Phase 2
Completed N=131
A Study of the Safety and Efficacy of Ustekinumab (CNTO 1275) in Participants With Crohn's Disease
Crohn Disease
Source: ClinicalTrials.gov NCT00265122 ↗
Enrolled (actual)
131
Serious AEs
8.3%
Results posted
Jul 2013
Primary outcomePrimary: Number of Participants in Population 1 With a Clinical Response at Week 8 — 13; 12; 8; 13 participants — p=0.337
Summary
The purpose of this study is to examine the safety and efficacy of CNTO 1275 in participants with active Crohn's Disease.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants in Population 1 With a Clinical Response at Week 8 |
13; 12; 8; 13; 21; 25 | 0.337 |
| SECONDARY Number of Participants in Population 2 With a Clinical Response at Week 8 |
6; 7 | — |
| SECONDARY Number of Participants in Population 1 With Clinical Remission at Week 8 |
6; 6; 3; 7; 9; 13 | 0.292 |
Eligibility Criteria
Inclusion Criteria
- Have moderately to severly active Crohn's disease or fistulizing Crohn's disease for at least 6 weeks' duration with a Crohn's disease activity index (CDAI) score of >=220 and <=450
- In Population 1, participants must have had active disease despite treatment with 5-ASA compounds, antibiotics, corticosteroids, and/or immunomodulators, including anti-TNF agents. In Population 2, participants must have had active disease and have failed to respond to infliximab at the maximum approved dose and treatment regimen for Crohn's disease as defined in the US package insert.
Exclusion Criteria
- Have local manifestations of Crohn's disease such as strictures, abscesses, or other disease complications for which surgery might be indicated
- Had intra-abdominal surgery within 6 months prior to entering the study
- Have received treatment with parenteral nutrition (ie, introduction of nutrition into the body via a route other than the mouth) (total parenteral nutrition [TPN]) within 6 weeks of baseline
Data sourced from ClinicalTrials.gov (NCT00265122). 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.