Study to Evaluate Efficacy and Safety of Two Drug Regimens in Subjects With Moderate to Severe Crohn's Disease

February 11, 2021 updated by: AbbVie

A Multicenter, Randomized, Double-Blind Study to Evaluate Higher Versus Standard Adalimumab Dosing Regimens for Induction and Maintenance Therapy in Subjects With Moderately to Severely Active Crohn's Disease and Evidence of Mucosal Ulceration

This study will evaluate higher versus standard adalimumab dosing regimens for induction and maintenance therapy in subjects with moderately to severely active Crohn's Disease and evidence of mucosal ulceration.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

514

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Austria
      • Innsbruck, Austria, 6020
        • Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249
      • Salzburg, Austria, 5020
        • LKH Salzburg and Paracelsus /ID# 126248
      • St Veit An Der Glan, Austria, 9300
        • Krankenhaus der Barmherzigen Bruder /ID# 126270
    • Oberoesterreich
      • Linz, Oberoesterreich, Austria, 4010
        • KH der Elisabethinen Linz GmbH /ID# 126280
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universitat Wien /ID# 126279
  • Belgium
      • Ghent, Belgium, 9000
        • AZ Maria Middelares /ID# 126194
      • Ghent, Belgium, 9000
        • AZ Sint-Lucas /ID# 126242
      • Leuven, Belgium, 3000
        • UZ Leuven /ID# 126240
      • Liege, Belgium, 4000
        • CHU de Liege /ID# 126241
      • Roeselare, Belgium, 8800
        • AZ-Delta /ID# 126195
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 4Z6
        • University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017
      • Edmonton, Alberta, Canada, T6G 2X8
        • University of Alberta /ID# 119022
    • Manitoba
      • Winnipeg, Manitoba, Canada, R3A 1R9
        • Winnipeg Regional Health Authority /ID# 119015
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3H 1V7
        • Qe Ii Hsc /Id# 127115
    • Ontario
      • London, Ontario, Canada, N6A 5A5
        • London Health Sciences Centre - University Hospital /ID# 119026
      • Sudbury, Ontario, Canada, P3E 5M4
        • Medicor Research Inc /ID# 119024
      • Vaughan, Ontario, Canada, L4L 4Y7
        • Toronto Digestive Disease Asso /ID# 119019
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital - McGill University Health Center /ID# 119025
  • Czechia
      • Ceske Budejovice, Czechia, 370 01
        • Nemocnice Ceske Budejovice a.s. /ID# 126266
      • Hradec Kralove, Czechia, 500 12
        • Hepato-Gastroenterologie HK s.r.o. /ID# 126269
      • Praha 9, Czechia, 190 00
        • ISCARE a.s. /ID# 137977
      • Usti Nad Labem, Czechia, 401 13
        • Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331
    • Olomoucky Kraj
      • Olomouc, Olomoucky Kraj, Czechia, 779 00
        • Fakultni Nemocnice Olomouc /ID# 126264
  • Denmark
      • Silkeborg, Denmark, 8600
        • Silkeborg Hospital /ID# 126251
    • Hovedstaden
      • Herlev, Hovedstaden, Denmark, 2730
        • Herlev Hospital /ID# 127741
  • France
      • Grenoble, France, 38043
        • Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200
      • Nice, France, 06202
        • Hopital l'Archet 2 /ID# 126238
      • SAINT-ETIENNE Cedex 1, France, 42270
        • CHU de Saint-Etienne, Hopital Nord /ID# 134450
      • Toulouse, France, 31059
        • Hopital Rangueil /ID# 126239
    • Hauts-de-France
      • Lille CEDEX, Hauts-de-France, France, 59045
        • CHRU Lille - Hopital Claude Huriez /ID# 127743
    • Meurthe-et-Moselle
      • Vandoeuvre les Nancy CEDEX, Meurthe-et-Moselle, France, 54511
        • CHU NANCY - Hopital Brabois Adultes /ID# 127742
    • Somme
      • Amiens CEDEX 1, Somme, France, 80054
        • CHU Amiens-Picardie Site Sud /ID# 126237
  • Germany
      • Berlin, Germany, 10117
        • Charite Universitaetsmedizin Berlin /ID# 126196
      • Berlin, Germany, 10318
        • Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257
      • Hamburg, Germany, 22297
        • Israelitisches Krankenhaus Hamburg /ID# 136549
      • Hamburg, Germany, 22559
        • Asklepios Westklinikum Hamburg /ID# 126275
      • Jena, Germany, 07747
        • Universitaetsklinikum Jena /ID# 126261
      • Leipzig, Germany, 04103
        • EUGASTRO GmbH /ID# 126259
      • Magdeburg, Germany, 39120
        • Universitatsklinikum Magdeburg /ID# 126256
      • Munster, Germany, 48159
        • Gastro Campus Research GbR /ID# 126274
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein /ID# 126260
  • Hungary
      • Budapest, Hungary, 1085
        • Semmelweis Egyetem /ID# 137896
      • Budapest, Hungary, 1124
        • Magyar Elhizastudomanyi KKft. /ID# 126276
      • Pecs, Hungary, 7624
        • Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895
      • Szeged, Hungary, 6720
        • University of Szeged /ID# 126263
  • Israel
      • Be'er Sheva, Israel, 84101
        • Soroka University Medical Center /ID# 126243
      • Jerusalem, Israel, 91120
        • Gastroenterology Institute, Division of Medicine /ID# 126245
      • Rehovot, Israel, 76100
        • Kaplan Medical Center /ID# 126246
    • Tel-Aviv
      • Petakh Tikva, Tel-Aviv, Israel, 4941492
        • Rabin Medical Center /ID# 126198
  • Italy
      • Brescia, Italy, 25123
        • Azienda Ospedaliera Spedali Civili /ID# 127744
      • Padua, Italy, 35128
        • Azienda Ospedaliera di Padova /ID# 126267
      • San Giovanni Rotondo, Italy, 71013
        • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856
    • Lazio
      • Rome, Lazio, Italy, 00152
        • UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745
      • Rome, Lazio, Italy, 00168
        • Policlinico Agostino Gemelli /ID# 127746
    • Lombardia
      • Milan, Lombardia, Italy, 20122
        • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221
    • Milano
      • Rozzano, Milano, Italy, 20089
        • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226
  • Netherlands
      • Rotterdam, Netherlands, 3015 CE
        • Erasmus Medisch Centrum /ID# 126228
      • Rotterdam, Netherlands, 3045 PM
        • Sint Franciscus Gasthuis /ID# 127877
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1105 AZ
        • Academisch Medical center Amsterdam /ID# 126227
  • Poland
      • Bydgoszcz, Poland, 85-168
        • Centrum Endoskopii Zabiegowej /ID# 126272
      • Czestochowa, Poland, 42-200
        • Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271
      • Pulawy, Poland, 24-100
        • KO-Med Centra Kliniczne Pulawi /ID# 126278
      • Warsaw, Poland, 03-580
        • NZOZ Vivamed /ID# 126255
    • Lodzkie
      • Lodz, Lodzkie, Poland, 90-302
        • Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-653
        • Endoterapia PFG sp. z o.o. /ID# 126199
  • Puerto Rico
      • San Juan, Puerto Rico, 00935
        • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735
  • Romania
      • Brasov, Romania, 500283
        • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277
      • Cluj, Romania, 400132
        • Tvm Med Serv Srl /Id# 126268
      • Oradea, Romania, 410167
        • Cabinet Medical Dr. Fratila SRL /ID# 126247
      • Zalau, Romania, 450117
        • Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224
    • Bucuresti
      • Sector 2, Bucuresti, Romania, 022328
        • Institutul Clinic Fundeni /ID# 127747
  • Slovakia
      • Bratislava, Slovakia, 831 04
        • Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262
      • Bratislava, Slovakia, 851 01
        • Gastroenterologicka ambulancia /ID# 137964
      • Lucenec, Slovakia, 984 01
        • Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748
      • Nove Mesto Nad Vahom, Slovakia, 915 01
        • Poliklinika Libris /ID# 126222
  • Spain
      • Barcelona, Spain, 08036
        • Hospital Clinic /ID# 127749
      • Girona, Spain, 17007
        • Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976
      • Leon, Spain, 24071
        • Hospital de Leon /ID# 141675
      • Madrid, Spain, 28040
        • Hospital Clinico Universitario San Carlos /ID# 126253
      • Pontevedra, Spain, 36071
        • Complejo Hospitalario Universitario de Pontevedra /ID# 138126
      • Zaragoza, Spain, 50009
        • Hospital Clinico Universitario Lozano Blesa /ID# 126252
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Hospital Parc Tauli de Sabadell /ID# 138124
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425
  • Switzerland
    • Sankt Gallen
      • St. Gallen, Sankt Gallen, Switzerland, 9007
        • Kantonsspital St. Gallen /ID# 127750
    • Zuerich
      • Zurich, Zuerich, Switzerland, 8006
        • Universitaetsspital Zuerich /ID# 127751
  • Ukraine
      • Kherson, Ukraine, 73000
        • Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754
      • Kiev, Ukraine, 04201
        • Kyiv City Clinical Hospital No.8 /ID# 126232
      • Lviv, Ukraine, 79011
        • Lviv Regional Clinical Hospital /ID# 126234
      • Zaporizhzhia, Ukraine, 69035
        • Public Institution 6th City Clinical Hospital /ID# 126236
    • Kharkivska Oblast
      • Kharkiv, Kharkivska Oblast, Ukraine, 61039
        • State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753
  • United Kingdom
      • Hull, United Kingdom, HU8 9HE
        • Hull University Teaching Hospitals NHS Trustust /ID# 126265
      • Southampton, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Fundation Trust /ID# 126225
      • Wolverhampton, United Kingdom, WV10 0QP
        • The Royal Wolverhampton NHS Tr /ID# 126201
    • London, City Of
      • London, London, City Of, United Kingdom, SE1 9RT
        • Guy's and St Thomas' NHS Found /ID# 144366
    • Norfolk
      • Norwich, Norfolk, United Kingdom, NR4 7UY
        • Norfolk and Norwich Univ Hosp /ID# 126197
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35209
        • Birmingham Gastroenterology Associates O.C /ID# 137282
      • Dothan, Alabama, United States, 36305
        • Digestive Health Specialists of the Southeast /ID# 122483
    • California
      • La Jolla, California, United States, 92093
        • Moore UC San Diego Cancer Center /ID# 119053
      • Los Angeles, California, United States, 90036
        • Axis Clinical Trials /ID# 130390
    • Colorado
      • Wheat Ridge, Colorado, United States, 80033
        • Rocky Mountain Gastroenterology /ID# 119038
    • Connecticut
      • Hamden, Connecticut, United States, 06518
        • Medical Research Ctr CT /ID# 119037
    • Florida
      • Naples, Florida, United States, 34102
        • Gastroenterology Group Naples /ID# 122493
      • Orlando, Florida, United States, 32806
        • Internal Med Specialists /ID# 137737
      • Winter Park, Florida, United States, 32789
        • Shafran Gastroenterology Ctr /ID# 119057
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Winship Cancer Institute of Emory University /ID# 136851
      • Atlanta, Georgia, United States, 30342
        • Atlanta Gastro Assoc /ID# 119065
      • Macon, Georgia, United States, 31201
        • Gastroenterology Associates of Central Georgia, LLC /ID# 119056
    • Illinois
      • Chicago, Illinois, United States, 60611-2927
        • Northwestern University Feinberg School of Medicine /ID# 119043
      • Chicago, Illinois, United States, 60637-1443
        • University of Chicago DCAM /ID# 119077
      • Urbana, Illinois, United States, 61801
        • Carle Foundation Hospital Digestive Health Research Center /ID# 136008
    • Louisiana
      • Shreveport, Louisiana, United States, 71105-6800
        • Louisana Research Center, LLC /ID# 136749
    • Maryland
      • Annapolis, Maryland, United States, 21228
        • Investigative Clinical Research /ID# 119033
      • Chevy Chase, Maryland, United States, 20815
        • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042
    • Massachusetts
      • Brockton, Massachusetts, United States, 02302
        • Commonwealth Clinical Studies /ID# 136850
    • Michigan
      • Ann Arbor, Michigan, United States, 48109
        • University of Michigan Health Systems /ID# 119076
    • Minnesota
      • Plymouth, Minnesota, United States, 55446
        • Minnesota Gastroenterology, P. A. /ID# 137280
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic /ID# 122489
    • Missouri
      • Kansas City, Missouri, United States, 64131
        • Kansas City Research Institute /ID# 119034
      • Mexico, Missouri, United States, 65265
        • Ctr for Digest and Liver Dis /ID# 119040
    • New York
      • Albany, New York, United States, 12208
        • Albany Medical College /ID# 140200
      • Great Neck, New York, United States, 11021
        • NYU Langone Long Island Clinical Research Associates /ID# 119035
      • New York, New York, United States, 10029
        • The Mount Sinai Hospital /ID# 127116
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC /ID# 119029
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • Consultants for Clinical Res /ID# 119052
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74135
        • Gastro United of Tulsa /ID# 122485
    • Oregon
      • Portland, Oregon, United States, 97225
        • The Oregon Clinic, Gastroenterology - West /ID# 135272
    • Rhode Island
      • Warwick, Rhode Island, United States, 02886
        • West Bay Clinical Research /ID# 138330
    • South Carolina
      • Charleston, South Carolina, United States, 29425
        • Medical University of South Carolina /ID# 138122
    • Tennessee
      • Chattanooga, Tennessee, United States, 37403
        • Erlanger Institute for Clinical Research /ID# 129008
      • Germantown, Tennessee, United States, 38138
        • Gastro One /ID# 119068
      • Nashville, Tennessee, United States, 37205
        • Nashville Med Res Inst /ID# 119050
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt Univ Med Ctr /ID# 125501
    • Texas
      • Dallas, Texas, United States, 75231
        • Texas Digestive Disease Consultants - Dallas /ID# 138121
      • Houston, Texas, United States, 77030-3411
        • Baylor College of Medicine /ID# 137277
      • Pflugerville, Texas, United States, 78660
        • Austin Institute for Clinical Research /ID# 125500
      • Southlake, Texas, United States, 76092
        • Texas Digestive Disease Consultants - Southlake /ID# 137283
    • Utah
      • Ogden, Utah, United States, 84403
        • Advanced Research Institute /ID# 119048
      • Salt Lake City, Utah, United States, 84112-5500
        • University of Utah /ID# 119062
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Gastro Assoc of Tidewater /ID# 135897
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Inst /ID# 127807
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036
      • Milwaukee, Wisconsin, United States, 53226-3522
        • Froedtert Memorial Lutheran Hospital /ID# 119081

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of Crohn's disease (CD) for at least 90 days, confirmed by endoscopy during the Screening Period.
  • Active CD with a Crohn's Disease Activity Index (CDAI) despite treatment with oral corticosteroids and/or immunosuppressants.
  • Mucosal ulceration on endoscopy.

Exclusion Criteria:

  • Subject with ulcerative colitis or indeterminate colitis.
  • Subject who has had surgical bowel resections in the past 6 months or is planning resection.
  • Subjects with an ostomy or ileoanal pouch.
  • Subject with symptomatic bowel stricture or abdominal or peri-anal abcess.
  • Subject who has short bowel syndrome.
  • Chronic recurring infections or active Tuberculosis (TB).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Induction: Standard Induction Dose
Participants randomized to receive received blinded adalimumab 160 mg at Baseline and matching placebo at Week 1, adalimumab 80 mg and matching placebo at Week 2, matching placebo at Week 3, and then adalimumab 40 mg every other week (eow) starting at Week 4 through Week 12.
Drug: Placebo
Drug: Adalimumab
Other Names:
  • Humira
Experimental: Induction: Higher Induction Dose
Participants randomized to receive blinded adalimumab 160 mg at Baseline, Week 1, Week 2, and Week 3. At Week 4, participants receive adalimumab 40 mg eow through Week 12.
Drug: Adalimumab
Other Names:
  • Humira
Experimental: Maintenance: Clinically Adjusted (CA) Regimen
Participants randomized to the CA regimen receive adalimumab 40 mg eow beginning at Week 12. The adalimumab dose will be escalated to every week (ew) starting as early as Week 14 and up to Week 54 based on Crohn's Disease Activity Index (CDAI) or high-sensitivity C-reactive protein (hs-CRP) values, using results from the prior or current study visit. Once participants in the CA regimen are escalated, they remain on adalimumab 40 mg ew dosing.
Drug: Adalimumab
Other Names:
  • Humira
Experimental: Maintenance: Therapeutic Drug Monitoring (TDM) Regimen
At Weeks 14, 28 and 42, the adalimumab dose for participants randomized to the TDM will be determined by protocol-established dose adjustment criteria. Doses will be determined using blinded serum concentrations at the prior visit (Weeks 12, 26 and 40, respectively) as well as the CDAI or hs-CRP values from the current or prior study visit. Participants who meet criteria for dose escalation at Weeks 14, 28 or 42 will receive 40 mg ew.
Drug: Adalimumab
Other Names:
  • Humira

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants Who Achieved Clinical Remission at Week 4
Time Frame: Week 4
Crohn's Disease Activity Index (CDAI) is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Week 4
Percentage of Participants With Endoscopic Response at Week 12
Time Frame: Week 12
Endoscopic response was scored using the Simplified Endoscopic Score for Crohn's Disease (SES-CD). The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score > 50% from Baseline (or for a Baseline SES-CD of 4, at least a 2 point reduction from Baseline) at Week 12.
Week 12
Number of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).
Adverse event (AE): any untoward medical occurrence that does not necessarily have a causal relationship with this treatment. The investigator assessed the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. Serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the subject and may require medical or surgical intervention to prevent any of the outcomes listed above. TEAEs: any event that began or worsened in severity after the first dose of study drug in the induction or maintenance study. Events with unknown severity were counted as severe. Events with unknown relationship to study drug were counted as drug-related.
From first dose of study drug until 70 days following last dose of study drug in the induction study (up to 12 weeks) or maintenance study (up to 56 weeks).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 12
Time Frame: Week 4 and Week 12
CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Week 4 and Week 12
Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at Week 12
Time Frame: Week 12

Clinical response was scored using CDAI, which assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline.

Endoscopic response was scored using the SES-CD, which evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic response was defined as SES-CD total score >50% from Baseline (or for Baseline SES-CD of 4, at least a 2-point reduction from Baseline) at Week 12.
Week 12
Percentage of Participants With Clinical Remission at Week 12
Time Frame: Week 12
Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Week 12
Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline
Time Frame: Week 12
Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Week 12
Percentage of Participants With Endoscopic Remission at Week 12
Time Frame: Week 12
Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.
Week 12
Change From Baseline in Fecal Calprotectin Level at Week 4
Time Frame: Baseline, Week 4
Baseline, Week 4
Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4
Time Frame: Week 4
Week 4
Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4
Time Frame: Week 4
Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.
Week 4
Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at Week 12
Time Frame: Week 12

Clinical remission was scored using the CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450.

Endoscopic remission was scored using the SES-CD.The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy. The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease. Endoscopic remission was defined as SES-CD ≤ 4 and at least a 2-point reduction versus baseline and no subscore greater than 1 in any individual variable.
Week 12
Percentage of Participants Who Achieved an SES-CD ≤ 2 at Week 12
Time Frame: Week 12
The SES-CD evaluates 4 endoscopic variables (ulcer size ranging from 0 [none] to 3 [very large]; ulcerated surface ranging from 0 [none] to 3 [>30%]; affected surface ranging from 0 [none] to 3 [>75%], and narrowing ranging from 0 [none] to 3 [cannot be passed]) in 5 segments assessed during ileocolonoscopy (ileum, right colon, transverse colon, sigmoid and left colon, and rectum). The total score is the sum of the 4 endoscopic variable scores and range from 0 to 56, where higher scores indicate more severe disease.
Week 12
Percentage of Participants With Clinical Response at Week 4
Time Frame: Week 4
Clinical response was scored using CDAI is used to assess the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from baseline.
Week 4
Percentage of Participants With Clinical Response at Week 12
Time Frame: Week 12
Clinical response was scored using CDAI. CDAI assesses the symptoms of participants with Crohn's Disease. Scores generally range from 0 to 600, where clinical remission of Crohn's disease is defined as CDAI < 150, and very severe disease is defined as CDAI > 450. Clinical response was defined as a decrease in CDAI ≥ 70 points from Baseline.
Week 12
Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at Week 4
Time Frame: Week 4
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 ≥ 8.
Week 4
Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at Week 12
Time Frame: Week 12
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 ≥ 8.
Week 12
Percentage of Participants Achieving Response in IBDQ Fatigue Item at Week 12
Time Frame: Week 12
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.
Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2014

Primary Completion (Actual)

January 30, 2020

Study Completion (Actual)

January 30, 2020

Study Registration Dates

First Submitted

February 17, 2014

First Submitted That Met QC Criteria

February 17, 2014

First Posted (Estimate)

February 19, 2014

Study Record Updates

Last Update Posted (Actual)

February 18, 2021

Last Update Submitted That Met QC Criteria

February 11, 2021

Last Verified

February 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • M14-115
  • 2013-001746-33 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD 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 Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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