NCT03306446

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

• Status: Unknown
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 203 (actual)
• Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed 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.

Conditions

• CD

Interventions

Type	Name	Description
DRUG	Start adalimumab in monotherapy	Discontinuation of Adalimumab in patients who achieved deep remission

Timeline

• Start date: 2015-03-17
• Primary completion: 2021-03-01
• Completion: 2025-03-01
• First posted: 2017-10-11
• Last updated: 2023-05-31

Locations

23 sites across 2 countries: Belgium, France