At a glance
ClinicalIndex Comparison RecordPhase 4Completed· 55 enrolled
Drug / intervention
Vedolizumab +2 moredrug
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.
An Open-Label, Phase 4 Study to Evaluate the Efficacy and Safety of Triple Combination Therapy With Vedolizumab IV, Adalimumab SC, and Oral Methotrexate in Early Treatment of Subjects With Crohn's Disease Stratified at Higher Risk for Developing Complications
In Brief
A Phase 4 clinical trial evaluating Vedolizumab, Adalimumab, and 1 other intervention for Crohn Disease. Completed, enrolled 55 participants across 32 sites in 2 countries.
Detailed Summary
The purpose of this study is to determine the effect of triple combination therapy with an anti-integrin (vedolizumab intravenous \[IV\]), a tumor necrosis factor (TNF) antagonist (adalimumab subcutaneously \[SC\]), and an immunomodulator (oral methotrexate) on endoscopic remission in participants with newly-diagnosed CD stratified at higher risk for complications.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsCrohn Disease
CountriesCanada, United States
Collaborators--
Timeline
Phase 4CompletedFinished
2017201820192020202120222023202420252026
First PostedMay 2016
Enrollment StartApr 2017
Primary CompletionSep 2020
Study CompletionJul 2022
TodayJul 2026
First PostedMay 6, 2016
Enrollment StartApr 18, 2017
Primary CompletionSep 22, 2020
Study CompletionJul 5, 2022
TodayJul 2, 2026
Enrollment to primary: 3.4 yearsPosted 10.2 years ago
Interventions
Vedolizumabdrug
Vedolizumab intravenous infusion.
Adalimumabdrug
Adalimumab injection for subcutaneous use.
Methotrexatedrug
Methotrexate oral tablets.