Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
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
2 other identifiers
interventional
952
20 countries
173
Brief Summary
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Mar 2014
Longer than P75 for phase_3
173 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 17, 2014
CompletedFirst Posted
Study publicly available on registry
February 19, 2014
CompletedStudy Start
First participant enrolled
March 27, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 5, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
November 11, 2019
CompletedResults Posted
Study results publicly available
October 8, 2020
CompletedNovember 23, 2020
September 1, 2020
5.4 years
February 17, 2014
August 19, 2020
November 19, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Week 8
Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52
The Mayo score is a tool designed to measure disease activity for ulcerative colitis. The FMS ranges from 0 (normal or inactive disease) to 12 (severe disease) and is calculated as the sum of 4 subscores (stool frequency, rectal bleeding, endoscopy \[confirmed by a central reader\], and physician's global assessment), each of which ranges from 0 (normal) to 3 (severe disease). Negative changes indicate improvement. Week 8 responders (per FMS) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease from baseline in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission per FMS is defined as Mayo Score ≤ 2 and no individual subscore \> 1.
Week 52
Secondary Outcomes (21)
Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8
Week 8
Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8
Week 8
Induction Period Ranked Secondary Endpoint 3: Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response (Increase of IBDQ ≥ 16 From Baseline) at Week 8
Week 8
Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8
Week 8
Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8
Week 8
- +16 more secondary outcomes
Study Arms (5)
Induction (Main Study + Japan Sub-study): I-SD
EXPERIMENTALInduction 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.
Induction (Main Study + Japan Sub-study): I-HD
EXPERIMENTALInduction 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.
Maintenance (Main Study + Japan Sub-study): M-SD
EXPERIMENTALMaintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
Maintenance (Main Study + Japan Sub-study): M-HD
EXPERIMENTALMaintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Maintenance (Main Study): TDM Regimen
EXPERIMENTALDouble-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.
Interventions
Eligibility Criteria
You may qualify if:
- 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. Mayo Score is confirmed by central reader.
You may not qualify 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).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (173)
Digestive Health Specialists of the Southeast /ID# 127844
Dothan, Alabama, 36305, United States
Ucsd /Id# 122313
La Jolla, California, 92093, United States
Rocky Mountain Clinical Resear /ID# 122180
Wheat Ridge, Colorado, 80033, United States
Medical Research Ctr CT /ID# 122179
Hamden, Connecticut, 06518, United States
Gastro Florida /ID# 170619
Clearwater, Florida, 33756, United States
Research Associates of South Florida,LLC /ID# 170309
Miami, Florida, 33156, United States
Gastroenterology Group Naples /ID# 127806
Naples, Florida, 34102, United States
Shafran Gastroenterology Ctr /ID# 122320
Winter Park, Florida, 32789, United States
Atlanta Gastro Assoc /ID# 122336
Atlanta, Georgia, 30342, United States
Gastro Assoc of Central GA /ID# 122318
Macon, Georgia, 31201, United States
Northwestern University Feinberg School of Medicine /ID# 122183
Chicago, Illinois, 60611-2927, United States
University of Chicago /ID# 122302
Chicago, Illinois, 60637-1443, United States
Carle Foundation Hospital /ID# 135955
Urbana, Illinois, 61801, United States
Louisiana Research Ctr. LLC /ID# 141655
Shreveport, Louisiana, 71105-6800, United States
University of Maryland Med Ctr /ID# 169734
Baltimore, Maryland, 21201, United States
MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
Chevy Chase, Maryland, 20815, United States
University of Michigan Hospitals /ID# 122240
Ann Arbor, Michigan, 48109, United States
Mayo Clinic - Rochester /ID# 122244
Rochester, Minnesota, 55905-0001, United States
Ctr for Digest and Liver Dis /ID# 122182
Mexico, Missouri, 65265, United States
NYU Langone Long Island CRA /ID# 122177
Great Neck, New York, 11021, United States
Icahn School of Med Mt. Sinai /ID# 127047
New York, New York, 10029, United States
Charlotte Gastro Hepatology /ID# 122235
Charlotte, North Carolina, 28207, United States
Wake Research Associates, LLC /ID# 122157
Raleigh, North Carolina, 27612, United States
Consultants for Clinical Res /ID# 122304
Cincinnati, Ohio, 45219, United States
Dayton Gastroenterology, Inc. /ID# 127804
Englewood, Ohio, 45415, United States
Gastro United of Tulsa /ID# 125436
Tulsa, Oklahoma, 74135, United States
The Oregon Clinic- Gastro West /ID# 135273
Portland, Oregon, 97225, United States
University of Pittsburgh MC /ID# 122331
Pittsburgh, Pennsylvania, 15260, United States
Erlanger Institute for Clinica /ID# 129009
Chattanooga, Tennessee, 37403, United States
Gastro One /ID# 122339
Germantown, Tennessee, 38138, United States
Vanderbilt Univ Med Ctr /ID# 125496
Nashville, Tennessee, 37232-0011, United States
DHAT Research Institute /ID# 170616
Garland, Texas, 75044-2208, United States
Biopharma Informatic Research /ID# 171150
Houston, Texas, 77024-2420, United States
Austin Center for Clinical Research /ID# 125396
Pflugerville, Texas, 78660, United States
Texas Digestive Disease Consul /ID# 141677
Southlake, Texas, 76092, United States
Texas Digestive Disease Consul /ID# 141678
Southlake, Texas, 76092, United States
Advanced Research Institute /ID# 126147
Ogden, Utah, 84403, United States
University of Utah /ID# 122333
Salt Lake City, Utah, 84112-5500, United States
New River Valley Research Inst /ID# 127801
Christiansburg, Virginia, 24073, United States
University of Washington /ID# 169721
Seattle, Washington, 98109, United States
WI Center for Advanced Res /ID# 122178
Milwaukee, Wisconsin, 53215, United States
Froedtert & the Medical College of Wisconsin /ID# 122261
Milwaukee, Wisconsin, 53226-3522, United States
KH der Elisabethinen Linz GmbH /ID# 127184
Linz, Upper Austria, 4010, Austria
Medizinische Universitat Wien /ID# 127186
Vienna, Vienna, 1090, Austria
Ordination Hainburg an der Don /ID# 127185
Hainburg an der Donau, 2410, Austria
Universitaetsklinik fuer Innere Medizin 1 /ID# 125944
Salzburg, 5020, Austria
KH der Barmherzigen Brueder /ID# 127183
Sankt Veit an der Glan, 9300, Austria
AZ Sint-Lucas /ID# 127187
Ghent, 9000, Belgium
UZ Leuven /ID# 126739
Leuven, 3000, Belgium
CHU de Liege /ID# 126740
Liège, 4000, Belgium
University of Calgary /ID# 125715
Calgary, Alberta, T2N 4Z6, Canada
Zeidler Ledcor Centre /ID# 125713
Edmonton, Alberta, T6G 2X8, Canada
Winnipeg Regional Health Autho /ID# 125712
Winnipeg, Manitoba, R3A 1R9, Canada
Qe Ii Hsc /Id# 127045
Halifax, Nova Scotia, B3H 1V7, Canada
London Health Sciences Centre /ID# 127055
London, Ontario, N6A 5A5, Canada
Mount Sinai Hosp.-Toronto /ID# 126590
Toronto, Ontario, M5G 1X5, Canada
Toronto Digestive Disease Asso /ID# 127075
Vaughan, Ontario, L4L 4Y7, Canada
McGill Univ HC /ID# 127046
Montreal, Quebec, H3G 1A4, Canada
Hepato-Gastroenterologie HK s.r.o. /ID# 127188
Hradec Králové, 500 12, Czechia
ISCARE a.s. /ID# 127837
Prague, 190 00, Czechia
Herlev Hospital /ID# 127191
Herlev, Capital Region, 2730, Denmark
Regionhospital Silkeborg /ID# 127190
Silkeborg, 8600, Denmark
CHRU Lille - Hôpital Claude Huriez /ID# 127197
Lille, Hauts-de-France, 59045, France
CHU NANCY - Hôpital Brabois Adultes /ID# 127196
Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511, France
CHU Amiens Picardie /ID# 127194
Amiens, Somme, 80054, France
CHU Estaing /ID# 127848
Clermont-Ferrand, 63100, France
CHU Dijon /ID# 127861
Dijon, 21000, France
CHU de Grenoble - Albet Michal /ID# 127195
Grenoble, 38043, France
CHU Saint ELOI /ID# 169007
Montpellier, 34295, France
CHU de Nice /ID# 127193
Nice, 06202, France
CHU de Saint-Etienne, Hopital Nord /ID# 134490
Saint-Etienne, 42270, France
Hopital Rangueil /ID# 127192
Toulouse, 31059, France
Universitatsklinik Regensburg /ID# 201265
Regensburg, Bavaria, 93053, Germany
Universitatsklinikum Frankfurt /ID# 170300
Frankfurt am Main, Hesse, 60590, Germany
Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199
Kiel, Schleswig-Holstein, 24105, Germany
Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203
Berlin, 10117, Germany
Mross, Berlin, DE /ID# 127201
Berlin, 10318, Germany
Gastrostudien GbR /ID# 169246
Berlin, D-10825, Germany
Asklepios Westklinikum Hamburg /ID# 127198
Hamburg, 22559, Germany
Universitaetsklinikum Jena /ID# 127205
Jena, 07747, Germany
EUGASTRO GmbH /ID# 127202
Leipzig, 04103, Germany
Universitatsklinikum Magdeburg /ID# 127200
Magdeburg, 39120, Germany
Gastro Campus Research GbR /ID# 126743
Münster, 48159, Germany
Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209
Pécs, Pecs, 7624, Hungary
Magyar Elhizastudomanyi KKft. /ID# 126589
Budapest, 1124, Hungary
Pannonia Maganorvosi Centrum Kft. /ID# 127207
Budapest, 1136, Hungary
Szegedi Tudomanyegyetem /ID# 127208
Szeged, 6720, Hungary
Rabin Medical Center /ID# 127212
Petakh Tikva, Tel Aviv, 4941492, Israel
Tel Aviv Sourasky Medical Center /ID# 201365
Tel Aviv, Tel Aviv, 6423906, Israel
Soroka University Medical Center /ID# 127213
Beersheba, 84101, Israel
Hadassah University Hospital /ID# 127211
Jerusalem, 91120, Israel
Kaplan Medical Center /ID# 127210
Rehovot, 76100, Israel
A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322
Bologna, Emilia-Romagna, 40138, Italy
Azienda Ospedaliera San Camillo Forlanini /ID# 127216
Rome, Lazio, 00152, Italy
Policlinico Agostino Gemelli /ID# 127217
Rome, Lazio, 00168, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138
Milan, Lombardy, 20122, Italy
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215
Rozzano, Milano, 20089, Italy
Azienda Ospedaliera Spedali Civili /ID# 127236
Brescia, 25123, Italy
Universita di Padova /ID# 127214
Padua, 35128, Italy
Ospedali Riuniti Villa Sofia-C /ID# 129323
Palermo, 90146, Italy
Policlinico Univ Tor Vergata /ID# 129321
Rome, 00133, Italy
IRCCS Casa Sollievo /ID# 127811
San Giovanni Rotondo, 71013, Italy
Yokoyama IBD Clinic /ID# 151560
Nagoya, Aichi-ken, 460-0022, Japan
Nagoya City University Hospital /ID# 124517
Nagoya, Aichi-ken, 467-8602, Japan
Toho University Sakura Medical Center /ID# 124497
Sakura-shi, Chiba, 285-8741, Japan
Fukuoka University Chikushi Hospital /ID# 124155
Chikushino-shi, Fukuoka, 818-8502, Japan
Kyushu University Hospital /ID# 124495
Fukuoka, Fukuoka, 812-8582, Japan
Hidaka Clinic of Coloproctology /ID# 125477
Kurume, Fukuoka, 839-0809, Japan
Kurume University Hospital /ID# 125275
Kurume-shi, Fukuoka, 830-0011, Japan
Hiroshima University Hospital /ID# 124496
Hiroshima, Hiroshima, 734-8551, Japan
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480
Sapporo, Hokkaido, 060-0033, Japan
Aoyama Clinic /ID# 127836
Kobe, Hyōgo, 650-0015, Japan
Hyogo College of Medicine College Hospital /Id# 127539
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Kitasato University Hospital /ID# 137694
Sagamihara-shi, Kanagawa, 252-0375, Japan
COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423
Yokohama, Kanagawa, 220-0045, Japan
Susaki Kuroshio Hospital /ID# 125202
Susaki-shi, Kochi, 785-8501, Japan
Japanese Red Cross Kyoto Daiichi Hos /ID# 127540
Kyoto, Kyoto, 605-0981, Japan
Osaka Medical College Hospital /ID# 126451
Takatsuki-shi, Osaka, 569-8686, Japan
Saitama Medical Center /ID# 128875
Kawagoe-shi, Saitama, 350-8550, Japan
Shiga University of Medical Science Hospital /ID# 127675
Ōtsu, Shiga, 520-2192, Japan
Hamamatsu South Hospital /ID# 124481
Hamamatsu, Shizuoka, 430-0846, Japan
Medical Hospital of Tokyo Medical and Dental University /ID# 128315
Bunkyo-ku, Tokyo, 113-8519, Japan
Kitasato Univ Kitasato Inst Ho /ID# 127001
Minato-ku, Tokyo, 108-8642, Japan
Kyorin University Hospital /ID# 148184
Mitaka-shi, Tokyo, 181-8611, Japan
Wakayama Medical University /ID# 124635
Wakayama, Wakayama, 641-8510, Japan
Tokyo Yamate Medical Center /ID# 125201
Tokyo, 169-0073, Japan
Academisch Medisch Centrum /ID# 126741
Amsterdam, North Holland, 1105 AZ, Netherlands
Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-168, Poland
Centrum Zdrowia MDM /ID# 170303
Warsaw, Masovian Voivodeship, 00-635, Poland
Endoterapia PFG Sp. z.o.o. /ID# 126513
Warsaw, Masovian Voivodeship, 02-653, Poland
Centrum Medyczne Pratia Gdynia /ID# 170301
Gdynia, Pomeranian Voivodeship, 81-338, Poland
NZOZ All-Medicus /ID# 128740
Katowice, Silesian Voivodeship, 40-659, Poland
H-T.Centrum Medyczne-Endoterapia /ID# 170305
Tychy, Silesian Voivodeship, 43-100, Poland
Centrum Medyczne LukaMed Joanna Luka /ID# 170302
Chojnice, 89-600, Poland
Centrum Medyczne Sw. Lukaza /ID# 126515
Częstochowa, 42-200, Poland
Centrum Diagnostyczno Lecznicze Barska /ID# 170304
Lodz, 91-347, Poland
KO-Med Centra Kliniczne Pulawy /ID# 127219
Puławy, 24-100, Poland
NZOZ Vivamed /ID# 127218
Warsaw, 03-580, Poland
C.M. Szpital Swietej Rodziny /ID# 127838
Lodz, Łódź Voivodeship, 90-302, Poland
Institutul Clinic Fundeni /ID# 127839
Sector 2, București, 022328, Romania
CMDTA Neomed SRL /ID# 127142
Brasov, 500283, Romania
Spitalul Clinic Judetean de Urgenta /ID# 125418
Cluj-Napoca, 400006, Romania
Tvm Med Serv Srl /Id# 127221
Cluj-Napoca, 400132, Romania
Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002
Oradea, 410167, Romania
Salvo-San-Ciobanca SRL /ID# 127140
Zalău, 450117, Romania
Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222
Bratislava, 831 04, Slovakia
Gastroenterologicka Ambulancia /ID# 125632
Bratislava, 851 01, Slovakia
Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322
Lučenec, 984 01, Slovakia
Hospital General Universitario de Alicante /ID# 129261
Alicante, 03550, Spain
Hospital Clinic de Barcelona /ID# 138147
Barcelona, 08036, Spain
Complejo Hospitalario Universitario de Ferrol /ID# 127840
Ferrol, 15405, Spain
Hospital Univ Dr. Negrin /ID# 127841
Las Palmas de Gran Canaria, 35010, Spain
Hospital Univ de la Princesa /ID# 135828
Madrid, 28006, Spain
Hospital General Universitario Gregorio Maranon /ID# 127224
Madrid, 28007, Spain
Hosp Univ 12 de Octubre /ID# 129257
Madrid, 28041, Spain
Hospital Universitario La Paz /ID# 127223
Madrid, 28046, Spain
Hosp Clin Univ de Valencia /ID# 170306
Valencia, 46010, Spain
Hosp Clin Univ Lozano Blesa /ID# 129255
Zaragoza, 50009, Spain
Kantonsspital St. Gallen /ID# 127843
Sankt Gallen, Canton of St. Gallen, 9007, Switzerland
University Hospital Zurich /ID# 127842
Zurich, Canton of Zurich, 8006, Switzerland
GI National Institute of Therapy named by L.T. Malaya /ID# 127231
Kharkiv, Kharkivs’ka Oblast’, 61039, Ukraine
Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233
Kherson, 73000, Ukraine
Municipal Clinical Hospital #8 /ID# 127235
Kiev, 04201, Ukraine
Lviv City Clinical Hospital NO.4 /ID# 127232
Lviv, 79011, Ukraine
CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137
Zaporizhzhia, 69035, Ukraine
Royal Hampshire County Hosp /ID# 169250
Winchester, Hampshire, SO22 5DG, United Kingdom
Norfolk and Norwich Univ Hosp /ID# 127139
Norwich, Norfolk, NR4 7UY, United Kingdom
Western General Hospital /ID# 204801
Edinburgh, EH4 2XU, United Kingdom
St. Mark's Hospital /ID# 127226
Harrow, HA1 3UJ, United Kingdom
Hull and East Yorkshire Hospitals NHS Trust /ID# 127225
Hull, HU8 9HE, United Kingdom
Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324
Oxford, OX3 9DU, United Kingdom
Southampton General Hospital /ID# 127228
Southampton, SO16 6YD, United Kingdom
The Royal Wolverhampton NHS Tr /ID# 127227
Wolverhampton, WV10 0QP, United Kingdom
Related Publications (4)
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.
PMID: 39162746DERIVEDVerstockt 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.
PMID: 37801628DERIVEDPonce-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.
PMID: 36905528DERIVEDGreener 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.
PMID: 34402466DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global Medical Services
- Organization
- AbbVie
Study Officials
- STUDY DIRECTOR
AbbVie Inc.
AbbVie
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 17, 2014
First Posted
February 19, 2014
Study Start
March 27, 2014
Primary Completion
September 5, 2019
Study Completion
November 11, 2019
Last Updated
November 23, 2020
Results First Posted
October 8, 2020
Record last verified: 2020-09
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
- Access Criteria
- Access to this clinical trial data can be requested by any qualified researchers who engage in rigorous, independent scientific research, and will be provided following review and approval of a research proposal and Statistical Analysis Plan (SAP) and execution of a Data Sharing Agreement (DSA). For more information on the process, or to submit a request, visit the following link.
AbbVie is committed to responsible data sharing regarding the clinical trials we sponsor. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information (e.g., protocols and clinical study reports), as long as the trials are not part of an ongoing or planned regulatory submission. This includes requests for clinical trial data for unlicensed products and indications.