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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03220841
Recruitment Status : Active, not recruiting
First Posted : July 18, 2017
Last Update Posted : October 23, 2020
Sponsor:
Collaborators:
Australasian Gastro Intestinal Research Foundation
AbbVie
Information provided by (Responsible Party):
Michael Kamm, 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Inflammatory Bowel Diseases Stricture; Bowel Drug: Adalimumab Injection Drug: Thiopurine Procedure: Endoscopic balloon dilatation Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 78 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Randomised controlled trial
Masking: None (Open Label)
Masking Description: Open label study
Primary Purpose: Treatment
Official Title: Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : September 18, 2020
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease
Drug Information available for: Adalimumab

Arm Intervention/treatment
Active Comparator: Standard drug therapy
Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter)
Drug: Adalimumab Injection
Standard dose adalimumab induction and maintenance

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.

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

Drug: 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.




Primary Outcome Measures :
  1. Improvement in obstructive symptoms. [ Time Frame: 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 :
  1. Improvement in symptoms [ Time Frame: 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.

  2. Improvement in biochemical inflammatory parameters [ Time Frame: 12 months ]
    Serum CRP and fecal calprotectin

  3. Improvement in imaging parameters (Intestinal ultrasound) [ Time Frame: 12 months ]
    Limberg's score

  4. Improvement in imaging parameters [ Time Frame: 12 months ]
    Modified MaRIA score

  5. Surgery [ Time Frame: 12 months ]
    The number of patients that require surgical resection of stricture due to failure of drug therapy.

  6. Improvement in patient reported outcomes (PROs) [ Time Frame: 12 months ]
    SF36

  7. Improvement in patient reported outcomes (PROs) [ Time Frame: 12 months ]
    IBDQ


Other Outcome Measures:
  1. Treatment Failure [ Time Frame: 12 months ]
    Number of patients who drop out of the study because of clinical symptoms, acute bowel obstruction, unscheduled endoscopic or surgical intervention.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03220841


Locations
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Australia, Victoria
St. Vincent's Hospital Melbourne
Melbourne, Victoria, Australia, 3065
Sponsors and Collaborators
St Vincent's Hospital Melbourne
Australasian Gastro Intestinal Research Foundation
AbbVie
Investigators
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Principal Investigator: Emily Wright, MBBS PhD St Vincent's Hospital Melbourne
Principal Investigator: Bronte Holt, MBBS PhD St Vincent's Hospital Melbourne
Principal Investigator: Michael Kamm, MBBS PhD St Vincent's Hospital Melbourne
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Responsible Party: Michael Kamm, Professor of Gastroenterology, St Vincent's Hospital Melbourne
ClinicalTrials.gov Identifier: NCT03220841    
Other Study ID Numbers: StVincentsMelbourneSTRIDENT1
First Posted: July 18, 2017    Key Record Dates
Last Update Posted: October 23, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by Michael Kamm, St Vincent's Hospital Melbourne:
Crohn Disease
Inflammatory Bowel Disease
Intestinal stricture
Additional relevant MeSH terms:
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Crohn Disease
Intestinal Diseases
Inflammatory Bowel Diseases
Constriction, Pathologic
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Pathological Conditions, Anatomical
Adalimumab
Anti-Inflammatory Agents
Antirheumatic Agents