This is a prospective, longitudinal, multicenter study conducted in a cohort of patients with early CD. This study will not change the patient/physician relationship.
The main objective will be to evaluate the sustained deep remission rate one year after discontinuation of a 12 month course of adalimumab in adult patients with early CD who have achieved deep remission at 12 months AND who were already in clinical remission (CDAI \< 150) and biomarker remission (CRP \< 5 mg/L and fecal calprotectin \< 250) at 6 months. The study will also address several questions: * What is the rate of deep remission after a 12-month course of adalimumab in early CD patients? * What is the rate of deep remission 12 months after adalimumab discontinuation in patients with deep remission after a 12-month course of adalimumab (thus defining sustained deep remission) AND who were already in clinical remission (CDAI \< 150) and biomarker remission (CRP \< 5 mg/L and fecal calprotectin \< 250) at 6 months? * What are the consequences of a treatment with adalimumab on the natural course of CD and long-term clinical outcomes (bowel damage, CD related surgeries and hospitalization, and patient-reported outcomes)? Therefore the study will give information on the effect of a 12-month course of adalimumab in early CD patients, impact of "drug holiday" after deep remission has been achieved, and long term effect of adalimumab on early CD course (relapses, CD-related surgery and hospitalizations, bowel damage, and patient-reported outcomes). The study will also assess predictors of loss of deep remission at 2-year evaluation in patients who achieved 1-year deep remission. Efficacy and tolerability of adalimumab will be assessed.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
203
Discontinuation of Adalimumab in patients who achieved deep remission
Chu Liege
Liège, Belgium
Chu Amiens
Amiens, France
Sustained deep remission rate
Number of patients with sustained deep remission at one year
Time frame: 12 months
2-year deep remission rate
Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission
Time frame: 2 years
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