A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease

PHASE3CompletedINTERVENTIONAL
Enrollment

215

Participants

Timeline

Start Date

December 20, 2018

Primary Completion Date

August 19, 2022

Study Completion Date

January 10, 2023

Conditions
Crohn Disease
Interventions
DRUG

Ustekinumab approximately 6 mg/kg (IV)

Participants will receive ustekinumab approximately 6mg/kg intravenously at Week 0.

DRUG

Placebo (SC)

Participants will receive SC injection of placebo at Week 0.

DRUG

Placebo (IV)

Participants will receive IV infusion of placebo at Week 0.

DRUG

Ustekinumab 90 mg (SC) Group 1

Participants will receive SC injection of ustekinumab 90 mg at Weeks 8 and 16.

DRUG

Ustekinumab 90 mg (SC) Group 2

Participants will receive SC injection of ustekinumab 90 mg at Weeks 0, 8 and 16.

Trial Locations (104)

168

Fondazione Policlinico Gemelli Università Cattolica, Roma

1020

Krankenhaus der Barmherzigen Brüder, Vienna

1090

Medizinische Universitaet Wien, Vienna

1307

University Hospital Dresden, Dresden

10029

Mount Sinai School of Medicine, New York

10128

AO Ordine Mauriziano, Torino

10825

GASTRO-Studien, Berlin

12203

Charite - Universitaetsmedizin Berlin (CCM), Berlin

15405

Hosp. Arquitecto Marcide, Ferrol

18288

Gastromottagningen, Stockholm

20089

Istituto Clinico Humanitas, Rozzano

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20251

Hamburgisches Forschungsinstitut fuer CED, HaFCED e.K., Hamburg

20502

Gastromottagningen, Malmo

20815

Chevy Chase Clinical Research, Chevy Chase

21339

Staedtisches Klinikum Lueneburg, Lüneburg

24105

Universitatsklinikum Schleswig Holstein Kiel, Kiel

26123

Praxis Dr. med. Ulf Helwig, Oldenburg

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28046

Hosp. Univ. La Paz, Madrid

28922

Hosp. Univ. Fundacion Alcorcon, Alcorcón

29010

Hosp Virgen de La Victoria, Málaga

29425

Medical University of South Carolina, Charleston

30024

Atlanta Gastroenterology Specialists, Suwanee

30120

Hosp. Univ. Virgen de La Arrixaca, Murcia

30322

Emory University, Atlanta

31008

Hosp. de Navarra, Pamplona

32224

Mayo Clinic Jacksonville, Jacksonville

32423

Gastroenterologische Gemeinschaftspraxis Minden, Minden

32605

Florida Research Network, LLC, Gainesville

32803

Advent Health, Orlando

33613

Florida Hospital Tampa, Tampa

34117

Gastroenterologie Opernstrasse, Kassel

34295

CHRU Montpellier - Hopital Saint-Eloi, Montpellier

35033

CHRU Hopital de Pontchaillou, Rennes

36071

Hosp. Montecelo, Pontevedra

36213

Hosp. Alvaro Cunqueiro, Vigo

37007

Hosp Clinico Univ de Salamanca, Salamanca

37212

Vanderbilt University Medical Center, Nashville

39008

Hosp. Univ. Marques de Valdecilla, Santander

39120

Universitätsklinikum Otto-von-Guericke-Universität Magdeburg, Magdeburg

39202

University of Mississippi Medical Center, Jackson

40536

University of Kentucky Chandler Medical Center, Lexington

43026

Ohio State University Hospital, Hilliard

44145

Northshore Gastroenterology Research, LLC, Westlake

46010

Hosp. Clinico Univ. de Valencia, Valencia

48108

Inje University Haeundae Paik Hospital, Busan

50009

Hosp. Clinico Univ. Lozano Blesa, Zaragoza

Hosp. Univ. Miguel Servet, Zaragoza

54511

CHU de Nancy_ Hopital Brabois, Vandœuvre-lès-Nancy

59037

CHRU de Lille Hopital Claude Huriez, Lille

60431

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus, Frankfurt

60590

Universitatsklinikum Frankfurt/ Medizinische Klinik 1, Frankfurt

63110

Washington University School Of Medicine, St Louis

66111

Zentrum für Gastroenterologie Saar MVZ GmbH, Saarbrücken

68167

Medizinische Fakultät Mannheim der Universität Heidelberg, Mannheim

69495

Hospices Civils de Lyon HCL, Pierre-Bénite

72076

Universitaetsklinik Tuebingen, Tübingen

73112

Oklahoma Digestive Disease Specialists, Oklahoma City

75571

CHU Hopital Saint Antoine, Paris

75701

Tyler Research Institute, LLC, Tyler

77025

Baylor College of Medicine, Houston

78229

Gastroenterology Research of America, LLC, San Antonio

78613

Texas Digestive Disease Consultants, Cedar Park

79106

Universitatsklinikum Freiburg, Freiburg im Breisgau

80907

Peak Gastroenterology Associates, Colorado Springs

81377

Klinikum der Universitaet Muenchen, München

85221

Medizinisches Versorgungszentrum (MVZ) Dachau, Dachau

89081

Universitaetsklinikum Ulm, Klinik fuer Innere Medizin II, Ulm

90146

Ospedale Villa Sofia-Cervello, Palermo

92093

University of California, San Diego, La Jolla

92110

Hopital Beaujon, Clichy

98101

Virginia Mason Medical Center, Seattle

98195

University of Washington, Seattle

98405

Washington Gastroenterology, PLLC, Tacoma

105554

Olla-Med, Llc, Moscow

197110

City Clinical Hospital #31, Saint Petersburg

450005

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

664079

Irkutsk State Medical Academy of Postgraduate Education, Irkutsk

30342-5020

Atlanta Gastroenterology Associates, (AGA) LLC - Emory Saint Joseph's, Atlanta

02115

Brigham And Women's Hospital, Boston

77030-2740

Houston Methodist Hospital, Houston

500 12

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

190 00

ISCARE a.s., Prague

D-86158

Klinikum Augsburg, Augsburg

06120

Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH, Halle

Unknown

Azienda Ospedaliera G.Salvini Ospedale di Rho, Rho

1091 AC

Onze Lieve Vrouwe Gasthuis, Amsterdam

2333 ZA

Leiden University Medical Center, Leiden

6229 HX

Maastricht Universitair Medisch Centrum, Maastricht

6525 GA

Radboudumc, Nijmegen

3015 GD

Erasmus MC, Rotterdam

3045 PM

Sint Franciscus Gasthuis, Rotterdam

03080

Seoul National University Hospital, Seoul

03722

Severance Hospital Yonsei University Health System, Seoul

05505

Asan Medical Center, Seoul

102-1703

KyungHee University Hospital, Seoul

08208

Corporacio Sanitari Parc Tauli, Sabadell

BL9 7TD

Pennine Acute Hospitals-Fairfield General Hospital, Bury

GL53 7AN

Gloucestershire Hospitals NHS Foundation Trust - Cheltenham, Cheltenham

EX2 5DW

Royal Devon & Exeter Hospital, Exeter

SE5 9RS

King's College Hospital NHS Foundation Trust, London

SW17 OQT

St George's Hospital, London

SO16 6YD

Southampton University Hospitals NHS Trust, Southampton

All Listed Sponsors
lead

Janssen-Cilag Ltd.

INDUSTRY

NCT03782376 - A Study to Evaluate Efficacy and Safety of Ustekinumab Re-induction Therapy in Participants With Moderately to Severely Active Crohn's Disease | Biotech Hunter | Biotech Hunter