Changing the coUrse of cRohn's Disease With an Early Use of Adalimumab
- Sponsor
- Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
- Study ID
- NCT03306446
- Phase
- PHASE4
- Status
- Unknown
Conditions
- CD
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 75 Years
- Healthy Volunteers
- Not accepted
Interventions
- Start adalimumab in monotherapy — DRUGDiscontinuation of Adalimumab in patients who achieved deep remission
Study Details
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.
Key Dates
- Start date
- Mar 17, 2015
- Status verified
- May 2023
- Primary completion
- Mar 31, 2021
- Completion
- Mar 31, 2025
Study Design
- Enrollment
- 203 participants (actual)
- Allocation
- NA
- Intervention model
- SINGLE_GROUP
- Primary purpose
- TREATMENT
Arms
- Experimental: Adalimumab in monotherapyStart Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.
Primary Outcome Measure
Sustained deep remission rate [ Time Frame: 12 months ]