Phase 3
Completed N=895
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
Source: ClinicalTrials.gov NCT00783718 ↗Enrolled (actual)
895
Serious AEs
12.7%
Results posted
Jul 2014
Primary outcomePrimary: Induction Phase: Percentage of Participants With a Clinical Response at Week 6 — 25.5; 47.1 percentage of participants — p=< 0.0001
Summary
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response 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 With a Clinical Response at Week 6 |
25.5; 47.1 | < 0.0001 sig |
| PRIMARY Maintenance Phase: Percentage of Participants in Clinical Remission at Week 52 |
15.9; 41.8; 44.8 | < 0.0001 sig |
| SECONDARY Induction Phase: Percentage of Participants in Clinical Remission at Week 6 |
5.4; 16.9 | 0.0009 sig |
| SECONDARY Induction Phase: Percentage of Participants With Mucosal Healing at Week 6 |
24.8; 40.9 | 0.0012 sig |
| SECONDARY Maintenance Phase: Percentage of Participants With Durable Clinical Response |
23.8; 56.6; 52.0 | < 0.0001 sig |
| SECONDARY Maintenance Phase: Percentage of Participants With Mucosal Healing at Week 52 |
19.8; 51.6; 56.0 | < 0.0001 sig |
| SECONDARY Maintenance Phase: Percentage of Participants With Durable Clinical Remission |
8.7; 20.5; 24.0 | 0.0079 sig |
| SECONDARY Maintenance Phase: Percentage of Participants With Corticosteroid-free Remission at Week 52 |
13.9; 31.4; 45.2 | 0.0120 sig |
Eligibility Criteria
Inclusion Criteria
Each patient must meet all of the following inclusion criteria to be enrolled in the study:
- Diagnosis of moderately to severely active ulcerative colitis
- Demonstrated, over the previous 5 year period, an inadequate response to, loss of response to, or intolerance at least 1 of the following agents:
- Immunomodulators
- Tumor necrosis factor-alpha (TNFα) antagonists
- Corticosteroids
- 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
- 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 (NCT00783718). 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.