Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year

PHASE3CompletedINTERVENTIONAL
Enrollment

386

Participants

Timeline

Start Date

March 29, 2018

Primary Completion Date

December 15, 2020

Study Completion Date

May 21, 2021

Conditions
Crohn Disease
Interventions
BIOLOGICAL

Placebo for Ustekinumab

Participants will receive placebo as SC injection to blind adalimumab.

BIOLOGICAL

Placebo for Adalimumab

Participants will receive placebo as IV infusion to blind ustekinumab.

BIOLOGICAL

Ustekinumab (6 mg/kg)

Participants will receive ustekinumab 6 mg/kg (weight based dosing) as IV infusion.

BIOLOGICAL

Ustekinumab (90 mg)

Participants will self-administer SC injection of ustekinumab 90 mg.

BIOLOGICAL

Adalimumab (40 mg)

Participants will self-administer multiple SC injections of adalimumab (each 40 mg) and will receive total dose of 160 mg at Week 0, 80 mg at Week 2, and 40 mg q2w from Week 4 to 56.

Trial Locations (182)

168

Fondazione Policlinico Gemelli Università Cattolica, Roma

1134

Magyar Honvedseg Egeszsegugyi Kozpont, Budapest

1202

2-nd MHAT, Sofia

3000

UZ Leuven, Leuven

3004

Alfred Hospital, Melbourne

3168

Monash Health, Monash Medical Centre, Clayton

3526

Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz, Miskolc

4101

Mater Hospital Brisbane Inflammatory Bowel Diseases, South Brisbane

5011

The Queen Elizabeth Hospital, Woodville South

5800

UMHAT 'Dr. Georgi Stranski', EAD, Pleven

6008

St John of God Subiaco Hospital, Subiaco

7002

MHAT Rousse, Rousse

7500

CHwapi, Tournai

9000

UZ Gent, Ghent

9020

Diagnostic Consulting Center Mladost - M Varna, Varna

10021

Weill Cornell Medical College, New York

10029

Mount Sinai School of Medicine, New York

10032

Columbia University Medical Center, New York

10128

AO Ordine Mauriziano, Torino

11021

NYU Langone Long Island Clinical Research Associates, Great Neck

11080

Clinical Hospital Center Zemun, Belgrade

Clinical Hospital Center Zvezdara, Belgrade

Clinical Hospital Center Bezanijska Kosa, Zemun

12027

Saratoga Schenectady Gastroenterology Associates, Burnt Hills

12601

Premier Medical Group Of The Hudson Valley, Pc, Poughkeepsie

13620

Seoul National University Bundang Hospital, Seongnam-si

14642

University of Rochester Medical Center, Rochester

16247

The Catholic university of Korea, St. Vincent's Hospital, Gyeonggi-do

17007

Hosp. Univ. Dr. Josep Trueta, Girona

17033

Penn State Milton S. Hershey Medical Center, Hershey

18000

University Clinical Center NIS, Niš

20010

Medstar Washington Hospital Center, Washington D.C.

20089

Istituto Clinico Humanitas, Rozzano

20157

ASST Fatebenefratelli Sacco, Milan

20815

Chevy Chase Clinical Research, Chevy Chase

21000

Clinical Center of Vojvodina, Vojvodina

22031

Verity Research, Inc, Fairfax

22559

Asklepios Westklinikum, Hamburg

23229

McGuire VAMC, Richmond

23320

Gastroenterology Associates of Tidewater, Chesapeake

23434

Virginia Gastroenterology Institute, Suffolk

23502

Digestive And Liver Disease Specialists, Norfolk

24502

Gastroenterology Associates of Central Virginia, Lynchburg

27599

University of North Carolina at Chapel Hill, Chapel Hill

27609

Duke University Hospital Medical Center, Raleigh

28403

Wilmington Gastroenterology Associates, Wilmington

28801

Digestive Health Partners, Asheville

29615

Gastroenterology Associates P.A., Greenville

30024

Atlanta Gastroenterology Specialists, PC, Suwanee

30510

Centrum Medyczne Pratia Poznan, Krakow

31082

Clinique Ambroise Pare, Toulouse

32127

Advanced Medical Research Center, Port Orange

32605

Florida Research Network, LLC, Gainesville

32751

Center for Advanced Gastroenterology, Maitland

33011

Hosp. Univ. Central de Asturias, Oviedo

33331

Cleveland Clinic Florida, Weston

33612

Apex Clinical Research, Tampa

33756

Gastro Florida, Clearwater

33777

Florida Center For Gastroenterology, Largo

34000

University Clinical Center Kragujevac, Kragujevac

34102

Gastroenterology Group Of Naples, Naples

34295

CHRU Montpellier - Hopital Saint-Eloi, Montpellier

35128

Azienda Ospedaliera di Padova, Padua

36608

Alabama Medical Group, Mobile

37007

Hosp Clinico Univ de Salamanca, Salamanca

37212

Vanderbilt University Medical Center, Nashville

39008

Hosp. Univ. Marques de Valdecilla, Santander

40138

Policlinico Sant'Orsola Malpighi, Bologna

40202

University of Louisville, Louisville

41009

Hosp. Virgen Macarena, Seville

41017

Tri-State Gastroenterology Assoc, Crestview Hills

41701

Gastroenterology Associates Of Hazard, Hazard

42270

CHU Saint Etienne, Saint-Priest-en-Jarez

42415

Yeungnam University Hospital, Daegu

43210

Ohio State University Hospital, Columbus

44035

Hotel Dieu, Nantes

44060

Great Lakes Gastroenterology Research, LLC, Mentor

44106

University Hospitals Case Medical Center, Cleveland

44122

Northshore Gastroenterology Research, LLC, Beachwood

45242

TriHealth Digestive Institute, Cincinnati

45440

Dayton Gastroenterology, Inc, Dayton

47012

Hosp. Univ. Rio Hortega, Valladolid

48047

Clinical Research Institute of Michigan, LLC, Chesterfield

48151

MVZ Portal10, Münster

48197

Huron Gastroenterology Associates Center for Digestive Care, Ypsilanti

50009

Hosp. Univ. Miguel Servet, Zaragoza

55905

Mayo Clinic, Rochester

58103

Fargo Gastroenterology Clinic, PC, Fargo

63104

Saint Louis University Hospital, St Louis

63141

Mercy Clinic East Community, St Louis

67124

Health Science Research Center, Pratt

69120

Uniklinikum Heidelberg, Heidelberg

70360

CroNOLA, LLC, Houma

70809

Texas Digestive Disease Consultants, Baton Rouge

71105

Louisiana Research Center, LLC, Shreveport

73112

Digestive Disease Specialists Inc, Oklahoma City

75010

Hopital Saint Louis, Paris

75044

DHAT Research Institute, Garland

75701

Tyler Research Institute, LLC, Tyler

76092

Texas Digestive Disease Consultants, Southlake

77030

Baylor College of Medicine, Houston

University of Texas at Houston Medical School, Houston

77530

Aztec Clinical Research, Inc., Channelview

78229

Gastroenterology Research of America, LLC, San Antonio

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

80054

CHU Amiens, Amiens

80907

Peak Gastroenterology Associates, Colorado Springs

83404

Grand Teton Research Group, PLLC, Idaho Falls

90146

Ospedale Villa Sofia-Cervello, Palermo

92114

Precision Research Institute, San Diego

98004

Washington Gastroenterology, PLLC, Bellevue

98125

AOU Policlinico G.Martino, Messina

98405

Washington Gastroenterology, PLLC, Tacoma

129090

GU Moscow Regional Research Clinical Institute n.a. M.F.Vla, Moscva

195257

Elizavetinskaya hospital, Saint Petersburg

197110

City Clinical Hospital #31, Saint Petersburg

344022

Rostov State Medical University, Rostov-on-Don

450005

GBUZ Respublican Clinical Hospital n.a. GG Kuvatova, Ufa

450071

City Clinical Hospital # 21, Ufa

620109

OOO MO New Hospital, Yekaterinburg

664079

Irkutsk State Medical Academy of Postgraduate Education, Irkutsk

06606

Gastro Associates of Fairfield County PC, Bridgeport

06810

Western Connecticut Health Network/Danbury Hospital, Danbury

15212-4756

Allegheny-Singer Research Institute, Pittsburgh

30130-100

Hospital Das Clinicas Da Ufmg, Belo Horizonte - MG

74535-170

Inst Goiano Gastroenterologia e Endoscopia Digest Ltda - Clinica de Gastro, Goiânia

36033-318

Endogastro Clínica de Gastroenterologia e Endoscopia Digestiva Lida, Juiz de Fora

90035-903

Hospital das Clinicas de Porto Alegre, Porto Alegre

14098-900

Hospital Das Clinicas Da Faculdade De Medicina De RPUSP HCRP, Ribeirão Preto

21941-590

Universidade Federal do Rio de Janeiro - Faculdade de Medicina, Rio de Janeiro

CEP: 22031-010

Hospital Copa D'Or, Rio de Janeiro

09060 870

Fundacao do ABC Centro Universitario FMABC, Santo André

T2N4Z6

University of Calgary, Calgary

L8S 4K1

McMaster University, Hamilton

N6A 5A5

London Health Sciences Centre, London

J4V 2H1

CISSS de la Monteregie Centre, Greenfield Park

H7P 3E5

CMIIM, Centre médical L'Enjeu, Mount Royal

656 91

Fakultní nemocnice u sv. Anny v Brn, Brno

268 31

Nemocnice Horovice, a.s., Hořovice

500 12

Hepato-gastroenterologie HK, s.r.o., Hradec Králové

100 34

Fakultni nemocnice Kralovske Vinohrady, Prague

190 00

ISCARE a.s., Prague

H-5600

Réthy Pál Kórház - Rendelőintézet, Békéscsaba

H-1088

Semmelweis Egyetem, Budapest

H-4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

H-9700

Markusovszky Egyetemi Oktatokorhaz, Szombathely

Unknown

Azienda Ospedaliera G.Salvini Ospedale di Rho, Rho

00133

Azienda Ospedaliera Universitaria 'Policlinico Tor Vergata', Roma

00135

Azienda Complesso Ospedaliero San Filippo Neri, Roma

1081 HV

VUMC Amsterdam, Amsterdam

6815 AD

Rijnstate Ziekenhuis, Arnhem

9713 GZ

UMCG, Groningen

2333 ZA

Leiden University Medical Center, Leiden

6525 GA

Radboudumc, Nijmegen

3045 PM

Sint Franciscus Gasthuis, Rotterdam

3083 AN

Ikazia Ziekenhuis, Rotterdam

15-322

Gastromed Kralisz Romatowski Stachurska Sp. j., Bialystok

80 382

Synexus Polska Sp z o o, Gdansk

30 363

Centrum Medyczne Plejady, Krakow

90-153

Uniwersytecki Szpital Kliniczny nr 1 im. N. Barlickiego, Lodz

20 954

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie Oddzial Gastroenterologii, Lublin

35-326

Centrum Medyczne Medyk, Rzeszów

81 756

Endoskopia Sp z o o z siedziba w Sopocie, Sopot

02-507

Centralny Szpital Kliniczny MSWiA w Warszawie, Warsaw

03 580

Niepubliczny Zaklad Opieki Zdrowotnej Vivamed Jadwiga Miecz, Warsaw

03-712

Gabinety Lekarskie Bodyclinic, Warsaw

50 449

Melita Medical Sp. z o.o., Wroclaw

22-400

ETG Zamosc, Zamość

03080

Seoul National University Hospital, Seoul

05505

Asan Medical Center, Seoul

06351

Samsung Medical Center, Seoul

120-752

Severance Hospital Yonsei University Health System, Seoul

08003

Hosp. Del Mar, Barcelona

08025

Hosp. de La Santa Creu I Sant Pau, Barcelona

08208

Corporacio Sanitari Parc Tauli, Sabadell

BA1 3NG

Royal United Hospital, Bath

BL9 7TD

Pennine Acute Hospitals-Fairfield General Hospital, Bury

KT2 7QB

Kingston Hospital, Kingston upon Thames

SE1 7EH

Guy's and St Thomas' Hospital, London

SW17 0QT

St George's Hospital, London

SO16 6YD

Southampton University Hospitals NHS Trust, Southampton

TA1 5DA

Musgrove Park Hospital, Taunton

All Listed Sponsors
lead

Janssen Scientific Affairs, LLC

INDUSTRY

NCT03464136 - Safety and Efficacy of Adalimumab Versus Ustekinumab for One Year | Biotech Hunter | Biotech Hunter