Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Phase 3
Active, not recruiting
- Conditions
- Crohn Disease
- Interventions
- Registration Number
- NCT02332356
- Lead Sponsor
- Tokyo Medical and Dental University
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
- Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI<150)
- Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)
Exclusion Criteria
- Contraindication for infliximab, adalimumab, or azathioprine
- Lactating woman
- Presence of malignancy
- Within 3 month from intestinal surgery
- Presence of an end stoma
- Planned surgery
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description step up azathioprine or adalimumab and infliximab Procedure: MREC patients receive therapeutic step up step down azathioprine or adalimumab and infliximab Procedure: MREC patients receive therapeutic step down
- Primary Outcome Measures
Name Time Method The rate of clinical remission at 104 weeks. 104 weeks
- Secondary Outcome Measures
Name Time Method The rate of hospitalization and operation 104 weeks
Related Research Topics
Explore scientific publications, clinical data analysis, treatment approaches, and expert-compiled information related to the mechanisms and outcomes of this trial. Click any topic for comprehensive research insights.
What molecular mechanisms underlie MREC-guided therapeutic optimization in Crohn's disease?
How does the combination of azathioprine with adalimumab or infliximab compare to standard-of-care therapies in Crohn's patients with subclinical inflammation?
Which biomarkers are associated with sustained clinical remission in Crohn's disease following MREC-based treatment escalation or de-escalation?
What are the potential adverse events of azathioprine, adalimumab, and infliximab in Crohn's disease management and how can they be managed?
Are there alternative therapeutic strategies or competitor drugs for Crohn's disease that target similar inflammatory pathways as NCT02332356?
Trial Locations
- Locations (1)
Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV
🇯🇵Tokyo, Japan
Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV🇯🇵Tokyo, Japan