Overview

Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease

Status:
Completed
Trial end date:
2017-01-03
Target enrollment:
Participant gender:
Summary
The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein [hs-CRP] and fecal calprotectin), and corticosteroid use, improves the rate of mucosal healing 48 weeks after randomization compared with management using less stringent criteria based only on CDAI and corticosteroid use.
Phase:
Phase 3
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Adalimumab
Azathioprine
Prednisone