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Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

Primary Purpose

Ulcerative Colitis (UC)

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Adalimumab
Placebo
Sponsored by
AbbVie
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Ulcerative Colitis (UC) focused on measuring Ulcerative Colitis

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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).

Sites / Locations

  • Digestive Health Specialists of the Southeast /ID# 127844
  • Ucsd /Id# 122313
  • Rocky Mountain Clinical Resear /ID# 122180
  • Medical Research Ctr CT /ID# 122179
  • Gastro Florida /ID# 170619
  • Research Associates of South Florida,LLC /ID# 170309
  • Gastroenterology Group Naples /ID# 127806
  • Shafran Gastroenterology Ctr /ID# 122320
  • Atlanta Gastro Assoc /ID# 122336
  • Gastro Assoc of Central GA /ID# 122318
  • Northwestern University Feinberg School of Medicine /ID# 122183
  • University of Chicago /ID# 122302
  • Carle Foundation Hospital /ID# 135955
  • Louisiana Research Ctr. LLC /ID# 141655
  • University of Maryland Med Ctr /ID# 169734
  • MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
  • University of Michigan Hospitals /ID# 122240
  • Mayo Clinic - Rochester /ID# 122244
  • Ctr for Digest and Liver Dis /ID# 122182
  • NYU Langone Long Island CRA /ID# 122177
  • Icahn School of Med Mt. Sinai /ID# 127047
  • Charlotte Gastro Hepatology /ID# 122235
  • Wake Research Associates, LLC /ID# 122157
  • Consultants for Clinical Res /ID# 122304
  • Dayton Gastroenterology, Inc. /ID# 127804
  • Gastro United of Tulsa /ID# 125436
  • The Oregon Clinic- Gastro West /ID# 135273
  • University of Pittsburgh MC /ID# 122331
  • Erlanger Institute for Clinica /ID# 129009
  • Gastro One /ID# 122339
  • Vanderbilt Univ Med Ctr /ID# 125496
  • DHAT Research Institute /ID# 170616
  • Biopharma Informatic Research /ID# 171150
  • Austin Center for Clinical Research /ID# 125396
  • Texas Digestive Disease Consul /ID# 141677
  • Texas Digestive Disease Consul /ID# 141678
  • Advanced Research Institute /ID# 126147
  • University of Utah /ID# 122333
  • New River Valley Research Inst /ID# 127801
  • University of Washington /ID# 169721
  • WI Center for Advanced Res /ID# 122178
  • Froedtert & the Medical College of Wisconsin /ID# 122261
  • KH der Elisabethinen Linz GmbH /ID# 127184
  • Medizinische Universitat Wien /ID# 127186
  • Ordination Hainburg an der Don /ID# 127185
  • Universitaetsklinik fuer Innere Medizin 1 /ID# 125944
  • KH der Barmherzigen Brueder /ID# 127183
  • AZ Sint-Lucas /ID# 127187
  • UZ Leuven /ID# 126739
  • CHU de Liege /ID# 126740
  • University of Calgary /ID# 125715
  • Zeidler Ledcor Centre /ID# 125713
  • Winnipeg Regional Health Autho /ID# 125712
  • Qe Ii Hsc /Id# 127045
  • London Health Sciences Centre /ID# 127055
  • Mount Sinai Hosp.-Toronto /ID# 126590
  • Toronto Digestive Disease Asso /ID# 127075
  • McGill Univ HC /ID# 127046
  • Hepato-Gastroenterologie HK s.r.o. /ID# 127188
  • ISCARE a.s. /ID# 127837
  • Herlev Hospital /ID# 127191
  • Regionhospital Silkeborg /ID# 127190
  • CHRU Lille - Hôpital Claude Huriez /ID# 127197
  • CHU NANCY - Hôpital Brabois Adultes /ID# 127196
  • CHU Amiens Picardie /ID# 127194
  • CHU Estaing /ID# 127848
  • CHU Dijon /ID# 127861
  • CHU de Grenoble - Albet Michal /ID# 127195
  • CHU Saint ELOI /ID# 169007
  • CHU de Nice /ID# 127193
  • CHU de Saint-Etienne, Hopital Nord /ID# 134490
  • Hopital Rangueil /ID# 127192
  • Universitatsklinik Regensburg /ID# 201265
  • Universitatsklinikum Frankfurt /ID# 170300
  • Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199
  • Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203
  • Mross, Berlin, DE /ID# 127201
  • Gastrostudien GbR /ID# 169246
  • Asklepios Westklinikum Hamburg /ID# 127198
  • Universitaetsklinikum Jena /ID# 127205
  • EUGASTRO GmbH /ID# 127202
  • Universitatsklinikum Magdeburg /ID# 127200
  • Gastro Campus Research GbR /ID# 126743
  • Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209
  • Magyar Elhizastudomanyi KKft. /ID# 126589
  • Pannonia Maganorvosi Centrum Kft. /ID# 127207
  • Szegedi Tudomanyegyetem /ID# 127208
  • Rabin Medical Center /ID# 127212
  • Tel Aviv Sourasky Medical Center /ID# 201365
  • Soroka University Medical Center /ID# 127213
  • Hadassah University Hospital /ID# 127211
  • Kaplan Medical Center /ID# 127210
  • A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322
  • Azienda Ospedaliera San Camillo Forlanini /ID# 127216
  • Policlinico Agostino Gemelli /ID# 127217
  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138
  • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215
  • Azienda Ospedaliera Spedali Civili /ID# 127236
  • Universita di Padova /ID# 127214
  • Ospedali Riuniti Villa Sofia-C /ID# 129323
  • Policlinico Univ Tor Vergata /ID# 129321
  • IRCCS Casa Sollievo /ID# 127811
  • Nagoya City University Hospital /ID# 124517
  • Yokoyama IBD Clinic /ID# 151560
  • Toho University Sakura Medical Center /ID# 124497
  • Fukuoka University Chikushi Hospital /ID# 124155
  • Kyushu University Hospital /ID# 124495
  • Kurume University Hospital /ID# 125275
  • Hidaka Clinic of Coloproctology /ID# 125477
  • Hiroshima University Hospital /ID# 124496
  • Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480
  • Aoyama Clinic /ID# 127836
  • Hyogo College of Medicine College Hospital /Id# 127539
  • Kitasato University Hospital /ID# 137694
  • COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423
  • Susaki Kuroshio Hospital /ID# 125202
  • Japanese Red Cross Kyoto Daiichi Hos /ID# 127540
  • Osaka Medical College Hospital /ID# 126451
  • Saitama Medical Center /ID# 128875
  • Shiga University of Medical Science Hospital /ID# 127675
  • Hamamatsu South Hospital /ID# 124481
  • Medical Hospital of Tokyo Medical and Dental University /ID# 128315
  • Kitasato Univ Kitasato Inst Ho /ID# 127001
  • Kyorin University Hospital /ID# 148184
  • Wakayama Medical University /ID# 124635
  • Tokyo Yamate Medical Center /ID# 125201
  • Academisch Medisch Centrum /ID# 126741
  • Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141
  • C.M. Szpital Swietej Rodziny /ID# 127838
  • Centrum Zdrowia MDM /ID# 170303
  • Endoterapia PFG Sp. z.o.o. /ID# 126513
  • Centrum Medyczne Pratia Gdynia /ID# 170301
  • NZOZ All-Medicus /ID# 128740
  • H-T.Centrum Medyczne-Endoterapia /ID# 170305
  • Centrum Medyczne LukaMed Joanna Luka /ID# 170302
  • Centrum Medyczne Sw. Lukaza /ID# 126515
  • Centrum Diagnostyczno Lecznicze Barska /ID# 170304
  • KO-Med Centra Kliniczne Pulawy /ID# 127219
  • NZOZ Vivamed /ID# 127218
  • Institutul Clinic Fundeni /ID# 127839
  • CMDTA Neomed SRL /ID# 127142
  • Spitalul Clinic Judetean de Urgenta /ID# 125418
  • Tvm Med Serv Srl /Id# 127221
  • Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002
  • Salvo-San-Ciobanca SRL /ID# 127140
  • Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222
  • Gastroenterologicka Ambulancia /ID# 125632
  • Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322
  • Hospital General Universitario de Alicante /ID# 129261
  • Hospital Clinic de Barcelona /ID# 138147
  • Complejo Hospitalario Universitario de Ferrol /ID# 127840
  • Hospital Univ Dr. Negrin /ID# 127841
  • Hospital Univ de la Princesa /ID# 135828
  • Hospital General Universitario Gregorio Maranon /ID# 127224
  • Hosp Univ 12 de Octubre /ID# 129257
  • Hospital Universitario La Paz /ID# 127223
  • Hosp Clin Univ de Valencia /ID# 170306
  • Hosp Clin Univ Lozano Blesa /ID# 129255
  • Kantonsspital St. Gallen /ID# 127843
  • University Hospital Zurich /ID# 127842
  • GI National Institute of Therapy named by L.T. Malaya /ID# 127231
  • Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233
  • Municipal Clinical Hospital #8 /ID# 127235
  • Lviv City Clinical Hospital NO.4 /ID# 127232
  • CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137
  • Royal Hampshire County Hosp /ID# 169250
  • Norfolk and Norwich Univ Hosp /ID# 127139
  • Western General Hospital /ID# 204801
  • St. Mark's Hospital /ID# 127226
  • Hull and East Yorkshire Hospitals NHS Trust /ID# 127225
  • Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324
  • Southampton General Hospital /ID# 127228
  • The Royal Wolverhampton NHS Tr /ID# 127227

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Induction (Main Study + Japan Sub-study): I-SD

Induction (Main Study + Japan Sub-study): I-HD

Maintenance (Main Study + Japan Sub-study): M-SD

Maintenance (Main Study + Japan Sub-study): M-HD

Maintenance (Main Study): TDM Regimen

Arm Description

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.

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.

Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.

Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement 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. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at 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
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per 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 response is defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission 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. Endoscopic remission is defined as an endoscopy subscore of 0.
Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6.
Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.
Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement 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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
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
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 FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
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
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 FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission is defined as FMS ≤ 2 with no subscore > 1.
Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopy subscore provided by the central reader.
Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement 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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader.
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
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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
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
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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
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
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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders 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 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters 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 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 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 Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain 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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline.
Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item 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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 [severe problem] to 7 [normal health]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline.

Full Information

First Posted
February 17, 2014
Last Updated
November 19, 2020
Sponsor
AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT02065622
Brief Title
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

2. Study Status

Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 27, 2014 (Actual)
Primary Completion Date
September 5, 2019 (Actual)
Study Completion Date
November 11, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ulcerative Colitis (UC)
Keywords
Ulcerative Colitis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
952 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Induction (Main Study + Japan Sub-study): I-SD
Arm Type
Experimental
Arm Description
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.
Arm Title
Induction (Main Study + Japan Sub-study): I-HD
Arm Type
Experimental
Arm Description
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.
Arm Title
Maintenance (Main Study + Japan Sub-study): M-SD
Arm Type
Experimental
Arm Description
Maintenance Standard Dose: Double-blind adalimumab 40 mg every other week (eow), for 44 weeks.
Arm Title
Maintenance (Main Study + Japan Sub-study): M-HD
Arm Type
Experimental
Arm Description
Maintenance Higher Dose: Double-blind adalimumab 40 mg every week (ew) for 44 weeks.
Arm Title
Maintenance (Main Study): TDM Regimen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Adalimumab
Other Intervention Name(s)
Humira
Intervention Type
Other
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Induction Period Primary Endpoint: Percentage of Participants With Clinical Remission Per Full Mayo Score (FMS) at Week 8
Description
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.
Time Frame
Week 8
Title
Maintenance Period Primary Endpoint: Percentage of Week 8 Responders (Per FMS) With Clinical Remission (Per FMS) at Week 52
Description
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.
Time Frame
Week 52
Secondary Outcome Measure Information:
Title
Induction Period Ranked Secondary Endpoint 1: Percentage of Participants With Endoscopic Improvement at Week 8
Description
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. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Time Frame
Week 8
Title
Induction Period Ranked Secondary Endpoint 2: Percentage of Participants With Fecal Calprotectin < 150 mg/kg at Week 8
Time Frame
Week 8
Title
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
Description
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of the responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Time Frame
Week 8
Title
Induction Period Ranked Secondary Endpoint 4: Percentage of Participants With Clinical Response Per FMS at Week 8
Description
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 response is defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Time Frame
Week 8
Title
Induction Period Ranked Secondary Endpoint 5: Percentage of Participants With Endoscopic Remission at Week 8
Description
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. Endoscopic remission is defined as an endoscopy subscore of 0.
Time Frame
Week 8
Title
Induction Period Ranked Secondary Endpoint 6: Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 8
Description
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The range for Bowel Symptom domain score is 10 (severe problem) to 70 (normal health). Response in IBDQ Bowel Symptom domain is defined as an increase of IBDQ Bowel Symptom domain score ≥ 6.
Time Frame
Week 8
Title
Induction Period Ranked Secondary Endpoint 7: Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 8
Description
The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). The IBDQ Fatigue item score range is from 1 (severe problem) to 7 (normal health). Response is defined as an increase of IBDQ Fatigue item score ≥ 1.
Time Frame
Week 8
Title
Maintenance Period Ranked Secondary Endpoint 1: Percentage of Week 8 Responders (Per FMS) With Endoscopic Improvement at Week 52
Description
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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1.
Time Frame
Week 52
Title
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
Description
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 FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1.
Time Frame
Week 52
Title
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
Description
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 FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Clinical remission is defined as FMS ≤ 2 with no subscore > 1.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 4: Percentage of Week 8 Remitters (Per FMS) With Clinical Remission (Per FMS) at Week 52
Description
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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopy subscore provided by the central reader.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 5: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Improvement at Week 52
Description
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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic improvement is defined as an endoscopy subscore of 0 or 1. Endoscopy subscore provided by the central reader.
Time Frame
Week 52
Title
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
Description
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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame
Week 52
Title
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
Description
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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame
Week 52
Title
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
Description
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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Total IBDQ score is the sum of responses to the individual IBDQ questions, and ranges from 32 to 224 with higher scores indicating a better quality of life.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 9: Percentage of Week 8 Non-Responders With Clinical Remission (Per FMS) at Week 52
Description
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 non-responders are defined as participants not meeting the criteria of response (defined as a decrease in FMS of ≥ 3 points and ≥ 30% from baseline, plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 10: Percentage of Week 8 Non-Remitters With Clinical Remission (Per FMS) at Week 52
Description
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 non-remitters are defined as participants not meeting the criteria of clinical remission at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 11: Percentage of Week 8 Responders (Per FMS) With Endoscopic Subscore of 0 at Week 52
Description
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 Full Mayo score) are defined as participants with a decrease in Full Mayo score of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 12: Percentage of Week 8 Remitters (Per FMS) With Endoscopic Subscore of 0 at Week 52
Description
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 remitters are defined as participants with clinical remission (per FMS) at Week 8. Clinical remission is defined as a FMS ≤ 2 with no subscore > 1. Endoscopic remission is defined as an endoscopy subscore of 0.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 13: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Bowel Symptom Domain at Week 52
Description
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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore [RBS] ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Bowel Symptom domain score range is 10 (severe problem) to 70 (normal health). Response is defined as increase of Bowel Symptom domain score ≥ 6 from baseline.
Time Frame
Week 52
Title
Maintenance Period Ranked Secondary Endpoint 14: Percentage of Week 8 Responders (Per FMS) With Response in IBDQ Fatigue Item at Week 52
Description
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 are defined as participants with a decrease in FMS of ≥ 3 points and ≥ 30% from Baseline plus a decrease in the rectal bleeding subscore (RBS) ≥ 1 or an absolute RBS ≤ 1. The IBDQ is a self-administered 32-item questionnaire to evaluate quality of life across 4 dimensional scores: bowel, systemic, social and emotional. Responses to each question range from 1 (severe problem) to 7 (normal health). Response in IBDQ fatigue item (range 1 [severe problem] to 7 [normal health]) is defined as increase of IBDQ fatigue item ≥ 1 from baseline.
Time Frame
Week 52

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
AbbVie Inc.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Digestive Health Specialists of the Southeast /ID# 127844
City
Dothan
State/Province
Alabama
ZIP/Postal Code
36305
Country
United States
Facility Name
Ucsd /Id# 122313
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
Rocky Mountain Clinical Resear /ID# 122180
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Medical Research Ctr CT /ID# 122179
City
Hamden
State/Province
Connecticut
ZIP/Postal Code
06518
Country
United States
Facility Name
Gastro Florida /ID# 170619
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
Research Associates of South Florida,LLC /ID# 170309
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Gastroenterology Group Naples /ID# 127806
City
Naples
State/Province
Florida
ZIP/Postal Code
34102
Country
United States
Facility Name
Shafran Gastroenterology Ctr /ID# 122320
City
Winter Park
State/Province
Florida
ZIP/Postal Code
32789
Country
United States
Facility Name
Atlanta Gastro Assoc /ID# 122336
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Gastro Assoc of Central GA /ID# 122318
City
Macon
State/Province
Georgia
ZIP/Postal Code
31201
Country
United States
Facility Name
Northwestern University Feinberg School of Medicine /ID# 122183
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611-2927
Country
United States
Facility Name
University of Chicago /ID# 122302
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637-1443
Country
United States
Facility Name
Carle Foundation Hospital /ID# 135955
City
Urbana
State/Province
Illinois
ZIP/Postal Code
61801
Country
United States
Facility Name
Louisiana Research Ctr. LLC /ID# 141655
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105-6800
Country
United States
Facility Name
University of Maryland Med Ctr /ID# 169734
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
MGG Group, Inc.Chevy Chase Clinical Research /ID# 122238
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
University of Michigan Hospitals /ID# 122240
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Facility Name
Mayo Clinic - Rochester /ID# 122244
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905-0001
Country
United States
Facility Name
Ctr for Digest and Liver Dis /ID# 122182
City
Mexico
State/Province
Missouri
ZIP/Postal Code
65265
Country
United States
Facility Name
NYU Langone Long Island CRA /ID# 122177
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Icahn School of Med Mt. Sinai /ID# 127047
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Charlotte Gastro Hepatology /ID# 122235
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Name
Wake Research Associates, LLC /ID# 122157
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Consultants for Clinical Res /ID# 122304
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Dayton Gastroenterology, Inc. /ID# 127804
City
Englewood
State/Province
Ohio
ZIP/Postal Code
45415
Country
United States
Facility Name
Gastro United of Tulsa /ID# 125436
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
The Oregon Clinic- Gastro West /ID# 135273
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
University of Pittsburgh MC /ID# 122331
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15260
Country
United States
Facility Name
Erlanger Institute for Clinica /ID# 129009
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37403
Country
United States
Facility Name
Gastro One /ID# 122339
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
Country
United States
Facility Name
Vanderbilt Univ Med Ctr /ID# 125496
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-0011
Country
United States
Facility Name
DHAT Research Institute /ID# 170616
City
Garland
State/Province
Texas
ZIP/Postal Code
75044-2208
Country
United States
Facility Name
Biopharma Informatic Research /ID# 171150
City
Houston
State/Province
Texas
ZIP/Postal Code
77024-2420
Country
United States
Facility Name
Austin Center for Clinical Research /ID# 125396
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Name
Texas Digestive Disease Consul /ID# 141677
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Texas Digestive Disease Consul /ID# 141678
City
Southlake
State/Province
Texas
ZIP/Postal Code
76092
Country
United States
Facility Name
Advanced Research Institute /ID# 126147
City
Ogden
State/Province
Utah
ZIP/Postal Code
84403
Country
United States
Facility Name
University of Utah /ID# 122333
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84112-5500
Country
United States
Facility Name
New River Valley Research Inst /ID# 127801
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
University of Washington /ID# 169721
City
Seattle
State/Province
Washington
ZIP/Postal Code
98109
Country
United States
Facility Name
WI Center for Advanced Res /ID# 122178
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States
Facility Name
Froedtert & the Medical College of Wisconsin /ID# 122261
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226-3522
Country
United States
Facility Name
KH der Elisabethinen Linz GmbH /ID# 127184
City
Linz
State/Province
Oberoesterreich
ZIP/Postal Code
4010
Country
Austria
Facility Name
Medizinische Universitat Wien /ID# 127186
City
Vienna
State/Province
Wien
ZIP/Postal Code
1090
Country
Austria
Facility Name
Ordination Hainburg an der Don /ID# 127185
City
Hainburg An Der Donau
ZIP/Postal Code
2410
Country
Austria
Facility Name
Universitaetsklinik fuer Innere Medizin 1 /ID# 125944
City
Salzburg
ZIP/Postal Code
5020
Country
Austria
Facility Name
KH der Barmherzigen Brueder /ID# 127183
City
St Veit An Der Glan
ZIP/Postal Code
9300
Country
Austria
Facility Name
AZ Sint-Lucas /ID# 127187
City
Ghent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
UZ Leuven /ID# 126739
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
CHU de Liege /ID# 126740
City
Liege
ZIP/Postal Code
4000
Country
Belgium
Facility Name
University of Calgary /ID# 125715
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4Z6
Country
Canada
Facility Name
Zeidler Ledcor Centre /ID# 125713
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 2X8
Country
Canada
Facility Name
Winnipeg Regional Health Autho /ID# 125712
City
Winnipeg
State/Province
Manitoba
ZIP/Postal Code
R3A 1R9
Country
Canada
Facility Name
Qe Ii Hsc /Id# 127045
City
Halifax
State/Province
Nova Scotia
ZIP/Postal Code
B3H 1V7
Country
Canada
Facility Name
London Health Sciences Centre /ID# 127055
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 5A5
Country
Canada
Facility Name
Mount Sinai Hosp.-Toronto /ID# 126590
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X5
Country
Canada
Facility Name
Toronto Digestive Disease Asso /ID# 127075
City
Vaughan
State/Province
Ontario
ZIP/Postal Code
L4L 4Y7
Country
Canada
Facility Name
McGill Univ HC /ID# 127046
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada
Facility Name
Hepato-Gastroenterologie HK s.r.o. /ID# 127188
City
Hradec Kralove
ZIP/Postal Code
500 12
Country
Czechia
Facility Name
ISCARE a.s. /ID# 127837
City
Praha 9
ZIP/Postal Code
190 00
Country
Czechia
Facility Name
Herlev Hospital /ID# 127191
City
Herlev
State/Province
Hovedstaden
ZIP/Postal Code
2730
Country
Denmark
Facility Name
Regionhospital Silkeborg /ID# 127190
City
Silkeborg
ZIP/Postal Code
8600
Country
Denmark
Facility Name
CHRU Lille - Hôpital Claude Huriez /ID# 127197
City
Lille CEDEX
State/Province
Hauts-de-France
ZIP/Postal Code
59045
Country
France
Facility Name
CHU NANCY - Hôpital Brabois Adultes /ID# 127196
City
Vandoeuvre les Nancy CEDEX
State/Province
Meurthe-et-Moselle
ZIP/Postal Code
54511
Country
France
Facility Name
CHU Amiens Picardie /ID# 127194
City
Amiens CEDEX 1
State/Province
Somme
ZIP/Postal Code
80054
Country
France
Facility Name
CHU Estaing /ID# 127848
City
Clermont Ferrand
ZIP/Postal Code
63100
Country
France
Facility Name
CHU Dijon /ID# 127861
City
Dijon
ZIP/Postal Code
21000
Country
France
Facility Name
CHU de Grenoble - Albet Michal /ID# 127195
City
Grenoble
ZIP/Postal Code
38043
Country
France
Facility Name
CHU Saint ELOI /ID# 169007
City
Montpellier Cedex 5
ZIP/Postal Code
34295
Country
France
Facility Name
CHU de Nice /ID# 127193
City
Nice
ZIP/Postal Code
06202
Country
France
Facility Name
CHU de Saint-Etienne, Hopital Nord /ID# 134490
City
SAINT-ETIENNE Cedex 1
ZIP/Postal Code
42270
Country
France
Facility Name
Hopital Rangueil /ID# 127192
City
Toulouse
ZIP/Postal Code
31059
Country
France
Facility Name
Universitatsklinik Regensburg /ID# 201265
City
Ratisbon
State/Province
Bayern
ZIP/Postal Code
93053
Country
Germany
Facility Name
Universitatsklinikum Frankfurt /ID# 170300
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Univ Hosp Schleswig-Holstein, Campus Kiel, Klinik furer Innere Medizin /ID# 127199
City
Kiel
State/Province
Schleswig-Holstein
ZIP/Postal Code
24105
Country
Germany
Facility Name
Charite Universitatsmedizin Berlin Campus Virchow Klinikum /ID# 127203
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Mross, Berlin, DE /ID# 127201
City
Berlin
ZIP/Postal Code
10318
Country
Germany
Facility Name
Gastrostudien GbR /ID# 169246
City
Berlin
ZIP/Postal Code
D-10825
Country
Germany
Facility Name
Asklepios Westklinikum Hamburg /ID# 127198
City
Hamburg
ZIP/Postal Code
22559
Country
Germany
Facility Name
Universitaetsklinikum Jena /ID# 127205
City
Jena
ZIP/Postal Code
07747
Country
Germany
Facility Name
EUGASTRO GmbH /ID# 127202
City
Leipzig
ZIP/Postal Code
04103
Country
Germany
Facility Name
Universitatsklinikum Magdeburg /ID# 127200
City
Magdeburg
ZIP/Postal Code
39120
Country
Germany
Facility Name
Gastro Campus Research GbR /ID# 126743
City
Munster
ZIP/Postal Code
48159
Country
Germany
Facility Name
Pecsi Tudomanyegyetem Klinikai Kozpont I. sz. Belgyogyaszati Klinika /ID# 127209
City
Pécs
State/Province
Pecs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
Magyar Elhizastudomanyi KKft. /ID# 126589
City
Budapest
ZIP/Postal Code
1124
Country
Hungary
Facility Name
Pannonia Maganorvosi Centrum Kft. /ID# 127207
City
Budapest
ZIP/Postal Code
1136
Country
Hungary
Facility Name
Szegedi Tudomanyegyetem /ID# 127208
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
Rabin Medical Center /ID# 127212
City
Petakh Tikva
State/Province
Tel-Aviv
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center /ID# 201365
City
Tel Aviv-Yafo
State/Province
Tel-Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
Soroka University Medical Center /ID# 127213
City
Be'er Sheva
ZIP/Postal Code
84101
Country
Israel
Facility Name
Hadassah University Hospital /ID# 127211
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Kaplan Medical Center /ID# 127210
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
A.O.U. Policlinico S.Orsola-Malpighi /ID# 129322
City
Bologna
State/Province
Emilia-Romagna
ZIP/Postal Code
40138
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo Forlanini /ID# 127216
City
Rome
State/Province
Lazio
ZIP/Postal Code
00152
Country
Italy
Facility Name
Policlinico Agostino Gemelli /ID# 127217
City
Rome
State/Province
Lazio
ZIP/Postal Code
00168
Country
Italy
Facility Name
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 127138
City
Milan
State/Province
Lombardia
ZIP/Postal Code
20122
Country
Italy
Facility Name
IBD Center - IRCCS Istituto Clinico Humanitas /ID# 127215
City
Rozzano
State/Province
Milano
ZIP/Postal Code
20089
Country
Italy
Facility Name
Azienda Ospedaliera Spedali Civili /ID# 127236
City
Brescia
ZIP/Postal Code
25123
Country
Italy
Facility Name
Universita di Padova /ID# 127214
City
Padova
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedali Riuniti Villa Sofia-C /ID# 129323
City
Palermo
ZIP/Postal Code
90146
Country
Italy
Facility Name
Policlinico Univ Tor Vergata /ID# 129321
City
Rome
ZIP/Postal Code
00133
Country
Italy
Facility Name
IRCCS Casa Sollievo /ID# 127811
City
San Giovanni Rotondo
ZIP/Postal Code
71013
Country
Italy
Facility Name
Nagoya City University Hospital /ID# 124517
City
Nagoya-shi
State/Province
Aichi
ZIP/Postal Code
467-8602
Country
Japan
Facility Name
Yokoyama IBD Clinic /ID# 151560
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
460-0022
Country
Japan
Facility Name
Toho University Sakura Medical Center /ID# 124497
City
Sakura-shi
State/Province
Chiba
ZIP/Postal Code
285-8741
Country
Japan
Facility Name
Fukuoka University Chikushi Hospital /ID# 124155
City
Chikushino
State/Province
Fukuoka
ZIP/Postal Code
818-8502
Country
Japan
Facility Name
Kyushu University Hospital /ID# 124495
City
Fukuoka-shi
State/Province
Fukuoka
ZIP/Postal Code
812-8582
Country
Japan
Facility Name
Kurume University Hospital /ID# 125275
City
Kurume-shi
State/Province
Fukuoka
ZIP/Postal Code
830-0011
Country
Japan
Facility Name
Hidaka Clinic of Coloproctology /ID# 125477
City
Kurume
State/Province
Fukuoka
ZIP/Postal Code
839-0809
Country
Japan
Facility Name
Hiroshima University Hospital /ID# 124496
City
Hiroshima-shi
State/Province
Hiroshima
ZIP/Postal Code
734-8551
Country
Japan
Facility Name
Hokkaido P.W.F.A.C. Sapporo-Kosei General Hospital /ID# 124480
City
Sapporo-shi
State/Province
Hokkaido
ZIP/Postal Code
060-0033
Country
Japan
Facility Name
Aoyama Clinic /ID# 127836
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0015
Country
Japan
Facility Name
Hyogo College of Medicine College Hospital /Id# 127539
City
Nishinomiya-shi
State/Province
Hyogo
ZIP/Postal Code
663-8501
Country
Japan
Facility Name
Kitasato University Hospital /ID# 137694
City
Sagamihara-shi
State/Province
Kanagawa
ZIP/Postal Code
252-0375
Country
Japan
Facility Name
COLO-PROCTOLOGY CENTER Matsushima Clinic /ID# 148423
City
Yokohama
State/Province
Kanagawa
ZIP/Postal Code
220-0045
Country
Japan
Facility Name
Susaki Kuroshio Hospital /ID# 125202
City
Susaki-shi
State/Province
Kochi
ZIP/Postal Code
785-8501
Country
Japan
Facility Name
Japanese Red Cross Kyoto Daiichi Hos /ID# 127540
City
Kyoto-shi
State/Province
Kyoto
ZIP/Postal Code
605-0981
Country
Japan
Facility Name
Osaka Medical College Hospital /ID# 126451
City
Takatsuki-shi
State/Province
Osaka
ZIP/Postal Code
569-8686
Country
Japan
Facility Name
Saitama Medical Center /ID# 128875
City
Kawagoe-shi
State/Province
Saitama
ZIP/Postal Code
350-8550
Country
Japan
Facility Name
Shiga University of Medical Science Hospital /ID# 127675
City
Otsu-shi
State/Province
Shiga
ZIP/Postal Code
520-2192
Country
Japan
Facility Name
Hamamatsu South Hospital /ID# 124481
City
Hamamatsu-shi
State/Province
Shizuoka
ZIP/Postal Code
430-0846
Country
Japan
Facility Name
Medical Hospital of Tokyo Medical and Dental University /ID# 128315
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Facility Name
Kitasato Univ Kitasato Inst Ho /ID# 127001
City
Minato-ku
State/Province
Tokyo
ZIP/Postal Code
108-8642
Country
Japan
Facility Name
Kyorin University Hospital /ID# 148184
City
Mitaka-shi
State/Province
Tokyo
ZIP/Postal Code
181-8611
Country
Japan
Facility Name
Wakayama Medical University /ID# 124635
City
Wakayama-shi
State/Province
Wakayama
ZIP/Postal Code
641-8510
Country
Japan
Facility Name
Tokyo Yamate Medical Center /ID# 125201
City
Tokyo
ZIP/Postal Code
169-0073
Country
Japan
Facility Name
Academisch Medisch Centrum /ID# 126741
City
Amsterdam
State/Province
Noord-Holland
ZIP/Postal Code
1105 AZ
Country
Netherlands
Facility Name
Szpital Uniwersytecki Nr 2 im. dr J.Biziela w Bydgoszczy /ID# 127141
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-168
Country
Poland
Facility Name
C.M. Szpital Swietej Rodziny /ID# 127838
City
Lodz
State/Province
Lodzkie
ZIP/Postal Code
90-302
Country
Poland
Facility Name
Centrum Zdrowia MDM /ID# 170303
City
Warsaw
State/Province
Mazowieckie
ZIP/Postal Code
00-635
Country
Poland
Facility Name
Endoterapia PFG Sp. z.o.o. /ID# 126513
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
02-653
Country
Poland
Facility Name
Centrum Medyczne Pratia Gdynia /ID# 170301
City
Gdynia
State/Province
Pomorskie
ZIP/Postal Code
81-338
Country
Poland
Facility Name
NZOZ All-Medicus /ID# 128740
City
Katowice
State/Province
Slaskie
ZIP/Postal Code
40-659
Country
Poland
Facility Name
H-T.Centrum Medyczne-Endoterapia /ID# 170305
City
Tychy
State/Province
Slaskie
ZIP/Postal Code
43-100
Country
Poland
Facility Name
Centrum Medyczne LukaMed Joanna Luka /ID# 170302
City
Chojnice
ZIP/Postal Code
89-600
Country
Poland
Facility Name
Centrum Medyczne Sw. Lukaza /ID# 126515
City
Czestochowa
ZIP/Postal Code
42-200
Country
Poland
Facility Name
Centrum Diagnostyczno Lecznicze Barska /ID# 170304
City
Lodz
ZIP/Postal Code
91-347
Country
Poland
Facility Name
KO-Med Centra Kliniczne Pulawy /ID# 127219
City
Pulawy
ZIP/Postal Code
24-100
Country
Poland
Facility Name
NZOZ Vivamed /ID# 127218
City
Warsaw
ZIP/Postal Code
03-580
Country
Poland
Facility Name
Institutul Clinic Fundeni /ID# 127839
City
Sector 2
State/Province
Bucuresti
ZIP/Postal Code
022328
Country
Romania
Facility Name
CMDTA Neomed SRL /ID# 127142
City
Brasov
ZIP/Postal Code
500283
Country
Romania
Facility Name
Spitalul Clinic Judetean de Urgenta /ID# 125418
City
Cluj
ZIP/Postal Code
400006
Country
Romania
Facility Name
Tvm Med Serv Srl /Id# 127221
City
Cluj
ZIP/Postal Code
400132
Country
Romania
Facility Name
Cabinet Medical Dr. Fratila SRL, Specialitatea Medicina Interna /ID# 127002
City
Oradea
ZIP/Postal Code
410167
Country
Romania
Facility Name
Salvo-San-Ciobanca SRL /ID# 127140
City
Zalau
ZIP/Postal Code
450117
Country
Romania
Facility Name
Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 127222
City
Bratislava
ZIP/Postal Code
831 04
Country
Slovakia
Facility Name
Gastroenterologicka Ambulancia /ID# 125632
City
Bratislava
ZIP/Postal Code
851 01
Country
Slovakia
Facility Name
Vseobecna Nemocnica s poliklinikou Lucenec /ID# 127322
City
Lucenec
ZIP/Postal Code
984 01
Country
Slovakia
Facility Name
Hospital General Universitario de Alicante /ID# 129261
City
Alicante
ZIP/Postal Code
03550
Country
Spain
Facility Name
Hospital Clinic de Barcelona /ID# 138147
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Complejo Hospitalario Universitario de Ferrol /ID# 127840
City
Ferrol
ZIP/Postal Code
15405
Country
Spain
Facility Name
Hospital Univ Dr. Negrin /ID# 127841
City
Las Palmas de Gran Canaria
ZIP/Postal Code
35010
Country
Spain
Facility Name
Hospital Univ de la Princesa /ID# 135828
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital General Universitario Gregorio Maranon /ID# 127224
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hosp Univ 12 de Octubre /ID# 129257
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
Hospital Universitario La Paz /ID# 127223
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Facility Name
Hosp Clin Univ de Valencia /ID# 170306
City
València
ZIP/Postal Code
46010
Country
Spain
Facility Name
Hosp Clin Univ Lozano Blesa /ID# 129255
City
Zaragoza
ZIP/Postal Code
50009
Country
Spain
Facility Name
Kantonsspital St. Gallen /ID# 127843
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
University Hospital Zurich /ID# 127842
City
Zurich
State/Province
Zuerich
ZIP/Postal Code
8006
Country
Switzerland
Facility Name
GI National Institute of Therapy named by L.T. Malaya /ID# 127231
City
Kharkiv
State/Province
Kharkivska Oblast
ZIP/Postal Code
61039
Country
Ukraine
Facility Name
Public Institution Kherson City Clinical Hospital named after le.le. Karabelesh /ID# 127233
City
Kherson
ZIP/Postal Code
73000
Country
Ukraine
Facility Name
Municipal Clinical Hospital #8 /ID# 127235
City
Kiev
ZIP/Postal Code
04201
Country
Ukraine
Facility Name
Lviv City Clinical Hospital NO.4 /ID# 127232
City
Lviv
ZIP/Postal Code
79011
Country
Ukraine
Facility Name
CNPE City Hospital No.6 of Zaporizhzhia City Counsil /ID# 127137
City
Zaporizhzhia
ZIP/Postal Code
69035
Country
Ukraine
Facility Name
Royal Hampshire County Hosp /ID# 169250
City
Winchester
State/Province
Hampshire
ZIP/Postal Code
SO22 5DG
Country
United Kingdom
Facility Name
Norfolk and Norwich Univ Hosp /ID# 127139
City
Norwich
State/Province
Norfolk
ZIP/Postal Code
NR4 7UY
Country
United Kingdom
Facility Name
Western General Hospital /ID# 204801
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
St. Mark's Hospital /ID# 127226
City
Harrow
ZIP/Postal Code
HA1 3UJ
Country
United Kingdom
Facility Name
Hull and East Yorkshire Hospitals NHS Trust /ID# 127225
City
Hull
ZIP/Postal Code
HU8 9HE
Country
United Kingdom
Facility Name
Oxford University Hospitals NHS Foundation Trust The John Radcliffe Hospital /ID# 129324
City
Oxford
ZIP/Postal Code
OX3 9DU
Country
United Kingdom
Facility Name
Southampton General Hospital /ID# 127228
City
Southampton
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
The Royal Wolverhampton NHS Tr /ID# 127227
City
Wolverhampton
ZIP/Postal Code
WV10 0QP
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
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.
IPD Sharing Time Frame
Data requests can be submitted at any time and the data will be accessible for 12 months, with possible extensions considered.
IPD Sharing 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.
IPD Sharing URL
https://www.abbvie.com/our-science/clinical-trials/clinical-trials-data-and-information-sharing/data-and-information-sharing-with-qualified-researchers.html
Citations:
PubMed Identifier
34402466
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.
Results Reference
derived
Links:
URL
http://rxabbvie.com/
Description
Related Info

Learn more about this trial

Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis

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