Crohn DiseasePhase 4STRIDENTNCT03220841
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
A Phase 4 study testing Adalimumab Injection, Thiopurine and Endoscopic balloon dilatation in people with Crohn Disease and Inflammatory Bowel Diseases, run by St Vincent's Hospital Melbourne at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
- What is being tested?
- Adalimumab Injection, Thiopurine and Endoscopic balloon dilatation
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 78 participants
- Where
- 1 siteAustralia
- Study dates
- 9 Oct 2017to Sep 2021
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
Who cannot join
- 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
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- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
- Being tested
- Adalimumab Injection, Thiopurine, Endoscopic balloon dilatation
- Keywords
- Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture
- Medical subject headings
- Crohn Disease, Inflammatory Bowel Diseases, Constriction, Pathologic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adalimumab InjectionDrug
Standard dose adalimumab induction and maintenance
ThiopurineDrug
Dose optimized thiopurine
Endoscopic balloon dilatationProcedure or surgery
Prior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm.
| Study group | Role | What they receive |
|---|---|---|
| Standard drug therapy | Active comparator | Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter) Receives: 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. Receives: Drug: Adalimumab Injection; Drug: Thiopurine; Procedure: Endoscopic balloon dilatation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 12 months
Secondary outcomes (7)
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.
Measured: 4, 8 and 12 months
Improvement in biochemical inflammatory parameters
Serum CRP and fecal calprotectin
Measured: 12 months
Improvement in imaging parameters (Intestinal ultrasound)
Limberg's score
Measured: 12 months
Improvement in imaging parameters
Modified MaRIA score
Measured: 12 months
Surgery
The number of patients that require surgical resection of stricture due to failure of drug therapy.
Measured: 12 months
Improvement in patient reported outcomes (PROs)
SF36
Measured: 12 months
Improvement in patient reported outcomes (PROs)
IBDQ
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2017
- Study start9 Oct 2017
- Primary completion18 Sep 2020
- Study completionSep 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Crohn DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomised controlled trial
- Masking
- None (open label)
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- St Vincent's Hospital Melbourne
- Sponsor type
- University, hospital or other
- Collaborators
- Australasian Gastro Intestinal Research Foundation, AbbVie
- Responsible party
- Principal investigator, Michael Kamm, St Vincent's Hospital Melbourne
- Investigators
- Emily Wright, MBBS PhD, Principal investigator, St Vincent's Hospital MelbourneBronte Holt, MBBS PhD, Principal investigator, St Vincent's Hospital MelbourneMichael Kamm, MBBS PhD, Principal investigator, St Vincent's Hospital Melbourne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03220841
- Sponsor's protocol ID
- StVincentsMelbourneSTRIDENT1
- Acronym
- STRIDENT
- Status last verified
- Oct 2020
- First submitted
- 6 Jul 2017
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40972879Lovett 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.
PubMed 40339148Schulberg 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.
PubMed 34890567
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
- ClinicalTrials.gov ID
- NCT03220841
- Acronym / sponsor ID
- STRIDENT / StVincentsMelbourneSTRIDENT1
- Conditions
- Crohn Disease, Inflammatory Bowel Diseases, Stricture; Bowel
- Keywords
- Crohn Disease, Inflammatory Bowel Disease, Intestinal stricture
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 78 participants (actual)
- Lead sponsor
- St Vincent's Hospital MelbourneUniversity, hospital or other
- Collaborators
- Australasian Gastro Intestinal Research Foundation, AbbVie
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 18 Sep 2020 (actual)
- Study completion
- Sep 2021 (estimated)
- First posted
- 18 Jul 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Standard drug therapy | Active comparator | Drug: Adalimumab Injection, Procedure: Endoscopic balloon dilatationAdalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter) |
| Intensive drug therapy | Experimental | Drug: Adalimumab Injection, Drug: Thiopurine, Procedure: Endoscopic balloon dilatationAdalimumab 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Inflammatory bowel disease patients with intestinal stricture(s) identified on CT, MRI or endoscopy.
Key exclusion criteria (11 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adalimumab InjectionStandard dose adalimumab induction and maintenance | Drug | Intensive drug therapy, Standard drug therapy |
| ThiopurineDose optimized thiopurine | Drug | Intensive drug therapy |
| Endoscopic balloon dilatationPrior to randomization, suitable patients may undergo endoscopic balloon dilatation. Patients undergoing dilatation will be stratified to ensure equal numbers in each study arm. | Procedure or surgery | Intensive drug therapy, Standard drug therapy |
Primary outcome
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.
7 secondary outcomes
Improvement in symptoms
Time frame: 4, 8 and 12 months
Improvement in biochemical inflammatory parameters
Time frame: 12 months
Improvement in imaging parameters (Intestinal ultrasound)
Time frame: 12 months
Improvement in imaging parameters
Time frame: 12 months
Surgery
Time frame: 12 months
Improvement in patient reported outcomes (PROs)
Time frame: 12 months
Improvement in patient reported outcomes (PROs)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2020.
- Derived from this study: PubMed 40972879Lovett 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.
- Derived from this study: PubMed 40339148Lovett 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.
- Derived from this study: PubMed 34890567Schulberg 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emily Wright, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
Bronte Holt, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
Michael Kamm, MBBS PhD principal investigator
St Vincent's Hospital Melbourne
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Adalimumab Injection, Thiopurine and Endoscopic balloon dilatation in people with Crohn Disease and Inflammatory Bowel Diseases, run by St Vincent's Hospital Melbourne at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in obstructive symptoms. (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03220841, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2020.