Evaluating treatment to a target of transmural healing in patients with moderately to severely active Crohn's disease: rationale, design and protocol for the randomised controlled VECTORS trial - PubM
11 hours ago
- #Crohn's disease
- #clinical trial
- #transmural healing
- The VECTORS trial evaluates transmural healing (TMH) as a treatment target for Crohn's disease (CD).
- This phase 4, randomized controlled trial involves 304 adult patients with moderately to severely active CD.
- Patients are assigned to one of two treatment target groups: TMH plus clinical/biomarker remission or clinical/biomarker remission alone.
- All participants receive vedolizumab, with additional dosing and escalation to meet assigned targets.
- Primary outcome measures corticosteroid-free endoscopic remission at week 48, with CD-related complications assessed at week 96.
- The trial is approved by ethics committees, with findings to be published in peer-reviewed journals.