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A Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating Adalimumab
Sponsor: Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives
Summary
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®).
Official title: An Open-label Randomized Trial COmparing staNdard of Care Versus Treat to Target With telemonitoRing and Patient Education in Patients With Ulcerative cOlitis Initiating adaLimumab: The CONTROL Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
238
Start Date
2020-01-14
Completion Date
2028-05
Last Updated
2023-05-31
Healthy Volunteers
No
Conditions
Interventions
Adalimumab
Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)
Calprotectin
Fecal calprotectin dosing at home with IBDoc
e-Monitoring
e-Monitoring at Week 6, Week 10, Week 14, Week 18, Week 22, Week 26, Week 34, Week 38, Week 42 and Week 48 The patient must complete the first 2 questions of the Mayo score: * Stool frequency * The frequency of bleeding He must also complete the information on his injections
Therapy Education
Patient Education at W0, W2, W14, W26 and W38.
Locations (24)
Centre hospitalier de Cholet
Cholet, Maine Et Loire, France
CHU Amiens- Picardie (site Sud)
Amiens, France
CHRU de Besançon - Hôpital Jean Minjoz
Besançon, France
CHU Caen Hôpital Côte de Nacre
Caen, France
CHU Estaing
Clermont-Ferrand, France
APHP - Hôpital Beaujon
Clichy, France
CH Colmar - Hôpital Pasteur
Colmar, France
Centre hospitalier de Douai
Douai, France
CHRU Lille Hôpital Claude Huriez
Lille, France
APHM - Hôpital Nord
Marseille, France
GHI Le Raincy-Montfermeil
Montfermeil, France
CHU Montpellier - Hôpital Saint Eloi
Montpellier, France
CHU Nantes - Hôpital Hotel Dieu
Nantes, France
CHU Nice- Hopital l'Archet
Nice, France
CHU Nîmes - Hôpital Universitaire Caremeau
Nîmes, France
CHU Bordeaux - Hôpital Haut Lévêque
Pessac, France
CHU Lyon Sud
Pierre-Bénite, France
CHU Rennes Hôpital Pontchaillou
Rennes, France
CH Saint Etienne Hopital Nord
Saint-Priest-en-Jarez, France
CH Toulon - CHITS CH Sainte Musse
Toulon, France
CHU Toulouse - Hôpital Rangueil
Toulouse, France
CH Tourcoing - Hôpital Gustave Dron
Tourcoing, France
CHU Nancy - Hôpital de Brabois
Vandœuvre-lès-Nancy, France
APHP - Hôpital du Kremlin-Bicêtre
Le Kremlin-Bicêtre, Île-de-France Region, France