Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
NCT ID: NCT02065622
Last Updated: 2020-11-23
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
952 participants
INTERVENTIONAL
2014-03-27
2019-11-11
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Induction (Main Study + Japan Sub-study): I-SD
Induction Standard Dose: Double-blind adalimumab regimen of 160 mg at Week 0 followed by 80 mg at Week 2, 40 mg at Week 4, and 40 mg at Week 6.
Adalimumab
Placebo
Induction (Main Study + Japan Sub-study): I-HD
Induction Higher Dose: Double-blind adalimumab regimen of 160 mg at Weeks 0, 1, 2, and 3 followed by 40 mg at Week 4, and 40 mg at Week 6.
Adalimumab
Maintenance (Main Study + Japan Sub-study): M-SD
Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
Adalimumab
Placebo
Maintenance (Main Study + Japan Sub-study): M-HD
Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Adalimumab
Maintenance (Main Study): TDM Regimen
Double-blind adalimumab 40 mg eow at Week 8 and Week 10, with possible dose adjustments at Weeks 12, 24, and 37 based on criteria assessing blinded adalimumab serum concentration and rectal bleeding subscore (RBS) assessments.
Adalimumab
Placebo
Interventions
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Adalimumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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. Mayo Score is confirmed by central reader.
Exclusion Criteria
* 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).
18 Years
75 Years
ALL
No
Sponsors
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AbbVie
INDUSTRY
Responsible Party
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Principal Investigators
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AbbVie Inc.
Role: STUDY_DIRECTOR
AbbVie
Locations
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Digestive Health Specialists of the Southeast /ID# 127844
Dothan, Alabama, United States
Ucsd /Id# 122313
La Jolla, California, United States
Rocky Mountain Clinical Resear /ID# 122180
Wheat Ridge, Colorado, United States
Medical Research Ctr CT /ID# 122179
Hamden, Connecticut, United States
Gastro Florida /ID# 170619
Clearwater, Florida, United States
Research Associates of South Florida,LLC /ID# 170309
Miami, Florida, United States
Gastroenterology Group Naples /ID# 127806
Naples, Florida, United States
Shafran Gastroenterology Ctr /ID# 122320
Winter Park, Florida, United States
Atlanta Gastro Assoc /ID# 122336
Atlanta, Georgia, United States
Gastro Assoc of Central GA /ID# 122318
Macon, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 122183
Chicago, Illinois, United States
University of Chicago /ID# 122302
Chicago, Illinois, United States
Carle Foundation Hospital /ID# 135955
Urbana, Illinois, United States
Louisiana Research Ctr. LLC /ID# 141655
Shreveport, Louisiana, United States
University of Maryland Med Ctr /ID# 169734
Baltimore, Maryland, United States
MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
Chevy Chase, Maryland, United States
University of Michigan Hospitals /ID# 122240
Ann Arbor, Michigan, United States
Mayo Clinic - Rochester /ID# 122244
Rochester, Minnesota, United States
Ctr for Digest and Liver Dis /ID# 122182
Mexico, Missouri, United States
NYU Langone Long Island CRA /ID# 122177
Great Neck, New York, United States
Icahn School of Med Mt. Sinai /ID# 127047
New York, New York, United States
Charlotte Gastro Hepatology /ID# 122235
Charlotte, North Carolina, United States
Wake Research Associates, LLC /ID# 122157
Raleigh, North Carolina, United States
Consultants for Clinical Res /ID# 122304
Cincinnati, Ohio, United States
Dayton Gastroenterology, Inc. /ID# 127804
Englewood, Ohio, United States
Gastro United of Tulsa /ID# 125436
Tulsa, Oklahoma, United States
The Oregon Clinic- Gastro West /ID# 135273
Portland, Oregon, United States
University of Pittsburgh MC /ID# 122331
Pittsburgh, Pennsylvania, United States
Erlanger Institute for Clinica /ID# 129009
Chattanooga, Tennessee, United States
Gastro One /ID# 122339
Germantown, Tennessee, United States
Vanderbilt Univ Med Ctr /ID# 125496
Nashville, Tennessee, United States
DHAT Research Institute /ID# 170616
Garland, Texas, United States
Biopharma Informatic Research /ID# 171150
Houston, Texas, United States
Austin Center for Clinical Research /ID# 125396
Pflugerville, Texas, United States
Texas Digestive Disease Consul /ID# 141677
Southlake, Texas, United States
Texas Digestive Disease Consul /ID# 141678
Southlake, Texas, United States
Advanced Research Institute /ID# 126147
Ogden, Utah, United States
University of Utah /ID# 122333
Salt Lake City, Utah, United States
New River Valley Research Inst /ID# 127801
Christiansburg, Virginia, United States
University of Washington /ID# 169721
Seattle, Washington, United States
WI Center for Advanced Res /ID# 122178
Milwaukee, Wisconsin, United States
Froedtert & the Medical College of Wisconsin /ID# 122261
Milwaukee, Wisconsin, United States
KH der Elisabethinen Linz GmbH /ID# 127184
Linz, Upper Austria, Austria
Medizinische Universitat Wien /ID# 127186
Vienna, Vienna, Austria
Ordination Hainburg an der Don /ID# 127185
Hainburg an der Donau, , Austria
Universitaetsklinik fuer Innere Medizin 1 /ID# 125944
Salzburg, , Austria
KH der Barmherzigen Brueder /ID# 127183
Sankt Veit an der Glan, , Austria
AZ Sint-Lucas /ID# 127187
Ghent, , Belgium
UZ Leuven /ID# 126739
Leuven, , Belgium
CHU de Liege /ID# 126740
Liège, , Belgium
University of Calgary /ID# 125715
Calgary, Alberta, Canada
Zeidler Ledcor Centre /ID# 125713
Edmonton, Alberta, Canada
Winnipeg Regional Health Autho /ID# 125712
Winnipeg, Manitoba, Canada
Qe Ii Hsc /Id# 127045
Halifax, Nova Scotia, Canada
London Health Sciences Centre /ID# 127055
London, Ontario, Canada
Mount Sinai Hosp.-Toronto /ID# 126590
Toronto, Ontario, Canada
Toronto Digestive Disease Asso /ID# 127075
Vaughan, Ontario, Canada
McGill Univ HC /ID# 127046
Montreal, Quebec, Canada
Hepato-Gastroenterologie HK s.r.o. /ID# 127188
Hradec Králové, , Czechia
ISCARE a.s. /ID# 127837
Prague, , Czechia
Herlev Hospital /ID# 127191
Herlev, Capital Region, Denmark
Regionhospital Silkeborg /ID# 127190
Silkeborg, , Denmark
CHRU Lille - Hôpital Claude Huriez /ID# 127197
Lille, Hauts-de-France, France
CHU NANCY - Hôpital Brabois Adultes /ID# 127196
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU Amiens Picardie /ID# 127194
Amiens, Somme, France
CHU Estaing /ID# 127848
Clermont-Ferrand, , France
CHU Dijon /ID# 127861
Dijon, , France
CHU de Grenoble - Albet Michal /ID# 127195
Grenoble, , France
CHU Saint ELOI /ID# 169007
Montpellier, , France
CHU de Nice /ID# 127193
Nice, , France
CHU de Saint-Etienne, Hopital Nord /ID# 134490
Saint-Etienne, , France
Hopital Rangueil /ID# 127192
Toulouse, , France
Universitatsklinik Regensburg /ID# 201265
Regensburg, Bavaria, Germany
Universitatsklinikum Frankfurt /ID# 170300
Frankfurt am Main, Hesse, Germany
Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199
Kiel, Schleswig-Holstein, Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203
Berlin, , Germany
Mross, Berlin, DE /ID# 127201
Berlin, , Germany
Gastrostudien GbR /ID# 169246
Berlin, , Germany
Asklepios Westklinikum Hamburg /ID# 127198
Hamburg, , Germany
Universitaetsklinikum Jena /ID# 127205
Jena, , Germany
EUGASTRO GmbH /ID# 127202
Leipzig, , Germany
Universitatsklinikum Magdeburg /ID# 127200
Magdeburg, , Germany
Gastro Campus Research GbR /ID# 126743
Münster, , Germany
Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209
Pécs, Pecs, Hungary
Magyar Elhizastudomanyi KKft. /ID# 126589
Budapest, , Hungary
Pannonia Maganorvosi Centrum Kft. /ID# 127207
Budapest, , Hungary
Szegedi Tudomanyegyetem /ID# 127208
Szeged, , Hungary
Rabin Medical Center /ID# 127212
Petakh Tikva, Tel Aviv, Israel
Tel Aviv Sourasky Medical Center /ID# 201365
Tel Aviv, Tel Aviv, Israel
Soroka University Medical Center /ID# 127213
Beersheba, , Israel
Hadassah University Hospital /ID# 127211
Jerusalem, , Israel
Kaplan Medical Center /ID# 127210
Rehovot, , Israel
A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322
Bologna, Emilia-Romagna, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 127216
Rome, Lazio, Italy
Policlinico Agostino Gemelli /ID# 127217
Rome, Lazio, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138
Milan, Lombardy, Italy
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215
Rozzano, Milano, Italy
Azienda Ospedaliera Spedali Civili /ID# 127236
Brescia, , Italy
Universita di Padova /ID# 127214
Padua, , Italy
Ospedali Riuniti Villa Sofia-C /ID# 129323
Palermo, , Italy
Policlinico Univ Tor Vergata /ID# 129321
Rome, , Italy
IRCCS Casa Sollievo /ID# 127811
San Giovanni Rotondo, , Italy
Yokoyama IBD Clinic /ID# 151560
Nagoya, Aichi-ken, Japan
Nagoya City University Hospital /ID# 124517
Nagoya, Aichi-ken, Japan
Toho University Sakura Medical Center /ID# 124497
Sakura-shi, Chiba, Japan
Fukuoka University Chikushi Hospital /ID# 124155
Chikushino-shi, Fukuoka, Japan
Kyushu University Hospital /ID# 124495
Fukuoka, Fukuoka, Japan
Hidaka Clinic of Coloproctology /ID# 125477
Kurume, Fukuoka, Japan
Kurume University Hospital /ID# 125275
Kurume-shi, Fukuoka, Japan
Hiroshima University Hospital /ID# 124496
Hiroshima, Hiroshima, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480
Sapporo, Hokkaido, Japan
Aoyama Clinic /ID# 127836
Kobe, Hyōgo, Japan
Hyogo College of Medicine College Hospital /Id# 127539
Nishinomiya-shi, Hyōgo, Japan
Kitasato University Hospital /ID# 137694
Sagamihara-shi, Kanagawa, Japan
COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423
Yokohama, Kanagawa, Japan
Susaki Kuroshio Hospital /ID# 125202
Susaki-shi, Kochi, Japan
Japanese Red Cross Kyoto Daiichi Hos /ID# 127540
Kyoto, Kyoto, Japan
Osaka Medical College Hospital /ID# 126451
Takatsuki-shi, Osaka, Japan
Saitama Medical Center /ID# 128875
Kawagoe-shi, Saitama, Japan
Shiga University of Medical Science Hospital /ID# 127675
Ōtsu, Shiga, Japan
Hamamatsu South Hospital /ID# 124481
Hamamatsu, Shizuoka, Japan
Medical Hospital of Tokyo Medical and Dental University /ID# 128315
Bunkyo-ku, Tokyo, Japan
Kitasato Univ Kitasato Inst Ho /ID# 127001
Minato-ku, Tokyo, Japan
Kyorin University Hospital /ID# 148184
Mitaka-shi, Tokyo, Japan
Wakayama Medical University /ID# 124635
Wakayama, Wakayama, Japan
Tokyo Yamate Medical Center /ID# 125201
Tokyo, , Japan
Academisch Medisch Centrum /ID# 126741
Amsterdam, North Holland, Netherlands
Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Centrum Zdrowia MDM /ID# 170303
Warsaw, Masovian Voivodeship, Poland
Endoterapia PFG Sp. z.o.o. /ID# 126513
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Pratia Gdynia /ID# 170301
Gdynia, Pomeranian Voivodeship, Poland
NZOZ All-Medicus /ID# 128740
Katowice, Silesian Voivodeship, Poland
H-T.Centrum Medyczne-Endoterapia /ID# 170305
Tychy, Silesian Voivodeship, Poland
Centrum Medyczne LukaMed Joanna Luka /ID# 170302
Chojnice, , Poland
Centrum Medyczne Sw. Lukaza /ID# 126515
Częstochowa, , Poland
Centrum Diagnostyczno Lecznicze Barska /ID# 170304
Lodz, , Poland
KO-Med Centra Kliniczne Pulawy /ID# 127219
Puławy, , Poland
NZOZ Vivamed /ID# 127218
Warsaw, , Poland
C.M. Szpital Swietej Rodziny /ID# 127838
Lodz, Łódź Voivodeship, Poland
Institutul Clinic Fundeni /ID# 127839
Sector 2, București, Romania
CMDTA Neomed SRL /ID# 127142
Brasov, , Romania
Spitalul Clinic Judetean de Urgenta /ID# 125418
Cluj-Napoca, , Romania
Tvm Med Serv Srl /Id# 127221
Cluj-Napoca, , Romania
Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002
Oradea, , Romania
Salvo-San-Ciobanca SRL /ID# 127140
Zalău, , Romania
Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222
Bratislava, , Slovakia
Gastroenterologicka Ambulancia /ID# 125632
Bratislava, , Slovakia
Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322
Lučenec, , Slovakia
Hospital General Universitario de Alicante /ID# 129261
Alicante, , Spain
Hospital Clinic de Barcelona /ID# 138147
Barcelona, , Spain
Complejo Hospitalario Universitario de Ferrol /ID# 127840
Ferrol, , Spain
Hospital Univ Dr. Negrin /ID# 127841
Las Palmas de Gran Canaria, , Spain
Hospital Univ de la Princesa /ID# 135828
Madrid, , Spain
Hospital General Universitario Gregorio Maranon /ID# 127224
Madrid, , Spain
Hosp Univ 12 de Octubre /ID# 129257
Madrid, , Spain
Hospital Universitario La Paz /ID# 127223
Madrid, , Spain
Hosp Clin Univ de Valencia /ID# 170306
Valencia, , Spain
Hosp Clin Univ Lozano Blesa /ID# 129255
Zaragoza, , Spain
Kantonsspital St. Gallen /ID# 127843
Sankt Gallen, Canton of St. Gallen, Switzerland
University Hospital Zurich /ID# 127842
Zurich, Canton of Zurich, Switzerland
GI National Institute of Therapy named by L.T. Malaya /ID# 127231
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233
Kherson, , Ukraine
Municipal Clinical Hospital #8 /ID# 127235
Kiev, , Ukraine
Lviv City Clinical Hospital NO.4 /ID# 127232
Lviv, , Ukraine
CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137
Zaporizhzhia, , Ukraine
Royal Hampshire County Hosp /ID# 169250
Winchester, Hampshire, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 127139
Norwich, Norfolk, United Kingdom
Western General Hospital /ID# 204801
Edinburgh, , United Kingdom
St. Mark's Hospital /ID# 127226
Harrow, , United Kingdom
Hull and East Yorkshire Hospitals NHS Trust /ID# 127225
Hull, , United Kingdom
Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324
Oxford, , United Kingdom
Southampton General Hospital /ID# 127228
Southampton, , United Kingdom
The Royal Wolverhampton NHS Tr /ID# 127227
Wolverhampton, , United Kingdom
Countries
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References
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Reppell M, Zheng X, Dreher I, Blaes J, Regan E, Haslberger T, Guay H, Pivorunas V, Smaoui N. HLA-DQA1*05 Associates With Anti-Tumor Necrosis Factor Immunogenicity and Low Adalimumab Trough Concentrations in Inflammatory Bowel Disease Patients From the SERENE Ulcerative Colitis and Crohn's Disease Studies. J Crohns Colitis. 2025 Jan 11;19(1):jjae129. doi: 10.1093/ecco-jcc/jjae129.
Verstockt B, Pivorunas V, Al Mahi N, Smaoui N, Guay H, Kennedy NA, Goodhand JR, Lin S, Bai BYH, Hanauer SB, Ferrante M, Panes J, Vermeire S. Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies. J Crohns Colitis. 2024 Apr 23;18(4):493-505. doi: 10.1093/ecco-jcc/jjad170.
Ponce-Bobadilla AV, Stodtmann S, Chen MJ, Winzenborg I, Mensing S, Blaes J, Haslberger T, Laplanche L, Dreher I, Mostafa NM. Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis. Clin Pharmacokinet. 2023 Apr;62(4):623-634. doi: 10.1007/s40262-023-01221-x. Epub 2023 Mar 11.
Greener T, Boland K, Milgrom R, Ben-Bassat O, Steinhart AH, Silverberg MS, Narula N. Higher adalimumab maintenance regimen is more effective than standard dose in anti-TNF experienced Crohn's disease patients. Eur J Gastroenterol Hepatol. 2021 Oct 1;33(10):1274-1279. doi: 10.1097/MEG.0000000000002250.
Provided Documents
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Document Type: Statistical Analysis Plan
Document Type: Study Protocol
Related Links
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Related Info
Other Identifiers
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2013-001682-16
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-033
Identifier Type: -
Identifier Source: org_study_id