At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 72 enrolled
Drug / intervention
vedolizumabdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Phase 2, Multiple Dose, Open-Label Study to Determine the Long Term Safety of MLN0002 in Patients With Ulcerative Colitis and Crohn's Disease
In Brief
A Phase 2 clinical trial evaluating vedolizumab for Ulcerative Colitis and Crohn's Disease. Completed, enrolled 72 participants across 1 site.
Detailed Summary
This was an open-label study to provide an opportunity for participants with Ulcerative Colitis (UC) who previously completed Study C13002 (NCT01177228), and for treatment-naïve participants with UC or Crohn's Disease (CD) to receive treatment with vedolizumab, and to determine the long term safety of vedolizumab in patients afflicted with these diseases.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsUlcerative Colitis, Crohn's Disease
CountriesCanada
Collaborators--
Timeline
Phase 2CompletedFinished
20082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartDec 2007
First PostedFeb 2008
Primary CompletionMar 2010
TodayJul 2026
First PostedFeb 21, 2008
Enrollment StartDec 1, 2007
Primary CompletionMar 1, 2010
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 18.4 years ago
Interventions
vedolizumabdrug
Vedolizumab for intravenous (IV) infusion