Phase 3
Completed N=1,281
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
Source: ClinicalTrials.gov NCT01369355 ↗Enrolled (actual)
1,281
Serious AEs
19.2%
Results posted
Feb 2017
Primary outcomePrimary: Number of Participants With Clinical Remission at Week 44 — 47; 63; 68 participants — p=0.040
◆ Published Evidence
Established
40citations · ~10 / year
Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease.
Summary
The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to treatment with intravenous ustekinumab in studies CNTO1275CRD3001 and CNTO1275CRD3002, compared to subcutaneously administered placebo.
Linked Publications (5)
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Population Pharmacokinetics and Exposure-Response Analyses of Ustekinumab in Patients With Moderately to Severely Active Crohn's Disease.
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Safety of Ustekinumab in Inflammatory Bowel Disease: Pooled Safety Analysis Through 5 Years in Crohn's Disease and 4 Years in Ulcerative Colitis.
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Matching-Adjusted Indirect Comparison Between Risankizumab and Ustekinumab for Induction and Maintenance Treatment of Moderately to Severely Active Crohn's Disease.
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Evolution of Symptoms After Ustekinumab Induction Therapy in Patients With Crohn's Disease.
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Anti-IL-12/23p40 antibodies for induction of remission in Crohn's disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Clinical Remission at Week 44 |
47; 63; 68 | 0.040 sig |
| SECONDARY Number of Participants With Clinical Response at Week 44 |
58; 75; 76 | 0.033 sig |
| SECONDARY Number of Participants in Clinical Remission at Week 44 Among Participants in Clinical Remission to Ustekinumab at Week 0 of Maintenance Study |
36; 44; 52 | 0.189 |
| SECONDARY Number of Participants With Corticosteroid-free Remission at Week 44 |
39; 55; 60 | 0.035 sig |
| SECONDARY Number of Participants in Clinical Remission at Week 44 in the Subset of Participants Who Were Refractory or Intolerant to Tumor Necrosis Factor (TNF) Antagonist Therapy |
16; 22; 23 | 0.140 |
Eligibility Criteria
Inclusion Criteria
- Patients who received study agent at the start of study CNTO1275CRD3001 or CNTO1275CRD3002 and completed the Week 8 visit. Exclusion Criteria:
- Patients who underwent a Crohn's disease-related surgery since the start of induction study CNTO1275CRD3001 or CNTO1275CRD3002
- Patients who started a protocol prohibited medication since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
- Patients with protocol-specified changes to their concomitant medications due to Crohn's disease (due to lack of efficacy) since the start of studies CNTO1275CRD3001 and CNTO1275CRD3002
Data sourced from ClinicalTrials.gov (NCT01369355) 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.