drugset / Trial / NCT03220841
Stricture Definition and Treatment (STRIDENT) Drug Therapy Study
Phase 4
Unknown
78 enrolled
St Vincent's Hospital Melbourne
AbbVie · collabAustralasian Gastro Intestinal Research Foundation · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2017-10-09
- Primary completion
- 2020-09-18
- Completion
- 2021-09
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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Adalimumab | Monoclonal antibody | 40 mg | — |
| Subject | Azathioprine | Small molecule | 2.5 mg/kg | — |
| Subject | MERCAPTOPURINE ANHYDROUS | Small molecule | 1.5 mg/kg | — |