Phase 3
Completed N=1,116
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Crohn's Disease
Source: ClinicalTrials.gov NCT00783692 ↗Enrolled (actual)
1,116
Serious AEs
22.0%
Results posted
Jul 2014
Primary outcomePrimary: Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 — 6.8; 14.5 percentage of participants — p=0.0206
Summary
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response and remission at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Induction Phase: Percentage of Participants Achieving Clinical Remission at Week 6 |
6.8; 14.5 | 0.0206 sig |
| PRIMARY Induction Phase: Percentage of Participants With Enhanced Clinical Response at Week 6 |
25.7; 31.4 | 0.2322 |
| PRIMARY Maintenance Phase: Percentage of Participants Achieving Clinical Remission at Week 52 |
21.6; 39.0; 36.4 | 0.0007 sig |
| SECONDARY Induction Phase: Change From Baseline in C-Reactive Protein (CRP) Levels at Week 6 |
-0.5; -0.9 | 0.9288 |
| SECONDARY Maintenance Phase: Percentage of Participants With Enhanced Clinical Response at Week 52 |
30.1; 43.5; 45.5 | 0.0132 sig |
| SECONDARY Maintenance Phase: Percentage of Participants in Corticosteroid-free Clinical Remission at Week 52 |
15.9; 31.7; 28.8 | 0.0154 sig |
| SECONDARY Maintenance Phase: Percentage of Participants With Durable Clinical Remission |
14.4; 21.4; 16.2 | 0.1036 |
Eligibility Criteria
Inclusion Criteria
- Age 18 to 80
- Diagnosis of moderately to severely active Crohn's disease (CD)
- CD 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 1 of the following agents, within protocol-specified parameters:
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Corticosteroids
- May be receiving a therapeutic dose of conventional therapies for irritable bowel disease (IBD) defined by the protocol
Exclusion Criteria
- Evidence of abdominal abscess at the initial screening visit, other than a minimum of 10 aphthous ulcerations involving a minimum of 10 contiguous cm of intestine
- 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 IBD therapies within either 30 or 60 days, depending on the medication, as stated in the protocol
- Chronic hepatitis B or C infection
- Active or latent tuberculosis
Data sourced from ClinicalTrials.gov (NCT00783692). 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.