A Phase 4 interventional study of Start adalimumab in monotherapy in CD, sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives. Active, not recruiting at 23 sites in 2 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-31.
Sponsored by Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives · Phase 4, Interventional, and Treatment
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:
Exclusion Criteria:
Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months.
Drug: Start adalimumab in monotherapy
Discontinuation of Adalimumab in patients who achieved deep remission
Also known as: begin humira in monotherapie in Early crohn disease patient
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
Impact of an early treatment with adalimumab on long-term clinical outcomes
Frequency and severity of adverse events in patients followed for 5 years
Time frame: 5 years
Plan to share: Undecided
No publications or documents are linked to this record.
This study is active, not recruiting, as verified in May 2023. You cannot join it, but the record below documents what was studied.
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Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives