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

Primary Purpose

Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel

Status
Unknown status
Phase
Phase 4
Locations
Australia
Study Type
Interventional
Intervention
Adalimumab Injection
Thiopurine
Endoscopic balloon dilatation
Sponsored by
St Vincent's Hospital Melbourne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Crohn Disease focused on measuring Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • St. Vincent's Hospital Melbourne

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard drug therapy

Intensive drug therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
Improvement in biochemical inflammatory parameters
Serum CRP and fecal calprotectin
Improvement in imaging parameters (Intestinal ultrasound)
Limberg's score
Improvement in imaging parameters
Modified MaRIA score
Surgery
The number of patients that require surgical resection of stricture due to failure of drug therapy.
Improvement in patient reported outcomes (PROs)
SF36
Improvement in patient reported outcomes (PROs)
IBDQ

Full Information

First Posted
July 6, 2017
Last Updated
October 22, 2020
Sponsor
St Vincent's Hospital Melbourne
Collaborators
Australasian Gastro Intestinal Research Foundation, AbbVie
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1. Study Identification

Unique Protocol Identification Number
NCT03220841
Brief Title
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Acronym
STRIDENT
Official Title
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
September 18, 2020 (Actual)
Study Completion Date
September 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St Vincent's Hospital Melbourne
Collaborators
Australasian Gastro Intestinal Research Foundation, AbbVie

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
Keywords
Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
Randomised controlled trial
Masking
None (Open Label)
Masking Description
Open label study
Allocation
Randomized
Enrollment
78 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard drug therapy
Arm Type
Active Comparator
Arm Description
Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)
Arm Title
Intensive drug therapy
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Adalimumab Injection
Intervention Description
Standard dose adalimumab induction and maintenance
Intervention Type
Drug
Intervention Name(s)
Thiopurine
Intervention Description
Dose optimized thiopurine
Intervention Type
Procedure
Intervention Name(s)
Endoscopic balloon dilatation
Intervention Description
Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.
Primary Outcome Measure Information:
Title
Improvement in obstructive symptoms.
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Improvement in symptoms
Description
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.
Time Frame
4, 8 and 12 months
Title
Improvement in biochemical inflammatory parameters
Description
Serum CRP and fecal calprotectin
Time Frame
12 months
Title
Improvement in imaging parameters (Intestinal ultrasound)
Description
Limberg's score
Time Frame
12 months
Title
Improvement in imaging parameters
Description
Modified MaRIA score
Time Frame
12 months
Title
Surgery
Description
The number of patients that require surgical resection of stricture due to failure of drug therapy.
Time Frame
12 months
Title
Improvement in patient reported outcomes (PROs)
Description
SF36
Time Frame
12 months
Title
Improvement in patient reported outcomes (PROs)
Description
IBDQ
Time Frame
12 months
Other Pre-specified Outcome Measures:
Title
Treatment Failure
Description
Number of patients who drop out of the study because of clinical symptoms, acute bowel obstruction, unscheduled endoscopic or surgical intervention.
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emily Wright, MBBS PhD
Organizational Affiliation
St Vincent's Hospital Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Bronte Holt, MBBS PhD
Organizational Affiliation
St Vincent's Hospital Melbourne
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Kamm, MBBS PhD
Organizational Affiliation
St Vincent's Hospital Melbourne
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Vincent's Hospital Melbourne
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3065
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34890567
Citation
Schulberg JD, Wright EK, Holt BA, Hamilton AL, Sutherland TR, Ross AL, Vogrin S, Miller AM, Connell WC, Lust M, Ding NS, Moore GT, Bell SJ, Shelton E, Christensen B, De Cruz P, Rong YJ, Kamm MA. Intensive drug therapy versus standard drug therapy for symptomatic intestinal Crohn's disease strictures (STRIDENT): an open-label, single-centre, randomised controlled trial. Lancet Gastroenterol Hepatol. 2022 Apr;7(4):318-331. doi: 10.1016/S2468-1253(21)00393-9. Epub 2021 Dec 8.
Results Reference
derived

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Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

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