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

Primary Purpose

Crohn Disease

Status

Completed

Phase

Phase 3

Locations

International

Study Type

Interventional

Intervention

Ustekinumab

About this trial

This is an interventional treatment trial for Crohn Disease

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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
Satisfy all inclusion criteria and none of the exclusion criteria specified in the main study

Exclusion Criteria:

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
Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified
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)

Sites / Locations

GZA Ziekenhuizen
Imelda Ziekenhuis
UZ Brussel
Cliniques Universitaires Saint-Luc
Universitair Ziekenhuis Antwerpen
AZ Maria Middelares
UZ Gent
Az Groeninge
UZ Leuven
CHC MontLegia
CHU de Liège
Algemeen Ziekenhuis Jan Palfijn Merksem
AZ Damiaan
Fakultni nemocnice Hradec Kralove
Hepato-gastroenterologie HK, s.r.o.
EGK s.r.o. - Sanatorium sv. Anny
AXON Clinical s.r.o.
MEDIENDO s.r.o.
ISCARE a.s.
Aalborg University Hospital
Aarhus Kommunehospital
Abdominalcenter K
Odense Universitetshospital
Silkeborg Hospital
Vejle Sygehus
Hopital Beaujon
CHU Grenoble
Hopital de Bicetre
Hopital Claude Huriez
CHU Saint Eloi
CHU de Nice Hopital de l Archet
Hopital Saint-Louis
CHU Bordeaux
Hospices Civils de Lyon HCL
CHU Saint-etienne
CHU Rangueil
CHU-Nancy
Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum
Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus
Medizinische Hochschule Hannover
Staedtisches Klinikum Lueneburg
Universitaetsklinikum Mannheim
MVZ Portal10
Policlinico di Bari Ospedale Giovanni XXIII
Policlinico Sant'Orsola Malpighi
Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
ASST Fatebenefratelli Sacco
Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar
Ospedale Villa Sofia-Cervello
Azienda Ospedaliera G.Salvini Ospedale di Rho
Azienda Ospedaliera San Camillo - Roma
Fondazione Policlinico Gemelli Università Cattolica
Istituto Clinico Humanitas
IRCCS Policlinico San Donato
AO Ordine Mauriziano
Azienda Sanitaria Universitaria Integrata di Udine
Meander Medisch Centrum
AMC
Albert Schweitzer Ziekenhuis
Rivas Zorggroep, Beatrixziekenhuis
UMCG
Erasmus MC
Centro Hospitalar e Universitário de Coimbra, EPE
Centro Hospitalar e Universitário do Algarve
Centro Hospitalar Lisboa Central, EPE - Hospital Santo Antonio dos Capuchos
Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria
Centro Hospitalar do Porto, EPE
Centro Hospitalar de São João, EPE
Centro Hospitalar de Tondela Viseu, EPE
FNsP F.D.R. Banska Bystrica
Gastroenterology Department GASTROMART s.r.o.
Gastroenterology Center ASSIDUO
University Hospital in Bratislava, St. Cyril and Method Hospital
KM Management spol. s r.o.
GASTRO I. s.r.o.
Gastroenterology Department ENDOMED, s.r.o.
Hosp. Gral. Univ. de Alicante
Hosp. Univ. Germans Trias I Pujol
Hosp. Clinic I Provincial de Barcelona
Hosp. Reina Sofia
Hosp. Arquitecto Marcide
Hosp. Univ. de Bellvitge
Hosp. Univ. de La Princesa
Hosp. Gral. Univ. Gregorio Maranon
Hosp. Univ. La Paz
Hosp. de Manises
Hosp. Univ. Son Espases
Hosp. Virgen Del Rocio
Hosp. Clinico Univ. de Valencia
Hosp. Univ. I Politecni La Fe
Hosp. Clinico Univ. Lozano Blesa
Skane University Hospital
Karolinska University Hospital
Medicinkliniken
Danderyd Hospital
Royal Victoria Hospital
County Durham and Darlington NHS Foundation Trust
Ninewells Hospital
Glasgow Royal Infirmary
Royal London Hospital
Guy's & St Thomas Hospital
Kings College Hospital NHS Trust
St George's University Hospital NHS Foundation Trust
Whiston Hospital
Salford Royal NHS Foundation Trust
Southampton University Hospital
Musgrove Park Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Arm Label

All Participants

Routine Care Arm

Treat to Target (T2T) Arm

Exploratory Extension period: From Week 48 to Week 104

Arm Description

At 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.

In 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.

UST 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.

At 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded)

Endoscopic response defined as showing a reduction from baseline in SES-CD (a validated instrument reflecting an endoscopist's global appraisal of mucosal lesions) score of >=50%. 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 calculated as sum of 4 variables for 5 bowel segments. Scores ranges 0-60. Higher scores indicates more severe disease. Randomized participants who stopped treatment before reaching Week 48 due to reasons other than lack/loss of efficacy were excluded from analysis.

Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF])

Endoscopic response defined as a reduction from baseline in SES-CD score of >= 50%. 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. The total SES-CD was calculated as the sum of the 4 variables for the 5 bowel segments. Scores range from 0 to 60, with higher scores indicating more severe disease. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward.

Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Clinical response defined as a >=100-point reduction from the baseline in Crohn's Disease Activity Index (CDAI) score, or a CDAI score of <150. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were considered as non-responder. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Clinical Remission defined as a CDAI score of <150 points. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were considered as non-remitter. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Percentage of participants with Endoscopic remission defined as SES-CD score <=2 at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) were reported. 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. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Mucosal healing is defined as the complete absence of mucosal ulcerations in any ileocolonic segment. 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. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (i.e. first 48 weeks of the study).

Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF])

Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF]) is defined as a CDAI score <150 and not taking any corticosteroids for at least 30 days prior to Week 48 and Endpoint assessment. The CDAI score is used to quantify the symptoms of participants with Crohn's Disease. A decrease in CDAI over time indicates improvement in disease activity. In general, CDAI score ranges from 0 to approximately 600; higher score indicates higher disease activities. Participants with missing data were analyzed as non-remitter. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Corticosteroid-free endoscopic response defined as a reduction from baseline in SES-CD score of >=50% and not taking any corticosteroids for at least 30 days prior to Weeks 16, 48 and endpoint (Week 48 [LOCF]). 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 score is sum of 4 variables. Scores range 0-60. Higher scores means severe disease. Participants with missing data were analyzed as No SES-CD Improvement. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (i.e., first 48 weeks).

Change From Baseline in Serum C-reactive Protein (CRP)

Change from baseline in serum CRP were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Change From Baseline in Fecal Calprotectin (FC)

Change from baseline in FC were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response

IBDQ response was defined as >= 16-point improvement in IBDQ total score from baseline. The IBDQ is 32-item questionnaire for participants with IBD used to evaluate disease-specific health-related quality of life. Each item score ranged from 1 (worst possible response) to 7 (best possible response). Each items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function. The 4 domains were scored as: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); 5 to 35 (social function). For each domain, higher score indicated better quality of life. Total score is sum of each item score and ranges from 32 to 224 with higher score indicating better quality of life. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (i.e, first 48 weeks).

Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain

Percentage of participants with 7-point change from baseline in WPAI scores for each domain were reported. WPAI is 6-item (7-day recall period) well-validated questionnaire to measure impairments in work and activities that produces 4 types of domains: absenteeism (work time missed), presenteeism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), activity impairment. Participants who answered first question of the questionnaire 'Are you currently employed' as 'Yes' were included in absenteeism, presenteeism, and work productivity. In activity impairment all participants were included. Each score range: 0-100, higher scores=greater impairment and less productivity. LOCF: Participants who had missing value at Week 48 or stopped treatment before reaching Week 48 had last non-missing value carried forward. Endpoint: last available postbaseline result in main analysis period (first 48 weeks).

Change From Baseline in IBDQ Score

The IBDQ is 32-item questionnaire used to evaluate disease-specific health-related quality of life. Each item score ranged from 1 (worst possible response) to 7 (best possible response). Items were grouped into 4 domains: bowel function, emotional status, systemic symptoms and social function with scored as follows: 10 to 70 (bowel symptoms); 5 to 35 (systemic symptoms); 12 to 84 (emotional function); and 5 to 35 (social function). Higher score, better quality of life. Total score is sum of each item score and ranges from 32 to 224. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (that is, first 48 weeks of the study). Only participants with non-missing baseline value and at least one non-missing post-baseline value during main treatment period were included in analysis.

Change From Baseline in European Quality Of Life 5 Dimensions 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score

EQ-5D-5L, validated quality-of-life instrument completed by participants. It consists of EQ-5D-5L descriptive system and EQ-VAS. EQ-5D-5L descriptive system comprises 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) describes participants current health state. Each dimension scores where 1 indicates no problems and 5 indicates extreme problems. EQ-5D-5L VAS records the respondent's self-rated, visual analogue scale score on a scale of 0-100, where 0 labelled as 'the worst health you can imagine and 100 labelled 'the best health you can imagine.' LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint defined as last available postbaseline result within main analysis period (i.e., first 48 weeks).

Changes From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale Score

The FACIT-F scale is a 13-item fatigue scale with a 7-day recall period. It measures the level of fatigue during the usual daily activities. The level of fatigue is measured on a 4-point Likert scale (0=very much fatigue to 4=not at all fatigue). The sum of all responses resulted in the FACIT-Fatigue score for a total possible score of 0 (worst score) to 52 (best score). LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score

The HADS Score is a validated 14-item scale with 7 of the items relating to anxiety and 7 relating to depression. Each item is scored from 0 to 3, with higher scores indicating greater likelihood of depression or anxiety. Cases of anxiety or depression are each defined by subscale scores of 8 or greater and categorized as normal (score of 0 to 7), mild (score of 8 to 10), moderate (score of 11 to 14), and severe (score of 15 to 21). LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Change From Baseline in WPAI Score

The WPAI questionnaire is a well-validated instrument to measure impairments in work and activities. It is a 6-item questionnaire with a 7-day recall period. The WPAI questionnaire produces 4 types of scores: absenteeism (work time missed), presenteesism (impairment at work/reduced on-the-job effectiveness), work productivity loss (overall work impairment/absenteeism plus presenteeism), and activity impairment. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Change From Baseline in Time Lost From Work

Time lost from work was collected by asking the participants a single question, "How many days did you miss from work due to your Crohn's disease in the last 4 weeks?" LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48

An adverse event is any untoward medical event that occurs in participants administered an investigational product, and it does not necessarily indicate only events with clear causal relationship with the relevant investigational product.

Change From Baseline in Body Weight

Change from baseline in body weight were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Change From Baseline in Body Mass Index (BMI)

Change from baseline in BMI were reported. BMI is a person's weight (in kilograms) divided by the square of height (in meters).LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (that is, first 48 weeks of the study).

Change From Baseline in Blood Pressure

Change from baseline in Blood Pressure (Systolic Blood Pressure [SPB] and Diastolic Blood Pressure [DBP]) were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (i.e. first 48 weeks of the study).

Change From Baseline in Pulse Rate

Change from baseline in pulse rate were reported. LOCF: Participants who had a missing value at Week 48 or who stopped treatment before reaching Week 48 had their last non-missing value carried forward. Endpoint is defined as the last available postbaseline result within the main analysis period (i.e. first 48 weeks of the study).

Full Information

NCT ID

NCT03107793

First Posted

March 28, 2017

Last Updated

August 16, 2023

Sponsor

Janssen-Cilag Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT03107793

Brief Title

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

Acronym

STARDUST

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Completed

Study Start Date

April 19, 2017 (Actual)

Primary Completion Date

April 30, 2020 (Actual)

Study Completion Date

July 20, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Janssen-Cilag Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Yes

Data Monitoring Committee

5. Study Description

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.

Detailed Description

Study investigates benefit of treat to target maintenance treatment strategy versus routine care to test hypothesis that 'treat to target' ustekinumab (UST) maintenance treatment strategy coupled with early endoscopic assessment will result in higher endoscopic response rate after 48 weeks of treatment, compared to pragmatic maintenance treatment strategy. It consists of screening (5 weeks); treatment period (Week 0 to 48); extension period (Weeks 48 to 104) and safety follow up visit (16 weeks after last dose). Participants will be given an option to enter ultrasound sub-study to assess intestinal ultrasound (IUS) parameters indicating transmural changes in response to treatment with UST in participants with Crohn's disease. Study treatment will be unaffected by participation in sub-study which is optional for participants of main study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Crohn Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

500 (Actual)

8. Arms, Groups, and Interventions

Arm Title

All Participants

Arm Type

Experimental

Arm Description

Arm Title

Routine Care Arm

Arm Type

Experimental

Arm Description

Arm Title

Treat to Target (T2T) Arm

Arm Type

Experimental

Arm Description

Arm Title

Exploratory Extension period: From Week 48 to Week 104

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

Ustekinumab

Intervention Description

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.

Primary Outcome Measure Information:

Title

Percentage of Participants With Endoscopic Response at Week 48

Description

Time Frame

Week 48

Secondary Outcome Measure Information:

Title

Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded)

Description

Time Frame

Week 48

Title

Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF])

Description

Time Frame

Week 48 (LOCF)

Title

Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Description

Time Frame

Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Description

Time Frame

Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Description

Time Frame

Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Description

Time Frame

Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF])

Description

Time Frame

Week 48 and Endpoint (Week 48 [LOCF])

Title

Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Description

Time Frame

Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in Serum C-reactive Protein (CRP)

Description

Time Frame

Baseline, Weeks 16, 48 and Endpoint (Week 48 [LOCF]

Title

Change From Baseline in Fecal Calprotectin (FC)

Description

Time Frame

Baseline, Weeks 16, 48 and Endpoint (Week 48 [LOCF])

Title

Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response

Description

Time Frame

Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain

Description

Time Frame

Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in IBDQ Score

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in European Quality Of Life 5 Dimensions 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Changes From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale Score

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in WPAI Score

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in Time Lost From Work

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48

Description

Time Frame

Up to Week 48

Title

Change From Baseline in Body Weight

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in Body Mass Index (BMI)

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in Blood Pressure

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

Title

Change From Baseline in Pulse Rate

Description

Time Frame

Baseline, Weeks 16, 48, and Endpoint (Week 48 [LOCF])

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Satisfy all inclusion criteria and none of the exclusion criteria specified in the main study Exclusion Criteria: 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 Currently has or is suspected to have an abscess. Recent cutaneous and perianal abscesses are not exclusionary if drained and adequately treated at least 3 weeks prior to baseline, or 8 weeks prior to baseline for intra-abdominal abscesses, provided there is no anticipated need for any further surgery. Participants with active fistulas may be included if there is no anticipation of a need for surgery and there are currently no abscesses identified 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)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Janssen Cilag Ltd. Clinical Trial

Organizational Affiliation

Janssen-Cilag Ltd.

Official's Role

Study Director

Facility Information:

Facility Name

GZA Ziekenhuizen

City

Antwerpen

ZIP/Postal Code

2018

Country

Belgium

Facility Name

Imelda Ziekenhuis

City

Bonheiden

ZIP/Postal Code

2820

Country

Belgium

Facility Name

UZ Brussel

City

Brussel

ZIP/Postal Code

1090

Country

Belgium

Facility Name

Cliniques Universitaires Saint-Luc

City

Brussel

ZIP/Postal Code

1200

Country

Belgium

Facility Name

Universitair Ziekenhuis Antwerpen

City

Edegem

ZIP/Postal Code

2650

Country

Belgium

Facility Name

AZ Maria Middelares

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

UZ Gent

City

Gent

ZIP/Postal Code

9000

Country

Belgium

Facility Name

Az Groeninge

City

Kortrijk

ZIP/Postal Code

8500

Country

Belgium

Facility Name

UZ Leuven

City

Leuven

ZIP/Postal Code

3000

Country

Belgium

Facility Name

CHC MontLegia

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

CHU de Liège

City

Liège

ZIP/Postal Code

4000

Country

Belgium

Facility Name

Algemeen Ziekenhuis Jan Palfijn Merksem

City

Merksem

ZIP/Postal Code

2170

Country

Belgium

Facility Name

AZ Damiaan

City

Oostende

ZIP/Postal Code

8400

Country

Belgium

Facility Name

Fakultni nemocnice Hradec Kralove

City

Hradec Kralove

ZIP/Postal Code

500 05

Country

Czechia

Facility Name

Hepato-gastroenterologie HK, s.r.o.

City

Hradec Kralove

ZIP/Postal Code

500 12

Country

Czechia

Facility Name

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

City

Prague

ZIP/Postal Code

13000

Country

Czechia

Facility Name

AXON Clinical s.r.o.

City

Prague

ZIP/Postal Code

15000

Country

Czechia

Facility Name

MEDIENDO s.r.o.

City

Prague

ZIP/Postal Code

186 00

Country

Czechia

Facility Name

ISCARE a.s.

City

Praha 9

ZIP/Postal Code

190 00

Country

Czechia

Facility Name

Aalborg University Hospital

City

Aalborg

ZIP/Postal Code

9100

Country

Denmark

Facility Name

Aarhus Kommunehospital

City

Aarhus C.

ZIP/Postal Code

DK-8000

Country

Denmark

Facility Name

Abdominalcenter K

City

København NV

ZIP/Postal Code

2400

Country

Denmark

Facility Name

Odense Universitetshospital

City

Odense

ZIP/Postal Code

5000

Country

Denmark

Facility Name

Silkeborg Hospital

City

Silkeborg

ZIP/Postal Code

8600

Country

Denmark

Facility Name

Vejle Sygehus

City

Vejle

ZIP/Postal Code

7100

Country

Denmark

Facility Name

Hopital Beaujon

City

Clichy

ZIP/Postal Code

92110

Country

France

Facility Name

CHU Grenoble

City

La Tronche

ZIP/Postal Code

38700

Country

France

Facility Name

Hopital de Bicetre

City

Le Kremlin Bicêtre

ZIP/Postal Code

94270

Country

France

Facility Name

Hopital Claude Huriez

City

Lille

ZIP/Postal Code

59037

Country

France

Facility Name

CHU Saint Eloi

City

Montpellier

ZIP/Postal Code

34295

Country

France

Facility Name

CHU de Nice Hopital de l Archet

City

Nice

ZIP/Postal Code

6202

Country

France

Facility Name

Hopital Saint-Louis

City

Paris

ZIP/Postal Code

75010

Country

France

Facility Name

CHU Bordeaux

City

Pessac

ZIP/Postal Code

33600

Country

France

Facility Name

Hospices Civils de Lyon HCL

City

Pierre Bénite

ZIP/Postal Code

69495

Country

France

Facility Name

CHU Saint-etienne

City

Saint Priest en jarez

ZIP/Postal Code

42270

Country

France

Facility Name

CHU Rangueil

City

Toulouse

ZIP/Postal Code

31059

Country

France

Facility Name

CHU-Nancy

City

Vandoeuvre les Nancy

ZIP/Postal Code

54511

Country

France

Facility Name

Charité - Universitätsmedizin Berlin, Campus Virchow Klinikum

City

Berlin

ZIP/Postal Code

13353

Country

Germany

Facility Name

Agaplesion Frankfurter Diakonie Kliniken GmbH, Markus Krankenhaus

City

Frankfurt

ZIP/Postal Code

60431

Country

Germany

Facility Name

Medizinische Hochschule Hannover

City

Hannover

ZIP/Postal Code

30625

Country

Germany

Facility Name

Staedtisches Klinikum Lueneburg

City

Lueneburg

ZIP/Postal Code

21339

Country

Germany

Facility Name

Universitaetsklinikum Mannheim

City

Mannheim

ZIP/Postal Code

68167

Country

Germany

Facility Name

MVZ Portal10

City

Muenster

ZIP/Postal Code

48151

Country

Germany

Facility Name

Policlinico di Bari Ospedale Giovanni XXIII

City

Bari

Country

Italy

Facility Name

Policlinico Sant'Orsola Malpighi

City

Bologna

ZIP/Postal Code

40138

Country

Italy

Facility Name

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

ASST Fatebenefratelli Sacco

City

Milano

ZIP/Postal Code

20157

Country

Italy

Facility Name

Ospedale Classificato Equiparato Sacro Cuore Don Calabria di Negrar

City

Negrar (VR)

ZIP/Postal Code

37024

Country

Italy

Facility Name

Ospedale Villa Sofia-Cervello

City

Palermo

ZIP/Postal Code

90146

Country

Italy

Facility Name

Azienda Ospedaliera G.Salvini Ospedale di Rho

City

RHO

Country

Italy

Facility Name

Azienda Ospedaliera San Camillo - Roma

City

Roma

ZIP/Postal Code

00152

Country

Italy

Facility Name

Fondazione Policlinico Gemelli Università Cattolica

City

Roma

ZIP/Postal Code

168

Country

Italy

Facility Name

Istituto Clinico Humanitas

City

Rozzano

ZIP/Postal Code

20089

Country

Italy

Facility Name

IRCCS Policlinico San Donato

City

San Donato Milanese

ZIP/Postal Code

20097

Country

Italy

Facility Name

AO Ordine Mauriziano

City

Torino

ZIP/Postal Code

10128

Country

Italy

Facility Name

Azienda Sanitaria Universitaria Integrata di Udine

City

Udine

ZIP/Postal Code

33100

Country

Italy

Facility Name

Meander Medisch Centrum

City

Amersfoort

ZIP/Postal Code

3813 TZ

Country

Netherlands

Facility Name

AMC

City

Amsterdam

ZIP/Postal Code

1105 AZ

Country

Netherlands

Facility Name

Albert Schweitzer Ziekenhuis

City

Dordrecht

ZIP/Postal Code

3318 AT

Country

Netherlands

Facility Name

Rivas Zorggroep, Beatrixziekenhuis

City

Gorinchem

ZIP/Postal Code

4200 AB

Country

Netherlands

Facility Name

UMCG

City

Groningen

ZIP/Postal Code

9713 GZ

Country

Netherlands

Facility Name

Erasmus MC

City

Rotterdam

ZIP/Postal Code

3015 CE

Country

Netherlands

Facility Name

Centro Hospitalar e Universitário de Coimbra, EPE

City

Coimbra

ZIP/Postal Code

3000-075

Country

Portugal

Facility Name

Centro Hospitalar e Universitário do Algarve

City

Faro

ZIP/Postal Code

8000-386

Country

Portugal

Facility Name

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

City

Lisboa

ZIP/Postal Code

1169-050

Country

Portugal

Facility Name

Centro Hospitalar Lisboa Norte, EPE/Hosp. Santa Maria

City

Lisboa

ZIP/Postal Code

1649-035

Country

Portugal

Facility Name

Centro Hospitalar do Porto, EPE

City

Porto

ZIP/Postal Code

4099-001

Country

Portugal

Facility Name

Centro Hospitalar de São João, EPE

City

Porto

ZIP/Postal Code

4200-319

Country

Portugal

Facility Name

Centro Hospitalar de Tondela Viseu, EPE

City

Viseu

ZIP/Postal Code

3504-509

Country

Portugal

Facility Name

FNsP F.D.R. Banska Bystrica

City

Banska Bystrica

ZIP/Postal Code

975 17

Country

Slovakia

Facility Name

Gastroenterology Department GASTROMART s.r.o.

City

Bardejov

ZIP/Postal Code

085 01

Country

Slovakia

Facility Name

Gastroenterology Center ASSIDUO

City

Bratislava

ZIP/Postal Code

811 08

Country

Slovakia

Facility Name

University Hospital in Bratislava, St. Cyril and Method Hospital

City

Bratislava

ZIP/Postal Code

851 07

Country

Slovakia

Facility Name

KM Management spol. s r.o.

City

Nitra

ZIP/Postal Code

949 01

Country

Slovakia

Facility Name

GASTRO I. s.r.o.

City

Presov

ZIP/Postal Code

080 01

Country

Slovakia

Facility Name

Gastroenterology Department ENDOMED, s.r.o.

City

Vranov nad Toplou

ZIP/Postal Code

093 01

Country

Slovakia

Facility Name

Hosp. Gral. Univ. de Alicante

City

Alicante

ZIP/Postal Code

3010

Country

Spain

Facility Name

Hosp. Univ. Germans Trias I Pujol

City

Badalona

ZIP/Postal Code

08916

Country

Spain

Facility Name

Hosp. Clinic I Provincial de Barcelona

City

Barcelona

ZIP/Postal Code

08036

Country

Spain

Facility Name

Hosp. Reina Sofia

City

Córdoba

ZIP/Postal Code

14004

Country

Spain

Facility Name

Hosp. Arquitecto Marcide

City

El Ferrol

ZIP/Postal Code

15405

Country

Spain

Facility Name

Hosp. Univ. de Bellvitge

City

L'Hospitalet de Llobregat

ZIP/Postal Code

08907

Country

Spain

Facility Name

Hosp. Univ. de La Princesa

City

Madrid

ZIP/Postal Code

28006

Country

Spain

Facility Name

Hosp. Gral. Univ. Gregorio Maranon

City

Madrid

ZIP/Postal Code

28007

Country

Spain

Facility Name

Hosp. Univ. La Paz

City

Madrid

ZIP/Postal Code

28046

Country

Spain

Facility Name

Hosp. de Manises

City

Manises

ZIP/Postal Code

46940

Country

Spain

Facility Name

Hosp. Univ. Son Espases

City

Palma de Mallorca

ZIP/Postal Code

07120

Country

Spain

Facility Name

Hosp. Virgen Del Rocio

City

Sevilla

ZIP/Postal Code

41013

Country

Spain

Facility Name

Hosp. Clinico Univ. de Valencia

City

Valencia

ZIP/Postal Code

46010

Country

Spain

Facility Name

Hosp. Univ. I Politecni La Fe

City

Valencia

ZIP/Postal Code

46026

Country

Spain

Facility Name

Hosp. Clinico Univ. Lozano Blesa

City

Zaragoza

ZIP/Postal Code

50009

Country

Spain

Facility Name

Skane University Hospital

City

Lund

ZIP/Postal Code

SE-22185

Country

Sweden

Facility Name

Karolinska University Hospital

City

Solna

ZIP/Postal Code

SE-17176

Country

Sweden

Facility Name

Medicinkliniken

City

Stockholm

ZIP/Postal Code

11281

Country

Sweden

Facility Name

Danderyd Hospital

City

Stockholm

ZIP/Postal Code

SE-11828

Country

Sweden

Facility Name

Royal Victoria Hospital

City

Belfast

ZIP/Postal Code

BT12 6BA

Country

United Kingdom

Facility Name

County Durham and Darlington NHS Foundation Trust

City

Darlington

ZIP/Postal Code

DL3 6HX

Country

United Kingdom

Facility Name

Ninewells Hospital

City

Dundee

ZIP/Postal Code

DD1 9SY

Country

United Kingdom

Facility Name

Glasgow Royal Infirmary

City

Glasgow

ZIP/Postal Code

G4 0SF

Country

United Kingdom

Facility Name

Royal London Hospital

City

London

ZIP/Postal Code

E1 1BB

Country

United Kingdom

Facility Name

Guy's & St Thomas Hospital

City

London

ZIP/Postal Code

SE1 7EH

Country

United Kingdom

Facility Name

Kings College Hospital NHS Trust

City

London

ZIP/Postal Code

SE5 9RS

Country

United Kingdom

Facility Name

St George's University Hospital NHS Foundation Trust

City

London

ZIP/Postal Code

SW17 0QT

Country

United Kingdom

Facility Name

Whiston Hospital

City

Prescot

ZIP/Postal Code

L35 5DR

Country

United Kingdom

Facility Name

Salford Royal NHS Foundation Trust

City

Salford

ZIP/Postal Code

M6 8HD

Country

United Kingdom

Facility Name

Southampton University Hospital

City

Southampton

ZIP/Postal Code

SO16 6YD

Country

United Kingdom

Facility Name

Musgrove Park Hospital

City

Taunton

ZIP/Postal Code

TA1 5DA

Country

United Kingdom

12. IPD Sharing Statement

Citations:

PubMed Identifier

35842121

Citation

Kucharzik 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.

Results Reference

derived

PubMed Identifier

35120656

Citation

Danese 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. Erratum In: Lancet Gastroenterol Hepatol. 2022 Apr;7(4):e8.

Results Reference

derived

Learn more about this trial

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

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