NCT01562951 - Assessment of Mucosal Activity to Improve the Prognosis of Patients With Crohn's Disease Treated With Immunosuppressants | Biotech Hunter

Enrollment

Participants

Timeline

Start Date

October 31, 2012

Primary Completion Date

March 31, 2014

Study Completion Date

March 31, 2014

Conditions

Crohn's DiseaseMucosal Inflammation

Interventions

DRUG

ADALIMUMAB

Adalimumab at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly.

DRUG

Placebo

PLACEBO at 160/80 mg and maintained on 40 mg eow until next colonoscopy performed at week 48. If before week 48, an increase of more than 50% is observed in calprotectin and/or hsCRP from baseline, over two consecutive follow up visits 2 weeks apart, the colonoscopy will be performed earlier. If patients have still significant endoscopic lesions, adalimumab or adalimumab placebo will be intensified to 40 mg weekly

Trial Locations (30)

1070

Hospital Erasme Bruxelles, Brussels

1200

Hospital Saint Luc Bruxelles, Brussels

2820

Imeldaziekenhuis Bonheiden, Bonheiden

4000

Centre Hospitalier Universitaire de Liege, Liège

8800

Heiling Hartzieknhuis Roeselare, Roeselare

9000

Hospital University Gent, Ghent

14004

Hospital Universitario Reina Sofia, Córdoba

28005

Hospital Universitario La Princesa, Madrid

28007

Hospital Gregorio Marañón, Madrid

28034

Hospital Ramón y Cajal, Madrid

33604

CHU Bordeaux - Hospital Haut-Leveque, Pessac

35010

Hospital Doctor Negrin, Las Palmas de Gran Canarias

41013

Hospital Virgen del Rocío, Seville

42270

CH Saint Etienne - Hospital Nord, Saint-Etienne

44093

CHU Nantes, Nantes

46010

Hospital Clínico de Valencia, Valencia

46940

Hospital de Manises, Manises

51092

CHRU Reims - Hospital Robert Debre, Reims

54500

CHU Nancy - Hospital de Brabois Adultes, Vandœuvre-lès-Nancy

59037

CHRU Lille - Hospital Claude Huriez, Lille

69495

CHU Lyon Sud, Lyon

75010

Hospital Saint Louis, Paris

76031

CHU Rouen - Hospital Charles Nicolle, Rouen

CHU Tours - Hospital Trousseau, Chambray

80054

CHU Amiens - Hospital Nord, Amiens

92110

Hospital Beaujon, Clichy

Unknown

Complejo Hospitalario Santiago de Compostela, Santiago de Compostela

Hospital Germans Trias i Pujol, Badalona

Hospital Lozano Blesa, Zaragoza

08025

Hospital Santa Creu i Sant Pau, Barcelona