Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Launched by ST VINCENT'S HOSPITAL MELBOURNE · Jul 13, 2017
Trial Information
Current as of April 30, 2025
Unknown status
Keywords
ClinConnect Summary
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.
Gender
ALL
Eligibility criteria
- 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.
About St Vincent's Hospital Melbourne
St Vincent's Hospital Melbourne is a leading healthcare institution renowned for its commitment to patient-centered care and clinical excellence. As a prominent clinical trial sponsor, the hospital is dedicated to advancing medical research and innovation across various therapeutic areas. With a robust infrastructure and a multidisciplinary team of experienced researchers, St Vincent's facilitates the development of new treatments and therapies, ensuring adherence to the highest ethical standards and regulatory requirements. The hospital's collaborative approach fosters partnerships with academic institutions and industry leaders, enhancing its capability to contribute significantly to the global medical community.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Melbourne, Victoria, Australia
Patients applied
Trial Officials
Emily Wright, MBBS PhD
Principal Investigator
St Vincent's Hospital Melbourne
Bronte Holt, MBBS PhD
Principal Investigator
St Vincent's Hospital Melbourne
Michael Kamm, MBBS PhD
Principal Investigator
St Vincent's Hospital Melbourne
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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