Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab

PHASE3CompletedINTERVENTIONAL
Enrollment

500

Participants

Timeline

Start Date

April 19, 2017

Primary Completion Date

April 30, 2020

Study Completion Date

July 20, 2021

Conditions
Crohn Disease
Interventions
DRUG

Ustekinumab

Participants will receive IV induction treatment with ustekinumab on a weight-tiered basis at a dose of approximately 6 milligram per kilogram (mg/kg) IV. At Week 8, all participants will receive a 90 mg SC injection of ustekinumab. During the routine care maintenance treatment period, in case of clinical worsening reported by the participant, consistent with disease flare in the investigator's judgment, clinical assessments of disease flare will be performed at the investigator's discretion.

Trial Locations (107)

168

Fondazione Policlinico Gemelli Università Cattolica, Roma

1090

UZ Brussel, Brussels

1200

Cliniques Universitaires Saint Luc, Brussels

2018

GZA Ziekenhuizen, Antwerp

2170

Algemeen Ziekenhuis Jan Palfijn Merksem, Merksem

2400

Abdominalcenter K, København NV

2650

Universitair Ziekenhuis Antwerpen, Edegem

2820

Imelda Ziekenhuis, Bonheiden

3000

UZ Leuven, Leuven

3010

Hosp. Gral. Univ. de Alicante, Alicante

4000

CHC MontLegia, Liège

CHU de Liege, Liège

5000

Odense Universitetshospital, Odense

6202

CHU de Nice Hopital de l Archet, Nice

7100

Vejle Sygehus, Vejle

8400

AZ Damiaan, Ostend

8500

Az Groeninge, Kortrijk

8600

Silkeborg Hospital, Silkeborg

9000

AZ Maria Middelares, Ghent

UZ Gent, Ghent

9100

Aalborg University Hospital, Aalborg

10128

AO Ordine Mauriziano, Torino

11281

Medicinkliniken, Stockholm

13000

EGK s.r.o. - Sanatorium sv. Anny, Prague

13353

Charite Universitatsmedizin Berlin Campus Virchow Klinikum, Berlin

14004

Hosp Reina Sofia, Córdoba

15000

AXON Clinical s.r.o., Prague

15405

Hosp. Arquitecto Marcide, Ferrol

20089

Istituto Clinico Humanitas, Rozzano

20097

IRCCS Policlinico San Donato, San Donato Milanese

20122

Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico, Milan

20157

ASST Fatebenefratelli Sacco, Milan

21339

Staedtisches Klinikum Lueneburg, Lüneburg

28006

Hosp. Univ. de La Princesa, Madrid

28007

Hosp. Gral. Univ. Gregorio Maranon, Madrid

28046

Hosp. Univ. La Paz, Madrid

30625

Medizinische Hochschule Hannover, Hanover

31059

CHU Rangueil, Toulouse

33100

Azienda Sanitaria Universitaria Integrata di Udine, Udine

33600

CHU Bordeaux, Pessac

34295

CHU Saint Eloi, Montpellier

37024

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar, Negrar (VR)

38700

CHU Grenoble, La Tronche

40138

Policlinico Sant'Orsola Malpighi, Bologna

41013

Hosp. Virgen Del Rocio, Seville

42270

CHU Saint Etienne, Saint-Priest-en-Jarez

46010

Hosp. Clinico Univ. de Valencia, Valencia

46026

Hosp. Univ. I Politecni La Fe, Valencia

46940

Hosp. de Manises, Manises

48151

MVZ Portal10, Münster

50009

Hosp. Clinico Univ. Lozano Blesa, Zaragoza

54511

CHU-Nancy, Vandœuvre-lès-Nancy

59037

Hopital Claude Huriez, Lille

60431

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus, Frankfurt

68167

Universitaetsklinikum Mannheim, Mannheim

69495

Hospices Civils de Lyon HCL, Pierre-Bénite

75010

Hopital Saint Louis, Paris

90146

Ospedale Villa Sofia-Cervello, Palermo

92110

Hopital Beaujon, Clichy

94270

Hopital de Bicetre, Le Kremlin-Bicêtre

500 05

Fakultni nemocnice Hradec Kralove, Hradec Králové

500 12

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

186 00

MEDIENDO s.r.o., Prague

190 00

ISCARE a.s., Prague

DK-8000

Aarhus Kommunehospital, Aarhus C

Unknown

Policlinico di Bari Ospedale Giovanni XXIII, Bari

Azienda Ospedaliera G.Salvini Ospedale di Rho, Rho

00152

Azienda Ospedaliera San Camillo - Roma, Roma

3813 TZ

Meander Medisch Centrum, Amersfoort

1105 AZ

AMC, Amsterdam

3318 AT

Albert Schweitzer Ziekenhuis, Dordrecht

4200 AB

Rivas Zorggroep, Beatrixziekenhuis, Gorinchem

9713 GZ

UMCG, Groningen

3015 CE

Erasmus MC, Rotterdam

3000-075

Centro Hospitalar e Universitário de Coimbra, EPE, Coimbra

8000-386

Centro Hospitalar e Universitário do Algarve, Faro

1169-050

Centro Hospitalar Lisboa Central, EPE - Hospital Santo Antonio dos Capuchos, Lisbon

1649-035

Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria, Lisbon

4099 001

Centro Hospitalar do Porto, EPE, Porto

4200 319

Centro Hospitalar de Sao Joao Epe, Porto

3504-509

Centro Hospitalar de Tondela Viseu, EPE, Viseu

975 17

FNsP F.D.R. Banska Bystrica, Banská Bystrica

085 01

Gastroenterology Department GASTROMART s.r.o., Bardejov

811 08

Gastroenterology Center ASSIDUO, Bratislava

851 07

University Hospital in Bratislava, St. Cyril and Method Hospital, Bratislava

949 01

KM Management spol. s r.o., Nitra

080 01

GASTRO I. s.r.o., Prešov

093 01

Gastroenterology Department ENDOMED, s.r.o., Vranov nad Topľou

08916

Hosp. Univ. Germans Trias I Pujol, Badalona

08036

Hosp Clinic de Barcelona, Barcelona

08907

Hosp. Univ. de Bellvitge, L'Hospitalet de Llobregat

07120

Hosp. Univ. Son Espases, Palma de Mallorca

SE-22185

Skane University Hospital, Lund

SE-17176

Karolinska University Hospital, Solna

SE-11828

Danderyd Hospital, Stockholm

BT12 6BA

Royal Victoria Hospital, Belfast

DL3 6HX

County Durham and Darlington NHS Foundation Trust, Darlington

DD1 9SY

Ninewells Hospital, Dundee

G4 0SF

Glasgow Royal Infirmary, Glasgow

E1 1BB

Royal London Hospital, London

SE1 7EH

Guys St Thomas Hospital, London

SE5 9RS

Kings College Hospital NHS Trust, London

SW17 0QT

St George's University Hospital NHS Foundation Trust, London

L35 5DR

Whiston Hospital, Prescot

M6 8HD

Salford Royal NHS Foundation Trust, Salford

SO16 6YD

Southampton University Hospital, Southampton

TA1 5DA

Musgrove Park Hospital, Taunton

All Listed Sponsors
lead

Janssen-Cilag Ltd.

INDUSTRY

NCT03107793 - Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab | Biotech Hunter | Biotech Hunter