Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Crohn Disease Clinical Trial

— STRIDENT  

Official title:

Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03220841
• Other study ID #: StVincentsMelbourneSTRIDENT1
• Status: Active, not recruiting
• Phase: Phase 4
• Start date: October 9, 2017
• Est. completion date: September 2021

Study information

• Verified date: October 2020
• Source: St Vincent's Hospital Melbourne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 78
• Est. completion date: September 2021
• Est. primary completion date: September 18, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Constriction, Pathologic
• Crohn Disease
• Inflammatory Bowel Diseases
• Intestinal Diseases
• Stricture; Bowel

Intervention

Drug:
• Adalimumab Injection
Standard dose adalimumab induction and maintenance
• 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.

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Melbourne	Melbourne	Victoria

Sponsors (3)

Lead Sponsor	Collaborator
St Vincent's Hospital Melbourne	AbbVie, Australasian Gastro Intestinal Research Foundation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Treatment Failure	Number of patients who drop out of the study because of clinical symptoms, acute bowel obstruction, unscheduled endoscopic or surgical intervention.	12 months
Primary	Improvement in obstructive symptoms.	Improved pain and or frequency of pain compared to baseline. Obstructive symptoms determined by prospective diary documenting number of episodes of pain in previous 2 weeks and severity of the pain episodes using four-level Likert scale.	12 months
Secondary	Improvement in symptoms	Improved pain and or frequency of pain compared to baseline. Obstructive symptoms determined by prospective diary documenting number of episodes of pain in previous 2 weeks and severity of the pain episodes using four-level Likert scale.	4, 8 and 12 months
Secondary	Improvement in biochemical inflammatory parameters	Serum CRP and fecal calprotectin	12 months
Secondary	Improvement in imaging parameters (Intestinal ultrasound)	Limberg's score	12 months
Secondary	Improvement in imaging parameters	Modified MaRIA score	12 months
Secondary	Surgery	The number of patients that require surgical resection of stricture due to failure of drug therapy.	12 months
Secondary	Improvement in patient reported outcomes (PROs)	SF36	12 months
Secondary	Improvement in patient reported outcomes (PROs)	IBDQ	12 months