Condition: Ulcerative Colitis · Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
PHASE: IV DESCRIPTIVE: Randomized, interventional, open label multicenter trial POPULATION: Moderate to severe ulcerative colitis STUDY TREATMENTS: Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26) and could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) for two months and then could be optimized up to 80mg EOW (or 40 EW according to patient and/or investigator preference) and azathioprine (2.0/2.5 mg/kg/ day) or methotrexate (25 mg EW) until V3 (W 38). OBJECTIVES: To assess the impact of a treat to target treatment follow up by e-Monitoring and fecal calprotectin dosing at home associated to an appropriate patient education versus standard treatment follow up at W48 in patients requiring a treatment with adalimumab (Humira®).
This description comes directly from the study's public registry record.
Xavier Hebuterne, MD PhD · 04 92 03 65 75 · hebuterne.x@chu-nice.fr
Always discuss trial participation with your own doctor first.
| Centre hospitalier de Cholet | Cholet, Maine Et Loire, France | Active Not Recruiting |
| CHU Amiens- Picardie (site Sud) | Amiens, France | Recruiting |
| CHRU de Besançon - Hôpital Jean Minjoz | Besançon, France | Active Not Recruiting |
| CHU Caen Hôpital Côte de Nacre | Caen, France | Withdrawn |
| CHU Estaing | Clermont-Ferrand, France | Recruiting |
| APHP - Hôpital Beaujon | Clichy, France | Recruiting |
| CH Colmar - Hôpital Pasteur | Colmar, France | Active Not Recruiting |
| Centre hospitalier de Douai | Douai, France | Terminated |
| CHRU Lille Hôpital Claude Huriez | Lille, France | Recruiting |
| APHM - Hôpital Nord | Marseille, France | Recruiting |
| GHI Le Raincy-Montfermeil | Montfermeil, France | Recruiting |
| CHU Montpellier - Hôpital Saint Eloi | Montpellier, France | Recruiting |
+ 12 more locations — full list on the registry record.
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Source record: clinicaltrials.gov/study/NCT04183608