Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

78 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-09

Study Completion Date

2021-09-30

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn Disease Inflammatory Bowel Diseases Stricture; Bowel

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomised controlled trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Open label study

Study Groups

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Standard drug therapy

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

Group Type ACTIVE_COMPARATOR

Adalimumab Injection

Intervention Type DRUG

Standard dose adalimumab induction and maintenance

Endoscopic balloon dilatation

Intervention Type PROCEDURE

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

Intensive drug therapy

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.

Group Type EXPERIMENTAL

Adalimumab Injection

Intervention Type DRUG

Standard dose adalimumab induction and maintenance

Thiopurine

Intervention Type DRUG

Dose optimized thiopurine

Endoscopic balloon dilatation

Intervention Type PROCEDURE

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

Interventions

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Adalimumab Injection

Standard dose adalimumab induction and maintenance

Intervention Type DRUG

Thiopurine

Dose optimized thiopurine

Intervention Type DRUG

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.

Intervention Type PROCEDURE

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No