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| Name | Class |
|---|---|
| Australasian Gastro Intestinal Research Foundation | OTHER |
| AbbVie | INDUSTRY |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard drug therapy | Active Comparator | Adalimumab monotherapy, Standard Dose induction (160mg at week 0, 80mg week 2 and 40mg fortnightly thereafter) |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Adalimumab Injection | Drug | Standard dose adalimumab induction and maintenance |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 4, 8 and 12 months |
| Improvement in biochemical inflammatory parameters |
| Measure | Description | Time Frame |
|---|---|---|
| Treatment Failure | Number of patients who drop out of the study because of clinical symptoms, acute bowel obstruction, unscheduled endoscopic or surgical intervention. | 12 months |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Vincent's Hospital Melbourne | Melbourne | Victoria | 3065 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40972879 | Derived | 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. | |
| 40339148 | 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. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| D015212 | Inflammatory Bowel Diseases |
| D003251 | Constriction, Pathologic |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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| ID | Term |
|---|---|
| D000068879 | Adalimumab |
| C520399 | 2-mercaptopurine |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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Randomised controlled trial
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Open label study
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| Thiopurine | Drug | Dose optimized thiopurine |
|
| 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. |
|
Serum CRP and fecal calprotectin |
| 12 months |
| Improvement in imaging parameters (Intestinal ultrasound) | Limberg's score | 12 months |
| Improvement in imaging parameters | Modified MaRIA score | 12 months |
| Surgery | The number of patients that require surgical resection of stricture due to failure of drug therapy. | 12 months |
| Improvement in patient reported outcomes (PROs) | SF36 | 12 months |
| Improvement in patient reported outcomes (PROs) | IBDQ | 12 months |
| 34890567 | 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. |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |