Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease

Sponsor
Tokyo Medical and Dental University
Study ID
NCT02332356
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
16 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Sep 30, 2014
Status verified
Nov 2023
Primary completion
Mar 31, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: step up
    Procedure: MREC patients receive therapeutic step up
  • No Intervention: observation step up
  • Active Comparator: step down
    Procedure: MREC patients receive therapeutic step down
  • No Intervention: observation step down

Primary Outcome Measure

The rate of clinical remission at 104 weeks. [ Time Frame: 104 weeks ]

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