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AzTrials

Crohn's DiseasePhase 3NCT02065570

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

A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by AbbVie at 143 sites in 20 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Crohn's Disease
What is being tested?
Adalimumab
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
514 participants
Where
143 sitesin 20 countries
Study dates
1 May 2014to 30 Jan 2020
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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).

Trial locations and contacts

143 sites in 20 countries.

143 sites in 20 countries

United States48 sites

  • Albany Medical College /ID# 140200

    Albany, New York, 12208

  • University of Michigan Health Systems /ID# 119076

    Ann Arbor, Michigan, 48109

  • Investigative Clinical Research /ID# 119033

    Annapolis, Maryland, 21228

  • Winship Cancer Institute of Emory University /ID# 136851

    Atlanta, Georgia, 30322

  • Atlanta Gastro Assoc /ID# 119065

    Atlanta, Georgia, 30342

  • Birmingham Gastroenterology Associates O.C /ID# 137282

    Birmingham, Alabama, 35209

  • Commonwealth Clinical Studies /ID# 136850

    Brockton, Massachusetts, 02302

  • Medical University of South Carolina /ID# 138122

    Charleston, South Carolina, 29425

  • Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041

    Charlotte, North Carolina, 28207

  • Erlanger Institute for Clinical Research /ID# 129008

    Chattanooga, Tennessee, 37403

  • Gastro Assoc of Tidewater /ID# 135897

    Chesapeake, Virginia, 23320

  • MGG Group Co, Inc.Chevy Chase Clinical Research /ID# 119042

    Chevy Chase, Maryland, 20815

  • Northwestern University Feinberg School of Medicine /ID# 119043

    Chicago, Illinois, 60611-2927

  • University of Chicago DCAM /ID# 119077

    Chicago, Illinois, 60637-1443

  • New River Valley Research Inst /ID# 127807

    Christiansburg, Virginia, 24073

  • Consultants for Clinical Res /ID# 119052

    Cincinnati, Ohio, 45219

  • Texas Digestive Disease Consultants - Dallas /ID# 138121

    Dallas, Texas, 75231

  • Digestive Health Specialists of the Southeast /ID# 122483

    Dothan, Alabama, 36305

  • Gastro One /ID# 119068

    Germantown, Tennessee, 38138

  • NYU Langone Long Island Clinical Research Associates /ID# 119035

    Great Neck, New York, 11021

  • Medical Research Ctr CT /ID# 119037

    Hamden, Connecticut, 06518

  • Baylor College of Medicine /ID# 137277

    Houston, Texas, 77030-3411

  • Kansas City Research Institute /ID# 119034

    Kansas City, Missouri, 64131

  • Moore UC San Diego Cancer Center /ID# 119053

    La Jolla, California, 92093

  • Axis Clinical Trials /ID# 130390

    Los Angeles, California, 90036

  • Gastroenterology Associates of Central Georgia, LLC /ID# 119056

    Macon, Georgia, 31201

  • Ctr for Digest and Liver Dis /ID# 119040

    Mexico, Missouri, 65265

  • Wisconsin Center for Advanced Research, a division of GI Associates, LLC /ID# 119036

    Milwaukee, Wisconsin, 53215

  • Froedtert Memorial Lutheran Hospital /ID# 119081

    Milwaukee, Wisconsin, 53226-3522

  • Gastroenterology Group Naples /ID# 122493

    Naples, Florida, 34102

  • Nashville Med Res Inst /ID# 119050

    Nashville, Tennessee, 37205

  • Vanderbilt Univ Med Ctr /ID# 125501

    Nashville, Tennessee, 37232-0011

  • The Mount Sinai Hospital /ID# 127116

    New York, New York, 10029

  • Advanced Research Institute /ID# 119048

    Ogden, Utah, 84403

  • Internal Med Specialists /ID# 137737

    Orlando, Florida, 32806

  • Austin Institute for Clinical Research /ID# 125500

    Pflugerville, Texas, 78660

  • Minnesota Gastroenterology, P. A. /ID# 137280

    Plymouth, Minnesota, 55446

  • The Oregon Clinic, Gastroenterology - West /ID# 135272

    Portland, Oregon, 97225

  • Wake Research Associates, LLC /ID# 119029

    Raleigh, North Carolina, 27612

  • Mayo Clinic /ID# 122489

    Rochester, Minnesota, 55905-0001

  • University of Utah /ID# 119062

    Salt Lake City, Utah, 84112-5500

  • Louisana Research Center, LLC /ID# 136749

    Shreveport, Louisiana, 71105-6800

  • Texas Digestive Disease Consultants - Southlake /ID# 137283

    Southlake, Texas, 76092

  • Gastro United of Tulsa /ID# 122485

    Tulsa, Oklahoma, 74135

  • Carle Foundation Hospital Digestive Health Research Center /ID# 136008

    Urbana, Illinois, 61801

  • West Bay Clinical Research /ID# 138330

    Warwick, Rhode Island, 02886

  • Rocky Mountain Gastroenterology /ID# 119038

    Wheat Ridge, Colorado, 80033

  • Shafran Gastroenterology Ctr /ID# 119057

    Winter Park, Florida, 32789

Other trials in United States

Germany9 sites

  • Charite Universitaetsmedizin Berlin /ID# 126196

    Berlin, 10117

  • Private Practice - Dr. Michael R. MroB Dipl. med. S. Schache /ID# 126257

    Berlin, 10318

  • Israelitisches Krankenhaus Hamburg /ID# 136549

    Hamburg, 22297

  • Asklepios Westklinikum Hamburg /ID# 126275

    Hamburg, 22559

  • Universitaetsklinikum Jena /ID# 126261

    Jena, 07747

  • Universitaetsklinikum Schleswig-Holstein /ID# 126260

    Kiel, Schleswig-Holstein, 24105

  • EUGASTRO GmbH /ID# 126259

    Leipzig, 04103

  • Universitatsklinikum Magdeburg /ID# 126256

    Magdeburg, 39120

  • Gastro Campus Research GbR /ID# 126274

    Münster, 48159

Other trials in Germany

Canada8 sites

  • University of Calgary Cumming School of Medicine Adult Cystic Fibrosis Clinic /ID# 119017

    Calgary, Alberta, T2N 4Z6

  • University of Alberta /ID# 119022

    Edmonton, Alberta, T6G 2X8

  • Medicor Research Inc /ID# 119024

    Greater Sudbury, Ontario, P3E 5M4

  • Qe Ii Hsc /Id# 127115

    Halifax, Nova Scotia, B3H 1V7

  • London Health Sciences Centre - University Hospital /ID# 119026

    London, Ontario, N6A 5A5

  • Montreal General Hospital - McGill University Health Center /ID# 119025

    Montreal, Quebec, H3G 1A4

  • Toronto Digestive Disease Asso /ID# 119019

    Vaughan, Ontario, L4L 4Y7

  • Winnipeg Regional Health Authority /ID# 119015

    Winnipeg, Manitoba, R3A 1R9

Other trials in Canada

Spain8 sites

  • Hospital Clinic /ID# 127749

    Barcelona, 08036

  • Hospital Universitario de Girona Doctor Josep Trueta /ID# 137976

    Girona, 17007

  • Hospital de Leon /ID# 141675

    León, 24071

  • Hospital Clinico Universitario San Carlos /ID# 126253

    Madrid, 28040

  • Hospital Universitario Puerta de Hierro, Majadahonda /ID# 140425

    Majadahonda, Madrid, 28222

  • Complejo Hospitalario Universitario de Pontevedra /ID# 138126

    Pontevedra, 36071

  • Hospital Parc Tauli de Sabadell /ID# 138124

    Sabadell, Barcelona, 08208

  • Hospital Clinico Universitario Lozano Blesa /ID# 126252

    Zaragoza, 50009

Other trials in Spain

France7 sites

  • CHU Amiens-Picardie Site Sud /ID# 126237

    Amiens, Somme, 80054

  • Centre Hospitalier Universitaire de Grenoble - Hopital Michallon /ID# 126200

    Grenoble, 38043

  • CHRU Lille - Hopital Claude Huriez /ID# 127743

    Lille, Hauts-de-France, 59045

  • Hopital l'Archet 2 /ID# 126238

    Nice, 06202

  • CHU de Saint-Etienne, Hopital Nord /ID# 134450

    Saint-Etienne, 42270

  • Hopital Rangueil /ID# 126239

    Toulouse, 31059

  • CHU NANCY - Hopital Brabois Adultes /ID# 127742

    Vandœuvre-lès-Nancy, Meurthe-et-Moselle, 54511

Other trials in France

Italy7 sites

  • Azienda Ospedaliera Spedali Civili /ID# 127744

    Brescia, 25123

  • Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221

    Milan, Lombardy, 20122

  • Azienda Ospedaliera di Padova /ID# 126267

    Padua, 35128

  • UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745

    Rome, Lazio, 00152

  • Policlinico Agostino Gemelli /ID# 127746

    Rome, Lazio, 00168

  • IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226

    Rozzano, Milano, 20089

  • Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856

    San Giovanni Rotondo, 71013

Other trials in Italy

Poland6 sites

  • Centrum Endoskopii Zabiegowej /ID# 126272

    Bydgoszcz, 85-168

  • Centrum Medyczne sw. Lukasza Sp. z o.o. /ID# 126271

    Częstochowa, 42-200

  • Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974

    Lodz, Łódź Voivodeship, 90-302

  • KO-Med Centra Kliniczne Pulawi /ID# 126278

    Puławy, 24-100

  • Endoterapia PFG sp. z o.o. /ID# 126199

    Warsaw, Masovian Voivodeship, 02-653

  • NZOZ Vivamed /ID# 126255

    Warsaw, 03-580

Other trials in Poland

Austria5 sites

  • Medizinische Universitat Innsbruck,Universitatsklinik fur Innere Medizin 1 /ID# 126249

    Innsbruck, 6020

  • KH der Elisabethinen Linz GmbH /ID# 126280

    Linz, Upper Austria, 4010

  • LKH Salzburg and Paracelsus /ID# 126248

    Salzburg, 5020

  • Krankenhaus der Barmherzigen Bruder /ID# 126270

    Sankt Veit an der Glan, 9300

  • Medizinische Universitat Wien /ID# 126279

    Vienna, State of Vienna, 1090

Other trials in Austria

Belgium5 sites

  • AZ Maria Middelares /ID# 126194

    Ghent, 9000

  • AZ Sint-Lucas /ID# 126242

    Ghent, 9000

  • UZ Leuven /ID# 126240

    Leuven, 3000

  • CHU de Liege /ID# 126241

    Liège, 4000

  • AZ-Delta /ID# 126195

    Roeselare, 8800

Other trials in Belgium

Czechia5 sites

  • Nemocnice Ceske Budejovice a.s. /ID# 126266

    České Budějovice, 370 01

  • Hepato-Gastroenterologie HK s.r.o. /ID# 126269

    Hradec Králové, 500 12

  • Fakultni Nemocnice Olomouc /ID# 126264

    Olomouc, Olomouc Region, 779 00

  • ISCARE a.s. /ID# 137977

    Prague, 190 00

  • Krajska zdravotni a.s. Masarykova nemocnice v Usti nad Labem o.z. /ID# 138331

    Ústí nad Labem, 401 13

Other trials in Czechia

Romania5 sites

  • Centrul Medical de Diagnostic si Tratament Ambulator Neomed SRL /ID# 126277

    Brasov, 500283

  • Tvm Med Serv Srl /Id# 126268

    Cluj-Napoca, 400132

  • Cabinet Medical Dr. Fratila SRL /ID# 126247

    Oradea, 410167

  • Institutul Clinic Fundeni /ID# 127747

    Sector 2, Bucharest, 022328

  • Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224

    Zalău, 450117

Other trials in Romania

Ukraine5 sites

  • State Institution L. T. Malaya Therapy National Institution of NAMS of Ukraine /ID# 127753

    Kharkiv, Kharkiv Oblast, 61039

  • Public Institution Kherson City Clinical Hospital named after le.le. Karabelesha /ID# 127754

    Kherson, 73000

  • Kyiv City Clinical Hospital No.8 /ID# 126232

    Kiev, 04201

  • Lviv Regional Clinical Hospital /ID# 126234

    Lviv, 79011

  • Public Institution 6th City Clinical Hospital /ID# 126236

    Zaporizhzhya, 69035

Other trials in Ukraine

United Kingdom5 sites

  • Hull University Teaching Hospitals NHS Trustust /ID# 126265

    Hull, HU8 9HE

  • Guy's and St Thomas' NHS Found /ID# 144366

    London, London, City of, SE1 9RT

  • Norfolk and Norwich Univ Hosp /ID# 126197

    Norwich, Norfolk, NR4 7UY

  • University Hospital Southampton NHS Fundation Trust /ID# 126225

    Southampton, SO16 6YD

  • The Royal Wolverhampton NHS Tr /ID# 126201

    Wolverhampton, WV10 0QP

Other trials in United Kingdom

Hungary4 sites

  • Semmelweis Egyetem /ID# 137896

    Budapest, 1085

  • Magyar Elhizastudomanyi KKft. /ID# 126276

    Budapest, 1124

  • Pecsi Tudomanyegyetem Klinikai l.sz. Belgyogyaszati Klinika /ID# 137895

    Pécs, 7624

  • University of Szeged /ID# 126263

    Szeged, 6720

Other trials in Hungary

Israel4 sites

  • Soroka University Medical Center /ID# 126243

    Beersheba, 84101

  • Gastroenterology Institute, Division of Medicine /ID# 126245

    Jerusalem, 91120

  • Rabin Medical Center /ID# 126198

    Petakh Tikva, Tel Aviv, 4941492

  • Kaplan Medical Center /ID# 126246

    Rehovot, 76100

Other trials in Israel

Slovakia4 sites

  • Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262

    Bratislava, 831 04

  • Gastroenterologicka ambulancia /ID# 137964

    Bratislava, 851 01

  • Vseobecna Nemocnica s poliklinikou Lucenec n.o. /ID# 127748

    Lučenec, 984 01

  • Poliklinika Libris /ID# 126222

    Nové Mesto nad Váhom, 915 01

Other trials in Slovakia

Netherlands3 sites

  • Academisch Medical center Amsterdam /ID# 126227

    Amsterdam, North Holland, 1105 AZ

  • Erasmus Medisch Centrum /ID# 126228

    Rotterdam, 3015 CE

  • Sint Franciscus Gasthuis /ID# 127877

    Rotterdam, 3045 PM

Other trials in Netherlands

Denmark2 sites

  • Herlev Hospital /ID# 127741

    Herlev, Capital Region, 2730

  • Silkeborg Hospital /ID# 126251

    Silkeborg, 8600

Other trials in Denmark

Switzerland2 sites

  • Kantonsspital St. Gallen /ID# 127750

    Sankt Gallen, Canton of St. Gallen, 9007

  • Universitaetsspital Zuerich /ID# 127751

    Zurich, Canton of Zurich, 8006

Other trials in Switzerland

Puerto Rico1 site

  • School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735

    San Juan, 00935

Other trials in Puerto Rico

About this study

Official title: 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.

Conditions
Crohn's Disease
Being tested
Adalimumab, Placebo
Keywords
Crohn's Disease
Medical subject headings
Crohn Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT02065570
Study groupRoleWhat they receive
Induction: Standard Induction DoseExperimentalParticipants 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.
Receives: Drug: Adalimumab; Drug: Placebo
Induction: Higher Induction DoseExperimentalParticipants 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.
Receives: Drug: Adalimumab
Maintenance: Clinically Adjusted (CA) RegimenExperimentalParticipants 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.
Receives: Drug: Adalimumab
Maintenance: Therapeutic Drug Monitoring (TDM) RegimenExperimentalAt 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.
Receives: Drug: Adalimumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Who Achieved Clinical Remission at 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.

    Measured: Week 4

  2. Percentage of Participants With Endoscopic Response at 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.

    Measured: Week 12

  3. Number of Participants With Treatment-Emergent Adverse Events (TEAEs)

    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.

    Measured: 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 outcomes (15)

  1. Percentage of Participants With Sustained Clinical Remission (Per CDAI) at Both Weeks 4 and 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.

    Measured: Week 4 and Week 12

  2. Percentage of Participants Who Achieve Clinical Response at Week 4 and Endoscopic Response at 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.

    Measured: Week 12

  3. Percentage of Participants With Clinical Remission at 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.

    Measured: Week 12

  4. Percentage of Participants Who Discontinued Corticosteroid Use and Achieved Clinical Remission at Week 12 Among Participants Taking Corticosteroids at Baseline

    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.

    Measured: Week 12

  5. Percentage of Participants With Endoscopic Remission at 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.

    Measured: Week 12

  6. Change From Baseline in Fecal Calprotectin Level at Week 4

    Measured: Baseline, Week 4

  7. Percentage of Participants With Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at Week 4

    Measured: Week 4

  8. Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g at 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.

    Measured: Week 4

  9. Percentage of Participants With Clinical Remission, Hs-CRP < 5 mg/L and Fecal Calprotectin < 250 µg/g and Endoscopic Remission at 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.

    Measured: Week 12

  10. Percentage of Participants Who Achieved an SES-CD ≤ 2 at 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.

    Measured: Week 12

  11. Percentage of Participants With Clinical Response at 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.

    Measured: Week 4

  12. Percentage of Participants With Clinical Response at 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.

    Measured: Week 12

  13. Percentage of Participants Achieving Response in Inflammatory Bowel Disease Questionnaire (IBDQ) Bowel Symptom Domain at 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.

    Measured: Week 4

  14. Percentage of Participants Achieving Response in IBDQ Bowel Symptom Domain at 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.

    Measured: Week 12

  15. Percentage of Participants Achieving Response in IBDQ Fatigue Item at 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.

    Measured: Week 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Feb 2014 (estimated)
  2. Study start1 May 2014
  3. Primary completion30 Jan 2020
  4. Study completion30 Jan 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
514 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02065570
Sponsor's protocol ID
M14-115
Other IDs
2013-001746-33
Status last verified
Feb 2021
First submitted
17 Feb 2014
Last updated
18 Feb 2021
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: 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.

Publications

  • Battat R, Kandi S, Lacerda AP, Levine P, Neimark E, Feagan BG, Rubin DT, Ji QC, Chen X, Polakow SB. Association of bile acid diarrhea with symptoms and disease activity in Crohn's disease: post-hoc clinical trial analysis of serum 7a-hydroxy-4cholestern-3-one, C4, in patients with active Crohn's disease. J Crohns Colitis. 2025 May 8;19(5):jjaf053. doi: 10.1093/ecco-jcc/jjaf053.

    PubMed 40202488

  • Reppell M, Zheng X, Dreher I, Blaes J, Regan E, Haslberger T, Guay H, Pivorunas V, Smaoui N. HLA-DQA1*05 Associates With Anti-Tumor Necrosis Factor Immunogenicity and Low Adalimumab Trough Concentrations in Inflammatory Bowel Disease Patients From the SERENE Ulcerative Colitis and Crohn's Disease Studies. J Crohns Colitis. 2025 Jan 11;19(1):jjae129. doi: 10.1093/ecco-jcc/jjae129.

    PubMed 39162746

  • Verstockt B, Pivorunas V, Al Mahi N, Smaoui N, Guay H, Kennedy NA, Goodhand JR, Lin S, Bai BYH, Hanauer SB, Ferrante M, Panes J, Vermeire S. Baseline TREM-1 Whole Blood Gene Expression Does Not Predict Response to Adalimumab Treatment in Patients with Ulcerative Colitis or Crohn's Disease in the SERENE Studies. J Crohns Colitis. 2024 Apr 23;18(4):493-505. doi: 10.1093/ecco-jcc/jjad170.

    PubMed 37801628

  • Ponce-Bobadilla AV, Stodtmann S, Chen MJ, Winzenborg I, Mensing S, Blaes J, Haslberger T, Laplanche L, Dreher I, Mostafa NM. Assessing the Impact of Immunogenicity and Improving Prediction of Trough Concentrations: Population Pharmacokinetic Modeling of Adalimumab in Patients with Crohn's Disease and Ulcerative Colitis. Clin Pharmacokinet. 2023 Apr;62(4):623-634. doi: 10.1007/s40262-023-01221-x. Epub 2023 Mar 11.

    PubMed 36905528

  • D'Haens GR, Sandborn WJ, Loftus EV Jr, Hanauer SB, Schreiber S, Peyrin-Biroulet L, Panaccione R, Panes J, Baert F, Colombel JF, Ferrante M, Louis E, Armuzzi A, Zhou Q, Goteti VS, Mostafa NM, Doan TT, Petersson J, Finney-Hayward T, Song AP, Robinson AM, Danese S. Higher vs Standard Adalimumab Induction Dosing Regimens and Two Maintenance Strategies: Randomized SERENE CD Trial Results. Gastroenterology. 2022 Jun;162(7):1876-1890. doi: 10.1053/j.gastro.2022.01.044. Epub 2022 Feb 3.

    PubMed 35122766

  • 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.

    PubMed 34402466

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Adalimumab in people with Crohn's Disease, run by AbbVie at 143 sites in 20 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 143 sites in United States, Germany, Canada, Spain, France and 15 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Who Achieved Clinical Remission at Week 4 (time frame: Week 4). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02065570, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2021; AzTrials last refreshed its copy on 7 Nov 2026.

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