Phase 3
N=416
Study of Vedolizumab in Patients With Moderate to Severe Crohn's Disease
Crohn's Disease
Bottom Line
View on ClinicalTrials.gov: NCT01224171 ↗Enrolled (actual)
416
Serious AEs
7.0%
Results posted
Jul 2014
Primary outcome: Primary: Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation — 12.1; 15.2 percentage of participants — p=0.4332
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- vedolizumab (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Millennium Pharmaceuticals, Inc.
- Primary completion
- Feb 2012
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants in Clinical Remission in the Tumor Necrosis Factor Alpha (TNFα) Antagonist Failure Subpopulation |
12.1; 15.2 | 0.4332 |
| SECONDARY Percentage of Participants in Clinical Remission at Week 6 in the Overall Population |
12.1; 19.1 | — |
| SECONDARY Percentage of Participants in Clinical Remission at Week 10 in the TNFα Antagonist Failure Subpopulation |
12.1; 26.6 | — |
| SECONDARY Percentage of Participants in Clinical Remission at Week 10 in the Overall Population |
13.0; 28.7 | — |
| SECONDARY Percentage of Participants With Sustained Clinical Remission in the TNFα Antagonist Failure Population |
8.3; 12.0 | — |
| SECONDARY Percentage of Participants With Sustained Clinical Remission in the Overall Population |
8.2; 15.3 | — |
| SECONDARY Percentage of Participants With Enhanced Clinical Response at Week 6 in the TNFα Antagonist Failure Subpopulation |
22.3; 39.2 | — |
| SECONDARY Number of Participants With Adverse Events (AEs) |
124; 117; 34; 34; 8; 4 | — |
Summary
This study in patients with moderately to severely active Crohn's disease is designed to establish the efficacy and safety of vedolizumab for the induction of clinical response and remission.
Eligibility Criteria
Inclusion Criteria
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease
- Crohn's Disease involvement of the ileum and/or colon
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance of at least one conventional therapy as defined by the protocol
- May be receiving a therapeutic dose of conventional therapies for inflammatory bowel disease (IBD) as defined by the protocol
Exclusion Criteria
- Evidence of abdominal abscess at the initial screening visit
- Extensive colonic resection, subtotal or total colectomy
- History of >3 small bowel resections or diagnosis of short bowel syndrome
- Ileostomy, colostomy, or known fixed symptomatic stenosis of the intestine
- Have received non permitted therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- Chronic hepatitis B or C infection; human immunodeficiency virus (HIV) infection
- Active or latent tuberculosis
Data sourced from ClinicalTrials.gov (NCT01224171). 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.