Stricture Definition and Treatment (STRIDENT) Drug Therapy Study

NCT03220841 | Unknown Phase 4 DMC

• 1 other identifier: StVincentsMelbourneSTRIDENT1
• Study Type: interventional
• Target: 78
• Locations: 1 country
• Sites: 1

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.

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Stricture; Bowel

Keywords

Crohn Disease; Inflammatory Bowel Disease; Intestinal stricture

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Improvement in symptoms

  4, 8 and 12 months

• Improvement in biochemical inflammatory parameters

  12 months

• Improvement in imaging parameters (Intestinal ultrasound)

  12 months

• Improvement in imaging parameters

  12 months

• Surgery

  12 months

Other Outcomes (1)

• Treatment Failure

  12 months

Study Arms (2)

Standard drug therapy

ACTIVE COMPARATOR

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

Drug: Adalimumab Injection; Procedure: Endoscopic balloon dilatation

Intensive drug therapy

EXPERIMENTAL

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; Drug: Thiopurine; Procedure: Endoscopic balloon dilatation

Interventions

Adalimumab Injection DRUG

Standard dose adalimumab induction and maintenance

Intensive drug therapy; Standard drug therapy

Thiopurine DRUG

Dose optimized thiopurine

Intensive drug therapy

Endoscopic balloon dilatation 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; Standard drug therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St Vincent's Hospital Melbourne: lead
• Australasian Gastro Intestinal Research Foundation: collaborator
• AbbVie: collaborator

Study Sites (1)

St. Vincent's Hospital Melbourne

Melbourne, Victoria, 3065, Australia

Location

Related Publications (3)

• Lovett GC, Schulberg JD, Hamilton AL, Wright EK, Holt BA, Sutherland TR, Ross AL, Kamm MA. Long-term Results of Drug Treatment for Crohn's Disease Strictures. Clin Gastroenterol Hepatol. 2025 Sep 17:S1542-3565(25)00805-5. doi: 10.1016/j.cgh.2025.09.014. Online ahead of print.

  PMID: 40972879 DERIVED

• Lovett GC, Schulberg JD, Hamilton AL, Wright EK, Sutherland TR, Ross AL, Kamm MA. Crohn's Disease Stricture Response to Treatment Assessed with Magnetic Resonance Imaging and Intestinal Ultrasound: STRIDENT Randomized Trial. Inflamm Bowel Dis. 2025 Oct 1;31(10):2777-2786. doi: 10.1093/ibd/izaf073.

  PMID: 40339148 DERIVED

• 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.

  PMID: 34890567 DERIVED

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases; Constriction, Pathologic

Interventions

Adalimumab; 2-mercaptopurine

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Open label study
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Gastroenterology

Model Details: Randomised controlled trial

Study Record Dates

• First Submitted: July 6, 2017
• First Posted: July 18, 2017
• Study Start: October 9, 2017
• Primary Completion: September 18, 2020
• Study Completion: September 1, 2021
• Last Updated: October 23, 2020

Record last verified: 2020-10

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)