Official Title

Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
  • Phase

    Phase 4
  • Study Type

  • Status

    Unknown status
  • Study Participants

Two 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.
Study Started
Oct 09
Primary Completion
Sep 18
Study Completion
Sep 30
Last Update
Oct 23

Drug Adalimumab Injection

Standard dose adalimumab induction and maintenance

Drug Thiopurine

Dose optimized thiopurine

Procedure Endoscopic balloon dilatation

Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.

Standard drug therapy Active Comparator

Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)

Intensive drug therapy Experimental

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
Inability to undergo MRI small bowel due to a contraindication.
No Results Posted