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

PHASE3CompletedINTERVENTIONAL
Enrollment

514

Participants

Timeline

Start Date

May 1, 2014

Primary Completion Date

January 30, 2020

Study Completion Date

January 30, 2020

Conditions
Crohn's Disease
Interventions
DRUG

Adalimumab

DRUG

Placebo

Trial Locations (143)

1085

Semmelweis Egyetem /ID# 137896, Budapest

1090

Medizinische Universitat Wien /ID# 126279, Vienna

1124

Magyar Elhizastudomanyi KKft. /ID# 126276, Budapest

2730

Herlev Hospital /ID# 127741, Herlev

3000

UZ Leuven /ID# 126240, Leuven

4000

CHU de Liege /ID# 126241, Liège

4010

KH der Elisabethinen Linz GmbH /ID# 126280, Linz

5020

LKH Salzburg and Paracelsus /ID# 126248, Salzburg

6020

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

6720

University of Szeged /ID# 126263, Szeged

7624

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

8006

Universitaetsspital Zuerich /ID# 127751, Zurich

8600

Silkeborg Hospital /ID# 126251, Silkeborg

8800

AZ-Delta /ID# 126195, Roeselare

9000

AZ Maria Middelares /ID# 126194, Ghent

AZ Sint-Lucas /ID# 126242, Ghent

9007

Kantonsspital St. Gallen /ID# 127750, Sankt Gallen

9300

Krankenhaus der Barmherzigen Bruder /ID# 126270, Sankt Veit an der Glan

10029

The Mount Sinai Hospital /ID# 127116, New York

10117

Charite Universitaetsmedizin Berlin /ID# 126196, Berlin

10318

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

11021

NYU Langone Long Island Clinical Research Associates /ID# 119035, Great Neck

12208

Albany Medical College /ID# 140200, Albany

17007

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

20089

IBD Center - IRCCS Istituto Clinico Humanitas /ID# 126226, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico /ID# 126221, Milan

20815

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

21228

Investigative Clinical Research /ID# 119033, Annapolis

22297

Israelitisches Krankenhaus Hamburg /ID# 136549, Hamburg

22559

Asklepios Westklinikum Hamburg /ID# 126275, Hamburg

23320

Gastro Assoc of Tidewater /ID# 135897, Chesapeake

24071

Hospital de Leon /ID# 141675, León

24073

New River Valley Research Inst /ID# 127807, Christiansburg

24105

Universitaetsklinikum Schleswig-Holstein /ID# 126260, Kiel

25123

Azienda Ospedaliera Spedali Civili /ID# 127744, Brescia

27612

Wake Research Associates, LLC /ID# 119029, Raleigh

28040

Hospital Clinico Universitario San Carlos /ID# 126253, Madrid

28207

Charlotte Gastroenterology and Hepatology, PLLC /ID# 119041, Charlotte

28222

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

29425

Medical University of South Carolina /ID# 138122, Charleston

30322

Winship Cancer Institute of Emory University /ID# 136851, Atlanta

30342

Atlanta Gastro Assoc /ID# 119065, Atlanta

31059

Hopital Rangueil /ID# 126239, Toulouse

31201

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

32789

Shafran Gastroenterology Ctr /ID# 119057, Winter Park

32806

Internal Med Specialists /ID# 137737, Orlando

34102

Gastroenterology Group Naples /ID# 122493, Naples

35128

Azienda Ospedaliera di Padova /ID# 126267, Padua

35209

Birmingham Gastroenterology Associates O.C /ID# 137282, Birmingham

36071

Complejo Hospitalario Universitario de Pontevedra /ID# 138126, Pontevedra

36305

Digestive Health Specialists of the Southeast /ID# 122483, Dothan

37205

Nashville Med Res Inst /ID# 119050, Nashville

37403

Erlanger Institute for Clinical Research /ID# 129008, Chattanooga

38043

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

38138

Gastro One /ID# 119068, Germantown

39120

Universitatsklinikum Magdeburg /ID# 126256, Magdeburg

42270

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

45219

Consultants for Clinical Res /ID# 119052, Cincinnati

48109

University of Michigan Health Systems /ID# 119076, Ann Arbor

48159

Gastro Campus Research GbR /ID# 126274, Münster

50009

Hospital Clinico Universitario Lozano Blesa /ID# 126252, Zaragoza

53215

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

54511

CHU NANCY - Hopital Brabois Adultes /ID# 127742, Vandœuvre-lès-Nancy

55446

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

59045

CHRU Lille - Hopital Claude Huriez /ID# 127743, Lille

61039

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

61801

Carle Foundation Hospital Digestive Health Research Center /ID# 136008, Urbana

64131

Kansas City Research Institute /ID# 119034, Kansas City

65265

Ctr for Digest and Liver Dis /ID# 119040, Mexico

69035

Public Institution 6th City Clinical Hospital /ID# 126236, Zaporizhzhia

71013

Fondazione di Religione e di Culto Casa Sollievo della Sofferenza /ID# 129856, San Giovanni Rotondo

73000

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

74135

Gastro United of Tulsa /ID# 122485, Tulsa

75231

Texas Digestive Disease Consultants - Dallas /ID# 138121, Dallas

76092

Texas Digestive Disease Consultants - Southlake /ID# 137283, Southlake

76100

Kaplan Medical Center /ID# 126246, Rehovot

78660

Austin Institute for Clinical Research /ID# 125500, Pflugerville

79011

Lviv Regional Clinical Hospital /ID# 126234, Lviv

80033

Rocky Mountain Gastroenterology /ID# 119038, Wheat Ridge

80054

CHU Amiens-Picardie Site Sud /ID# 126237, Amiens

84101

Soroka University Medical Center /ID# 126243, Beersheba

84403

Advanced Research Institute /ID# 119048, Ogden

90036

Axis Clinical Trials /ID# 130390, Los Angeles

91120

Gastroenterology Institute, Division of Medicine /ID# 126245, Jerusalem

92093

Moore UC San Diego Cancer Center /ID# 119053, La Jolla

97225

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

400132

Tvm Med Serv Srl /Id# 126268, Cluj-Napoca

410167

Cabinet Medical Dr. Fratila SRL /ID# 126247, Oradea

450117

Salvo-san Ciobanca SRL / Medicina Interna /ID# 126224, Zalău

500283

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

4941492

Rabin Medical Center /ID# 126198, Petakh Tikva

06518

Medical Research Ctr CT /ID# 119037, Hamden

60611-2927

Northwestern University Feinberg School of Medicine /ID# 119043, Chicago

60637-1443

University of Chicago DCAM /ID# 119077, Chicago

71105-6800

Louisana Research Center, LLC /ID# 136749, Shreveport

02302

Commonwealth Clinical Studies /ID# 136850, Brockton

55905-0001

Mayo Clinic /ID# 122489, Rochester

02886

West Bay Clinical Research /ID# 138330, Warwick

37232-0011

Vanderbilt Univ Med Ctr /ID# 125501, Nashville

77030-3411

Baylor College of Medicine /ID# 137277, Houston

84112-5500

University of Utah /ID# 119062, Salt Lake City

53226-3522

Froedtert Memorial Lutheran Hospital /ID# 119081, Milwaukee

T2N 4Z6

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

T6G 2X8

University of Alberta /ID# 119022, Edmonton

R3A 1R9

Winnipeg Regional Health Authority /ID# 119015, Winnipeg

B3H 1V7

Qe Ii Hsc /Id# 127115, Halifax

P3E 5M4

Medicor Research Inc /ID# 119024, Greater Sudbury

N6A 5A5

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

L4L 4Y7

Toronto Digestive Disease Asso /ID# 119019, Vaughan

H3G 1A4

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

779 00

Fakultni Nemocnice Olomouc /ID# 126264, Olomouc

370 01

Nemocnice Ceske Budejovice a.s. /ID# 126266, České Budějovice

500 12

Hepato-Gastroenterologie HK s.r.o. /ID# 126269, Hradec Králové

190 00

ISCARE a.s. /ID# 137977, Prague

401 13

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

06202

Hopital l'Archet 2 /ID# 126238, Nice

07747

Universitaetsklinikum Jena /ID# 126261, Jena

04103

EUGASTRO GmbH /ID# 126259, Leipzig

00152

UOSD - Azienda Ospedaliera San Camillo Forlanini /ID# 127745, Rome

00168

Policlinico Agostino Gemelli /ID# 127746, Rome

1105 AZ

Academisch Medical center Amsterdam /ID# 126227, Amsterdam

3015 CE

Erasmus Medisch Centrum /ID# 126228, Rotterdam

3045 PM

Sint Franciscus Gasthuis /ID# 127877, Rotterdam

02-653

Endoterapia PFG sp. z o.o. /ID# 126199, Warsaw

85-168

Centrum Endoskopii Zabiegowej /ID# 126272, Bydgoszcz

42-200

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

24-100

KO-Med Centra Kliniczne Pulawi /ID# 126278, Puławy

03-580

NZOZ Vivamed /ID# 126255, Warsaw

90-302

Centrum.Medyczne. Szpital Swietej Rodziny /ID# 137974, Lodz

00935

School of Medicine University of Puerto Rico-Medical Science Campus /ID# 137735, San Juan

022328

Institutul Clinic Fundeni /ID# 127747, Sector 2

831 04

Gastroenterologicke centrum ASSIDUO a IBD centrum /ID# 126262, Bratislava

851 01

Gastroenterologicka ambulancia /ID# 137964, Bratislava

984 01

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

915 01

Poliklinika Libris /ID# 126222, Nové Mesto nad Váhom

08208

Hospital Parc Tauli de Sabadell /ID# 138124, Sabadell

08036

Hospital Clinic /ID# 127749, Barcelona

04201

Kyiv City Clinical Hospital No.8 /ID# 126232, Kiev

SE1 9RT

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

NR4 7UY

Norfolk and Norwich Univ Hosp /ID# 126197, Norwich

HU8 9HE

Hull University Teaching Hospitals NHS Trustust /ID# 126265, Hull

SO16 6YD

University Hospital Southampton NHS Fundation Trust /ID# 126225, Southampton

WV10 0QP

The Royal Wolverhampton NHS Tr /ID# 126201, Wolverhampton

Sponsors

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INDUSTRY