Clinical trial NCT02065622: Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Ulcerative Colitis (UC)
Keywords: Ulcerative Colitis
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2014-02-19
Enrollment: 952
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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).

Primary outcomes:
measure: Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8
timeFrame: Week 8
measure: Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52
timeFrame: Week 52
Secondary outcomes:
measure: Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8
timeFrame: Week 8
measure: Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8
timeFrame: Week 8
measure: 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
timeFrame: Week 8
measure: Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8
timeFrame: Week 8
measure: Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8
timeFrame: Week 8
measure: Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8
timeFrame: Week 8
measure: Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8
timeFrame: Week 8
measure: Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 2: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 3: Percentage of Week 8 Responders With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 6: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 7: Percentage of Week 8 Remitters (Per FMS) With Steroid Usage at Baseline and Steroid Free at Least 90 Days and With Clinical Remission (Per FMS) at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 8: Percentage of Week 8 Responders (Per FMS) With IBDQ Response (Increase of IBDQ ≥ 16 From Baseline) at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52
timeFrame: Week 52
measure: Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52
timeFrame: Week 52
Other outcomes:
Locations:
city: Dothan
country: United States
facility: Digestive Health Specialists of the Southeast /ID# 127844
state: Alabama
city: La Jolla
country: United States
facility: Ucsd /Id# 122313
state: California
city: Wheat Ridge
country: United States
facility: Rocky Mountain Clinical Resear /ID# 122180
state: Colorado
city: Hamden
country: United States
facility: Medical Research Ctr CT /ID# 122179
state: Connecticut
city: Clearwater
country: United States
facility: Gastro Florida /ID# 170619
state: Florida
city: Miami
country: United States
facility: Research Associates of South Florida,LLC /ID# 170309
state: Florida
city: Naples
country: United States
facility: Gastroenterology Group Naples /ID# 127806
state: Florida
city: Winter Park
country: United States
facility: Shafran Gastroenterology Ctr /ID# 122320
state: Florida
city: Atlanta
country: United States
facility: Atlanta Gastro Assoc /ID# 122336
state: Georgia
city: Macon
country: United States
facility: Gastro Assoc of Central GA /ID# 122318
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 122183
state: Illinois
city: Chicago
country: United States
facility: University of Chicago /ID# 122302
state: Illinois
city: Urbana
country: United States
facility: Carle Foundation Hospital /ID# 135955
state: Illinois
city: Shreveport
country: United States
facility: Louisiana Research Ctr. LLC /ID# 141655
state: Louisiana
city: Baltimore
country: United States
facility: University of Maryland Med Ctr /ID# 169734
state: Maryland
city: Chevy Chase
country: United States
facility: MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
state: Maryland
city: Ann Arbor
country: United States
facility: University of Michigan Hospitals /ID# 122240
state: Michigan
city: Rochester
country: United States
facility: Mayo Clinic - Rochester /ID# 122244
state: Minnesota
city: Mexico
country: United States
facility: Ctr for Digest and Liver Dis /ID# 122182
state: Missouri
city: Great Neck
country: United States
facility: NYU Langone Long Island CRA /ID# 122177
state: New York
city: New York
country: United States
facility: Icahn School of Med Mt. Sinai /ID# 127047
state: New York
city: Charlotte
country: United States
facility: Charlotte Gastro Hepatology /ID# 122235
state: North Carolina
city: Raleigh
country: United States
facility: Wake Research Associates, LLC /ID# 122157
state: North Carolina
city: Cincinnati
country: United States
facility: Consultants for Clinical Res /ID# 122304
state: Ohio
city: Englewood
country: United States
facility: Dayton Gastroenterology, Inc. /ID# 127804
state: Ohio
city: Tulsa
country: United States
facility: Gastro United of Tulsa /ID# 125436
state: Oklahoma
city: Portland
country: United States
facility: The Oregon Clinic- Gastro West /ID# 135273
state: Oregon
city: Pittsburgh
country: United States
facility: University of Pittsburgh MC /ID# 122331
state: Pennsylvania
city: Chattanooga
country: United States
facility: Erlanger Institute for Clinica /ID# 129009
state: Tennessee
city: Germantown
country: United States
facility: Gastro One /ID# 122339
state: Tennessee
city: Nashville
country: United States
facility: Vanderbilt Univ Med Ctr /ID# 125496
state: Tennessee
city: Garland
country: United States
facility: DHAT Research Institute /ID# 170616
state: Texas
city: Houston
country: United States
facility: Biopharma Informatic Research /ID# 171150
state: Texas
city: Pflugerville
country: United States
facility: Austin Center for Clinical Research /ID# 125396
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consul /ID# 141677
state: Texas
city: Southlake
country: United States
facility: Texas Digestive Disease Consul /ID# 141678
state: Texas
city: Ogden
country: United States
facility: Advanced Research Institute /ID# 126147
state: Utah
city: Salt Lake City
country: United States
facility: University of Utah /ID# 122333
state: Utah
city: Christiansburg
country: United States
facility: New River Valley Research Inst /ID# 127801
state: Virginia
city: Seattle
country: United States
facility: University of Washington /ID# 169721
state: Washington
city: Milwaukee
country: United States
facility: WI Center for Advanced Res /ID# 122178
state: Wisconsin
city: Milwaukee
country: United States
facility: Froedtert & the Medical College of Wisconsin /ID# 122261
state: Wisconsin
city: Linz
country: Austria
facility: KH der Elisabethinen Linz GmbH /ID# 127184
state: Oberoesterreich
city: Vienna
country: Austria
facility: Medizinische Universitat Wien /ID# 127186
state: Wien
city: Hainburg An Der Donau
country: Austria
facility: Ordination Hainburg an der Don /ID# 127185
city: Salzburg
country: Austria
facility: Universitaetsklinik fuer Innere Medizin 1 /ID# 125944
city: St Veit An Der Glan
country: Austria
facility: KH der Barmherzigen Brueder /ID# 127183
city: Ghent
country: Belgium
facility: AZ Sint-Lucas /ID# 127187
city: Leuven
country: Belgium
facility: UZ Leuven /ID# 126739
city: Liege
country: Belgium
facility: CHU de Liege /ID# 126740
city: Calgary
country: Canada
facility: University of Calgary /ID# 125715
state: Alberta
city: Edmonton
country: Canada
facility: Zeidler Ledcor Centre /ID# 125713
state: Alberta
city: Winnipeg
country: Canada
facility: Winnipeg Regional Health Autho /ID# 125712
state: Manitoba
city: Halifax
country: Canada
facility: Qe Ii Hsc /Id# 127045
state: Nova Scotia
city: London
country: Canada
facility: London Health Sciences Centre /ID# 127055
state: Ontario
city: Toronto
country: Canada
facility: Mount Sinai Hosp.-Toronto /ID# 126590
state: Ontario
city: Vaughan
country: Canada
facility: Toronto Digestive Disease Asso /ID# 127075
state: Ontario
city: Montreal
country: Canada
facility: McGill Univ HC /ID# 127046
state: Quebec
city: Hradec Kralove
country: Czechia
facility: Hepato-Gastroenterologie HK s.r.o. /ID# 127188
city: Praha 9
country: Czechia
facility: ISCARE a.s. /ID# 127837
city: Herlev
country: Denmark
facility: Herlev Hospital /ID# 127191
state: Hovedstaden
city: Silkeborg
country: Denmark
facility: Regionhospital Silkeborg /ID# 127190
city: Lille CEDEX
country: France
facility: CHRU Lille - Hôpital Claude Huriez /ID# 127197
state: Hauts-de-France
city: Vandoeuvre les Nancy CEDEX
country: France
facility: CHU NANCY - Hôpital Brabois Adultes /ID# 127196
state: Meurthe-et-Moselle
city: Amiens CEDEX 1
country: France
facility: CHU Amiens Picardie /ID# 127194
state: Somme
city: Clermont Ferrand
country: France
facility: CHU Estaing /ID# 127848
city: Dijon
country: France
facility: CHU Dijon /ID# 127861
city: Grenoble
country: France
facility: CHU de Grenoble - Albet Michal /ID# 127195
city: Montpellier Cedex 5
country: France
facility: CHU Saint ELOI /ID# 169007
city: Nice
country: France
facility: CHU de Nice /ID# 127193
city: SAINT-ETIENNE Cedex 1
country: France
facility: CHU de Saint-Etienne, Hopital Nord /ID# 134490
city: Toulouse
country: France
facility: Hopital Rangueil /ID# 127192
city: Ratisbon
country: Germany
facility: Universitatsklinik Regensburg /ID# 201265
state: Bayern
city: Frankfurt
country: Germany
facility: Universitatsklinikum Frankfurt /ID# 170300
state: Hessen
city: Kiel
country: Germany
facility: Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203
city: Berlin
country: Germany
facility: Mross, Berlin, DE /ID# 127201
city: Berlin
country: Germany
facility: Gastrostudien GbR /ID# 169246
city: Hamburg
country: Germany
facility: Asklepios Westklinikum Hamburg /ID# 127198
city: Jena
country: Germany
facility: Universitaetsklinikum Jena /ID# 127205
city: Leipzig
country: Germany
facility: EUGASTRO GmbH /ID# 127202
city: Magdeburg
country: Germany
facility: Universitatsklinikum Magdeburg /ID# 127200
city: Munster
country: Germany
facility: Gastro Campus Research GbR /ID# 126743
city: Pécs
country: Hungary
facility: Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209
state: Pecs
city: Budapest
country: Hungary
facility: Magyar Elhizastudomanyi KKft. /ID# 126589
city: Budapest
country: Hungary
facility: Pannonia Maganorvosi Centrum Kft. /ID# 127207
city: Szeged
country: Hungary
facility: Szegedi Tudomanyegyetem /ID# 127208
city: Petakh Tikva
country: Israel
facility: Rabin Medical Center /ID# 127212
state: Tel-Aviv
city: Tel Aviv-Yafo
country: Israel
facility: Tel Aviv Sourasky Medical Center /ID# 201365
state: Tel-Aviv
city: Be'er Sheva
country: Israel
facility: Soroka University Medical Center /ID# 127213
city: Jerusalem
country: Israel
facility: Hadassah University Hospital /ID# 127211
city: Rehovot
country: Israel
facility: Kaplan Medical Center /ID# 127210
city: Bologna
country: Italy
facility: A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322
state: Emilia-Romagna
city: Rome
country: Italy
facility: Azienda Ospedaliera San Camillo Forlanini /ID# 127216
state: Lazio
city: Rome
country: Italy
facility: Policlinico Agostino Gemelli /ID# 127217
state: Lazio
city: Milan
country: Italy
facility: Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138
state: Lombardia
city: Rozzano
country: Italy
facility: IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215
state: Milano
city: Brescia
country: Italy
facility: Azienda Ospedaliera Spedali Civili /ID# 127236
city: Padova
country: Italy
facility: Universita di Padova /ID# 127214
city: Palermo
country: Italy
facility: Ospedali Riuniti Villa Sofia-C /ID# 129323
city: Rome
country: Italy
facility: Policlinico Univ Tor Vergata /ID# 129321
city: San Giovanni Rotondo
country: Italy
facility: IRCCS Casa Sollievo /ID# 127811
city: Nagoya-shi
country: Japan
facility: Nagoya City University Hospital /ID# 124517
state: Aichi
city: Nagoya
country: Japan
facility: Yokoyama IBD Clinic /ID# 151560
state: Aichi
city: Sakura-shi
country: Japan
facility: Toho University Sakura Medical Center /ID# 124497
state: Chiba
city: Chikushino
country: Japan
facility: Fukuoka University Chikushi Hospital /ID# 124155
state: Fukuoka
city: Fukuoka-shi
country: Japan
facility: Kyushu University Hospital /ID# 124495
state: Fukuoka
city: Kurume-shi
country: Japan
facility: Kurume University Hospital /ID# 125275
state: Fukuoka
city: Kurume
country: Japan
facility: Hidaka Clinic of Coloproctology /ID# 125477
state: Fukuoka
city: Hiroshima-shi
country: Japan
facility: Hiroshima University Hospital /ID# 124496
state: Hiroshima
city: Sapporo-shi
country: Japan
facility: Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Aoyama Clinic /ID# 127836
state: Hyogo
city: Nishinomiya-shi
country: Japan
facility: Hyogo College of Medicine College Hospital /Id# 127539
state: Hyogo
city: Sagamihara-shi
country: Japan
facility: Kitasato University Hospital /ID# 137694
state: Kanagawa
city: Yokohama
country: Japan
facility: COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423
state: Kanagawa
city: Susaki-shi
country: Japan
facility: Susaki Kuroshio Hospital /ID# 125202
state: Kochi
city: Kyoto-shi
country: Japan
facility: Japanese Red Cross Kyoto Daiichi Hos /ID# 127540
state: Kyoto
city: Takatsuki-shi
country: Japan
facility: Osaka Medical College Hospital /ID# 126451
state: Osaka
city: Kawagoe-shi
country: Japan
facility: Saitama Medical Center /ID# 128875
state: Saitama
city: Otsu-shi
country: Japan
facility: Shiga University of Medical Science Hospital /ID# 127675
state: Shiga
city: Hamamatsu-shi
country: Japan
facility: Hamamatsu South Hospital /ID# 124481
state: Shizuoka
city: Bunkyo-ku
country: Japan
facility: Medical Hospital of Tokyo Medical and Dental University /ID# 128315
state: Tokyo
city: Minato-ku
country: Japan
facility: Kitasato Univ Kitasato Inst Ho /ID# 127001
state: Tokyo
city: Mitaka-shi
country: Japan
facility: Kyorin University Hospital /ID# 148184
state: Tokyo
city: Wakayama-shi
country: Japan
facility: Wakayama Medical University /ID# 124635
state: Wakayama
city: Tokyo
country: Japan
facility: Tokyo Yamate Medical Center /ID# 125201
city: Amsterdam
country: Netherlands
facility: Academisch Medisch Centrum /ID# 126741
state: Noord-Holland
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141
state: Kujawsko-pomorskie
city: Lodz
country: Poland
facility: C.M. Szpital Swietej Rodziny /ID# 127838
state: Lodzkie
city: Warsaw
country: Poland
facility: Centrum Zdrowia MDM /ID# 170303
state: Mazowieckie
city: Warszawa
country: Poland
facility: Endoterapia PFG Sp. z.o.o. /ID# 126513
state: Mazowieckie
city: Gdynia
country: Poland
facility: Centrum Medyczne Pratia Gdynia /ID# 170301
state: Pomorskie
city: Katowice
country: Poland
facility: NZOZ All-Medicus /ID# 128740
state: Slaskie
city: Tychy
country: Poland
facility: H-T.Centrum Medyczne-Endoterapia /ID# 170305
state: Slaskie
city: Chojnice
country: Poland
facility: Centrum Medyczne LukaMed Joanna Luka /ID# 170302
city: Czestochowa
country: Poland
facility: Centrum Medyczne Sw. Lukaza /ID# 126515
city: Lodz
country: Poland
facility: Centrum Diagnostyczno Lecznicze Barska /ID# 170304
city: Pulawy
country: Poland
facility: KO-Med Centra Kliniczne Pulawy /ID# 127219
city: Warsaw
country: Poland
facility: NZOZ Vivamed /ID# 127218
city: Sector 2
country: Romania
facility: Institutul Clinic Fundeni /ID# 127839
state: Bucuresti
city: Brasov
country: Romania
facility: CMDTA Neomed SRL /ID# 127142
city: Cluj
country: Romania
facility: Spitalul Clinic Judetean de Urgenta /ID# 125418
city: Cluj
country: Romania
facility: Tvm Med Serv Srl /Id# 127221
city: Oradea
country: Romania
facility: Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002
city: Zalau
country: Romania
facility: Salvo-San-Ciobanca SRL /ID# 127140
city: Bratislava
country: Slovakia
facility: Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222
city: Bratislava
country: Slovakia
facility: Gastroenterologicka Ambulancia /ID# 125632
city: Lucenec
country: Slovakia
facility: Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante /ID# 129261
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona /ID# 138147
city: Ferrol
country: Spain
facility: Complejo Hospitalario Universitario de Ferrol /ID# 127840
city: Las Palmas de Gran Canaria
country: Spain
facility: Hospital Univ Dr. Negrin /ID# 127841
city: Madrid
country: Spain
facility: Hospital Univ de la Princesa /ID# 135828
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon /ID# 127224
city: Madrid
country: Spain
facility: Hosp Univ 12 de Octubre /ID# 129257
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 127223
city: València
country: Spain
facility: Hosp Clin Univ de Valencia /ID# 170306
city: Zaragoza
country: Spain
facility: Hosp Clin Univ Lozano Blesa /ID# 129255
city: St. Gallen
country: Switzerland
facility: Kantonsspital St. Gallen /ID# 127843
state: Sankt Gallen
city: Zurich
country: Switzerland
facility: University Hospital Zurich /ID# 127842
state: Zuerich
city: Kharkiv
country: Ukraine
facility: GI National Institute of Therapy named by L.T. Malaya /ID# 127231
state: Kharkivska Oblast
city: Kherson
country: Ukraine
facility: Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233
city: Kiev
country: Ukraine
facility: Municipal Clinical Hospital #8 /ID# 127235
city: Lviv
country: Ukraine
facility: Lviv City Clinical Hospital NO.4 /ID# 127232
city: Zaporizhzhia
country: Ukraine
facility: CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137
city: Winchester
country: United Kingdom
facility: Royal Hampshire County Hosp /ID# 169250
state: Hampshire
city: Norwich
country: United Kingdom
facility: Norfolk and Norwich Univ Hosp /ID# 127139
state: Norfolk
city: Edinburgh
country: United Kingdom
facility: Western General Hospital /ID# 204801
city: Harrow
country: United Kingdom
facility: St. Mark's Hospital /ID# 127226
city: Hull
country: United Kingdom
facility: Hull and East Yorkshire Hospitals NHS Trust /ID# 127225
city: Oxford
country: United Kingdom
facility: Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324
city: Southampton
country: United Kingdom
facility: Southampton General Hospital /ID# 127228
city: Wolverhampton
country: United Kingdom
facility: The Royal Wolverhampton NHS Tr /ID# 127227
Study officials:
affiliation: AbbVie
name: AbbVie Inc.
role: STUDY_DIRECTOR
References:
citation: 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.