Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab — CURE  

CD Clinical Trial

Official title: Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab

Status Active, not recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• CD
• Crohn Disease

• NCT number: NCT03306446
• Study type: Interventional
• Source: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: March 17, 2015
• Completion date: March 2025