A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis

PHASE4CompletedINTERVENTIONAL
Enrollment

65

Participants

Timeline

Start Date

December 31, 2016

Primary Completion Date

June 30, 2022

Study Completion Date

January 31, 2023

Conditions
Ulcerative Colitis
Interventions
DRUG

Azathioprine

Azathioprine alone versus Azathioprine and IFX

DRUG

Infliximab

DRUG

Prednisolone

DRUG

Hydrocortisone

Trial Locations (16)

25030

Chu Besancon, Besançon

34295

Chu Montpellier, Montpellier

42270

Chu Saint Etienne, Saint-Etienne

54500

CHU NANCY - Hopital Brabois, Vandœuvre-lès-Nancy

67000

CHU de CLERMONT FERRAND- Hopital Estain, Clermont-Ferrand

75010

Hopital Saint Louis, Paris

75012

Hopital St Antoine, Paris

75014

Hopital Saint Joseph, Paris

76031

Chu Rouen, Rouen

92110

APHP- Hopital BEAUJON, Clichy

92700

Hopital Louis Mourrier, Colombes

94010

Henri Mondor Hospital, Créteil

Unknown

Chu Kremlin Bicetre, Le Kremlin-Bicêtre

CHRU Lille, Lille

CHU RENNES - Hopital Pontchaillou, Rennes

06200

CHU de NICE- Hopital Archet 2, Nice

All Listed Sponsors
lead

Groupe d'Etude Therapeutique des Affections Inflammatoires Digestives

OTHER

NCT02425852 - A Randomized, Multicenter Open Label Study Comparing Early Administration of Azathioprine Plus IFX to Steroids Plus Azathioprine for Acute Severe Colitis | Biotech Hunter | Biotech Hunter