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
- Aged 18 years or older in primary or secondary care
- Documented diagnosis of CD previously confirmed by endoscopy and histology at least 3 months prior to enrollment
- Taking any brand or dosage of an oral aminosalicylate for at least 6 months prior to enrollment
- Subject-confirmed compliance with current aminosalicylate therapy (taking at least 75% of prescribed doses)
- CD currently in clinical remission, defined as:
- A Harvey-Bradshaw Index (HBI) score ≤ 4 at enrollment visit AND
- No escalation in medication for the treatment of a CD flare within 3 months prior to enrollment AND
- No use of systemic corticosteroids for CD (2 continuous weeks or more) within the 3 months prior to enrollment AND
- Clinician judgement of disease remission
- Able to participate fully in all aspects of the clinical trial
- Written informed consent obtained and documented
Exclusion Criteria
- A current diagnosis of ulcerative colitis, indeterminate colitis, microscopic colitis, or diverticular disease- associated colitis
- A diagnosis of short-bowel syndrome
- Active perianal disease (note: a history of perianal disease is permitted)
- Active fistulizing disease (note: a history of fistulizing disease is permitted)
- A flare of CD within 3 months prior to enrollment requiring initiation/escalation of medical therapy or surgery
- Use of systemic corticosteroids for CD (2 continuous weeks or more) within 3 months prior to enrollment
- A major resective bowel surgery for CD (ileal resection, ileocecal resection, proctocolectomy, colectomy, enterectomy, ostomy formation and repair, anastomosis/reanastomosis) within 6 months prior to enrollment
- Unwillingness to stop taking aminosalicylates for the duration of the trial
- Untreated bile salt malabsorption that, in the opinion of the investigator, may interfere with accurate study HBI assessment
- Serious underlying disease other than CD that, in the opinion of the investigator, may interfere with the subject’s ability to participate fully in the study
- History of active alcohol or drug abuse that, in the opinion of the investigator, may interfere with the subject’s ability to comply with the study procedures
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