STopping Aminosalicylate Therapy in Inactive Crohn’s Disease A Randomized, Open-label, Non-inferiority Trial
Description
STATIC is pragmatic, open-label, randomized, non-inferiority trial, in which CD patients in remission will be randomized to either continue aminosalicylate therapy or withdraw treatment. The primary objective of the trial is to determine whether withdrawal of aminosalicylates is non-inferior to continuation of aminosalicylates in Crohn’s disease (CD). The primary endpoint of the trial is highly clinically meaningful, namely occurrence of any CD‑related complication (surgery, hospitalization, or other complication) within 24 months after enrollment.
STATIC has been badged with the approval of the CIRC Network. CIRC was founded in late 2016 through close collaboration with Crohn’s and Colitis Canada. Our mission is to establish an infrastructure for collaborative research amongst a network of academic and community IBD practices throughout Canada.
Study Design
In this parallel-group, open-label, randomized, non-inferiority trial, 1580 subjects with CD in remission will be allocated in a 1:1 ratio to either continue their aminosalicylate therapy or withdraw their aminosalicylate. The trial will be conducted in centres throughout North America, Europe and Australia in both secondary and primary care. All cases deemed by the local investigator to have met any component of the primary endpoint will be adjudicated by an independent, blinded, adjudication panel.
Where is the study taking place?
This study is recruiting participants in Hamilton, Windsor, Winnipeg, North Bay, and Vancouver.
Where can I find more information?
Kathleen Walker
CIRC Project Manager/Study CRA
info@circ-ccrm.ca
Lee Williamson
Robarts Project Manager
STATIC@robartsinc.com