Phase 3
Completed N=498
Study of Treat to Target Versus Routine Care Maintenance Strategies in Crohn's Disease Patients Treated With Ustekinumab
Crohn Disease
Source: ClinicalTrials.gov NCT03107793 ↗
Enrolled (actual)
498
Serious AEs
10.1%
Results posted
May 2021
Primary outcomePrimary: Percentage of Participants With Endoscopic Response at Week 48 — 37.9; 29.9 Percentage of Participants — p== 0.0871
◆ Published Evidence
Established
97citations · ~32 / year
Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease.
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.
Linked Publications (4)
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Early Ultrasound Response and Progressive Transmural Remission After Treatment With Ustekinumab in Crohn's Disease.
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Clinical trial: Clinical and endoscopic outcomes with ustekinumab in patients with Crohn's disease: Results from the long-term extension period of STARDUST.
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Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
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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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Endoscopic Response at Week 48 |
37.9; 29.9 | = 0.0871 |
| SECONDARY Percentage of Participants With Endoscopic Response at Week 48 (Premature Drop-outs Excluded) |
43.0; 32.3 | — |
| SECONDARY Percentage of Participants With Endoscopic Response at Week 48 (Last Observation Carried Forward [LOCF]) |
40.2; 30.8 | — |
| SECONDARY Percentage of Participants With Clinical Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) |
84.5; 89.6; 68.0; 77.8; 89.5; 89.6 | — |
| SECONDARY Percentage of Participants With Clinical Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) |
72.1; 74.2; 61.6; 69.7; 77.2; 78.3 | — |
| SECONDARY Percentage of Participants With Endoscopic Remission at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) |
11.4; 11.4; 14.5; 11.9; 15.4 | — |
| SECONDARY Percentage of Participants With Mucosal Healing at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) |
16.0; 14.2; 16.7; 14.6; 17.6 | — |
| SECONDARY Percentage of Participants With Corticosteroid-free Clinical Remission at Week 48 and Endpoint (Week 48 [LOCF]) |
56.6; 63.3; 70.8; 69.7 | — |
| SECONDARY Percentage of Participants With Corticosteroid-free Endoscopic Response at Weeks 16, 48, and Endpoint (Week 48 [LOCF]) |
26.5; 33.8; 28.5; 36.1; 29.4 | — |
| SECONDARY Change From Baseline in Serum C-reactive Protein (CRP) |
-7.717; -7.345; -7.839; -7.909; -7.839; -7.909 | — |
| SECONDARY Change From Baseline in Fecal Calprotectin (FC) |
-988.8; -728.2; -1191.6; -744.4; -1191.6; -744.4 | — |
| SECONDARY Percentage of Participants With Inflammatory Bowel Disease Questionnaire (IBDQ) Response |
71.7; 75.1; 58.4; 67.0; 77.2; 77.8 | — |
| SECONDARY Percentage of Participants With 7-point Change From Baseline in Work Productivity and Activity Impairment (WPAI) Scores for Each Domain |
34.9; 39.6; 35.0; 36.4; 34.9; 36.3 | — |
| SECONDARY Change From Baseline in IBDQ Score |
41.3; 44.7; 43.7; 44.3; 43.7; 44.3 | — |
| SECONDARY Change From Baseline in European Quality Of Life 5 Dimensions 5 Level (EQ-5D-5L) Visual Analog Scale (VAS) Score |
16.7; 18.7; 16.5; 16.1; 16.5; 16.1 | — |
| SECONDARY Changes From Baseline in Functional Assessment of Chronic Illness Therapy-fatigue (FACIT-F) Scale Score |
9.1; 11.6; 9.9; 10.0; 9.9; 10.0 | — |
| SECONDARY Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Score |
-2.5; -2.5; -2.5; -2.4; -2.5; -2.7 | — |
| SECONDARY Change From Baseline in WPAI Score |
-12.9; -12.5; -13.9; -14.8; -13.0; -12.1 | — |
| SECONDARY Change From Baseline in Time Lost From Work |
-1.7; -1.8; -1.8; -2.2; -1.8; -2.2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) That Occurred in Participants Administered With Ustekinumab up to Week 48 |
188; 179 | — |
| SECONDARY Change From Baseline in Body Weight |
1.56; 1.16; 2.38; 1.39; 2.38; 1.39 | — |
| SECONDARY Change From Baseline in Body Mass Index (BMI) |
0.54; 0.37; 0.82; 0.46; 0.82; 0.46 | — |
| SECONDARY Change From Baseline in Blood Pressure |
2.3; 0.3; 1.9; 0.5; 1.9; 0.5 | — |
| SECONDARY Change From Baseline in Pulse Rate |
-1.5; -2.0; -0.2; -1.7; -0.2; -1.7 | — |
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 ( =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)
Data sourced from ClinicalTrials.gov (NCT03107793) and the linked publication. Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.