Summary

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

Description

Summary

To evaluate safety and efficacy of two dosing regimens in achieving clinical remission in subjects with moderately to severely active Ulcerative Colitis.

Official Title

A Double-Blind, Randomized, Multicenter Study of Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Ulcerative Colitis

Keywords

Ulcerative Colitis (UC) Ulcerative Colitis Colitis Ulcer Colitis, Ulcerative Adalimumab

Eligibility

You can join if…

Open to people ages 18–75

  • Diagnosis of Ulcerative Colitis (UC) for at least 90 days, confirmed by endoscopy during Screening period.
  • Active UC with Mayo Score of 6 to 12 points and endoscopy subscore of 2 to 3 despite concurrent or prior treatment with a full and adequate course, in the opinion of the Investigator, with oral corticosteroids or immunosuppressants or both.

You CAN'T join if...

  • Subject with Crohn's disease (CD) or indeterminate colitis (IC).
  • Current diagnosis of fulminant colitis and/or toxic megacolon.
  • Subjects with disease limited to the rectum (ulcerative proctitis) during the screening endoscopy.
  • Chronic recurring infections or active Tuberculosis (TB).

Locations

  • UCSD accepting new patients
    La Jolla, California, 92037, United States
  • University of Utah accepting new patients
    Salt Lake City, Utah, 84112-5500, United States
  • Advanced Research Institute accepting new patients
    Ogden, Utah, 84405-6779, United States
  • Rocky Mountain Clinical Resear accepting new patients
    Wheat Ridge, Colorado, 80033, United States
  • The Oregon Clinic- Gastro West completed
    Portland, Oregon, 97225, United States
  • University of Washington not yet accepting patients
    Seattle, Washington, 98109, United States
  • Austin Center for Clinical Res accepting new patients
    Austin, Texas, 78756, United States
  • Texas Digestive Disease Consul accepting new patients
    Southlake, Texas, 76092, United States
  • Percuro Clinical Research, Ltd not yet accepting patients
    Victoria, British Columbia, V8V 3M9, Canada
  • DHAT Research Institute accepting new patients
    Richardson, Texas, 75082, United States
  • Gastro United of Tulsa accepting new patients
    Tulsa, Oklahoma, 74135, United States
  • Biopharma Informatic Research accepting new patients
    Houston, Texas, 77084, United States
  • University of Calgary accepting new patients
    Calgary, Alberta, T2N 4Z6, Canada
  • Zeidler Ledcor Centre accepting new patients
    Edmonton, Alberta, T6G 2X8, Canada
  • Covenant Health not yet accepting patients
    Edmonton, Alberta, T6L 6K3, Canada
  • Louisiana Research Ctr. LLC accepting new patients
    Shreveport, Louisiana, 71105-6800, United States
  • Ctr for Digest and Liver Dis accepting new patients
    Mexico, Missouri, 65265, United States
  • Mayo Clinic accepting new patients
    Rochester, Minnesota, 55905-0001, United States
  • Winnipeg Regional Health Autho accepting new patients
    Winnipeg, Manitoba, R3A 1R9, Canada
  • Gastro One accepting new patients
    Germantown, Tennessee, 38138, United States
  • Carle Cancer Center accepting new patients
    Urbana, Illinois, 61801, United States
  • Froedtert and Medical College completed
    Milwaukee, Wisconsin, 53226-3522, United States
  • University of Chicago accepting new patients
    Chicago, Illinois, 60637-1443, United States
  • Northwestern University accepting new patients
    Chicago, Illinois, 60611-2927, United States
  • WI Center for Advanced Res accepting new patients
    Milwaukee, Wisconsin, 53215, United States
  • Vanderbilt Univ Med Ctr accepting new patients
    Nashville, Tennessee, 37232-0011, United States
  • Erlanger Institute for Clinica completed
    Chattanooga, Tennessee, 37403, United States
  • Digestive Health Specialist SE accepting new patients
    Dothan, Alabama, 36305, United States
  • Consultants for Clinical Res accepting new patients
    Cincinnati, Ohio, 45219, United States
  • Gastrointestinal Specialists not yet accepting patients
    Marietta, Georgia, 30060, United States
  • Dayton Gastroenterology, Inc. accepting new patients
    Englewood, Ohio, 45415, United States
  • Atlanta Gastro Assoc accepting new patients
    Atlanta, Georgia, 30342, United States
  • University of Michigan completed
    Ann Arbor, Michigan, 48109, United States
  • Gastro Assoc of Central GA accepting new patients
    Macon, Georgia, 31201, United States
  • Florida Research Network, LLC not yet accepting patients
    Gainesville, Florida, 32605, United States
  • Gastro Florida not yet accepting patients
    Clearwater, Florida, 33756, United States
  • Charlotte Gastro Hepatology accepting new patients
    Charlotte, North Carolina, 28207, United States
  • New River Valley Research Inst accepting new patients
    Christiansburg, Virginia, 24073, United States
  • University of Pittsburgh MC accepting new patients
    Pittsburgh, Pennsylvania, 15260, United States
  • Shafran Gastroenterology Ctr accepting new patients
    Winter Park, Florida, 32789, United States
  • London Health Sciences Centre completed
    London, Ontario, N6A 5A5, Canada
  • Mount Sinai Hosp.-Toronto accepting new patients
    Toronto, Ontario, M5G 1X5, Canada
  • Toronto Digestive Disease Asso accepting new patients
    Vaughan, Ontario, L4L 4Y7, Canada
  • Gastroenterology Group Naples accepting new patients
    Naples, Florida, 34102, United States
  • Wake Research Associates, LLC accepting new patients
    Raleigh, North Carolina, 27612, United States
  • MGG Group, Inc. accepting new patients
    Chevy Chase, Maryland, 20815-7313, United States
  • Research Associates of South Florida,LLC not yet accepting patients
    Miami, Florida, 33134, United States
  • University of Maryland Med Ctr not yet accepting patients
    Baltimore, Maryland, 21201-1509, United States
  • Icahn School of Med Mt. Sinai accepting new patients
    New York, New York, 10029, United States
  • NYU Langone Long Island CRA not yet accepting patients
    Great Neck, New York, 11021, United States
  • Medical Research Ctr CT accepting new patients
    Hamden, Connecticut, 06518, United States
  • McGill Univ HC accepting new patients
    Montreal, Quebec, H3G 1A4, Canada
  • Qe Ii Hsc accepting new patients
    Halifax, Nova Scotia, B3H 1V7, Canada
  • Royal Hampshire County Hosp accepting new patients
    Winchester, Hampshire, SO22 5DG, United Kingdom
  • Northwick Park Hospital accepting new patients
    Harrow, HA1 3UJ, United Kingdom
  • Hull and East Yorkshire NHS accepting new patients
    Hull, HU8 9HE, United Kingdom
  • Norfolk and Norwich Univ Hosp accepting new patients
    Norwich, NR4 7UY, United Kingdom
  • John Radcliffe Hospital accepting new patients
    Oxford, OX3 9DU, United Kingdom
  • Southampton General Hospital accepting new patients
    Southampton, SO16 6YD, United Kingdom
  • The Royal Wolverhampton NHS Tr accepting new patients
    Wolverhampton, WV10 0QP, United Kingdom
  • Herlev Hospital accepting new patients
    Herlev, Hovedstaden, 2730, Denmark
  • Aalborg University Hospital not yet accepting patients
    Aalborg, Nordjylland, 9000, Denmark
  • Regionhospital Silkeborg accepting new patients
    Silkeborg, 8600, Denmark
  • Nagoya City University Hospital in progress, not accepting new patients
    Nagoya-shi, Aichi, 467-8602, Japan
  • Yokoyama IBD Clinic in progress, not accepting new patients
    Nagoya, Aichi, 460-0022, Japan
  • Toho University Sakura Med Ctr in progress, not accepting new patients
    Sakura-shi, Chiba, 285-8741, Japan
  • Fukuoka Univ Chikushi Hosp in progress, not accepting new patients
    Chikushino, Fukuoka, 818-8502, Japan
  • Kyushu University Hospital in progress, not accepting new patients
    Fukuoka-shi, Fukuoka, 812-8582, Japan
  • Kurume University Hospital in progress, not accepting new patients
    Kurume-shi, Fukuoka, 830-0011, Japan
  • Hidaka Coloproctology Clinic in progress, not accepting new patients
    Kurume, Fukuoka, 839-0809, Japan
  • Hokkaido Sapporo-Kosei Gen Hos in progress, not accepting new patients
    Sapporo, Hokkaido, 060-0033, Japan
  • Aoyama Clinic in progress, not accepting new patients
    Kobe, Hyogo, 650-0015, Japan
  • The Hospital of Hyogo College of Medicine in progress, not accepting new patients
    Nishinomiya, Hyogo, 663-8501, Japan
  • Kitasato University Hospital in progress, not accepting new patients
    Sagamihara-shi, Kanagawa, 252-0375, Japan
  • Matsushima Clinic in progress, not accepting new patients
    Yokohama, Kanagawa, 220-0045, Japan
  • Susaki Kuroshio Hospital not yet accepting patients
    Susaki, Kochi, 785-8501, Japan
  • JP Red Cross Kyoto Daiichi Hos accepting new patients
    Kyoto-shi, Kyoto, 605-0981, Japan
  • Osaka Medical College Hospital in progress, not accepting new patients
    Takatsuki, Osaka, 569-0801, Japan
  • Saitama Medical Center in progress, not accepting new patients
    Kawagoe-shi, Saitama, 350-8550, Japan
  • Shiga Univ Med Science Hosp in progress, not accepting new patients
    Otsu, Shiga, 520-2192, Japan
  • Hamamatsu Minami Hospital in progress, not accepting new patients
    Hamamatsu-shi, Shizuoka, 430-0846, Japan
  • Medical Hospital of Tokyo Medical and Dental University in progress, not accepting new patients
    Bunkyo-ku, Tokyo, 113-8519, Japan
  • Kitasato Univ Kitasato Inst Ho in progress, not accepting new patients
    Minato-ku, Tokyo, 108-8642, Japan
  • Kyorin University Hospital in progress, not accepting new patients
    Mitaka-shi, Tokyo, 181-8611, Japan
  • Hiroshima University Hospital in progress, not accepting new patients
    Hiroshima, 734-8551, Japan
  • Tokyo Yamate Medical Center not yet accepting patients
    Tokyo, 169-0073, Japan
  • Wakayama Medical University in progress, not accepting new patients
    Wakayama, 641-8510, Japan
  • Academisch Medisch Centrum accepting new patients
    Amsterdam, Noord-Holland, 1105 AZ, Netherlands
  • CHU de Liege accepting new patients
    Liège, Liege, 4000, Belgium
  • AZ Sint-Lucas accepting new patients
    Ghent, 9000, Belgium
  • UZ Leuven accepting new patients
    Leuven, 3000, Belgium
  • CHRU Lille - Hôpital Claude Huriez accepting new patients
    Lille CEDEX, Hauts-de-France, 59045, France
  • CHU NANCY - Hôpital Brabois Adultes accepting new patients
    Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, 54511, France
  • CHU Amiens Picardie accepting new patients
    Amiens CEDEX 1, Somme, 80054, France
  • CHU Estaing accepting new patients
    Clermont Ferrand, 63100, France
  • CHU Dijon - Complexe du Bocage accepting new patients
    Dijon, 21000, France
  • CHU de Grenoble - Albet Michal accepting new patients
    Grenoble, 38043, France
  • CHU Saint ELOIS accepting new patients
    Montpellier Cedex 5, 34295, France
  • CHU de Nice accepting new patients
    Nice, 06202, France
  • Hopital Nord accepting new patients
    Saint Priest En Jarez, 42270, France
  • Hopital Rangueil accepting new patients
    Toulouse, 31059, France
  • Universitatsklinik Regensburg not yet accepting patients
    Ratisbon, Bayern, 93053, Germany
  • Universitatsklinikum Frankfurt accepting new patients
    Frankfurt, Hessen, 60590, Germany
  • Univ Hosp Schleswig-Holstein accepting new patients
    Kiel, Schleswig-Holstein, 24105, Germany
  • Charité Universitätsmedizin Campus Mitte not yet accepting patients
    Berlin, 10117, Germany
  • Mross, Berlin, DE completed
    Berlin, 10318, Germany
  • Gastrostudien GbR not yet accepting patients
    Berlin, D-10825, Germany
  • Asklepios Westklinikum Hamburg accepting new patients
    Hamburg, 22559, Germany
  • Universitaetsklinikum Jena accepting new patients
    Jena, 07747, Germany
  • EUGASTRO GmbH accepting new patients
    Leipzig, 04103, Germany
  • Universitatsklinikum Magdeburg accepting new patients
    Magdeburg, 39120, Germany
  • Gastro Gemeinschaftspraxis accepting new patients
    Munster, 48159, Germany
  • Hospital General Univ Alicante accepting new patients
    Alicante, 03550, Spain
  • Hospital Clinic de Barcelona accepting new patients
    Barcelona, 08036, Spain
  • Hospital Arquitecto Marcide accepting new patients
    Ferrol, 15405, Spain
  • Hospital Univ Dr. Negrin accepting new patients
    Las Palmas de Gran Canaria, 35010, Spain
  • Hospital Univ de la Princesa accepting new patients
    Madrid, 28006, Spain
  • Hospital General Universitario Gregorio Maranon not yet accepting patients
    Madrid, 28009, Spain
  • Hosp Univ 12 de Octubre not yet accepting patients
    Madrid, 28041, Spain
  • Hospital Universitario La Paz accepting new patients
    Madrid, 28046, Spain
  • Hosp Clin Univ de Valencia not yet accepting patients
    Valencia, 46010, Spain
  • HCU Lozano Blesa accepting new patients
    Zaragoza, 50009, Spain
  • Kantonsspital St. Gallen accepting new patients
    St. Gallen, Sankt Gallen, 9007, Switzerland
  • University Hospital Zurich accepting new patients
    Zurich, 8091, Switzerland
  • Hepato-Gastro HK, s.r.o. accepting new patients
    Hradec Kralove, 500 12, Czechia
  • ISCARE I.V.F. a.s. not yet accepting patients
    Prague, 170 00, Czechia
  • Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy accepting new patients
    Bydgoszcz, Kujawsko-pomorskie, 85-168, Poland
  • C.M. Szpital Swietej Rodziny accepting new patients
    Łódź, Lodzkie, 90-302, Poland
  • Centrum Zdrowia Matki, Dziecka i Mlodziezy accepting new patients
    Warszawa, Mazowieckie, 01-783, Poland
  • Endoterapia PFG Sp. z.o.o. accepting new patients
    Warszawa, Mazowieckie, 02-653, Poland
  • Medica Pro Familia S.A Gdynia accepting new patients
    Gdynia, Pomorskie, 81-338, Poland
  • NZOZ All-Medicus accepting new patients
    Katowice, Slaskie, 40-659, Poland
  • H-T.Centrum Medyczne-Endoterapia not yet accepting patients
    Tychy, Slaskie, 43-100, Poland
  • Centrum Medyczne LukaMed accepting new patients
    Chojnice, 89-600, Poland
  • Centrum Medyczne Sw. Lukaza accepting new patients
    Czestochowa, 42-200, Poland
  • Centrum Diagnostyczno Lecznicz not yet accepting patients
    Lodz, 91-347, Poland
  • KO-MED Centra Kliniczne Sp. zo accepting new patients
    Pulawy, 24-100, Poland
  • NZOZ Vivamed accepting new patients
    Warsaw, 03-580, Poland
  • AKH Wien accepting new patients
    Vienna, Wein, 1090, Austria
  • Ordination Hainburg an der Don accepting new patients
    Hainburg An Der Donau, 2410, Austria
  • KH der Elisabethinen Linz GmbH accepting new patients
    Linz, 4020, Austria
  • LKH Salzburg and Paracelsus accepting new patients
    Salzburg, 5020, Austria
  • KH der Barmherzigen Brueder not yet accepting patients
    St Veit An Der Glan, 9300, Austria
  • Lama Medical Care not yet accepting patients
    Bratislava, 831 04, Slovakia
  • Gastroenterologicka Ambulancia not yet accepting patients
    Bratislava, 85101, Slovakia
  • Nemocnica s poliklinikou Lucenec accepting new patients
    Lucenec, 984 01, Slovakia
  • Pecsi Tudomanyegyetem accepting new patients
    Pécs, Pecs, 7624, Hungary
  • Magyar Elhizastudomanyi KKft. accepting new patients
    Budapest, 1124, Hungary
  • Pannonia Maganorvosi Centrum K accepting new patients
    Budapest, 1136, Hungary
  • Szegedi Tudomanyegyetem completed
    Szeged, 6720, Hungary
  • A.O.U. Policlinico S.Orsola-Malpighi accepting new patients
    Bologna, Emilia-Romagna, 40138, Italy
  • Azienda Ospedaliera San Camillo Forlanini accepting new patients
    Rome, Lazio, 00152, Italy
  • AO Univ Policlinico Agostino G accepting new patients
    Rome, Lazio, 00168, Italy
  • Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico accepting new patients
    Milan, Lombardia, 20122, Italy
  • Istituto Clinico Humanitas accepting new patients
    Rozzano, Milano, 20089, Italy
  • Univ. degli Studi di Brescia accepting new patients
    Brescia, 25123, Italy
  • Universita di Padova accepting new patients
    Padua, 35100, Italy
  • Ospedali Riuniti Villa Sofia-C accepting new patients
    Palermo, 90146, Italy
  • Policlinico Univ Tor Vergata accepting new patients
    Rome, 00133, Italy
  • IRCCS Casa Sollievo accepting new patients
    San Giovanni Rotondo, 71013, Italy
  • SI Inst of Therapy AMS of UA accepting new patients
    Харків, Kharkivska Oblast, 61039, Ukraine
  • Kherson City Clinical Hospital accepting new patients
    Kherson, 73000, Ukraine
  • Municipal Clinical Hospital #8 accepting new patients
    Kiev, 04201, Ukraine
  • Lviv Municipal City Clinical accepting new patients
    Lviv, 79007, Ukraine
  • City Clinical Hospital #6 accepting new patients
    Zaporizhia, 69035, Ukraine
  • Clinic Fundeni Institute accepting new patients
    Bucharest, Bucuresti, 022328, Romania
  • CMDTA Neomed SRL completed
    Brasov, 500283, Romania
  • Spitalul Clinic Judetean de Ur accepting new patients
    Cluj, 400006, Romania
  • Tvm Med Serv Srl accepting new patients
    Cluj, 400132, Romania
  • Cabinet Medical Dr. Fratila SR not yet accepting patients
    Oradea, 410167, Romania
  • Salvo-San-Ciobanca SRL completed
    Zalau, 450117, Romania
  • Rabin Medical Center accepting new patients
    Petakh Tikva, Tel-Aviv, 4941492, Israel
  • Tel Aviv Sourasky Medical Ctr not yet accepting patients
    Tel Aviv-Yafo, Tel-Aviv, 6423906, Israel
  • Soroka Medical Ctr accepting new patients
    Be'er Sheva, 84101, Israel
  • Hadassah University Hospital accepting new patients
    Jerusalem, 91120, Israel
  • Kaplan Medical Center accepting new patients
    Rehovot, 76100, Israel

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
AbbVie
Links
http://rxabbvie.com/
ID
NCT02065622
Phase
Phase 3
Study Type
Interventional
Last Updated
May 8, 2018