Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease
NCT ID: NCT02065570
Last Updated: 2021-02-18
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
514 participants
INTERVENTIONAL
2014-05-01
2020-01-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Induction: Standard Induction Dose
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.
Adalimumab
Placebo
Induction: Higher Induction Dose
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Adalimumab
Maintenance: Clinically Adjusted (CA) Regimen
Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.
Adalimumab
Maintenance: Therapeutic Drug Monitoring (TDM) Regimen
At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM will be determined by protocol-established dose adjustment criteria. Doses will be determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 will receive 40 mg ew.
Adalimumab
Interventions
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Adalimumab
Placebo
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
* Mucosal ulceration on endoscopy.
Exclusion Criteria
* Subject who has had surgical bowel resections in the past 6 months or is planning resection.
* Subjects with an ostomy or ileoanal pouch.
* Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
* Subject who has short bowel syndrome.
* 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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Birmingham Gastroenterology Associates O.C /ID# 137282
Birmingham, Alabama, United States
Digestive Health Specialists of the Southeast /ID# 122483
Dothan, Alabama, United States
Moore UC San Diego Cancer Center /ID# 119053
La Jolla, California, United States
Axis Clinical Trials /ID# 130390
Los Angeles, California, United States
Rocky Mountain Gastroenterology /ID# 119038
Wheat Ridge, Colorado, United States
Medical Research Ctr CT /ID# 119037
Hamden, Connecticut, United States
Gastroenterology Group Naples /ID# 122493
Naples, Florida, United States
Internal Med Specialists /ID# 137737
Orlando, Florida, United States
Shafran Gastroenterology Ctr /ID# 119057
Winter Park, Florida, United States
Winship Cancer Institute of Emory University /ID# 136851
Atlanta, Georgia, United States
Atlanta Gastro Assoc /ID# 119065
Atlanta, Georgia, United States
Gastroenterology Associates of Central Georgia, LLC /ID# 119056
Macon, Georgia, United States
Northwestern University Feinberg School of Medicine /ID# 119043
Chicago, Illinois, United States
University of Chicago DCAM /ID# 119077
Chicago, Illinois, United States
Carle Foundation Hospital Digestive Health Research Center /ID# 136008
Urbana, Illinois, United States
Louisana Research Center, LLC /ID# 136749
Shreveport, Louisiana, United States
Investigative Clinical Research /ID# 119033
Annapolis, Maryland, United States
MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042
Chevy Chase, Maryland, United States
Commonwealth Clinical Studies /ID# 136850
Brockton, Massachusetts, United States
University of Michigan Health Systems /ID# 119076
Ann Arbor, Michigan, United States
Minnesota Gastroenterology, P. A. /ID# 137280
Plymouth, Minnesota, United States
Mayo Clinic /ID# 122489
Rochester, Minnesota, United States
Kansas City Research Institute /ID# 119034
Kansas City, Missouri, United States
Ctr for Digest and Liver Dis /ID# 119040
Mexico, Missouri, United States
Albany Medical College /ID# 140200
Albany, New York, United States
NYU Langone Long Island Clinical Research Associates /ID# 119035
Great Neck, New York, United States
The Mount Sinai Hospital /ID# 127116
New York, New York, United States
Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041
Charlotte, North Carolina, United States
Wake Research Associates, LLC /ID# 119029
Raleigh, North Carolina, United States
Consultants for Clinical Res /ID# 119052
Cincinnati, Ohio, United States
Gastro United of Tulsa /ID# 122485
Tulsa, Oklahoma, United States
The Oregon Clinic, Gastroenterology - West /ID# 135272
Portland, Oregon, United States
West Bay Clinical Research /ID# 138330
Warwick, Rhode Island, United States
Medical University of South Carolina /ID# 138122
Charleston, South Carolina, United States
Erlanger Institute for Clinical Research /ID# 129008
Chattanooga, Tennessee, United States
Gastro One /ID# 119068
Germantown, Tennessee, United States
Nashville Med Res Inst /ID# 119050
Nashville, Tennessee, United States
Vanderbilt Univ Med Ctr /ID# 125501
Nashville, Tennessee, United States
Texas Digestive Disease Consultants - Dallas /ID# 138121
Dallas, Texas, United States
Baylor College of Medicine /ID# 137277
Houston, Texas, United States
Austin Institute for Clinical Research /ID# 125500
Pflugerville, Texas, United States
Texas Digestive Disease Consultants - Southlake /ID# 137283
Southlake, Texas, United States
Advanced Research Institute /ID# 119048
Ogden, Utah, United States
University of Utah /ID# 119062
Salt Lake City, Utah, United States
Gastro Assoc of Tidewater /ID# 135897
Chesapeake, Virginia, United States
New River Valley Research Inst /ID# 127807
Christiansburg, Virginia, United States
Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036
Milwaukee, Wisconsin, United States
Froedtert Memorial Lutheran Hospital /ID# 119081
Milwaukee, Wisconsin, United States
KH der Elisabethinen Linz GmbH /ID# 126280
Linz, Upper Austria, Austria
Medizinische Universitat Wien /ID# 126279
Vienna, Vienna, Austria
Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249
Innsbruck, , Austria
LKH Salzburg and Paracelsus /ID# 126248
Salzburg, , Austria
Krankenhaus der Barmherzigen Bruder /ID# 126270
Sankt Veit an der Glan, , Austria
AZ Maria Middelares /ID# 126194
Ghent, , Belgium
AZ Sint-Lucas /ID# 126242
Ghent, , Belgium
UZ Leuven /ID# 126240
Leuven, , Belgium
CHU de Liege /ID# 126241
Liège, , Belgium
AZ-Delta /ID# 126195
Roeselare, , Belgium
University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017
Calgary, Alberta, Canada
University of Alberta /ID# 119022
Edmonton, Alberta, Canada
Winnipeg Regional Health Authority /ID# 119015
Winnipeg, Manitoba, Canada
Qe Ii Hsc /Id# 127115
Halifax, Nova Scotia, Canada
Medicor Research Inc /ID# 119024
Greater Sudbury, Ontario, Canada
London Health Sciences Centre - University Hospital /ID# 119026
London, Ontario, Canada
Toronto Digestive Disease Asso /ID# 119019
Vaughan, Ontario, Canada
Montreal General Hospital - McGill University Health Center /ID# 119025
Montreal, Quebec, Canada
Fakultni Nemocnice Olomouc /ID# 126264
Olomouc, Olomoucký kraj, Czechia
Nemocnice Ceske Budejovice a.s. /ID# 126266
České Budějovice, , Czechia
Hepato-Gastroenterologie HK s.r.o. /ID# 126269
Hradec Králové, , Czechia
ISCARE a.s. /ID# 137977
Prague, , Czechia
Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331
Ústí nad Labem, , Czechia
Herlev Hospital /ID# 127741
Herlev, Capital Region, Denmark
Silkeborg Hospital /ID# 126251
Silkeborg, , Denmark
CHRU Lille - Hopital Claude Huriez /ID# 127743
Lille, Hauts-de-France, France
CHU NANCY - Hopital Brabois Adultes /ID# 127742
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, France
CHU Amiens-Picardie Site Sud /ID# 126237
Amiens, Somme, France
Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200
Grenoble, , France
Hopital l'Archet 2 /ID# 126238
Nice, , France
CHU de Saint-Etienne, Hopital Nord /ID# 134450
Saint-Etienne, , France
Hopital Rangueil /ID# 126239
Toulouse, , France
Universitaetsklinikum Schleswig-Holstein /ID# 126260
Kiel, Schleswig-Holstein, Germany
Charite Universitaetsmedizin Berlin /ID# 126196
Berlin, , Germany
Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257
Berlin, , Germany
Israelitisches Krankenhaus Hamburg /ID# 136549
Hamburg, , Germany
Asklepios Westklinikum Hamburg /ID# 126275
Hamburg, , Germany
Universitaetsklinikum Jena /ID# 126261
Jena, , Germany
EUGASTRO GmbH /ID# 126259
Leipzig, , Germany
Universitatsklinikum Magdeburg /ID# 126256
Magdeburg, , Germany
Gastro Campus Research GbR /ID# 126274
Münster, , Germany
Semmelweis Egyetem /ID# 137896
Budapest, , Hungary
Magyar Elhizastudomanyi KKft. /ID# 126276
Budapest, , Hungary
Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895
Pécs, , Hungary
University of Szeged /ID# 126263
Szeged, , Hungary
Rabin Medical Center /ID# 126198
Petakh Tikva, Tel Aviv, Israel
Soroka University Medical Center /ID# 126243
Beersheba, , Israel
Gastroenterology Institute, Division of Medicine /ID# 126245
Jerusalem, , Israel
Kaplan Medical Center /ID# 126246
Rehovot, , Israel
UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745
Rome, Lazio, Italy
Policlinico Agostino Gemelli /ID# 127746
Rome, Lazio, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221
Milan, Lombardy, Italy
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226
Rozzano, Milano, Italy
Azienda Ospedaliera Spedali Civili /ID# 127744
Brescia, , Italy
Azienda Ospedaliera di Padova /ID# 126267
Padua, , Italy
Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856
San Giovanni Rotondo, , Italy
Academisch Medical center Amsterdam /ID# 126227
Amsterdam, North Holland, Netherlands
Erasmus Medisch Centrum /ID# 126228
Rotterdam, , Netherlands
Sint Franciscus Gasthuis /ID# 127877
Rotterdam, , Netherlands
Endoterapia PFG sp. z o.o. /ID# 126199
Warsaw, Masovian Voivodeship, Poland
Centrum Endoskopii Zabiegowej /ID# 126272
Bydgoszcz, , Poland
Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271
Częstochowa, , Poland
KO-Med Centra Kliniczne Pulawi /ID# 126278
Puławy, , Poland
NZOZ Vivamed /ID# 126255
Warsaw, , Poland
Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974
Lodz, Łódź Voivodeship, Poland
School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735
San Juan, , Puerto Rico
Institutul Clinic Fundeni /ID# 127747
Sector 2, București, Romania
Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277
Brasov, , Romania
Tvm Med Serv Srl /Id# 126268
Cluj-Napoca, , Romania
Cabinet Medical Dr. Fratila SRL /ID# 126247
Oradea, , Romania
Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224
Zalău, , Romania
Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262
Bratislava, , Slovakia
Gastroenterologicka ambulancia /ID# 137964
Bratislava, , Slovakia
Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748
Lučenec, , Slovakia
Poliklinika Libris /ID# 126222
Nové Mesto nad Váhom, , Slovakia
Hospital Parc Tauli de Sabadell /ID# 138124
Sabadell, Barcelona, Spain
Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425
Majadahonda, Madrid, Spain
Hospital Clinic /ID# 127749
Barcelona, , Spain
Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976
Girona, , Spain
Hospital de Leon /ID# 141675
León, , Spain
Hospital Clinico Universitario San Carlos /ID# 126253
Madrid, , Spain
Complejo Hospitalario Universitario de Pontevedra /ID# 138126
Pontevedra, , Spain
Hospital Clinico Universitario Lozano Blesa /ID# 126252
Zaragoza, , Spain
Kantonsspital St. Gallen /ID# 127750
Sankt Gallen, Canton of St. Gallen, Switzerland
Universitaetsspital Zuerich /ID# 127751
Zurich, Canton of Zurich, Switzerland
State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753
Kharkiv, Kharkivs’ka Oblast’, Ukraine
Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754
Kherson, , Ukraine
Kyiv City Clinical Hospital No.8 /ID# 126232
Kiev, , Ukraine
Lviv Regional Clinical Hospital /ID# 126234
Lviv, , Ukraine
Public Institution 6th City Clinical Hospital /ID# 126236
Zaporizhzhia, , Ukraine
Guy's and St Thomas' NHS Found /ID# 144366
London, London, City of, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 126197
Norwich, Norfolk, United Kingdom
Hull University Teaching Hospitals NHS Trustust /ID# 126265
Hull, , United Kingdom
University Hospital Southampton NHS Fundation Trust /ID# 126225
Southampton, , United Kingdom
The Royal Wolverhampton NHS Tr /ID# 126201
Wolverhampton, , United Kingdom
Countries
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References
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Battat R, Kandi S, Lacerda AP, Levine P, Neimark E, Feagan BG, Rubin DT, Ji QC, Chen X, Polakow SB. Association of bile acid diarrhea with symptoms and disease activity in Crohn's disease: post-hoc clinical trial analysis of serum 7a-hydroxy-4cholestern-3-one, C4, in patients with active Crohn's disease. J Crohns Colitis. 2025 May 8;19(5):jjaf053. doi: 10.1093/ecco-jcc/jjaf053.
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.
D'Haens GR, Sandborn WJ, Loftus EV Jr, Hanauer SB, Schreiber S, Peyrin-Biroulet L, Panaccione R, Panes J, Baert F, Colombel JF, Ferrante M, Louis E, Armuzzi A, Zhou Q, Goteti VS, Mostafa NM, Doan TT, Petersson J, Finney-Hayward T, Song AP, Robinson AM, Danese S. Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results. Gastroenterology. 2022 Jun;162(7):1876-1890. doi: 10.1053/j.gastro.2022.01.044. Epub 2022 Feb 3.
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: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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Related Info
Other Identifiers
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2013-001746-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
M14-115
Identifier Type: -
Identifier Source: org_study_id
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