Transmural healing (TMH) is recognized as a potentially important measure of Crohn's disease (CD) activity but not a formal target. Observational studies suggest that TMH may be associated with better long-term outcomes. The study will evaluate TMH using noninvasive intestinal ultrasound (IUS), a patient-friendly technique that can be performed routinely in clinical practice. The aim of the study is to determine if treating to a target of corticosteroid-free (CS-free) IUS outcomes + clinical symptoms + biomarkers is superior to a target of clinical symptoms + biomarkers alone in achieving CS-free endoscopic remission measured by the Simple Endoscopic Score for Crohn's Disease (SES-CD).
- Category
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Trial status
Recruiting
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Trial phase
Phase 4 Drug TrialTrials of approved medications to provide “real world evidence” of efficacy and safety in clinical practice.
- Registry listing
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ERM Project ID
107850
Trial contact details
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Contact person
IBD Clinical Trials Team
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Phone
07 3163 8195
What you need to know
Who can take part?
To participate you must:
Be aged 18 - 80
Have diagnosed moderately to severely active CD verified by endoscopy and histology
Not have been treated with Vedolizumab, Etrolizumab or Natalizumab
Have blood test results in normal ranges
Not be pregnant or planning pregnancy
Not have another bowel condition or other medical condition that may interfere with your ability to participate
Not have surgery planned for during the study
Not have a neurological condition
Not have an active infection
Not have a history of malignancy
Please note, some medications may cause you to be ineligible.
What is involved for me?
Colonoscopy with biopsy
Blood tests
Daily diary completion
Vital Signs
ECG
Questionnaires
Physical exam
Stool tests
Urine tests
Regular study appointments
Treatment by IV infusion
