drugset / Trial / NCT02332356
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
RandomizedParallel-groupOpen-labelPrevention
Summary
This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.
Timeline
- Start
- 2014-09
- Primary completion
- 2024-03
- Completion
- 2024-03
Publications
- Background Takenaka K, Ohtsuka K, Kitazume Y, Nagahori M, Fujii T, Saito E, Naganuma M, Araki A, Watanabe M. Comparison of magnetic resonance and balloon enteroscopic examination of the small intestine in patients with Crohn's disease. Gastroenterology. 2014 Aug;147(2):334-342.e3. doi: 10.1053/j.gastro.2014.04.008. Epub 2014 Apr 13.
- Background Hyun SB, Kitazume Y, Nagahori M, Toriihara A, Fujii T, Tsuchiya K, Suzuki S, Okada E, Araki A, Naganuma M, Watanabe M. Magnetic resonance enterocolonography is useful for simultaneous evaluation of small and large intestinal lesions in Crohn's disease. Inflamm Bowel Dis. 2011 May;17(5):1063-72. doi: 10.1002/ibd.21510. Epub 2010 Oct 25.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Adalimumab | Monoclonal antibody | — | — |
| Comparator | Azathioprine | Small molecule | — | — |
| Comparator | Infliximab | Monoclonal antibody | — | — |