Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
STARDUST
3 other identifiers
interventional
500
12 countries
107
Brief Summary
The purpose of this study is to evaluate the efficacy of a treat to target strategy coupled with early endoscopic assessment versus a clinically driven (routine care) approach in achieving endoscopic response.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2017
Typical duration for phase_3
107 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 28, 2017
CompletedFirst Posted
Study publicly available on registry
April 11, 2017
CompletedStudy Start
First participant enrolled
April 19, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2020
CompletedResults Posted
Study results publicly available
May 19, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
July 20, 2021
CompletedApril 29, 2025
April 1, 2025
3 years
March 28, 2017
April 28, 2021
April 25, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Percentage of Participants With Endoscopic Response at Week 48
Endoscopic response defined as showing a reduction from baseline in simple endoscopic score for Crohn's disease (SES-CD) of greater than or equal to (\>=) 50 percent (%). SES-CD is a validated instrument reflecting an endoscopist global appraisal of mucosal lesions in Crohn's disease. SES-CD grades lesions by location (5 bowel segments: ileum, right colon, transverse colon, left colon, and rectum) using 4 endoscopic variables: ulcer size, extent of ulcerated surface, extent of affected surface, and presence/type of narrowing. Total SES-CD is sum of 4 variables for all 5 bowel segments. Scores range from 0-60 with higher scores indicating more severe disease. Randomized participants who stopped treatment before reaching Week 48 due to any reason, or participants without endoscopic data at Week 48 were analyzed as nonresponders.
Week 48
Secondary Outcomes (23)
Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded)
Week 48
Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF])
Week 48 (LOCF)
Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF])
Weeks 16, 48, and Endpoint (Week 48 [LOCF])
Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF])
Weeks 16, 48, and Endpoint (Week 48 [LOCF])
Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF])
Weeks 16, 48, and Endpoint (Week 48 [LOCF])
- +18 more secondary outcomes
Study Arms (4)
All Participants
EXPERIMENTALAt Week (Wk) 0, all eligible participants will initiate intravenous (IV) induction treatment with ustekinumab (UST) on a weight-tiered basis at a dose of approximately 6 milligram per kilogram (mg/kg). At Week 8, all participants will receive a 90 milligram (mg) subcutaneous (SC) injection of ustekinumab. At Week 16, participants who do not achieve a Crohn's Disease Activity Index (CDAI) improvement of greater than or equal to (\>=) 70 points versus Week 0 (CDAI 70) will leave the study. Remaining participants will be randomized in a 1:1 ratio to either one of two arms for open label maintenance treatment up to Week 48: the treat to target arm or the routine care arm. From Week 48, participants will continue ustekinumab treatment in the study extension period, up to Week 104. Dosing frequency will be adjusted in the extension period for the participants failing to meet the treatment target.
Routine Care Arm
EXPERIMENTALIn the routine care arm, assessment visits will be scheduled according to the timing of maintenance treatment injections up to Week 48, which will be in compliance with the EU SmPC for ustekinumab for the treatment of Crohn's disease, in which dosing every 12 weeks is recommended. At Week 16, (that is, 8 weeks after the first SC dose) participants continuing in the study will have demonstrated a CDAI-70 response. Nonetheless, participants who have not shown adequate response based on the investigator's judgment may receive a second SC dose at Week 16. 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.
Treat to Target (T2T) Arm
EXPERIMENTALUST maintenance treatment assignment will be based on centrally-read colonoscopy (at Wk16). Participants with \<25% improvement in SES-CD score at Wk16 will be assigned to Q8 (8-weekly) treatment and will receive UST 90mg SC at Wk16. In contrast, participants with \>=25% improvement in SES-CD score at Wk16 will be assigned to Q12 treatment and will receive next UST dose (90 mg SC) at Wk20. At assessment visits (from Wk24 for participants assigned to the Q8 regimen or from Wk20 for the Q12 group) UST maintenance treatment (up to Wk 48) will be directed by T2T assessments. Participants meeting target will continue with same UST dosing frequency. The dosing frequency will be optimized for all participants failing to meet the target at assessment visit. Those previously on Q12 regimens will be adjusted to Q8 dosing; those previously on Q8 regimens will be adjusted to Q4 dosing. Participants subsequently failing to meet the target will not be able to adjust further and will leave the study.
Exploratory Extension period: From Week 48 to Week 104
EXPERIMENTALAt Week 48, dose de-escalation will be implemented for participants with both endoscopic remission (SES-CD score \<=2) and corticosteroid-free clinical remission of at least 16 weeks duration. Participants receiving 12 weekly dosing frequency (Q12) ustekinumab will maintain this dosing frequency. Participants with either clinical remission or endoscopic remission, but not both, at Week 48 will continue with same dosing frequency or de-escalate provided maintenance of corticosteroid-free clinical remission and biomarker remission at 2 consecutive visits. Participants with neither corticosteroid-free clinical remission nor endoscopic remission will escalate dose or leave study if already on 4 weekly dosing frequency (Q4) dose. If neither clinical remission nor biomarker remission is evident at the next visit, participant will leave study. Later in the extension period, only those who achieve corticosteroid-free clinical remission and biomarker remission will undergo dose de-escalation.
Interventions
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.
Eligibility Criteria
You may qualify if:
- Main Study:
- Have active, moderate to severe, ileal and/or colonic Crohn's disease, demonstrated by: baseline CDAI score of greater than or equal to (\>=) 220 and less than equal to (\<=) 450, and endoscopy with evidence of active Crohn's disease (defined as simple endoscopic score for Crohn's disease \[SES-CD\] score \>=3 excluding the contribution of the narrowing component score) obtained within the 5 week screening period. A prior endoscopy may be used only if obtained within 3 months prior to baseline (Week 0), in which case the prior endoscopy must be centrally read again and SES-CD calculated based on this second, centralized read-out
- Has had an inadequate response with, lost response to, was intolerant to, or had medical contraindications to either conventional therapy, or one previous biologic therapy approved for the treatment of Crohn's disease in the countries in which the study is conducted
- Are eligible according to tuberculosis (TB) infection screening criteria
- Must sign an informed consent form (ICF) or their legally acceptable representative if applicable must sign) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study.
- Sub-study:
- Be enrolled into the main study at a participating site
- Sign a separate ICF indicating that they understand the purpose of and procedures required for this sub-study and are willing to participate in the sub-study
You may not qualify if:
- Main Study:
- Has complications of Crohn's disease such as symptomatic strictures or stenoses, short gut syndrome, or any other manifestation that might be anticipated to require surgery, could preclude the use of the Crohn's Disease Activity Index (CDAI) to assess response to therapy, or would possibly confound the ability to assess the effect of treatment with ustekinumab
- Has had any kind of bowel resection within 6 months prior to baseline
- Has a draining (i.e, functioning) stoma or ostomy
- Has received more than one previous biologic therapy approved for the treatment of Crohn's disease in the countries in which the study is conducted
- Sub-study:
- Obesity or other characteristics considered likely to preclude intestinal ultrasound (IUS) visualization of the affected bowel segment
- Normal bowel wall thickness (BWT) (that is, \<=2.0 millimeter \[mm\] for the terminal ileum; \<=3.0 mm for the colon) for all bowel segments at baseline (Week 0)
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (107)
GZA Ziekenhuizen
Antwerp, 2018, Belgium
Imelda Ziekenhuis
Bonheiden, 2820, Belgium
UZ Brussel
Brussels, 1090, Belgium
Cliniques Universitaires Saint Luc
Brussels, 1200, Belgium
Universitair Ziekenhuis Antwerpen
Edegem, 2650, Belgium
AZ Maria Middelares
Ghent, 9000, Belgium
UZ Gent
Ghent, 9000, Belgium
Az Groeninge
Kortrijk, 8500, Belgium
UZ Leuven
Leuven, 3000, Belgium
CHC MontLegia
Liège, 4000, Belgium
CHU de Liege
Liège, 4000, Belgium
Algemeen Ziekenhuis Jan Palfijn Merksem
Merksem, 2170, Belgium
AZ Damiaan
Ostend, 8400, Belgium
Fakultni nemocnice Hradec Kralove
Hradec Králové, 500 05, Czechia
Hepato-gastroenterologie HK, s.r.o.
Hradec Králové, 500 12, Czechia
EGK s.r.o. - Sanatorium sv. Anny
Prague, 13000, Czechia
AXON Clinical s.r.o.
Prague, 15000, Czechia
MEDIENDO s.r.o.
Prague, 186 00, Czechia
ISCARE a.s.
Prague, 190 00, Czechia
Aalborg University Hospital
Aalborg, 9100, Denmark
Aarhus Kommunehospital
Aarhus C, DK-8000, Denmark
Abdominalcenter K
København NV, 2400, Denmark
Odense Universitetshospital
Odense, 5000, Denmark
Silkeborg Hospital
Silkeborg, 8600, Denmark
Vejle Sygehus
Vejle, 7100, Denmark
Hopital Beaujon
Clichy, 92110, France
CHU Grenoble
La Tronche, 38700, France
Hopital de Bicetre
Le Kremlin-Bicêtre, 94270, France
Hopital Claude Huriez
Lille, 59037, France
CHU Saint Eloi
Montpellier, 34295, France
CHU de Nice Hopital de l Archet
Nice, 6202, France
Hopital Saint Louis
Paris, 75010, France
CHU Bordeaux
Pessac, 33600, France
Hospices Civils de Lyon HCL
Pierre-Bénite, 69495, France
CHU Saint Etienne
Saint-Priest-en-Jarez, 42270, France
CHU Rangueil
Toulouse, 31059, France
CHU-Nancy
Vandœuvre-lès-Nancy, 54511, France
Charite Universitatsmedizin Berlin Campus Virchow Klinikum
Berlin, 13353, Germany
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Frankfurt, 60431, Germany
Medizinische Hochschule Hannover
Hanover, 30625, Germany
Staedtisches Klinikum Lueneburg
Lüneburg, 21339, Germany
Universitaetsklinikum Mannheim
Mannheim, 68167, Germany
MVZ Portal10
Münster, 48151, Germany
Policlinico di Bari Ospedale Giovanni XXIII
Bari, Italy
Policlinico Sant'Orsola Malpighi
Bologna, 40138, Italy
Fondazione IRCCS Ca Granda Ospedale Maggiore Policlinico
Milan, 20122, Italy
ASST Fatebenefratelli Sacco
Milan, 20157, Italy
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
Negrar (VR), 37024, Italy
Ospedale Villa Sofia-Cervello
Palermo, 90146, Italy
Azienda Ospedaliera G.Salvini Ospedale di Rho
Rho, Italy
Azienda Ospedaliera San Camillo - Roma
Roma, 00152, Italy
Fondazione Policlinico Gemelli Università Cattolica
Roma, 168, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
IRCCS Policlinico San Donato
San Donato Milanese, 20097, Italy
AO Ordine Mauriziano
Torino, 10128, Italy
Azienda Sanitaria Universitaria Integrata di Udine
Udine, 33100, Italy
Meander Medisch Centrum
Amersfoort, 3813 TZ, Netherlands
AMC
Amsterdam, 1105 AZ, Netherlands
Albert Schweitzer Ziekenhuis
Dordrecht, 3318 AT, Netherlands
Rivas Zorggroep, Beatrixziekenhuis
Gorinchem, 4200 AB, Netherlands
UMCG
Groningen, 9713 GZ, Netherlands
Erasmus MC
Rotterdam, 3015 CE, Netherlands
Centro Hospitalar e Universitário de Coimbra, EPE
Coimbra, 3000-075, Portugal
Centro Hospitalar e Universitário do Algarve
Faro, 8000-386, Portugal
Centro Hospitalar Lisboa Central, EPE - Hospital Santo Antonio dos Capuchos
Lisbon, 1169-050, Portugal
Centro Hospitalar Lisboa Norte EPE Hosp. Santa Maria
Lisbon, 1649-035, Portugal
Centro Hospitalar do Porto, EPE
Porto, 4099 001, Portugal
Centro Hospitalar de Sao Joao Epe
Porto, 4200 319, Portugal
Centro Hospitalar de Tondela Viseu, EPE
Viseu, 3504-509, Portugal
FNsP F.D.R. Banska Bystrica
Banská Bystrica, 975 17, Slovakia
Gastroenterology Department GASTROMART s.r.o.
Bardejov, 085 01, Slovakia
Gastroenterology Center ASSIDUO
Bratislava, 811 08, Slovakia
University Hospital in Bratislava, St. Cyril and Method Hospital
Bratislava, 851 07, Slovakia
KM Management spol. s r.o.
Nitra, 949 01, Slovakia
GASTRO I. s.r.o.
Prešov, 080 01, Slovakia
Gastroenterology Department ENDOMED, s.r.o.
Vranov nad Topľou, 093 01, Slovakia
Hosp. Gral. Univ. de Alicante
Alicante, 3010, Spain
Hosp. Univ. Germans Trias I Pujol
Badalona, 08916, Spain
Hosp Clinic de Barcelona
Barcelona, 08036, Spain
Hosp Reina Sofia
Córdoba, 14004, Spain
Hosp. Arquitecto Marcide
Ferrol, 15405, Spain
Hosp. Univ. de Bellvitge
L'Hospitalet de Llobregat, 08907, Spain
Hosp. Univ. de La Princesa
Madrid, 28006, Spain
Hosp. Gral. Univ. Gregorio Maranon
Madrid, 28007, Spain
Hosp. Univ. La Paz
Madrid, 28046, Spain
Hosp. de Manises
Manises, 46940, Spain
Hosp. Univ. Son Espases
Palma de Mallorca, 07120, Spain
Hosp. Virgen Del Rocio
Seville, 41013, Spain
Hosp. Clinico Univ. de Valencia
Valencia, 46010, Spain
Hosp. Univ. I Politecni La Fe
Valencia, 46026, Spain
Hosp. Clinico Univ. Lozano Blesa
Zaragoza, 50009, Spain
Skane University Hospital
Lund, SE-22185, Sweden
Karolinska University Hospital
Solna, SE-17176, Sweden
Medicinkliniken
Stockholm, 11281, Sweden
Danderyd Hospital
Stockholm, SE-11828, Sweden
Royal Victoria Hospital
Belfast, BT12 6BA, United Kingdom
County Durham and Darlington NHS Foundation Trust
Darlington, DL3 6HX, United Kingdom
Ninewells Hospital
Dundee, DD1 9SY, United Kingdom
Glasgow Royal Infirmary
Glasgow, G4 0SF, United Kingdom
Royal London Hospital
London, E1 1BB, United Kingdom
Guys St Thomas Hospital
London, SE1 7EH, United Kingdom
Kings College Hospital NHS Trust
London, SE5 9RS, United Kingdom
St George's University Hospital NHS Foundation Trust
London, SW17 0QT, United Kingdom
Whiston Hospital
Prescot, L35 5DR, United Kingdom
Salford Royal NHS Foundation Trust
Salford, M6 8HD, United Kingdom
Southampton University Hospital
Southampton, SO16 6YD, United Kingdom
Musgrove Park Hospital
Taunton, TA1 5DA, United Kingdom
Related Publications (4)
Hasskamp J, Meinhardt C, Timmer A. Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease. Cochrane Database Syst Rev. 2025 May 13;5(5):CD007572. doi: 10.1002/14651858.CD007572.pub4.
PMID: 40357993DERIVEDPeyrin-Biroulet L, Vermeire S, D'Haens G, Panes J, Dignass A, Magro F, Nazar M, Le Bars M, Lahaye M, Ni L, Bravata I, Lavie F, Daperno M, Lukas M, Armuzzi A, Lowenberg M, Gaya DR, Danese S. Clinical trial: Clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease: Results from the long-term extension period of STARDUST. Aliment Pharmacol Ther. 2024 Jan;59(2):175-185. doi: 10.1111/apt.17751. Epub 2023 Nov 30.
PMID: 38036946DERIVEDKucharzik T, Wilkens R, D'Agostino MA, Maconi G, Le Bars M, Lahaye M, Bravata I, Nazar M, Ni L, Ercole E, Allocca M, Machkova N, de Voogd FAE, Palmela C, Vaughan R, Maaser C; STARDUST Intestinal Ultrasound study group. Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease. Clin Gastroenterol Hepatol. 2023 Jan;21(1):153-163.e12. doi: 10.1016/j.cgh.2022.05.055. Epub 2022 Jul 14.
PMID: 35842121DERIVEDDanese S, Vermeire S, D'Haens G, Panes J, Dignass A, Magro F, Nazar M, Le Bars M, Lahaye M, Ni L, Bravata I, Lavie F, Daperno M, Lukas M, Armuzzi A, Lowenberg M, Gaya DR, Peyrin-Biroulet L; STARDUST study group. Treat to target versus standard of care for patients with Crohn's disease treated with ustekinumab (STARDUST): an open-label, multicentre, randomised phase 3b trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):294-306. doi: 10.1016/S2468-1253(21)00474-X. Epub 2022 Feb 1.
PMID: 35120656DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- European Medicines Agency (EMEA) Advisor-Immunology
- Organization
- Janssen-Cilag International N.V.
Study Officials
- STUDY DIRECTOR
Janssen Cilag Ltd. Clinical Trial
Janssen-Cilag Ltd.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 28, 2017
First Posted
April 11, 2017
Study Start
April 19, 2017
Primary Completion
April 30, 2020
Study Completion
July 20, 2021
Last Updated
April 29, 2025
Results First Posted
May 19, 2021
Record last verified: 2025-04