STATIC TRIAL: The STopping Aminosalicylate Therapy in Inactive Crohn’s Disease A Randomized, Open-label, Non-inferiority Trial (STATIC)
PI: Dr. Vipul Jairath, University of Western Ontario
Co-Investigators
Dr. Gordon Moran – UK
Prof. Silvio Danese – Italy
Prof. A. Dorofeyev – 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.
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
For more information on Inclusion & Exclusion Criteria, click here.
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