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RECRUITING
NCT04183608
PHASE4

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

View on ClinicalTrials.gov

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

Interventions

DRUG

Adalimumab

Patients will all receive Adalimumab 160/80/40mg EOW until V1 (W14) followed by 40mg EOW until V2 (W26)

DIAGNOSTIC_TEST

Calprotectin

Fecal calprotectin dosing at home with IBDoc

OTHER

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

OTHER

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