Official Title
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Phase
Phase 4Lead Sponsor
University of New South WalesStudy Type
InterventionalStatus
Unknown statusIndication/Condition
Crohn Disease Inflammatory Bowel Diseases Stricture; BowelIntervention/Treatment
Adalimumab Injection Thiopurine ...Study Participants
78Two thirds of patients with Crohn's disease require intestinal surgery at some time in their life. Intestinal strictures, that is narrowing of the bowel due to inflammation and scarring, are the most common reason for surgery. Despite the high frequency, associated disability, and cost there are no are no treatment strategies that aim to improve the outcome of this disease complication. The STRIDENT (stricture definition and treatment) studies aim to develop such strategies.
Prospective randomised controlled study. Patients with Crohn's Disease who have symptomatic inflammatory intestinal strictures will be randomised to receive standard drug therapy (Anti-TNF monotherapy at standard dose) or intensive drug therapy (Intense Anti-TNF dose induction and escalation for continued inflammation in combination with thiopurine) for 12 months.
Standard dose adalimumab induction and maintenance
Dose optimized thiopurine
Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.
Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)
Adalimumab in combination with dose optimized thiopurine, Intensive induction (160mg weekly for 4 weeks then 40mg fortnightly). Anti-TNF dose may be increased if ongoing inflammation every 4 months until study endpoint.
Inclusion Criteria: Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy. Exclusion Criteria: Acute bowel obstruction requiring urgent surgical intervention Deemed by treating physician to have high risk of acute bowel obstruction Concurrent active perianal sepsis Internal fistulising disease in association with strictures (entero-enteric stulas) Low rectal or anal strictures Evidence of dysplasia or malignancy from stricture biopsies or adjacent mucosal biopsies Patients for whom endoscopy is not suitable due to co-morbidities or clinical state Inability to give informed consent Suspected perforation of the gastrointestinal tract Pregnancy Inability to undergo MRI small bowel due to a contraindication.
