Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Phase 4

• Conditions: Inflammatory Bowel Diseases; Crohn Disease; Stricture; Bowel
• Interventions: Drug: Adalimumab Injection; Procedure: Endoscopic balloon dilatation; Drug: Thiopurine

• Registration Number: NCT03220841
• Lead Sponsor: St Vincent's Hospital Melbourne

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations
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Related News

Study Timeline

• Study First Submitted: 2017-07-06
• Study First Submitted QC: 2017-07-13
• Study First Posted: 2017-07-18
• Study Start: 2017-10-09
• Primary Completion: 2020-09-18
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-22
• Last Update Posted: 2020-10-23
• Study Completion: 2021-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 78

Inclusion Criteria

• Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard drug therapy	Endoscopic balloon dilatation	Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)
Intensive drug therapy	Thiopurine	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.
Intensive drug therapy	Endoscopic balloon dilatation	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.
Standard drug therapy	Adalimumab Injection	Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)
Intensive drug therapy	Adalimumab Injection	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.

Primary Outcome Measures

Name	Time	Method
Improvement in obstructive symptoms.	12 months	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.

Secondary Outcome Measures

Name	Time	Method
Improvement in imaging parameters	12 months	Modified MaRIA score
Surgery	12 months	The number of patients that require surgical resection of stricture due to failure of drug therapy.
Improvement in patient reported outcomes (PROs)	12 months	IBDQ
Improvement in symptoms	4, 8 and 12 months	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.
Improvement in biochemical inflammatory parameters	12 months	Serum CRP and fecal calprotectin
Improvement in imaging parameters (Intestinal ultrasound)	12 months	Limberg's score

Trial Locations

Locations (1)

St. Vincent's Hospital Melbourne; 🇦🇺 Melbourne, Victoria, Australia