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STATIC

STATIC TRIAL: The STopping Aminosalicylate Therapy in Inactive Crohn’s Disease A Randomized, Open-label, Non-inferiority Trial (STATIC)

 

Co-Investigators

Dr. Gordon Moran – UK

Prof. Silvio Danese – Italy

Prof. A. Dorofeyev – Ukraine

Participating Sites [Canada]

University of Alberta, Division of Gastroenterology/Department of Medicine

University of Alberta, Division of Gastroenterology/Department of Medicine

LHSC – University Campus

University of Manitoba

The Office of Dr. Osman Tarabain

Mount Sinai Hospital

University of Calgary

GIRI (GI Research Institute)

McGill University Health Centre (MUHC) Montreal General Hospital

Oshawa Clinic

PerCuro Clinical Research Ltd

Centre Hospitalier Universitaire de Sherbrooke (CHUS) – Hotel-Dieu

 

Multiple Collaborating sites including centres in United Kingdom (UK), Italy, and Ukraine

Purpose

The primary objective is to determine whether withdrawal of aminosalicylates is non-inferior to continuation of aminosalicylates in Crohn’s disease (CD) subjects in remission with regard to a primary endpoint of any CD-related complication (composite of either a CD-related or CD treatment-related surgery, hospitalization, or other complication) within 24 months after enrollment.

 

Study Design

STATIC is a pragmatic, open-label, non-inferiority trial, in which CD patients in remission will be randomized to either continue aminosalicylate therapy or withdraw treatment.

 

Inclusion/Exclusion Criteria

Inclusion Criteria

Exclusion Criteria

 

Targets

Anticipated sample size: 1580

Start: September 2017
Anticipated end: (site activities) MAY 2025
Additional sites are welcome!

Please contact Vipul Jairath at vjairath@uwo.ca