 149900
    Topeka, Kansas, 66606, United States
  • Options Health Research, LLC /ID# 150010
    Tulsa, Oklahoma, 74104, United States
  • Kansas City Research Institute /ID# 149888
    Kansas City, Missouri, 64131, United States
  • Mayo Clinic /ID# 149894
    Rochester, Minnesota, 55905, United States
  • Washington University School of Medicine /ID# 149899
    Saint Louis, Missouri, 63110, United States
  • Wisconsin Center for Advanced Research GI Associates, LLC /ID# 149863
    Milwaukee, Wisconsin, 53215, United States
  • University of Louisville, MDA /ID# 149884
    Louisville, Kentucky, 40202, United States
  • University of Cincinnati Physicians /ID# 149977
    Cincinnati, Ohio, 45267, United States
  • Center for Digestive Health /ID# 150008
    Troy, Michigan, 48098, United States
  • Gastrointestinal Specialists of Georgia /ID# 150015
    Marietta, Georgia, 30060, United States
  • Gastroenterology Associates of Central Georgia, LLC /ID# 149870
    Macon, Georgia, 31201, United States
  • Toronto Digestive Disease Associates, Inc. /ID# 149877
    Vaughan, L4L 4Y7, Canada
  • University of Florida /ID# 150033
    Gainesville, Florida, 32608, United States
  • Nature Coast Clinical Research /ID# 149975
    Inverness, Florida, 34452, United States
  • University of North Carolina at Chapel Hill /ID# 149982
    Chapel Hill, North Carolina, 27599-7080, United States
  • University of Virginia Health System /ID# 149881
    Charlottesville, Virginia, 22908, United States
  • Medical University of South Carolina /ID# 150018
    Charleston, South Carolina, 29425, United States
  • Internal Medicine Specialists /ID# 149880
    Orlando, Florida, 32806, United States
  • MGG Group, Inc. /ID# 149865
    Chevy Chase, Maryland, 20815, United States
  • Charm City Research Group /ID# 150040
    Towson, Maryland, 21204, United States
  • Investigative Clinical Research /ID# 149886
    Annapolis, Maryland, 21401, United States
  • The Center for Gastrointestinal Disorders /ID# 150012
    Hollywood, Florida, 33021, United States
  • Montreal General Hospital /ID# 149871
    Montreal, H3G 1A4, Canada
  • Weill Cornell Medical College of Cornell University /ID# 149895
    New York, New York, 10021, United States
  • NYU Langone Long Island Clinical Research Assoc., LLP /ID# 149976
    Great Neck, New York, 11021, United States
  • Lovisenberg Diakonale Sykehus /ID# 149967
    Oslo, 0456, Norway
  • John Radcliffe Hospital /ID# 149963
    Headington, Oxford, OX3 9DU, United Kingdom
  • Manchester Royal Infirmary /ID# 150006
    Manchester, M13 9WL, United Kingdom
  • Aarhus University Hospital /ID# 149919
    Aarhus, 8000, Denmark
  • Hvidovre Universitets Hospital /ID# 149890
    Hvidovre, 2650, Denmark
  • Academic Medical Center Amsterdam /ID# 149932
    Amsterdam, 1105 AZ, Netherlands
  • UMC Utrecht /ID# 149933
    Utrecht, 3584 CX, Netherlands
  • CHU Sart Tilman /ID# 149912
    Liege, 4000, Belgium
  • CHU Amiens Picardie /ID# 149921
    Amiens Cedex 01, 80054, France
  • CHRU de Lille, Hopital Claude Huriez /ID# 149897
    Lille Cedex, 59037, France
  • CHU De Nancy /ID# 149896
    Vandoeuvre Les Nancy Cedex, 54511, France
  • Charite Universitatesmedizin Berlin, CCM /ID# 149924
    Berlin, 13353, Germany
  • DRK-Kliniken Westend /ID# 149905
    Berlin, 14050, Germany
  • Universitaetsklinikum Schleswig-Holstein /ID# 149936
    Kiel, 24105, Germany
  • Medizinisches Versorgungszentrum Portal 10 /ID# 149930
    Munster, 48155, Germany
  • Complex Hospital University of Ferrol (CHUF) /ID# 149996
    Ferrol, A Coruna, 15405, Spain
  • Hospital Universitario La Paz /ID# 149997
    Madrid, 28046, Spain
  • Santa Familia Centrum Badan, Profilaktyki i Leczenia /ID# 149979
    Lodz, 90-302, Poland
  • Centralny Szpital Kliniczny MSWiA w Warszawie /ID# 149978
    Warsaw, 02-507, Poland
  • Hepato-Gastroenterologie HK, s.r.o. /ID# 149882
    Hradec Kralove, 500 12, Czechia
  • KM Management s.r.o., Nitra, SK /ID# 149949
    Nitra, 949 01, Slovakia
  • Gastro I.S.R.O. /ID# 149948
    Presov, 080 01, Slovakia
  • Magyar Elhizastudomanyi Kozpont Kft. /ID# 149907
    Budapest, 1076, Hungary
  • Azienda Ospedaliero Universitaria di Bologna /ID# 149958
    Bolonga, 40138, Italy
  • Azienda Ospedaliero- Universitaria Mater Domini /ID# 149927
    Catanzaro, 88100, Italy
  • Complesso integrato Columbus /ID# 149950
    Rome, 00168, Italy
  • Cabinet Particular Policlinic Algomed SRL /ID# 149993
    Timisoara, jud. Timis, 300002, Romania
  • Southern District Health Board /ID# 149964
    Dunedin, 9016, New Zealand
  • Rabin Medical Center /ID# 149942
    Petach Tikva, 4941492, Israel
  • Sheba Medical Center /ID# 149945
    Ramat Gan, 5265601, Israel
  • Assaf Harofeh Medical Center /ID# 149943
    Zerifin, 70300, Israel

Details

Status
accepting new patients by invitation only
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
ID
NCT02782663
Phase
Phase 2
Lead Scientist
Jonathan Terdiman
Study Type
Interventional
Last Updated
August 1, 2017