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

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ClinicalTrials.gov Identifier: NCT02332356
Recruitment Status : Recruiting
First Posted : January 6, 2015
Last Update Posted : January 6, 2015
Sponsor:
Information provided by (Responsible Party):
Toshimitsu Fujii, MD PhD, 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.

Condition or disease Intervention/treatment Phase
Crohn Disease Drug: azathioprine or adalimumab and infliximab Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Study Start Date : September 2014
Estimated Primary Completion Date : March 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Arm Intervention/treatment
Active Comparator: step up
Procedure: MREC patients receive therapeutic step up
Drug: azathioprine or adalimumab and infliximab
No Intervention: observation step up
Active Comparator: step down
Procedure: MREC patients receive therapeutic step down
Drug: azathioprine or adalimumab and infliximab
No Intervention: observation step down



Primary Outcome Measures :
  1. The rate of clinical remission at 104 weeks. [ Time Frame: 104 weeks ]

Secondary Outcome Measures :
  1. The rate of hospitalization and operation [ Time Frame: 104 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   16 Years to 65 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02332356


Contacts
Contact: Toshimitsu Fujii +81 3 58035877 tfujii.gast@tmd.ac.jp

Locations
Japan
Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV Recruiting
Tokyo, Japan, 113-8519
Contact: Toshimitsu Fujii    +81 3 58035877    tfujii.gast@tmd.ac.jp   
Sponsors and Collaborators
Tokyo Medical and Dental University
Investigators
Principal Investigator: Toshimitsu Fujii Tokyo Medical and Dental University Hospital

Publications:
Responsible Party: Toshimitsu Fujii, MD PhD, Gastroenterology and Hepatology, Tokyo Medical and Dental University
ClinicalTrials.gov Identifier: NCT02332356     History of Changes
Other Study ID Numbers: MREC study
First Posted: January 6, 2015    Key Record Dates
Last Update Posted: January 6, 2015
Last Verified: January 2015

Keywords provided by Toshimitsu Fujii, MD PhD, Tokyo Medical and Dental University:
Crohn Disease
Inflammatory Bowel Diseases
Disease Attributes

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Adalimumab
Infliximab
Azathioprine
Anti-Inflammatory Agents
Antirheumatic Agents
Dermatologic Agents
Gastrointestinal Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs