Study Comparing Episodic Adalimumab Monotherapy Versus Standard Step-Up Care with Corticosteroids in Newly Diagnosed Crohns Disease

What this Trial Is About

Researchers are evaluating the long-term safety and effectiveness of periodic adalimumab as an initial treatment for newly diagnosed Crohns disease CD patients. The study compares this approach to the standard step-up care that begins with corticosteroids. The goal is to improve treatment outcomes and reduce side effects by avoiding overtreatment, especially since current markers cannot predict disease progression at diagnosis. This trial addresses the limitations of existing therapies, such as delayed use of disease-modifying biologicals and risks associated with combination treatments. Participants are randomly assigned to one of two groups one receives episodic subcutaneous adalimumab monotherapy for 6 months as the first-line treatment, while the other follows the standard step-up care starting with corticosteroids. This study is a phase 4 trial that focuses on comparing these two treatment strategies over time, with detailed monitoring of drug effects and disease progression. During the study, participants will be closely monitored through clinical visits, imaging tests like ileo-colonoscopy and small bowel MRI or CT-enterography, and use of the myIBDcoach app for remote monitoring. Researchers will assess the number of yearly quarters of corticosteroid-free remission at week 96 as the primary outcome. Additional measures include bowel damage progression, adverse events, corticosteroid use, endoscopic remission, time to remission, quality of life, and healthcare costs. The total study duration includes assessments at weeks 24, 48, and 96 to capture both short- and long-term effects of the treatments.

Control Crohn Safe Trial