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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Adalimumab in monotherapy | Experimental | Start Adalimumab in monotherapy at 160 mg at inclusion, 80 mg on 2nd week and 40 mg/week each other week over 12 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Start adalimumab in monotherapy | Drug | Discontinuation of Adalimumab in patients who achieved deep remission |
|
| Measure | Description | Time Frame |
|---|---|---|
| Sustained deep remission rate | Number of patients with sustained deep remission at one year | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 2-year deep remission rate | Number of patients with 2-year deep remission rate among patients who did not achieve 1-year remission | 2 years |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of an early treatment with adalimumab on long-term clinical outcomes | Frequency and severity of adverse events in patients followed for 5 years | 5 years |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yoram Bouhnik, MD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Laurent Peyrin-Biroulet, MD, PhD | Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chu Liege | Liège | Belgium | ||||
| Chu Amiens |
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| Amiens |
| France |
| Chu Besancon | Besançon | France |
| CHU de Caen- Hopital de la Cote de Nacre | Caen | 14033 | France |
| CHU de CLERMONT FERRAND- Hopital Estain | Clermont-Ferrand | 67000 | France |
| APHP- Hopital BEAUJON | Clichy | 92110 | France |
| CHU de Colmar- Hopital Trousseau Medecine A | Colmar | 68024 | France |
| Chu Lille | Lille | France |
| CHU de Montpellier- Hopital saint Eloi | Montpellier | 34295 | France |
| CHU NANTES - Hôpital Hôtel Dieu | Nantes | 44093 | France |
| CHU de NICE- Hopital Archet 2 | Nice | 06200 | France |
| CHU de Nimes- Hopital Carémeau | Nîmes | 30029 | France |
| APHP- Hopital COCHIN | Paris | 75014 | France |
| APHP- Hopital BICHAT | Paris | 75018 | France |
| IMM | Paris | 75674 | France |
| CHU Bordeaux- Hopital Haut Levèque | Pessac | 33600 | France |
| CHU LYON- Hopital Lyon Sud | Pierre-Bénite | 69495 | France |
| CHU RENNES - Hopital Pontchaillou | Rennes | France |
| CHU de Saint Etienne- Hopital Nord | Saint-Priest-en-Jarez | 42270 | France |
| CHU de TOULOUSE | Toulouse | 31403 | France |
| CHU de Tours - Hopital Trousseau | Tours | 37044 | France |
| CH Valenciennes | Valenciennes | 59322 | France |
| CHU NANCY - Hopital Brabois | Vandœuvre-lès-Nancy | 54500 | France |