UC is a chronic, idiopathic form of intestinal inflammatory disease (IBD) that affects the colon, most commonly afflicting adults aged 30-40 years and resulting in disability and lower quality of life (1). It is characterized by relapsing and remitting mucosal inflammation, starting in the rectum and extending to proximal segments of the colon. Although biologic therapies have provided clinical benefits to patients, these goals are still poorly met, due to the limited knowledge of the underlying mechanisms of immunopathology and the lack of predictive biomarkers that would allow proper patient stratification. The hypothesis of this study is that by identifying new biomarkers in blood, stool and tissue that (i) predict response (or non-response) to therapy prior to the start of treatment and (ii) predict response to therapy in the early phase of treatment will allow to find the right treatment for the right patient (personalized medicine).
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The percentage of subjects who achieve clinical response at week 14.
Timeframe: The percentage of subjects who achieve clinical response at week 14
The percentage of subjects who achieve deep clinical remission at week 14.
Timeframe: The percentage of subjects who achieve deep clinical remission at week 14
The percentage of subjects who achieve deep clinical remission at week 26.
Timeframe: The percentage of subjects who achieve deep clinical remission at week 26.
The percentage of subjects who achieve deep clinical remission at week 52.
Timeframe: The percentage of subjects who achieve deep clinical remission at week 52.
The percentage of subjects who achieve mucosal healing at week 14.
Timeframe: The percentage of subjects who achieve mucosal healing at week 14.
The percentage of subjects who achieve mucosal healing at week 52.
Timeframe: The percentage of subjects who achieve mucosal healing at week 52.
The percentage of subjects who achieve symptomatic remission at week 14.
Timeframe: The percentage of subjects who achieve symptomatic remission at week 14.
The percentage of subjects who achieve symptomatic remission at week 26.
Timeframe: The percentage of subjects who achieve symptomatic remission at week 26.
The percentage of subjects who achieve symptomatic remission at week 52.
Timeframe: The percentage of subjects who achieve symptomatic remission at week 52.